Biologics in Rheumatology: New Developments, Clinical Uses and Health Implications

Coziana Ciurtin, PhD and David A. Isenberg (Editors)
Consultant Rheumatologist, University College London, Department of Rheumatology, London, UK

Series: New Developments in Medical Research
BISAC: MED083000

Clear

$270.00

Volume 10

Issue 1

Volume 2

Volume 3

Special issue: Resilience in breaking the cycle of children’s environmental health disparities
Edited by I Leslie Rubin, Robert J Geller, Abby Mutic, Benjamin A Gitterman, Nathan Mutic, Wayne Garfinkel, Claire D Coles, Kurt Martinuzzi, and Joav Merrick

eBook

Digitally watermarked, DRM-free.
Immediate eBook download after purchase.

Product price
Additional options total:
Order total:

Quantity:

Details

Significant progress has been acquired in the treatment of rheumatic conditions with the introduction of biologic therapies, which has enabled better control of disease activity and improved patients’ long-term outcome. Apart from several biologic treatments already licensed for use in autoimmune rheumatic conditions, numerous other agents are currently under investigation. This rapid expansion of the therapeutic armamentarium requires a critical analysis of individual biologic options and their clinical indications, in order to facilitate the optimal use of these new therapies. The authors felt that a comprehensive book revisiting all the evidence available regarding the efficacy, cost-effectiveness and health implications of the use of biologics in rheumatology was needed in order to integrate the clinical, ethical and socio-economic aspects related to their use. This book is aimed at specialist doctors, trainees, nurses and health professionals working in the field of rheumatology. It critically appraises the level of evidence behind the use of biologic agents in diverse autoimmune diseases, comprising separate chapters which focus on rheumatoid arthritis, systemic lupus erythematosus, myositis, systemic sclerosis, Sjogren’s syndrome, seronegative spondyloarthropathies, psoriatic arthritis and psoriasis, small, medium and large vessel vasculitis, osteoporosis, and interstitial lung disease associated with rheumatic conditions. In addition, the book explores aspects related to the use of biologic agents, such as ethical considerations of consenting patients to take part in clinical trials with biologics, and adolescent and adult rheumatology nurse perspectives related to patients’ benefits of biologic therapies. Particular interest is given to the use of biologics during pregnancy and assessment of their infectious risks. A separate chapter explores the off-target benefits associated with the use of anti-TNF therapies. Several chapters include data about cost-effectiveness, and national and international guidelines for the use of biologic agents in different rheumatic conditions. (Imprint: Nova Biomedical)

Preface

Biological Treatments in Autoimmune Rheumatic Diseases

Chapter 1. Biologic Therapies for Systemic Lupus Erythematosus
Maria Mouyis, Coziana Ciurtin and David A. Isenberg (Northwick Park University Hospital, London, UK, and others)

Chapter 2. Biologics in Juvenile Systemic Lupus Erythematosus
Claire-Louise Murphy and Nicola Ambrose (University College London Hospital, London, UK)

Chapter 3. Biologic Treatments for Idiopathic Inflammatory Myopathies
Serena Fasano and David A. Isenberg (Second University of Naples, Naples, Italy)

Chapter 4. Biologic Treatment Advances in Sjӧgren’s Syndrome: Understanding the Implications of using Biologic Therapies in Selected Categories of Patients
Coziana Ciurtin, Nicolyn Thompson and David A. Isenberg (University College London, London, UK)

Chapter 5. Biologic Therapies in Systemic Sclerosis
Svetlana Nihtyanova and Christopher P. Denton (UCL Medical School, Royal Free Campus, London, UK)

Chapter 6. The Role of Biologics in the Treatment of Small and Medium Vessel Vasculitis
Lubna Ghani and Eleana Ntatsaki (Royal Free Hospital, London, UK, and others)

Chapter 7. Imaging and Pathogenesis in Large Vessel Vasculitis: Early Lessons for Biologic Treatments
Philip P. Stapleton, Katerina Achilleos, Dimos Merinopoulos, and Bhaskar Dasgupta (Southend University Hospital, Essex, UK)

Chapter 8. Biologics in Behçet Syndrome
Emon Khan (University College London, London, UK)

Biologic Treatments in Chronic Inflammation Arthritides

Chapter 9. Tumour Necrosis Factor Inhibitors used in the Treatment of Rheumatoid Arthritis: Evidence of Safety, Efficacy and Health Implication
Laura Attipoe, Katie Bechman and Coziana Ciurtin (University College London Hospital, London, UK, and others)

Chapter 10. Biologic Treatments (Other than Anti-TNF Therapy) Licensed for Use in Rheumatoid Arthritis
Laura Attipoe, Katie Bechman and Coziana Ciurtin (University College London Hospital, London, UK, and others)

Chapter 11. New Biologic Agents and Biosimilars Developed for Rheumatoid Arthritis
Laura Attipoe, Katie Bechman and Coziana Ciurtin (University College London Hospital, London, UK, and others)

Chapter 12. Biologics in Spondyloarthritis
Mediola Ismajli and Maria Leandro (University College London Hospital, London, UK)

Chapter 13. Established and New Biologic Therapies for Psoriatic Arthritis and Psoriasis
Benjamin J Thomas, Sarah Elyoussi and Coziana Ciurtin (UCL Medical School, London, UK, and others)

Chapter 14. Biologics in Juvenile Idiopathic Arthritis
Charalampia Papadopoulou and Nicola Ambrose (Institute of Child Health, UCL, London, UK, and others)

Miscellanea

Chapter 15. Biologic Disease Modifying Anti-Rheumatic Drugs in Pregnancy and Breast-Feeding Period
Hanh Nguyen and Ian Giles (University College London, London, UK)

Chapter 16. Biologic Therapy in Osteoporosis: New Developments, Clinical uses and Health Implications
Maria Mouyis and Judith Bubbear (Northwick Park Hospital, London, UK, and others)

Chapter 17. Biologic Treatments for Pulmonary Involvement in Rheumatic Disease
Helen S. Garthwaite and Joanna C. Porter (University College London, London, UK)

Chapter 18. Additional Benefits of Tumour Necrosis Factor Inhibitor Therapies
Angela Pakozdi and Vanessa Morris (University College London, London, UK)

Chapter 19. Infection and Biologics
Maria Krutikov and Jessica Manson (University College London, London, UK)

Chapter 20. Participant Information Sheets in Clinical Research: Compromising the Ethics of Informed Consent?
Andra Negoescu, and Leslie Gelling (Addenbrooke’s Hospital, Cambridge, UK, and others)

Chapter 21. Biologic Treatment: The Young Patients’ Perspective
Nicola Daly (University College London, London, UK)

Chapter 22. Strategies and Safety Nets: Nurse-Led Care of the Patient on Biologics
Pauline Buck and Victoria Howard (University College London, London, UK)

Index

Chapter 1

[1] S. C. Croca, T. Rodrigues, and D. A. Isenberg, “Assessment of a lupus nephritis cohort over a 30-year period,” Rheumatology (Oxford), vol. 50, pp. 1424-30, Aug. 2011.
[2] P. Elfving, K. Puolakka, H. Kautiainen, L. J. Virta, T. Pohjolainen, and O. Kaipiainen-Seppanen, “Mortality and causes of death among incident cases of systemic lupus erythematosus in Finland 2000-2008,” Lupus, vol. 23, pp. 1430-4, Nov. 2014.
[3] J. Trager and M. M. Ward, “Mortality and causes of death in systemic lupus erythematosus,” Curr Opin Rheumatol, vol. 13, pp. 345-51, Sep. 2001.
[4] M. Abu-Shakra and V. Novack, “Mortality and multiple causes of death in systemic lupus erythematosus -- role of the death certificate,” J Rheumatol, vol. 39, pp. 458-60, Mar. 2012.
[5] Z. Liu and A. Davidson, “Taming lupus-a new understanding of pathogenesis is leading to clinical advances,” Nat Med, vol. 18, pp. 871-82, Jun. 2012.
[6] W. Su and M. P. Madaio, “Recent advances in the pathogenesis of lupus nephritis: autoantibodies and B cells,” Semin Nephrol, vol. 23, pp. 564-8, Nov. 2003.
[7] L. C. Huber, S. Gay, O. Distler, and D. S. Pisetsky, “The effect of UVB on lupus skin: new light on the role of apoptosis in the pathogenesis of autoimmunity,” Rheumatology (Oxford), vol. 45, pp. 500-1, May 2006.
[8] E. L. Greidinger, “Apoptosis in lupus pathogenesis,” Front Biosci, vol. 6, pp. D1392-402, Nov. 1 2001.
[9] A. Kuhn, J. Wenzel, and H. Weyd, “Photosensitivity, apoptosis, and cytokines in the pathogenesis of lupus erythematosus: a critical review,” Clin Rev Allergy Immunol, vol. 47, pp. 148-62, Oct. 2014.
[10] L. E. Munoz, C. van Bavel, S. Franz, J. Berden, M. Herrmann, and J. van der Vlag, “Apoptosis in the pathogenesis of systemic lupus erythematosus,” Lupus, vol. 17, pp. 371-5, May 2008.
[11] L. Reininger, M. L. Santiago, S. Takahashi, L. Fossati, and S. Izui, “T helper cell subsets in the pathogenesis of systemic lupus erythematosus,” Ann Med Interne (Paris), vol. 147, pp. 467-71, 1996.
[12] X. Yang, B. Sun, H. Wang, C. Yin, X. Wang, and X. Ji, “Increased serum IL-10 in lupus patients promotes apoptosis of T cell subsets via the caspase 8 pathway initiated by Fas signaling,” J Biomed Res, vol. 29, pp. 232-40, May 2015.
[13] J. C. Crispin, S. A. Apostolidis, M. I. Finnell, and G. C. Tsokos, “Induction of PP2A Bbeta, a regulator of IL-2 deprivation-induced T-cell apoptosis, is deficient in systemic lupus erythematosus,” Proc Natl Acad Sci US, vol. 108, pp. 12443-8, Jul. 26 2011.
[14] R. K. Dinesh, B. J. Skaggs, A. La Cava, B. H. Hahn, and R. P. Singh, “CD8+ Tregs in lupus, autoimmunity, and beyond,” Autoimmun Rev, vol. 9, pp. 560-8, Jun. 2010.
[15] C. G. Katsiari, S. N. Liossis, A. M. Dimopoulos, D. V. Charalambopoulo, M. Mavrikakis, and P. P. Sfikakis, “CD40L overexpression on T cells and monocytes from patients with systemic lupus erythematosus is resistant to calcineurin inhibition,” Lupus, vol. 11, pp. 370-8, 2002.
[16] C. Toong, S. Adelstein, and T. G. Phan, “Clearing the complexity: immune complexes and their treatment in lupus nephritis,” Int J Nephrol Renovasc Dis, vol. 4, pp. 17-28, 2011.
[17] A. Chang, S. G. Henderson, D. Brandt, N. Liu, R. Guttikonda, C. Hsieh et al., “In situ B cell-mediated immune responses and tubulointerstitial inflammation in human lupus nephritis,” J Immunol, vol. 186, pp. 1849-60, Feb. 1 2011.
[18] M. Takao, “[Targeted therapy and progressive multifocal leukoencephalopathy (PML): PML in the era of monoclonal antibody therapies],” Brain Nerve, vol. 65, pp. 1363-74, Nov. 2013.
[19] G. Turchetti, J. Yazdany, I. Palla, E. Yelin, and M. Mosca, “Systemic lupus erythematosus and the economic perspective: a systematic literature review and points to consider,” Clin Exp Rheumatol, vol. 30, pp. S116-22, Jul.-Aug. 2012.
[20] J. Cho, S. Chang, N. Shin, B. Choi, H. Oh, M. Yoon et al., “Costs of illness and quality of life in patients with systemic lupus erythematosus in South Korea,” Lupus, vol. 23, pp. 949-957, Feb. 21 2014.
[21] A. E. Clarke, M. B. Urowitz, N. Monga, and J. G. Hanly, “Costs associated with severe and nonsevere systemic lupus erythematosus in Canada,” Arthritis Care Res (Hoboken), vol. 67, pp. 431-6, Mar. 2015.
[22] D. E. Furst, A. Clarke, A. W. Fernandes, T. Bancroft, K. Gajria, W. Greth et al., “Resource utilization and direct medical costs in adult systemic lupus erythematosus patients from a commercially insured population,” Lupus, vol. 22, pp. 268-78, Mar. 2013.
[23] P. Panopalis, J. Yazdany, J. Z. Gillis, L. Julian, L. Trupin, A. O. Hersh et al., “Health care costs and costs associated with changes in work productivity among persons with systemic lupus erythematosus,” Arthritis Rheum, vol. 59, pp. 1788-95, Dec. 15 2008.
[24] P. Panopalis, M. Petri, S. Manzi, D. A. Isenberg, C. Gordon, J. L. Senecal et al., “The systemic lupus erythematosus Tri-Nation study: cumulative indirect costs,” Arthritis Rheum, vol. 57, pp. 64-70, Feb. 15 2007.
[25] G. Gironimi, A. E. Clarke, V. H. Hamilton, D. S. Danoff, D. A. Bloch, J. F. Fries et al., “Why health care costs more in the US: comparing health care expenditures between systemic lupus erythematosus patients in Stanford and Montreal,” Arthritis Rheum, vol. 39, pp. 979-87, Jun. 1996.
[26] N. Sutcliffe, A. E. Clarke, R. Taylor, C. Frost, and D. A. Isenberg, “Total costs and predictors of costs in patients with systemic lupus erythematosus,” Rheumatology (Oxford), vol. 40, pp. 37-47, Jan. 2001.
[27] M. M. Ward, “Access to care and the incidence of endstage renal disease due to systemic lupus erythematosus,” J Rheumatol, vol. 37, pp. 1158-63, Jun. 2010.
[28] E. M. Williams, K. Ortiz, M. Flournoy-Floyd, L. Bruner, and D. Kamen, “Systemic lupus erythematosus observations of travel burden: A qualitative inquiry,” Int J Rheum Dis, Jul. 14 2015.
[29] A. Lateef, M. Lahiri, G. G. Teng, and S. Vasoo, “Use of rituximab in the treatment of refractory systemic lupus erythematosus: Singapore experience,” Lupus, vol. 19, pp. 765-70, May 2010.
[30] A. M. Ryan, S. A. Sokolowski, C. K. Ng, N. Shirai, M. Collinge, A. C. Shen et al., “Comparative nonclinical assessments of the proposed biosimilar PF-05280586 and rituximab (MabThera(R)),” Toxicol Pathol, vol. 42, pp. 1069-81, Oct. 2014.
[31] A. da Silva, U. Kronthaler, V. Koppenburg, M. Fink, I. Meyer, A. Papandrikopoulou et al., “Target-directed development and preclinical characterization of the proposed biosimilar rituximab GP2013,” Leuk Lymphoma, vol. 55, pp. 1609-17, Jul. 2014.
[32] M. Petri, S. Perez-Gutthann, J. C. Longenecker, and M. Hochberg, “Morbidity of systemic lupus erythematosus: role of race and socioeconomic status,” Am J Med, vol. 91, pp. 345-53, Oct. 1991.
[33] A. Pons-Estel, L. J. Catoggio, M. H. Cardiel, E. R. Soriano, S. Gentiletti, A. R. Villa et al., “The GLADEL multinational Latin American prospective inception cohort of 1,214 patients with systemic lupus erythematosus: ethnic and disease heterogeneity among ‘Hispanics,’ “ Medicine (Baltimore), vol. 83, pp. 1-17, Jan. 2004.
[34] L. C. Plantinga, C. Drenkard, R. E. Patzer, M. Klein, M. R. Kramer, S. Pastan et al., “Sociodemographic and geographic predictors of quality of care in United States patients with end-stage renal disease due to lupus nephritis,” Arthritis Rheumatol, vol. 67, pp. 761-72, Mar. 2015.
[35] D. L. Horowitz and R. Furie, “Belimumab is approved by the FDA: what more do we need to know to optimize decision making?” Curr Rheumatol Rep, vol. 14, pp. 318-23, Aug. 2012.
[36] J. Harris, “QALYfying the value of life,” J Med Ethics, vol. 13, pp. 117-23, Sep. 1987.
[37] G. J. Weiner, “Rituximab: mechanism of action,” Semin Hematol, vol. 47, pp. 115-23, Apr. 2010.
[38] D. Albert, J. Dunham, S. Khan, J. Stansberry, S. Kolasinski, D. Tsai et al., “Variability in the biological response to anti-CD20 B cell depletion in systemic lupus erythaematosus,” Ann Rheum Dis, vol. 67, pp. 1724-31, Dec. 2008.
[39] D. G. Maloney, “Mechanism of action of rituximab,” Anticancer Drugs, vol. 12 Suppl. 2, pp. S1-4, Jun. 2001.
[40] B. Bonavida, “Rituximab-induced inhibition of antiapoptotic cell survival pathways: implications in chemo/immunoresistance, rituximab unresponsiveness, prognostic and novel therapeutic interventions,” Oncogene, vol. 26, pp. 3629-36, May 28 2007.
[41] M. J. Leandro, G. Cambridge, J. C. Edwards, M. R. Ehrenstein, and D. A. Isenberg, “B cell depletion in the treatment of patients with systemic lupus erythematosus: a longitudinal analysis of 24 patients,” Rheumatology (Oxford), vol. 44, pp. 1542-5, Dec. 2005.
[42] J. Merrill, J. Buyon, R. Furie, K. Latinis, C. Gordon, H. J. Hsieh et al., “Assessment of flares in lupus patients enrolled in a phase II/III study of rituximab (EXPLORER),” Lupus, vol. 20, pp. 709-16, Jun. 2011.
[43] B. H. Rovin, R. Furie, K. Latinis, R. J. Looney, F. C. Fervenza, J. Sanchez-Guerrero et al., “Efficacy and safety of rituximab in patients with active proliferative lupus nephritis: the Lupus Nephritis Assessment with Rituximab study,” Arthritis Rheum, vol. 64, pp. 1215-26, Apr. 2012.
[44] L. Iaccarino, E. Bartoloni, L. Carli, F. Ceccarelli, F. Conti, S. De Vita et al., “Efficacy and safety of off-label use of rituximab in refractory lupus: data from the Italian Multicentre Registry,” Clin Exp Rheumatol, vol. 33, pp. 449-56, Jul.-Aug. 2015.
[45] R. A. Hickman, R. Hira-Kazal, C. S. Yee, V. Toescu, and C. Gordon, “The efficacy and safety of rituximab in a chart review study of 15 patients with systemic lupus erythematosus,” Clin Rheumatol, vol. 34, pp. 263-71, Feb. 2015.
[46] V. Reddy, D. Jayne, D. Close, and D. Isenberg, “B cell depletion in SLE: clinical and trial experience with rituximab and ocrelizumab and implications for study design,” Arthritis Res Ther, vol. 15 Suppl. 1, p. S2, 2013.
[47] M. B. Condon, D. Ashby, R. J. Pepper, H. T. Cook, J. B. Levy, M. Griffith et al., “Prospective observational single-centre cohort study to evaluate the effectiveness of treating lupus nephritis with rituximab and mycophenolate mofetil but no oral steroids,” Ann Rheum Dis, vol. 72, pp. 1280-6, Aug. 2013.
[48] A. N. Ezeonyeji and D. A. Isenberg, “Early treatment with rituximab in newly diagnosed systemic lupus erythematosus patients: a steroid-sparing regimen,” Rheumatology (Oxford), vol. 51, pp. 476-81, Mar. 2012.
[49] J. E. Montoya, H. G. Luna, N. G. Vergara, J. R. Amparo, and G. R. Cristal-Luna, “Incidence of infusion-related reaction to monoclonal antibody rituximab: a national kidney and transplant institute experience,” Ann Acad Med Singapore, vol. 41, pp. 125-6, Mar. 2012.
[50] Y. Pehlivan, B. Kisacik, V. K. Bosnak, and A. M. Onat, “Rituximab seems to be a safer alternative in patients with active rheumatoid arthritis with tuberculosis,” BMJ Case Rep, vol. 2013, 2013.
[51] M. L. Burr, A. P. Malaviya, J. H. Gaston, A. J. Carmichael, and A. J. Ostor, “Rituximab in rheumatoid arthritis following anti-TNF-associated tuberculosis,” Rheumatology (Oxford), vol. 47, pp. 738-9, May 2008.
[52] Y. X. Koo, D. S. Tan, I. B. Tan, M. Tao, and S. T. Lim, “Hepatitis B virus reactivation in a patient with resolved hepatitis B virus infection receiving maintenance rituximab for malignant B cell lymphoma,” Ann Intern Med, vol. 150, pp. 655-6, May 5 2009.
[53] B. Terrier, D. Saadoun, D. Sene, J. Sellam, L. Perard, B. Coppere et al., “Efficacy and tolerability of rituximab with or without PEGylated interferon alfa-2b plus ribavirin in severe hepatitis C virus-related vasculitis: a long-term followup study of thirty-two patients,” Arthritis Rheum, vol. 60, pp. 2531-40, Aug. 2009.
[54] C. Rodriguez-Escalera and A. Fernandez-Nebro, “The use of rituximab to treat a patient with ankylosing spondylitis and hepatitis B,” Rheumatology (Oxford), vol. 47, pp. 1732-3, Nov. 2008.
[55] Y. H. Ahn, H. G. Kang, J. M. Lee, H. J. Choi, I. S. Ha, and H. I. Cheong, “Development of antirituximab antibodies in children with nephrotic syndrome,” Pediatr Nephrol, vol. 29, pp. 1461-4, Aug. 2014.
[56] A. Vultaggio, E. Maggi, and A. Matucci, “Immediate adverse reactions to biologicals: from pathogenic mechanisms to prophylactic management,” Curr Opin Allergy Clin Immunol, vol. 11, pp. 262-8, Jun. 2011.
[57] G. Cambridge, D. A. Isenberg, J. C. Edwards, M. J. Leandro, T. S. Migone, M. Teodorescu et al., “B cell depletion therapy in systemic lupus erythematosus: relationships among serum B lymphocyte stimulator levels, autoantibody profile and clinical response,” Ann Rheum Dis, vol. 67, pp. 1011-6, Jul. 2008.
[58] A. Podolskaya, M. Stadermann, C. Pilkington, S. D. Marks, and K. Tullus, “B cell depletion therapy for 19 patients with refractory systemic lupus erythematosus,” Arch Dis Child, vol. 93, pp. 401-6, May 2008.
[59] S. S. Dias, V. Rodriguez-Garcia, H. Nguyen, C. Pericleous, and D. Isenberg, “Longer duration of B cell depletion is associated with better outcome,” Rheumatology (Oxford), vol. 54, pp. 1876-81, Oct. 2015.
[60] J. H. Anolik, J. Barnard, T. Owen, B. Zheng, S. Kemshetti, R. J. Looney et al., “Delayed memory B cell recovery in peripheral blood and lymphoid tissue in systemic lupus erythematosus after B cell depletion therapy,” Arthritis Rheum, vol. 56, pp. 3044-56, Sep. 2007.
[61] I. de la Torre, M. J. Leandro, J. C. Edwards, and G. Cambridge, “Baseline serum immunoglobulin levels in patients with rheumatoid arthritis: relationships with clinical parameters and with B cell dynamics following rituximab,” Clin Exp Rheumatol, vol. 30, pp. 554-60, Jul.-Aug. 2012.
[62] M. Heusele, P. Clerson, B. Guery, M. Lambert, D. Launay, G. Lefevre et al., “Risk factors for severe bacterial infections in patients with systemic autoimmune diseases receiving rituximab,” Clin Rheumatol, vol. 33, pp. 799-805, Jun. 2014.
[63] C. Diaz-Lagares, S. Croca, S. Sangle, E. M. Vital, F. Catapano, A. Martinez-Berriotxoa et al., “Efficacy of rituximab in 164 patients with biopsy-proven lupus nephritis: pooled data from European cohorts,” Autoimmun Rev, vol. 11, pp. 357-64, Mar. 2012.
[64] S. C. Hofmann, M. J. Leandro, S. D. Morris, and D. A. Isenberg, “Effects of rituximab-based B cell depletion therapy on skin manifestations of lupus erythematosus--report of 17 cases and review of the literature,” Lupus, vol. 22, pp. 932-9, Aug. 2013.
[65] H. Beckwith and L. Lightstone, “Rituximab in systemic lupus erythematosus and lupus nephritis,” Nephron Clin Pract, vol. 128, pp. 250-4, 2014.
[66] S. O’Brien and A. Osterborg, “Ofatumumab: a new CD20 monoclonal antibody therapy for B cell chronic lymphocytic leukemia,” Clin Lymphoma Myeloma Leuk, vol. 10, pp. 361-8, Oct. 2010.
[67] G. Nightingale, “Ofatumumab: a novel anti-CD20 monoclonal antibody for treatment of refractory chronic lymphocytic leukemia,” Ann Pharmacother, vol. 45, pp. 1248-55, Oct. 2011.
[68] M. Hoyle, L. Crathorne, R. Garside, and C. Hyde, “Ofatumumab for the treatment of chronic lymphocytic leukaemia in patients who are refractory to fludarabine and alemtuzumab: a critique of the submission from GSK,” Health Technol Assess, vol. 15 Suppl. 1, pp. 61-7, May 2011.
[69] P. C. Taylor, E. Quattrocchi, S. Mallett, R. Kurrasch, J. Petersen, and D. J. Chang, “Ofatumumab, a fully human anti-CD20 monoclonal antibody, in biological-naïve, rheumatoid arthritis patients with an inadequate response to methotrexate: a randomised, double-blind, placebo-controlled clinical trial,” Ann Rheum Dis, vol. 70, pp. 2119-25, Dec. 2011.
[70] R. Kurrasch, J. C. Brown, M. Chu, J. Craigen, P. Overend, B. Patel et al., “Subcutaneously administered ofatumumab in rheumatoid arthritis: a phase I/II study of safety, tolerability, pharmacokinetics, and pharmacodynamics,” J Rheumatol, vol. 40, pp. 1089-96, Jul. 2013.
[71] M. Ostergaard, B. Baslund, W. Rigby, B. Rojkovich, C. Jorgensen, P. T. Dawes et al., “Ofatumumab, a human anti-CD20 monoclonal antibody, for treatment of rheumatoid arthritis with an inadequate response to one or more disease-modifying antirheumatic drugs: results of a randomised, double-blind, placebo-controlled, phase I/II study,” Arthritis Rheum, vol. 62, pp. 2227-38, Aug. 2010.
[72] H. Struemper, M. Sale, B. R. Patel, M. Ostergaard, A. Osterborg, W. G. Wierda et al., “Population pharmacokinetics of ofatumumab in patients with chronic lymphocytic leukemia, follicular lymphoma, and rheumatoid arthritis,” J Clin Pharmacol, vol. 54, pp. 818-27, Jul. 2014.
[73] C. C. Thornton, N. Ambrose, and Y. Ioannou, “Ofatumumab: a novel treatment for severe systemic lupus erythematosus,” Rheumatology (Oxford), vol. 54, pp. 559-60, Mar. 2015.
[74] F. Morschhauser, P. Marlton, U. Vitolo, O. Linden, J. F. Seymour, M. Crump et al., “Results of a phase I/II study of ocrelizumab, a fully humanised anti-CD20 mAb, in patients with relapsed/refractory follicular lymphoma,” Ann Oncol, vol. 21, pp. 1870-6, Sep. 2010.
[75] P. P. Tak, P. J. Mease, M. C. Genovese, J. Kremer, B. Haraoui, Y. Tanaka et al., “Safety and efficacy of ocrelizumab in patients with rheumatoid arthritis and an inadequate response to at least one tumor necrosis factor inhibitor: results of a forty-eight-week randomised, double-blind, placebo-controlled, parallel-group phase III trial,” Arthritis Rheum, vol. 64, pp. 360-70, Feb. 2012.
[76] E. F. Mysler, A. J. Spindler, R. Guzman, M. Bijl, D. Jayne, R. A. Furie et al., “Efficacy and safety of ocrelizumab in active proliferative lupus nephritis: results from a randomised, double-blind, phase III study,” Arthritis Rheum, vol. 65, pp. 2368-79, Sep. 2013.
[77] M. Ramos-Casals, I. Sanz, X. Bosch, J. H. Stone, and M. A. Khamashta, “B cell-depleting therapy in systemic lupus erythematosus,” Am J Med, vol. 125, pp. 327-36, Apr. 2012.
[78] L. Kappos, D. Li, P. A. Calabresi, P. O’Connor, A. Bar-Or, F. Barkhof et al., “Ocrelizumab in relapsing-remitting multiple sclerosis: a phase 2, randomised, placebo-controlled, multicentre trial,” Lancet, vol. 378, pp. 1779-87, Nov. 19 2011.
[79] R. M. Sharkey, H. Karacay, C. H. Chang, W. J. McBride, I. D. Horak, and D. M. Goldenberg, “Improved therapy of non-Hodgkin’s lymphoma xenografts using radionuclides pretargeted with a new anti-CD20 bispecific antibody,” Leukemia, vol. 19, pp. 1064-9, Jun. 2005.
[80] B. Godeau, “B cell depletion in immune thrombocytopenia,” Semin Hematol, vol. 50 Suppl. 1, pp. S75-82, Jan. 2013.
[81] R. M. Faria and D. A. Isenberg, “Three different B cell depletion (anti-CD20 monoclonal antibodies) treatments for severe resistant systemic lupus erythematosus,” Lupus, vol. 19, pp. 1256-7, Sep. 2010.
[82] A. R. Rezvani and D. G. Maloney, “Rituximab resistance,” Best Pract Res Clin Haematol, vol. 24, pp. 203-16, Jun. 2011.
[83] E. A. Rossi, C. H. Chang, and D. M. Goldenberg, “Anti-CD22/CD20 Bispecific antibody with enhanced trogocytosis for treatment of Lupus,” PLoS One, vol. 9, p. e98315, 2014.
[84] V. Strand, M. Petri, K. Kalunian, C. Gordon, D. J. Wallace, K. Hobbs et al., “Epratuzumab for patients with moderate to severe flaring SLE: health-related quality of life outcomes and corticosteroid use in the randomised controlled ALLEVIATE trials and extension study SL0006,” Rheumatology (Oxford), vol. 53, pp. 502-11, Mar. 2014.
[85] D. J. Wallace, K. Kalunian, M. A. Petri, V. Strand, F. A. Houssiau, M. Pike et al., “Efficacy and safety of epratuzumab in patients with moderate/severe active systemic lupus erythematosus: results from EMBLEM, a phase IIb, randomised, double-blind, placebo-controlled, multicentre study,” Ann Rheum Dis, vol. 73, pp. 183-90, Jan. 2014.
[86] C. Daridon, D. Blassfeld, K. Reiter, H. E. Mei, C. Giesecke, D. M. Goldenberg et al., “Epratuzumab targeting of CD22 affects adhesion molecule expression and migration of B cells in systemic lupus erythematosus,” Arthritis Res Ther, vol. 12, p. R204, 2010.
[87] S. D. Steinfeld, L. Tant, G. R. Burmester, N. K. Teoh, W. A. Wegener, D. M. Goldenberg et al., “Epratuzumab (humanised anti-CD22 antibody) in primary Sjogren’s syndrome: an open-label phase I/II study,” Arthritis Res Ther, vol. 8, p. R129, 2006.
[88] G. J. Dennis, “Belimumab: a BLyS-specific inhibitor for the treatment of systemic lupus erythematosus,” Clin Pharmacol Ther, vol. 91, pp. 143-9, Jan. 2012.
[89] S. Manzi, J. Sanchez-Guerrero, J. T. Merrill, R. Furie, D. Gladman, S. V. Navarra et al., “Effects of belimumab, a B lymphocyte stimulator-specific inhibitor, on disease activity across multiple organ domains in patients with systemic lupus erythematosus: combined results from two phase III trials,” Ann Rheum Dis, vol. 71, pp. 1833-8, Nov. 2012.
[90] R. F. van Vollenhoven, M. A. Petri, R. Cervera, D. A. Roth, B. N. Ji, C. S. Kleoudis et al., “Belimumab in the treatment of systemic lupus erythematosus: high disease activity predictors of response,” Ann Rheum Dis, vol. 71, pp. 1343-9, Aug. 2012.
[91] M. A. Dooley, F. Houssiau, C. Aranow, D. P. D’Cruz, A. Askanase, D. A. Roth et al., “Effect of belimumab treatment on renal outcomes: results from the phase 3 belimumab clinical trials in patients with SLE,” Lupus, vol. 22, pp. 63-72, Jan. 2013.
[92] D. J. Wallace, S. Navarra, M. A. Petri, A. Gallacher, M. Thomas, R. Furie et al., “Safety profile of belimumab: pooled data from placebo-controlled phase 2 and 3 studies in patients with systemic lupus erythematosus,” Lupus, vol. 22, pp. 144-54, Feb. 2013.
[93] F. B. Vincent, D. Saulep-Easton, W. A. Figgett, K. A. Fairfax, and F. Mackay, “The BAFF/APRIL system: emerging functions beyond B cell biology and autoimmunity,” Cytokine Growth Factor Rev, vol. 24, pp. 203-15, Jun. 2013.
[94] M. C. Genovese, R. M. Fleischmann, M. Greenwald, J. Satterwhite, M. Veenhuizen, L. Xie et al., “Tabalumab, an anti-BAFF monoclonal antibody, in patients with active rheumatoid arthritis with an inadequate response to TNF inhibitors,” Ann Rheum Dis, vol. 72, pp. 1461-8, Sep. 1 2013.
[95] D. A. Isenberg, M. Petri, K. Kalunian, Y. Tanaka, M. B. Urowitz, R. W. Hoffman et al., “Efficacy and safety of subcutaneous tabalumab in patients with systemic lupus erythematosus: results from ILLUMINATE-1, a 52-week, phase III, multicentre, randomised, double-blind, placebo-controlled study,” Ann Rheum Dis, Sep. 3 2015.
[96] J. S. Smolen, M. E. Weinblatt, D. van der Heijde, W. F. Rigby, R. van Vollenhoven, C. O. Bingham, 3rd et al., “Efficacy and safety of tabalumab, an anti-B cell-activating factor monoclonal antibody, in patients with rheumatoid arthritis who had an inadequate response to methotrexate therapy: results from a phase III multicentre, randomised, double-blind study,” Ann Rheum Dis, vol. 74, pp. 1567-70, Aug. 2015.
[97] M. C. Genovese, E. Lee, J. Satterwhite, M. Veenhuizen, D. Disch, P. Y. Berclaz et al., “A phase 2 dose-ranging study of subcutaneous tabalumab for the treatment of patients with active rheumatoid arthritis and an inadequate response to methotrexate,” Ann Rheum Dis, vol. 72, pp. 1453-60, Sep. 1 2013.
[98] J. T. Merrill, R. F. van Vollenhoven, J. P. Buyon, R. A. Furie, W. Stohl, M. Morgan-Cox et al., “Efficacy and safety of subcutaneous tabalumab, a monoclonal antibody to B cell activating factor, in patients with systemic lupus erythematosus: results from ILLUMINATE-2, a 52-week, phase III, multicentre, randomised, double-blind, placebo-controlled study,” Ann Rheum Dis, Aug. 20 2015.
[99] B. Gatto, “Atacicept, a homodimeric fusion protein for the potential treatment of diseases triggered by plasma cells,” Curr Opin Investig Drugs, vol. 9, pp. 1216-27, Nov. 2008.
[100] R. J. Looney, “B cell-targeted therapies for systemic lupus erythematosus: an update on clinical trial data,” Drugs, vol. 70, pp. 529-40, Mar. 26 2010.
[101] D. Isenberg, C. Gordon, D. Licu, S. Copt, C. P. Rossi, and D. Wofsy, “Efficacy and safety of atacicept for prevention of flares in patients with moderate-to-severe systemic lupus erythematosus (SLE): 52-week data (APRIL-SLE randomised trial),” Ann Rheum Dis, Jun. 20 2014.
[102] D. Isenberg, C. Gordon, D. Licu, S. Copt, C. P. Rossi, and D. Wofsy, “Efficacy and safety of atacicept for prevention of flares in patients with moderate-to-severe systemic lupus erythematosus (SLE): 52-week data (APRIL-SLE randomised trial),” Ann Rheum Dis, vol. 74, pp. 2006-15, Nov. 2015.
[103] E. M. Ginzler, S. Wax, A. Rajeswaran, S. Copt, J. Hillson, E. Ramos et al., “Atacicept in combination with MMF and corticosteroids in lupus nephritis: results of a prematurely terminated trial,” Arthritis Res Ther, vol. 14, p. R33, 2012.
[104] E. Cogollo, M. A. Silva, and D. Isenberg, “Profile of atacicept and its potential in the treatment of systemic lupus erythematosus,” Drug Des Devel Ther, vol. 9, pp. 1331-9, 2015.
[105] J. Morel and M. Hahne, “To target or not to target APRIL in systemic lupus erythematosus: that is the question!,” Arthritis Res Ther, vol. 15, p. 107, 2013.
[106] R. A. Furie, G. Leon, M. Thomas, M. A. Petri, A. D. Chu, C. Hislop et al., “A phase 2, randomised, placebo-controlled clinical trial of blisibimod, an inhibitor of B cell activating factor, in patients with moderate-to-severe systemic lupus erythematosus, the PEARL-SC study,” Ann Rheum Dis, vol. 74, pp. 1667-75, Sep. 2015.
[107] W. Stohl, J. T. Merrill, R. J. Looney, J. Buyon, D. J. Wallace, M. H. Weisman et al., “Treatment of systemic lupus erythematosus patients with the BAFF antagonist “peptibody” blisibimod (AMG 623/A-623): results from randomised, double-blind phase 1a and phase 1b trials,” Arthritis Res Ther, vol. 17, p. 215, 2015.
[108] M. Petri, D. J. Wallace, A. Spindler, V. Chindalore, K. Kalunian, E. Mysler et al., “Sifalimumab, a human anti-interferon-alpha monoclonal antibody, in systemic lupus erythematosus: a phase I randomised, controlled, dose-escalation study,” Arthritis Rheum, vol. 65, pp. 1011-21, Apr. 2013.
[109] A. Mathian, M. Hie, F. Cohen-Aubart, and Z. Amoura, “Targeting interferons in systemic lupus erythematosus: current and future prospects,” Drugs, vol. 75, pp. 835-46, May 2015.
[110] R. Narwal, L. K. Roskos, and G. J. Robbie, “Population pharmacokinetics of sifalimumab, an investigational anti-interferon-alpha monoclonal antibody, in systemic lupus erythematosus,” Clin Pharmacokinet, vol. 52, pp. 1017-27, Nov. 2013.
[111] B. R. Lauwerys, J. Ducreux, and F. A. Houssiau, “Type I interferon blockade in systemic lupus erythematosus: where do we stand?,” Rheumatology (Oxford), vol. 53, pp. 1369-76, Aug. 2014.
[112] J. T. Merrill, D. J. Wallace, M. Petri, K. A. Kirou, Y. Yao, W. I. White et al., “Safety profile and clinical activity of sifalimumab, a fully human anti-interferon alpha monoclonal antibody, in systemic lupus erythematosus: a phase I, multicentre, double-blind randomised study,” Ann Rheum Dis, vol. 70, pp. 1905-13, Nov. 2011.
[113] A. Mathian, M. Hie, F. Cohen-Aubart, and Z. Amoura, “Targeting Interferons in Systemic Lupus Erythematosus: Current and Future Prospects,” Drugs, vol. 75, pp. 835-846, May 2015.
[114] B. W. Higgs, W. Zhu, C. Morehouse, W. I. White, P. Brohawn, X. Guo et al., “A phase 1b clinical trial evaluating sifalimumab, an anti-IFN-alpha monoclonal antibody, shows target neutralisation of a type I IFN signature in blood of dermatomyositis and polymyositis patients,” Ann Rheum Dis, vol. 73, pp. 256-62, Jan. 2014.
[115] J. M. McBride, J. Jiang, A. R. Abbas, A. Morimoto, J. Li, R. Maciuca et al., “Safety and pharmacodynamics of rontalizumab in patients with systemic lupus erythematosus: results of a phase I, placebo-controlled, double-blind, dose-escalation study,” Arthritis Rheum, vol. 64, pp. 3666-76, Nov. 2012.
[116] K. C. Kalunian, J. T. Merrill, R. Maciuca, J. M. McBride, M. J. Townsend, X. Wei et al., “A Phase II study of the efficacy and safety of rontalizumab (rhuMAb interferon-alpha) in patients with systemic lupus erythematosus (ROSE),” Ann Rheum Dis, Jun. 2 2015.
[117] C. Morehouse, L. D. Chang, L. W. Wang, P. Brohawn, S. Ueda, G. Illei et al., “Target Modulation of a Type I Interferon (IFN) Gene Signature with Sifalimumab or Anifrolumab in Systemic Lupus Erythematosus (SLE) Patients in Two Open Label Phase 2 Japanese Trials,” Arthritis and Rheumatology, vol. 66, pp. S313-S314, Oct. 2014.
[118] A. Y. Hoi and G. O. Littlejohn, “Abatacept in the treatment of lupus,” Expert Opin Biol Ther, vol. 12, pp. 1399-406, Oct. 2012.
[119] J. T. Merrill, R. Burgos-Vargas, R. Westhovens, A. Chalmers, D. D’Cruz, D. J. Wallace et al., “The efficacy and safety of abatacept in patients with non-life-threatening manifestations of systemic lupus erythematosus: results of a twelve-month, multicenter, exploratory, phase IIb, randomised, double-blind, placebo-controlled trial,” Arthritis Rheum, vol. 62, pp. 3077-87, Oct. 2010.
[120] D. Wofsy, J. L. Hillson, and B. Diamond, “Abatacept for lupus nephritis: alternative definitions of complete response support conflicting conclusions,” Arthritis Rheum, vol. 64, pp. 3660-5, Nov. 2012.
[121] R. Furie, K. Nicholls, T. T. Cheng, F. Houssiau, R. Burgos-Vargas, S. L. Chen et al., “Efficacy and safety of abatacept in lupus nephritis: a twelve-month, randomised, double-blind study,” Arthritis Rheumatol, vol. 66, pp. 379-89, Feb. 2014.
[122] J. I. Shin, S. J. Park, and M. A. Saleem, “The beneficial effect of abatacept in lupus nephritis may include stabilization of beta1 integrin activation in podocytes and Treg cell repopulation: comment on the article by Furie et al.,” Arthritis Rheumatol, vol. 66, pp. 2913-4, Oct. 2014.
[123] “Treatment of lupus nephritis with abatacept: the Abatacept and Cyclophosphamide Combination Efficacy and Safety Study,” Arthritis Rheumatol, vol. 66, pp. 3096-104, Nov. 2014.
[124] G. G. Illei, Y. Shirota, C. H. Yarboro, J. Daruwalla, E. Tackey, K. Takada et al., “Tocilizumab in systemic lupus erythematosus: data on safety, preliminary efficacy, and impact on circulating plasma cells from an open-label phase I dosage-escalation study,” Arthritis Rheum, vol. 62, pp. 542-52, Feb. 2010.
[125] M. Suzuki, M. Hashizume, H. Yoshida, and M. Mihara, “Anti-inflammatory mechanism of tocilizumab, a humanised anti-IL6R antibody: effect on the expression of chemokine and adhesion molecule,” Rheumatol Int, vol. 30, pp. 309-15, Jan. 2010.
[126] D. Killock, “Rheumatoid arthritis: Tocilizumab is efficacious in active RA as little as 1 week after treatment,” Nat Rev Rheumatol, vol. 7, p. 683, Dec. 2011.
[127] S. Yokota, T. Imagawa, M. Mori, T. Miyamae, Y. Aihara, S. Takei et al., “Efficacy and safety of tocilizumab in patients with systemic-onset juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled, withdrawal phase III trial,” Lancet, vol. 371, pp. 998-1006, Mar. 22 2008.
[128] N. Nishimoto, N. Miyasaka, K. Yamamoto, S. Kawai, T. Takeuchi, and J. Azuma, “Long-term safety and efficacy of tocilizumab, an anti-IL6 receptor monoclonal antibody, in monotherapy, in patients with rheumatoid arthritis (the STREAM study): evidence of safety and efficacy in a 5-year extension study,” Ann Rheum Dis, vol. 68, pp. 1580-4, Oct. 2009.
[129] Z. Xu, E. Bouman-Thio, C. Comisar, B. Frederick, B. Van Hartingsveldt, J. C. Marini et al., “Pharmacokinetics, pharmacodynamics and safety of a human anti-IL6 monoclonal antibody (sirukumab) in healthy subjects in a first-in-human study,” Br J Clin Pharmacol, vol. 72, pp. 270-81, Aug. 2011.
[130] C. Aranow, R. van Vollenhoven, B. H. Rovin, C. Wagner, B. Zhou, R. Gordon et al., “A Phase 2, Multicenter, Randomised, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy and Safety of Sirukumab in Patients with Active Lupus Nephritis,” Arthritis and Rheumatology, vol. 66, pp. S1239-S1239, Oct. 2014.
[131] R. van Vollenhoven, C. Aranow, B. Rovin, C. Wagner, B. Zhou, R. Gordon et al., “A Phase 2, Multicenter, Randomised, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy and Safety of Sirukumab in Patients with Active Lupus Nephritis,” Ann Rheum Dis, vol. 73, pp. 78-78, Jun. 2014.
[132] U. Thanarajasingam and T. B. Niewold, “Sirukumab: a novel therapy for lupus nephritis?” Expert Opin Investig Drugs, vol. 23, pp. 1449-1455, Oct. 2014.
[133] U. Thanarajasingam and T. B. Niewold, “Sirukumab: a novel therapy for lupus nephritis?” Expert Opin Investig Drugs, vol. 23, pp. 1449-55, Oct. 2014.
[134] P. Hillmen, P. Muus, U. Duhrsen, A. M. Risitano, J. Schubert, L. Luzzatto et al., “Effect of the complement inhibitor eculizumab on thromboembolism in patients with paroxysmal nocturnal hemoglobinuria,” Blood, vol. 110, pp. 4123-8, Dec. 1 2007.
[135] “Eculizumab: 5G1.1, h5G1.1, long-acting anti-C5 monoclonal antibody 5G1-1, long-acting anti-C5 monoclonal antibody 5G1.1,” Drugs R D, vol. 8, pp. 61-8, 2007.
[136] C. F. Larrea, F. Cofan, F. Oppenheimer, J. M. Campistol, G. Escolar, and M. Lozano, “Efficacy of eculizumab in the treatment of recurrent atypical hemolytic-uremic syndrome after renal transplantation,” Transplantation, vol. 89, pp. 903-4, Apr. 15 2010.
[137] R. Coppo, L. Peruzzi, A. Amore, S. Martino, L. Vergano, I. Lastauka et al., “Dramatic effects of eculizumab in a child with diffuse proliferative lupus nephritis resistant to conventional therapy,” Pediatr Nephrol, vol. 30, pp. 167-72, Jan. 2015.

Chapter 2

[1] R. Mina and H. I. Brunner, “Pediatric lupus--are there differences in presentation, genetics, response to therapy, and damage accrual compared with adult lupus?,” Rheum Dis Clin North Am, vol. 36, pp. 53-80, vii-viii, Feb. 2010.
[2] B. M. Kisiel, J. Kosinska, M. Wierzbowska, L. Rutkowska-Sak, E. Musiej-Nowakowska, M. Wudarski et al., “Differential association of juvenile and adult systemic lupus erythematosus with genetic variants of oestrogen receptors alpha and beta,” Lupus, vol. 20, pp. 85-9, Jan. 2011.
[3] E. C. Fernandes, C. A. Silva, A. L. Braga, A. M. Sallum, L. M. Campos, and S. C. Farhat, “Exposure to Air Pollutants and Disease Activity in Juvenile-Onset Systemic Lupus Erythematosus Patients,” Arthritis Care Res (Hoboken), vol. 67, pp. 1609-1614, Nov. 2015.
[4] T. A. Morgan, L. Watson, L. J. McCann, and M. W. Beresford, “Children and adolescents with SLE: not just little adults,” Lupus, vol. 22, pp. 1309-19, Oct. 2013.
[5] L. B. Tucker, A. G. Uribe, M. Fernandez, L. M. Vila, G. McGwin, M. Apte et al., “Adolescent onset of lupus results in more aggressive disease and worse outcomes: results of a nested matched case-control study within LUMINA, a multiethnic US cohort (LUMINA LVII),” Lupus, vol. 17, pp. 314-22, Apr. 2008.
[6] S. A. Zimmerman and R. E. Ware, “Clinical significance of the antinuclear antibody test in selected children with idiopathic thrombocytopenic purpura,” J Pediatr Hematol Oncol, vol. 19, pp. 297-303, Jul.-Aug. 1997.
[7] K. S. Irving, D. Sen, H. Tahir, C. Pilkington, and D. A. Isenberg, “A comparison of autoimmune liver disease in juvenile and adult populations with systemic lupus erythematosus-a retrospective review of cases,” Rheumatology (Oxford), vol. 46, pp. 1171-3, Jul. 2007.
[8] C. Quinlan, S. D. Marks, and K. Tullus, “Why are kids with lupus at an increased risk of cardiovascular disease?” Pediatr Nephrol, Sep. 23 2015.
[9] I. E. Hoffman, B. R. Lauwerys, F. De Keyser, T. W. Huizinga, D. Isenberg, L. Cebecauer et al., “Juvenile-onset systemic lupus erythematosus: different clinical and serological pattern than adult-onset systemic lupus erythematosus,” Ann Rheum Dis, vol. 68, pp. 412-5, Mar. 2009.
[10] T. D. Bennett, M. Fluchel, A. O. Hersh, K. N. Hayward, A. L. Hersh, T. V. Brogan et al., “Macrophage activation syndrome in children with systemic lupus erythematosus and children with juvenile idiopathic arthritis,” Arthritis Rheum, vol. 64, pp. 4135-42, Dec. 2012.
[11] M. L. Mannion and T. Beukelman, “Risk of malignancy associated with biologic agents in pediatric rheumatic disease,” Curr Opin Rheumatol, vol. 26, pp. 538-42, Sep. 2014.
[12] T. Dorner and J. Kay, “Biosimilars in rheumatology: current perspectives and lessons learnt,” Nat Rev Rheumatol, Aug. 18 2015.
[13] L. B. Tucker, S. Menon, J. G. Schaller, and D. A. Isenberg, “Adult- and childhood-onset systemic lupus erythematosus: a comparison of onset, clinical features, serology, and outcome,” Br J Rheumatol, vol. 34, pp. 866-72, Sep. 1995.
[14] H. Almoallim, Y. Al-Ghamdi, H. Almaghrabi, and O. Alyasi, “Anti-Tumor Necrosis Factor-alpha Induced Systemic Lupus Erythematosus (),” Open Rheumatol J, vol. 6, pp. 315-9, 2012.
[15] A. Midgley, L. Watson, and M. W. Beresford, “New insights into the pathogenesis and management of lupus in children,” Arch Dis Child, vol. 99, pp. 563-7, Jun. 2014.
[16] A. Pontillo, E. C. Reis, B. L. Liphaus, C. A. Silva, and M. Carneiro-Sampaio, “Inflammasome polymorphisms in juvenile systemic lupus erythematosus,” Autoimmunity, pp. 1-4, Jul. 16 2015.
[17] A. Belot and R. Cimaz, “Monogenic forms of systemic lupus erythematosus: new insights into SLE pathogenesis,” Pediatr Rheumatol Online J, vol. 10, p. 21, 2012.
[18] L. E. Ballantine, J. Ong, A. Midgley, L. Watson, B. F. Flanagan, and M. W. Beresford, “The pro-inflammatory potential of T cells in juvenile-onset systemic lupus erythematosus,” Pediatr Rheumatol Online J, vol. 12, p. 4, 2014.
[19] A. Midgley and M. W. Beresford, “Increased expression of low density granulocytes in juvenile-onset systemic lupus erythematosus patients correlates with disease activity,” Lupus, Oct. 8 2015.
[20] M. J. Leandro, G. Cambridge, J. C. Edwards, M. R. Ehrenstein, and D. A. Isenberg, “B cell depletion in the treatment of patients with systemic lupus erythematosus: a longitudinal analysis of 24 patients,” Rheumatology (Oxford), vol. 44, pp. 1542-5, Dec. 2005.
[21] D. A. Isenberg, “Rituximab-it was the best of times, it was the worst of times,” Autoimmun Rev, vol. 11, pp. 790-1, Sep 2012.
[22] J. Aytan and M. A. Bukhari, “Use of biologics in SLE: a review of the evidence from a clinical perspective,” Rheumatology (Oxford), Sep. 30 2015.
[23] T. Y. Lu, K. P. Ng, G. Cambridge, M. J. Leandro, J. C. Edwards, M. Ehrenstein et al., “A retrospective seven-year analysis of the use of B cell depletion therapy in systemic lupus erythematosus at University College London Hospital: the first fifty patients,” Arthritis Rheum, vol. 61, pp. 482-7, Apr. 15 2009.
[24] M. E. Tsanyan, S. K. Soloviev, S. G. Radenska-Lopovok, A. V. Torgashina, E. V. Nikolaeva, Y. B. Khrennikov et al., “Clinical And Morphological Improvement Of Lupus Nephritis Treated With Rituximab,” Folia Med (Plovdiv), vol. 56, pp. 245-52, Oct.-Dec. 2014.
[25] L. Watson, M. Beresford, C. Maynes, C. Pilkington, S. Marks, Y. Glackin et al., “The indications, efficacy and adverse events of rituximab in a large cohort of patients with juvenile-onset SLE,” Lupus, Aug. 12 2014.
[26] J. T. Merrill, C. M. Neuwelt, D. J. Wallace, J. C. Shanahan, K. M. Latinis, J. C. Oates et al., “Efficacy and safety of rituximab in moderately-to-severely active systemic lupus erythematosus: the randomised, double-blind, phase II/III systemic lupus erythematosus evaluation of rituximab trial,” Arthritis Rheum, vol. 62, pp. 222-33, Jan. 2010.
[27] B. H. Rovin, R. Furie, K. Latinis, R. J. Looney, F. C. Fervenza, J. Sanchez-Guerrero et al., “Efficacy and safety of rituximab in patients with active proliferative lupus nephritis: the Lupus Nephritis Assessment with Rituximab study,” Arthritis Rheum, vol. 64, pp. 1215-26, Apr. 2012.
[28] R. A. Hickman, R. Hira-Kazal, C. S. Yee, V. Toescu, and C. Gordon, “The efficacy and safety of rituximab in a chart review study of 15 patients with systemic lupus erythematosus,” Clin Rheumatol, vol. 34, pp. 263-71, Feb. 2015.
[29] L. Watson, M. W. Beresford, C. Maynes, C. Pilkington, S. D. Marks, Y. Glackin et al., “The indications, efficacy and adverse events of rituximab in a large cohort of patients with juvenile-onset SLE,” Lupus, vol. 24, pp. 10-7, Jan. 2015.
[30] L. Lightstone, “Minimising steroids in lupus nephritis--will B cell depletion pave the way?” Lupus, vol. 22, pp. 390-9, Apr. 2013.
[31] M. B. Condon, D. Ashby, R. J. Pepper, H. T. Cook, J. B. Levy, M. Griffith et al., “Prospective observational single-centre cohort study to evaluate the effectiveness of treating lupus nephritis with rituximab and mycophenolate mofetil but no oral steroids,” Ann Rheum Dis, vol. 72, pp. 1280-6, Aug. 2013.
[32] J. Worch, O. Makarova, and B. Burkhardt, “Immunreconstitution and infectious complications after rituximab treatment in children and adolescents: what do we know and what can we learn from adults?” Cancers (Basel), vol. 7, pp. 305-28, 2015.
[33] Y. Liang, L. Zhang, J. Gao, D. Hu, and Y. Ai, “Rituximab for children with immune thrombocytopenia: a systematic review,” PLoS One, vol. 7, p. e36698, 2012.
[34] T. J. Lehman, C. Singh, A. Ramanathan, R. Alperin, A. Adams, L. Barinstein et al., “Prolonged improvement of childhood onset systemic lupus erythematosus following systematic administration of rituximab and cyclophosphamide,” Pediatr Rheumatol Online J, vol. 12, p. 3, 2014.
[35] P. Schneider, F. MacKay, V. Steiner, K. Hofmann, J. L. Bodmer, N. Holler et al., “BAFF, a novel ligand of the tumor necrosis factor family, stimulates B cell growth,” J Exp Med, vol. 189, pp. 1747-56, Jun. 7 1999.
[36] M. Yan, J. R. Brady, B. Chan, W. P. Lee, B. Hsu, S. Harless et al., “Identification of a novel receptor for B lymphocyte stimulator that is mutated in a mouse strain with severe B cell deficiency,” Curr Biol, vol. 11, pp. 1547-52, Oct. 2 2001.
[37] W. Stohl, “Biologic differences between various inhibitors of the BLyS/BAFF pathway: should we expect differences between belimumab and other inhibitors in development?,” Curr Rheumatol Rep, vol. 14, pp. 303-9, Aug. 2012.
[38] S. D. Hong, A. Reiff, H. T. Yang, T. S. Migone, C. D. Ward, K. Marzan et al., “B lymphocyte stimulator expression in pediatric systemic lupus erythematosus and juvenile idiopathic arthritis patients,” Arthritis Rheum, vol. 60, pp. 3400-9, Nov. 2009.
[39] S. V. Navarra, R. M. Guzman, A. E. Gallacher, S. Hall, R. A. Levy, R. E. Jimenez et al., “Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial,” Lancet, vol. 377, pp. 721-31, Feb. 26 2011.
[40] B. H. Hahn, “Belimumab for systemic lupus erythematosus,” N Engl J Med, vol. 368, pp. 1528-35, Apr. 18 2013.
[41] “Profile of atacicept and its potential in the treatment of systemic lupus erythematosus [Corrigendum],” Drug Des Devel Ther, vol. 9, p. 1865, 2015.
[42] E. M. Ginzler, S. Wax, A. Rajeswaran, S. Copt, J. Hillson, E. Ramos et al., “Atacicept in combination with MMF and corticosteroids in lupus nephritis: results of a prematurely terminated trial,” Arthritis Res Ther, vol. 14, p. R33, 2012.
[43] V. Rao and C. Gordon, “Evaluation of epratuzumab as a biologic therapy in systemic lupus erythematosus,” Immunotherapy, vol. 6, pp. 1165-75, 2014.
[44] E. F. Mysler, A. J. Spindler, R. Guzman, M. Bijl, D. Jayne, R. A. Furie et al., “Efficacy and safety of ocrelizumab in active proliferative lupus nephritis: results from a randomised, double-blind, phase III study,” Arthritis Rheum, vol. 65, pp. 2368-79, Sep. 2013.
[45] C. C. Thornton, N. Ambrose, and Y. Ioannou, “Ofatumumab: a novel treatment for severe systemic lupus erythematosus,” Rheumatology (Oxford), vol. 54, pp. 559-60, Mar. 2015.
[46] R. Coppo, L. Peruzzi, A. Amore, S. Martino, L. Vergano, I. Lastauka et al., “Dramatic effects of eculizumab in a child with diffuse proliferative lupus nephritis resistant to conventional therapy,” Pediatr Nephrol, vol. 30, pp. 167-72, Jan. 2015.
[47] Y. M. Mosaad, A. Hammad, Z. Fawzy, A. El-Refaaey, Z. Tawhid, E. M. Hammad et al., “C1q rs292001 polymorphism and C1q antibodies in juvenile lupus and their relation to lupus nephritis,” Clin Exp Immunol, vol. 182, pp. 23-34, Oct. 2015.
[48] F. Kanakoudi-Tsakalidou, E. Farmaki, V. Tzimouli, A. Taparkou, G. Paterakis, M. Trachana et al., “Simultaneous changes in serum HMGB1 and IFN-alpha levels and in LAIR-1 expression on plasmatoid dendritic cells of patients with juvenile SLE. New therapeutic options?” Lupus, vol. 23, pp. 305-12, Mar. 2014.
[49] U. Thanarajasingam and T. B. Niewold, “Sirukumab: a novel therapy for lupus nephritis?” Expert Opin Investig Drugs, vol. 23, pp. 1449-55, Oct. 2014.
[50] J. C. Szepietowski, S. Nilganuwong, A. Wozniacka, A. Kuhn, F. Nyberg, R. F. van Vollenhoven et al., “Phase I, randomised, double-blind, placebo-controlled, multiple intravenous, dose-ascending study of sirukumab in cutaneous or systemic lupus erythematosus,” Arthritis Rheum, vol. 65, pp. 2661-71, Oct. 2013.
[51] N. Ruperto, A. Ravelli, S. Oliveira, M. Alessio, D. Mihaylova, S. Pasic et al., “The Pediatric Rheumatology International Trials Organization/American College of Rheumatology provisional criteria for the evaluation of response to therapy in juvenile systemic lupus erythematosus: prospective validation of the definition of improvement,” Arthritis Rheum, vol. 55, pp. 355-63, Jun. 15 2006.
[52] C. S. Yee, D. A. Isenberg, A. Prabu, K. Sokoll, L. S. Teh, A. Rahman et al., “BILAG-2004 index captures systemic lupus erythematosus disease activity better than SLEDAI-2000,” Ann Rheum Dis, vol. 67, pp. 873-6, Jun. 2008.
[53] B. Lattanzi, A. Consolaro, N. Solari, N. Ruperto, A. Martini, and A. Ravelli, “Measures of disease activity and damage in pediatric systemic lupus erythematosus: British Isles Lupus Assessment Group (BILAG), European Consensus Lupus Activity Measurement (ECLAM), Systemic Lupus Activity Measure (SLAM), Systemic Lupus Erythematosus Disease Activity Index (SLEDAI), Physician’s Global Assessment of Disease Activity (MD Global), and Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SLICC/ACR DI; SDI),” Arthritis Care Res (Hoboken), vol. 63 Suppl. 11, pp. S112-7, Nov. 2011.

Chapter 3

[1] S. K. Shinjo, F. H. C. de Souza, and J. C. B. de Moraes, “Dermatomyositis and polymyositis: from immunopathology to immunotherapy (immunobiologics),” Rev. Bras. Reumatol. vol. 53, no. 1, pp. 101–110, Feb. 2013.
[2] T. D. Levine, “Rituximab in the treatment of dermatomyositis: an open-label pilot study,” Arthritis Rheum., vol. 52, no. 2, pp. 601–607, Feb. 2005.
[3] C. C. Mok, L. Y. Ho, and C. H. To, “Rituximab for refractory polymyositis: an open-label prospective study,” J. Rheumatol., vol. 34, no. 9, pp. 1864–1868, Sep. 2007.
[4] R. Valiyil, L. Casciola-Rosen, G. Hong, A. Mammen, and L. Christopher-Stine, “Rituximab therapy for myopathy associated with anti-signal recognition particle antibodies: a case series,” Arthritis Care Res., vol. 62, no. 9, pp. 1328–1334, Sep. 2010.
[5] R. Rios Fernández, J.-L. Callejas Rubio, D. Sánchez Cano, J.-A. Sáez Moreno, and N. Ortego Centeno, “Rituximab in the treatment of dermatomyositis and other inflammatory myopathies. A report of 4 cases and review of the literature,” Clin. Exp. Rheumatol., vol. 27, no. 6, pp. 1009–1016, Dec. 2009.
[6] H. V. Dinh, C. McCormack, S. Hall, and H. M. Prince, “Rituximab for the treatment of the skin manifestations of dermatomyositis: a report of 3 cases,” J. Am. Acad. Dermatol., vol. 56, no. 1, pp. 148–153, Jan. 2007.
[7] L. Chung, M. C. Genovese, and D. F. Fiorentino, “A pilot trial of rituximab in the treatment of patients with dermatomyositis,” Arch. Dermatol., vol. 143, no. 6, pp. 763–767, Jun. 2007.
[8] L. G. Rider, A. L. Yip, I. Horkayne-Szakaly, R. Volochayev, J. A. Shrader, M. L. Turner, H. H. Kong, M. S. Jain, A. V. Jansen, C. V. Oddis, T. A. Fleisher, and F. W. Miller, “Novel assessment tools to evaluate clinical and laboratory responses in a subset of patients enrolled in the Rituximab in Myositis trial,” Clin. Exp. Rheumatol., vol. 32, no. 5, pp. 689–696, Oct. 2014.
[9] M. A. Cooper, D. L. Willingham, D. E. Brown, A. R. French, F. F. Shih, and A. J. White, “Rituximab for the treatment of juvenile dermatomyositis: a report of four pediatric patients,” Arthritis Rheum., vol. 56, no. 9, pp. 3107–3111, Sep. 2007.
[10] B. Bader-Meunier, H. Decaluwe, C. Barnerias, R. Gherardi, P. Quartier, A. Faye, V. Guigonis, A. Pagnier, K. Brochard, J. Sibilia, J.-E. Gottenberg, C. Bodemer, and Club Rhumatismes et Inflammation, “Safety and efficacy of rituximab in severe juvenile dermatomyositis: results from 9 patients from the French Autoimmunity and Rituximab registry,” J. Rheumatol., vol. 38, no. 7, pp. 1436–1440, Jul. 2011.
[11] M. Sem, O. Molberg, M. B. Lund, and J. T. Gran, “Rituximab treatment of the anti-synthetase syndrome: a retrospective case series,” Rheumatol. Oxf. Engl. vol. 48, no. 8, pp. 968–971, Aug. 2009.
[12] E. Vandenbroucke, J. C. Grutters, J. Altenburg, W. G. Boersma, E. J. ter Borg, and J. M. M. van den Bosch, “Rituximab in life threatening antisynthetase syndrome,” Rheumatol. Int., vol. 29, no. 12, pp. 1499–1502, Oct. 2009.
[13] M. Couderc, J.-E. Gottenberg, X. Mariette, E. Hachulla, J. Sibilia, O. Fain, A. Hot, M. Dougados, L. Euller-Ziegler, P. Bourgeois, C. Larroche, A. Tournadre, Z. Amoura, B. Mazières, P. Arlet, M. De Bandt, T. Schaeverbeke, and M. Soubrier, “Efficacy and safety of rituximab in the treatment of refractory inflammatory myopathies in adults: results from the AIR registry,” Rheumatol. Oxf. Engl. vol. 50, no. 12, pp. 2283–2289, Dec. 2011.
[14] C. V. Oddis, A. M. Reed, R. Aggarwal, L. G. Rider, D. P. Ascherman, M. C. Levesque, R. J. Barohn, B. M. Feldman, M. O. Harris-Love, D. C. Koontz, N. Fertig, S. S. Kelley, S. L. Pryber, F. W. Miller, H. E. Rockette, and and the RIM Study Group, “Rituximab in the treatment of refractory adult and juvenile dermatomyositis and adult polymyositis: A randomised, placebo-phase trial,” Arthritis Rheum., vol. 65, no. 2, pp. 314–324, Feb. 2013.
[15] L. G. Rider, E. H. Giannini, H. I. Brunner, N. Ruperto, L. James-Newton, A. M. Reed, P. A. Lachenbruch, F. W. Miller, and International Myositis Assessment and Clinical Studies Group, “International consensus on preliminary definitions of improvement in adult and juvenile myositis,” Arthritis Rheum., vol. 50, no. 7, pp. 2281–2290, Jul. 2004.
[16] M. de Visser, “Editorial: The efficacy of rituximab in refractory myositis: The jury is still out,” Arthritis Rheum., vol. 65, no. 2, pp. 303–306, Feb. 2013.
[17] R. Aggarwal, A. Bandos, A. M. Reed, D. P. Ascherman, R. J. Barohn, B. M. Feldman, F. W. Miller, L. G. Rider, M. O. Harris-Love, M. C. Levesque, and C. V. Oddis, “Predictors of Clinical Improvement in Rituximab-Treated Refractory Adult and Juvenile Dermatomyositis and Adult Polymyositis,” Arthritis Rheumatol. Hoboken NJ, vol. 66, no. 3, pp. 740–749, Mar. 2014.
[18] L. Nalotto, L. Iaccarino, M. Zen, M. Gatto, E. Borella, M. Domenighetti, L. Punzi, and A. Doria, “Rituximab in refractory idiopathic inflammatory myopathies and antisynthetase syndrome: personal experience and review of the literature,” Immunol. Res., vol. 56, no. 2–3, pp. 362–370, Jul. 2013.
[19] P. Efthimiou, “Tumor necrosis factor-alpha in inflammatory myopathies: pathophysiology and therapeutic implications,” Semin. Arthritis Rheum. vol. 36, no. 3, pp. 168–172, Dec. 2006.
[20] G. J. D. Hengstman, F. H. J. van den Hoogen, P. Barrera, M. G. Netea, A. Pieterse, L. B. A. van de Putte, and B. G. M. van Engelen, “Successful treatment of dermatomyositis and polymyositis with anti-tumor-necrosis-factor-alpha: preliminary observations,” Eur. Neurol., vol. 50, no. 1, pp. 10–15, 2003.
[21] I. Uthman and J. El-Sayad, “Refractory polymyositis responding to infliximab,” Rheumatology, vol. 43, no. 9, pp. 1198–1199, Sep. 2004.
[22] M. Dastmalchi, C. Grundtman, H. Alexanderson, C. P. Mavragani, H. Einarsdottir, S. B. Helmers, K. Elvin, M. K. Crow, I. Nennesmo, and I. E. Lundberg, “A high incidence of disease flares in an open pilot study of infliximab in patients with refractory inflammatory myopathies,” Ann. Rheum. Dis., vol. 67, no. 12, pp. 1670–1677, Dec. 2008.
[23] G. J. D. Hengstman, J. L. De Bleecker, E. Feist, J. Vissing, C. P. Denton, M. N. Manoussakis, H. Slott Jensen, B. G. M. van Engelen, and F. H. J. van den Hoogen, “Open-label trial of anti-TNF-alpha in dermato- and polymyositis treated concomitantly with methotrexate,” Eur. Neurol., vol. 59, no. 3–4, pp. 159–163, 2008.
[24] P. Riley, L. J. McCann, S. M. Maillard, P. Woo, K. J. Murray, and C. A. Pilkington, “Effectiveness of infliximab in the treatment of refractory juvenile dermatomyositis with calcinosis,” Rheumatol. Oxf. Engl. vol. 47, no. 6, pp. 877–880, Jun. 2008.
[25] T. C. P. da Silva, F. Zon Pretti, and S. K. Shinjo, “Adalimumab in anti-synthetase syndrome,” Jt. Bone Spine Rev. Rhum., vol. 80, no. 4, p. 432, Jul. 2013.
[26] M. G. Brunasso, W. Aberer, and C. Massone, “New onset of dermatomyositis/
polymyositis during anti-TNF-α therapies: a systematic literature review,” ScientificWorldJournal, vol. 2014, p. 179180, 2014.
[27] H. Sprott, M. Glatzel, and B. A. Michel, “Treatment of myositis with etanercept (Enbrel), a recombinant human soluble fusion protein of TNF-alpha type II receptor and IgG1,” Rheumatol. Oxf. Engl. vol. 43, no. 4, pp. 524–526, Apr. 2004.
[28] F. Iannone, C. Scioscia, P. C. F. Falappone, M. Covelli, and G. Lapadula, “Use of etanercept in the treatment of dermatomyositis: a case series,” J. Rheumatol., vol. 33, no. 9, pp. 1802–1804, Sep. 2006.
[29] P. Efthimiou, S. Schwartzman, and L. J. Kagen, “Possible role for tumour necrosis factor inhibitors in the treatment of resistant dermatomyositis and polymyositis: a retrospective study of eight patients,” Ann. Rheum. Dis., vol. 65, no. 9, pp. 1233–1236, Sep. 2006.
[30] Muscle Study Group, “A randomised, pilot trial of etanercept in dermatomyositis,” Ann. Neurol., vol. 70, no. 3, pp. 427–436, Sep. 2011.
[31] I. Lundberg, A.-K. Ulfgren, P. Nyberg, U. Andersson, and L. Klareskog, “Cytokine production in muscle tissue of patients with idiopathic inflammatory myopathies,” Arthritis Rheum., vol. 40, no. 5, pp. 865–874, Maggio 1997.
[32] N. Okiyama, T. Sugihara, Y. Iwakura, H. Yokozeki, N. Miyasaka, and H. Kohsaka, “Therapeutic effects of interleukin-6 blockade in a murine model of polymyositis that does not require interleukin-17A,” Arthritis Rheum., vol. 60, no. 8, pp. 2505–2512, Aug. 2009.
[33] M. Narazaki, K. Hagihara, Y. Shima, A. Ogata, T. Kishimoto, and T. Tanaka, “Therapeutic effect of tocilizumab on two patients with polymyositis,” Rheumatol. Oxf. Engl. vol. 50, no. 7, pp. 1344–1346, Jul. 2011.
[34] M. Kondo, Y. Murakawa, T. Matsumura, O. Matsumoto, M. Taira, M. Moriyama, Y. Sumita, and S. Yamaguchi, “A case of overlap syndrome successfully treated with tocilizumab: a hopeful treatment strategy for refractory dermatomyositis?” Rheumatology, p. keu234, May 2014.
[35] K. Murata and M. C. Dalakas, “Expression of the costimulatory molecule BB-1, the ligands CTLA-4 and CD28, and their mRNA in inflammatory myopathies,” Am. J. Pathol., vol. 155, no. 2, pp. 453–460, Aug. 1999.
[36] J. L. Musuruana and J. A. Cavallasca, “Abatacept for treatment of refractory polymyositis,” Jt. Bone Spine Rev. Rhum., vol. 78, no. 4, pp. 431–432, Jul. 2011.
[37] B. Arabshahi, R. A. Silverman, O. Y. Jones, and L. G. Rider, “Abatacept and sodium thiosulfate for treatment of recalcitrant juvenile dermatomyositis complicated by ulceration and calcinosis,” J. Pediatr., vol. 160, no. 3, pp. 520–522, Mar. 2012.
[38] A. M. Kerola and M. J. Kauppi, “Abatacept as a successful therapy for myositis—a case-based review,” Clin. Rheumatol. vol. 34, no. 3, pp. 609–612, Mar. 2015.
[39] “http://acrabstracts.org/abstract/abatacept-in-the-treatment-of-adult-dermatomyositis-and-polymyositis-a-randomised-treatment-delayed-start-trial.”
[40] P. Englund, I. Nennesmo, L. Klareskog, and I. E. Lundberg, “Interleukin-1alpha expression in capillaries and major histocompatibility complex class I expression in type II muscle fibers from polymyositis and dermatomyositis patients: important pathogenic features independent of inflammatory cell clusters in muscle tissue,” Arthritis Rheum., vol. 46, no. 4, pp. 1044–1055, Apr. 2002.
[41] M. Zong, C. Dorph, M. Dastmalchi, H. Alexanderson, J. Pieper, P. Amoudruz, S. B. Helmers, I. Nennesmo, V. Malmström, and I. E. Lundberg, “Anakinra treatment in patients with refractory inflammatory myopathies and possible predictive response biomarkers: a mechanistic study with 12 months follow-up,” Ann. Rheum. Dis., vol. 73, no. 5, pp. 913–920, May 2014.
[42] M. L. Kosmidis, H. Alexopoulos, A. G. Tzioufas, and M. C. Dalakas, “The effect of anakinra, an IL1 receptor antagonist, in patients with sporadic inclusion body myositis (sIBM): a small pilot study,” J. Neurol. Sci., vol. 334, no. 1–2, pp. 123–125, Nov. 2013.
[43] E. C. Baechler, H. Bilgic, and A. M. Reed, “Type I interferon pathway in adult and juvenile dermatomyositis,” Arthritis Res. Ther., vol. 13, no. 6, p. 249, 2011.
[44] B. W. Higgs, W. Zhu, C. Morehouse, W. I. White, P. Brohawn, X. Guo, M. Rebelatto, C. Le, A. Amato, D. Fiorentino, S. A. Greenberg, J. Drappa, L. Richman, W. Greth, B. Jallal, and Y. Yao, “A phase 1b clinical trial evaluating sifalimumab, an anti-IFN-α monoclonal antibody, shows target neutralisation of a type I IFN signature in blood of dermatomyositis and polymyositis patients,” Ann. Rheum. Dis., vol. 73, no. 1, pp. 256–262, Jan. 2014.
[45] X. Guo, B. W. Higgs, M. Rebelatto, W. Zhu, W. Greth, Y. Yao, L. K. Roskos, and W. I. White, “Suppression of soluble T cell-associated proteins by an anti-interferon-α monoclonal antibody in adult patients with dermatomyositis or polymyositis,” Rheumatol. Oxf. Engl. vol. 53, no. 4, pp. 686–695, Apr. 2014.
[46] M. C. Dalakas, G. Rakocevic, J. Schmidt, M. Salajegheh, B. McElroy, M. O. Harris-Love, J. A. Shrader, E. W. Levy, J. Dambrosia, R. L. Kampen, D. A. Bruno, and A. D. Kirk, “Effect of Alemtuzumab (CAMPATH 1-H) in patients with inclusion-body myositis,” Brain J. Neurol., vol. 132, no. Pt 6, pp. 1536–1544, Jun. 2009.
[47] T. Ruck, S. Bittner, T. Kuhlmann, H. Wiendl, and S. G. Meuth, “Long-term efficacy of alemtuzumab in polymyositis,” Rheumatol. Oxf. Engl. vol. 54, no. 3, pp. 560–562, Mar. 2015.
[48] J. L. Jones, C.-L. Phuah, A. L. Cox, S. A. Thompson, M. Ban, J. Shawcross, A. Walton, S. J. Sawcer, A. Compston, and A. J. Coles, “IL-21 drives secondary autoimmunity in patients with multiple sclerosis, following therapeutic lymphocyte depletion with alemtuzumab (Campath-1H),” J. Clin. Invest. vol. 119, no. 7, pp. 2052–2061, Jul. 2009.
[49] A. A. Amato, K. Sivakumar, N. Goyal, W. S. David, M. Salajegheh, J. Praestgaard, E. Lach-Trifilieff, A.-U. Trendelenburg, D. Laurent, D. J. Glass, R. Roubenoff, B. S. Tseng, and S. A. Greenberg, “Treatment of sporadic inclusion body myositis with bimagrumab,” Neurology, vol. 83, no. 24, pp. 2239–2246, Dec. 2014.
[50] P. Szodoray, P. Alex, N. Knowlton, M. Centola, I. Dozmorov, I. Csipo, A. T. Nagy, T. Constantin, A. Ponyi, B. Nakken, and K. Danko, “Idiopathic inflammatory myopathies, signified by distinctive peripheral cytokines, chemokines and the TNF family members B-cell activating factor and a proliferation inducing ligand,” Rheumatol. Oxf. Engl., vol. 49, no. 10, pp. 1867–1877, Oct. 2010.
[51] C. Crescioli, M. Sottili, P. Bonini, L. Cosmi, P. Chiarugi, P. Romagnani, G. B. Vannelli, M. Colletti, A. M. Isidori, M. Serio, A. Lenzi, and L. Di Luigi, “Inflammatory response in human skeletal muscle cells: CXCL10 as a potential therapeutic target,” Eur. J. Cell Biol., vol. 91, no. 2, pp. 139–149, Feb. 2012.
[52] B. De Paepe, K. K. Creus, and J. L. De Bleecker, “The tumor necrosis factor superfamily of cytokines in the inflammatory myopathies: potential targets for therapy,” Clin. Dev. Immunol., vol. 2012, p. 369432, 2012.
[53] Takada K, Bookbinder S, Furie R, Oddis C, Mojcik C, Bombara M et al., “A pilot study of eculizumab in patients with dermatomyositis,” Arthritis Rheum., vol. 46, no. Suppl., p. S489, 2002.
[54] “https://clinicaltrials.gov/ct2/show/NCT02612857.”

Chapter 4

[1] U. F. Kamel, P. Maddison, and R. Whitaker, “Impact of primary Sjogren’s syndrome on smell and taste: effect on quality of life,” Rheumatology (Oxford), vol. 48, pp. 1512-4, Dec 2009.
[2] B. Strombeck, C. Ekdahl, R. Manthorpe, I. Wikstrom, and L. Jacobsson, “Health-related quality of life in primary Sjogren’s syndrome, rheumatoid arthritis and fibromyalgia compared to normal population data using SF-36,” Scand J Rheumatol, vol. 29, pp. 20-8, 2000.
[3] J. Champey, E. Corruble, J. E. Gottenberg, C. Buhl, T. Meyer, C. Caudmont, et al., “Quality of life and psychological status in patients with primary Sjogren’s syndrome and sicca symptoms without autoimmune features,” Arthritis Rheum, vol. 55, pp. 451-7, Jun 15 2006.
[4] G. Nocturne and X. Mariette, “Advances in understanding the pathogenesis of primary Sjogren’s syndrome,” Nat Rev Rheumatol, vol. 9, pp. 544-56, Sep 2013.
[5] G. Hernandez-Molina, C. Avila-Casado, F. Cardenas-Velazquez, C. Hernandez-Hernandez, M. L. Calderillo, V. Marroquin, et al., “Similarities and differences between primary and secondary Sjogren’s syndrome,” J Rheumatol, vol. 37, pp. 800-8, Apr 2010.
[6] E. Abrol, C. Gonzalez-Pulido, J. M. Praena-Fernandez, and D. A. Isenberg, “A retrospective study of long-term outcomes in 152 patients with primary Sjogren’s syndrome: 25-year experience,” Clin Med, vol. 14, pp. 157-64, Apr 2014.
[7] E. Theander, G. Henriksson, O. Ljungberg, T. Mandl, R. Manthorpe, and L. T. Jacobsson, “Lymphoma and other malignancies in primary Sjogren’s syndrome: a cohort study on cancer incidence and lymphoma predictors,” Ann Rheum Dis, vol. 65, pp. 796-803, Jun 2006.
[8] J. P. Ioannidis, V. A. Vassiliou, and H. M. Moutsopoulos, “Long-term risk of mortality and lymphoproliferative disease and predictive classification of primary Sjogren’s syndrome,” Arthritis Rheum, vol. 46, pp. 741-7, Mar 2002.
[9] M. N. Lazarus, D. Robinson, V. Mak, H. Moller, and D. A. Isenberg, “Incidence of cancer in a cohort of patients with primary Sjogren’s syndrome,” Rheumatology (Oxford), vol. 45, pp. 1012-5, Aug 2006.
[10] M. J. Fritzler, J. D. Pauls, T. D. Kinsella, and T. J. Bowen, “Antinuclear, anticytoplasmic, and anti-Sjogren’s syndrome antigen A (SS-A/Ro) antibodies in female blood donors,” Clin Immunol Immunopathol, vol. 36, pp. 120-8, Jul 1985.
[11] V. Goeb, V. Salle, P. Duhaut, F. Jouen, A. Smail, J. P. Ducroix, et al., “Clinical significance of autoantibodies recognizing Sjogren’s syndrome A (SSA), SSB, calpastatin and alpha-fodrin in primary Sjogren’s syndrome,” Clin Exp Immunol, vol. 148, pp. 281-7, May 2007.
[12] C. Diaz-Lopez, C. Geli, H. Corominas, N. Malat, C. Diaz-Torner, J. M. Llobet, et al., “Are there clinical or serological differences between male and female patients with primary Sjogren’s syndrome?,” Journal of Rheumatology, vol. 31, pp. 1352-1355, Jul 2004.
[13] R. Cervera, J. Font, M. Ramos-Casals, M. Garcia-Carrasco, J. Rosas, R. M. Morla, et al., “Primary Sjogren’s syndrome in men: clinical and immunological characteristics,” Lupus, vol. 9, pp. 61-4, 2000.
[14] M. Garcia-Carrasco, M. Ramos-Casals, J. Rosas, L. Pallares, J. Calvo-Alen, R. Cervera, et al., “Primary Sjogren syndrome: clinical and immunologic disease patterns in a cohort of 400 patients,” Medicine (Baltimore), vol. 81, pp. 270-80, Jul 2002.
[15] S. C. Shiboski, C. H. Shiboski, L. Criswell, A. Baer, S. Challacombe, H. Lanfranchi, et al., “American College of Rheumatology classification criteria for Sjogren’s syndrome: a data-driven, expert consensus approach in the Sjogren’s International Collaborative Clinical Alliance cohort,” Arthritis Care Res (Hoboken), vol. 64, pp. 475-87, Apr 2012.
[16] C. Vitali, S. Bombardieri, R. Jonsson, H. M. Moutsopoulos, E. L. Alexander, S. E. Carsons, et al., “Classification criteria for Sjogren’s syndrome: a revised version of the European criteria proposed by the American-European Consensus Group,” Ann Rheum Dis, vol. 61, pp. 554-8, Jun 2002.
[17] Y. Zhao, Y. Li, L. Wang, X. F. Li, C. B. Huang, G. C. Wang, et al., “Primary Sjogren syndrome in Han Chinese: clinical and immunological characteristics of 483 patients,” Medicine (Baltimore), vol. 94, p. e667, Apr 2015.
[18] P. Han, P. Suarez-Durall, and R. Mulligan, “Dry mouth: a critical topic for older adult patients,” J Prosthodont Res, vol. 59, pp. 6-19, Jan 2015.
[19] F. S. Usuba, J. B. Lopes, R. Fuller, J. H. Yamamoto, M. R. Alves, S. G. Pasoto, et al., “Sjogren’s syndrome: An underdiagnosed condition in mixed connective tissue disease,” Clinics (Sao Paulo), vol. 69, pp. 158-62, Mar 2014.
[20] M. Iacopino, “Sjogren syndrome: reduced quality of life as an oral-systemic consequence,” J Can Dent Assoc, vol. 76, p. a98, 2010.
[21] M. Stewart, K. M. Berg, S. Cha, and W. H. Reeves, “Salivary dysfunction and quality of life in Sjogren syndrome: a critical oral-systemic connection,” J Am Dent Assoc, vol. 139, pp. 291-9; quiz 358-9, Mar 2008.
[22] R. Priori, A. Minniti, M. Derme, B. Antonazzo, F. Brancatisano, S. Ghirini, et al., “Quality of Sexual Life in Women with Primary Sjogren Syndrome,” J Rheumatol, vol. 42, pp. 1427-31, Aug 2015.
[23] G. Lindahl, E. Hedfors, L. Klareskog, and U. Forsum, “Epithelial HLA-DR expression and T lymphocyte subsets in salivary glands in Sjogren’s syndrome,” Clin Exp Immunol, vol. 61, pp. 475-82, Sep 1985.
[24] Alunno, F. Carubbi, O. Bistoni, S. Caterbi, E. Bartoloni, B. Bigerna, et al., “CD4
(-)CD8(-) T cells in primary Sjogren’s syndrome: association with the extent of glandular involvement,” J Autoimmun, vol. 51, pp. 38-43, Jun 2014.
[25] M. Ramos-Casals, M. Garcia-Carrasco, R. Cervera, X. Filella, O. Trejo, G. de la Red,
et al., “Th1/Th2 cytokine imbalance in patients with Sjogren syndrome secondary to hepatitis C virus infection,” Semin Arthritis Rheum, vol. 32, pp. 56-63, Aug 2002.
[26] S. A. Lim, D. H. Nam, J. H. Lee, S. K. Kwok, S. H. Park, and S. H. Chung, “Association of IL21 cytokine with severity of primary Sjogren syndrome dry eye,” Cornea, vol. 34, pp. 248-52, Mar 2015.
[27] E. H. Kang, Y. J. Lee, J. Y. Hyon, P. Y. Yun, and Y. W. Song, “Salivary cytokine profiles in primary Sjogren’s syndrome differ from those in non-Sjogren sicca in terms of TNF-alpha levels and Th-1/Th-2 ratios,” Clin Exp Rheumatol, vol. 29, pp. 970-6, Nov-Dec 2011.
[28] E. Baimpa, I. J. Dahabreh, M. Voulgarelis, and H. M. Moutsopoulos, “Hematologic manifestations and predictors of lymphoma development in primary Sjogren syndrome: clinical and pathophysiologic aspects,” Medicine (Baltimore), vol. 88, pp. 284-93, Sep 2009.
[29] P. Risselada, A. A. Kruize, R. Goldschmeding, F. P. Lafeber, J. W. Bijlsma, and J. A. van Roon, “The prognostic value of routinely performed minor salivary gland assessments in primary Sjogren’s syndrome,” Ann Rheum Dis, vol. 73, pp. 1537-40, Aug 2014.
[30] K. Obinata, T. Sato, K. Ohmori, M. Shindo, and M. Nakamura, “A comparison of diagnostic tools for Sjogren syndrome, with emphasis on sialography, histopathology, and ultrasonography,” Oral Surg Oral Med Oral Pathol Oral Radiol Endod, vol. 109, pp. 129-34, Jan 2010.
[31] R. Bamba, N. J. Sweiss, A. J. Langerman, J. B. Taxy, and E. A. Blair, “The minor salivary gland biopsy as a diagnostic tool for Sjogren syndrome,” Laryngoscope, vol. 119, pp. 1922-6, Oct 2009.
[32] C. Vitali, G. Palombi, C. Baldini, M. Benucci, S. Bombardieri, M. Covelli, et al., “Sjogren’s Syndrome Disease Damage Index and disease activity index: scoring systems for the assessment of disease damage and disease activity in Sjogren’s syndrome, derived from an analysis of a cohort of Italian patients,” Arthritis Rheum, vol. 56, pp. 2223-31, Jul 2007.
[33] R. Seror, E. Theander, J. G. Brun, M. Ramos-Casals, V. Valim, T. Dorner, et al., “Validation of EULAR primary Sjogren’s syndrome disease activity (ESSDAI) and patient indexes (ESSPRI),” Ann Rheum Dis, vol. 74, pp. 859-66, May 2015.
[34] R. Seror, P. Ravaud, X. Mariette, H. Bootsma, E. Theander, A. Hansen, et al., “EULAR Sjogren’s Syndrome Patient Reported Index (ESSPRI): development of a consensus patient index for primary Sjogren’s syndrome,” Ann Rheum Dis, vol. 70, pp. 968-72, Jun 2011.
[35] Campar and D. A. Isenberg, “Primary Sjogren’s syndrome activity and damage indices comparison,” Eur J Clin Invest, vol. 40, pp. 636-44, Jul 2010.
[36] S. J. Bowman, N. Sutcliffe, D. A. Isenberg, F. Goldblatt, M. Adler, E. Price, et al., “Sjogren’s Systemic Clinical Activity Index (SCAI)--a systemic disease activity measure for use in clinical trials in primary Sjogren’s syndrome,” Rheumatology (Oxford), vol. 46, pp. 1845-51, Dec 2007.
[37] P. Brito-Zeron, B. Kostov, R. Solans, G. Fraile, C. Suarez-Cuervo, A. Casanovas, et al., “Systemic activity and mortality in primary Sjogren syndrome: predicting survival using the EULAR-SS Disease Activity Index (ESSDAI) in 1045 patients,” Ann Rheum Dis, Nov 28 2014.
[38] R. Seror, E. Theander, J. G. Brun, M. Ramos-Casals, V. Valim, T. Dorner, et al., “Validation of EULAR primary Sjogren’s syndrome disease activity (ESSDAI) and patient indexes (ESSPRI),” Ann Rheum Dis, vol. 74, pp. 859-66, May 2015.
[39] G. Nocturne and X. Mariette, “Sjogren Syndrome-associated lymphomas: an update on pathogenesis and management,” Br J Haematol, vol. 168, pp. 317-27, Feb 2015.
[40] S. Salomonsson, B. L. Rozell, M. Heimburger, and M. Wahren-Herlenius, “Minor salivary gland immunohistology in the diagnosis of primary Sjogren’s syndrome,” J Oral Pathol Med, vol. 38, pp. 282-8, Mar 2009.
[41] Toda, “Autoantigens and Sjogren syndrome,” Cornea, vol. 21, pp. S13-6, Mar 2002.
[42] Y. F. Huang, Q. Cheng, C. M. Jiang, S. An, L. Xiao, Y. C. Gou, et al., “The immune factors involved in the pathogenesis, diagnosis, and treatment of Sjogren’s syndrome,” Clin Dev Immunol, vol. 2013, p. 160491, 2013.
[43] R. F. Abu-Helu, I. D. Dimitriou, E. K. Kapsogeorgou, H. M. Moutsopoulos, and M. N. Manoussakis, “Induction of salivary gland epithelial cell injury in Sjogren’s syndrome: in vitro assessment of T cell-derived cytokines and Fas protein expression,” J Autoimmun, vol. 17, pp. 141-53, Sep 2001.
[44] M. Ohlsson, K. Skarstein, A. I. Bolstad, A. C. Johannessen, and R. Jonsson, “Fas-induced apoptosis is a rare event in Sjogren’s syndrome,” Lab Invest, vol. 81, pp. 95-105, Jan 2001.
[45] C. S. Tam, M. Wolf, H. M. Prince, E. H. Januszewicz, D. Westerman, K. I. Lin, et al., “Fludarabine, cyclophosphamide, and rituximab for the treatment of patients with chronic lymphocytic leukemia or indolent non-Hodgkin lymphoma,” Cancer, vol. 106, pp. 2412-20, Jun 1 2006.
[46] D. Rudnicka, A. Oszmiana, D. K. Finch, I. Strickland, D. J. Schofield, D. C. Lowe,
et al., “Rituximab causes a polarization of B cells that augments its therapeutic function in NK-cell-mediated antibody-dependent cellular cytotoxicity,” Blood, vol. 121, pp. 4694-702, Jun 6 2013.
[47] T. van Meerten, R. S. van Rijn, S. Hol, A. Hagenbeek, and S. B. Ebeling, “Complement-induced cell death by rituximab depends on CD20 expression level and acts complementary to antibody-dependent cellular cytotoxicity,” Clin Cancer Res, vol. 12, pp. 4027-35, Jul 1 2006.
[48] Saraux, V. Devauchelle, S. Jousse, and P. Youinou, “Rituximab in rheumatic diseases,” Joint Bone Spine, vol. 74, pp. 4-6, Jan 2007.
[49] G. Somer, D. E. Tsai, L. Downs, B. Weinstein, and S. J. Schuster, “Improvement in Sjogren’s syndrome following therapy with rituximab for marginal zone lymphoma,” Arthritis Rheum, vol. 49, pp. 394-8, Jun 15 2003.
[50] M. Voulgarelis, S. Giannouli, D. Anagnostou, and A. G. Tzioufas, “Combined therapy with rituximab plus cyclophosphamide/doxorubicin/vincristine/prednisone (CHOP) for Sjogren’s syndrome-associated B cell aggressive non-Hodgkin’s lymphomas,” Rheumatology (Oxford), vol. 43, pp. 1050-3, Aug 2004.
[51] T. Ring, M. Kallenbach, J. Praetorius, S. Nielsen, and B. Melgaard, “Successful treatment of a patient with primary Sjogren’s syndrome with Rituximab,” Clin Rheumatol, vol. 25, pp. 891-4, Nov 2006.
[52] Z. Touma, J. Sayad, and T. Arayssi, “Successful treatment of Sjogren’s syndrome with rituximab,” Scand J Rheumatol, vol. 35, pp. 323-5, Jul-Aug 2006.
[53] Ahmadi-Simab, P. Lamprecht, B. Nolle, M. Ai, and W. L. Gross, “Successful treatment of refractory anterior scleritis in primary Sjogren’s syndrome with rituximab,” Ann Rheum Dis, vol. 64, pp. 1087-8, Jul 2005.
[54] Pijpe, G. W. van Imhoff, F. K. Spijkervet, J. L. Roodenburg, G. J. Wolbink, K. Mansour, et al., “Rituximab treatment in patients with primary Sjogren’s syndrome: an open-label phase II study,” Arthritis Rheum, vol. 52, pp. 2740-50, Sep 2005.
[55] J. E. Gottenberg, G. Cinquetti, C. Larroche, B. Combe, E. Hachulla, O. Meyer, et al., “Efficacy of rituximab in systemic manifestations of primary Sjogren’s syndrome: results in 78 patients of the AutoImmune and Rituximab registry,” Ann Rheum Dis, vol. 72, pp. 1026-31, Jun 2013.
[56] R. Seror, C. Sordet, L. Guillevin, E. Hachulla, C. Masson, M. Ittah, et al., “Tolerance and efficacy of rituximab and changes in serum B cell biomarkers in patients with systemic complications of primary Sjogren’s syndrome,” Ann Rheum Dis, vol. 66, pp. 351-7, Mar 2007.
[57] V. Devauchelle-Pensec, Y. Pennec, J. Morvan, J. O. Pers, C. Daridon, S. Jousse-Joulin, et al., “Improvement of Sjogren’s syndrome after two infusions of rituximab (anti-CD20),” Arthritis Rheum, vol. 57, pp. 310-7, Mar 15 2007.
[58] J. M. Meijer, P. M. Meiners, A. Vissink, F. K. Spijkervet, W. Abdulahad, N. Kamminga, et al., “Effectiveness of rituximab treatment in primary Sjogren’s syndrome: a randomised, double-blind, placebo-controlled trial,” Arthritis Rheum, vol. 62, pp. 960-8, Apr 2010.
[59] J. Pijpe, J. M. Meijer, H. Bootsma, J. E. van der Wal, F. K. Spijkervet, C. G. Kallenberg, et al., “Clinical and histologic evidence of salivary gland restoration supports the efficacy of rituximab treatment in Sjogren’s syndrome,” Arthritis Rheum, vol. 60, pp. 3251-6, Nov 2009.
[60] F. Carubbi, P. Cipriani, A. Marrelli, P. Benedetto, P. Ruscitti, O. Berardicurti, et al., “Efficacy and safety of rituximab treatment in early primary Sjogren’s syndrome:
a prospective, multi-center, follow-up study,” Arthritis Res Ther, vol. 15, p. R172, 2013.
[61] P. M. Meiners, S. Arends, J. M. Meijer, R. V. Moerman, F. K. Spijkervet, A. Vissink, et al., “Efficacy of retreatment with rituximab in patients with primary Sjogren’s syndrome,” Clin Exp Rheumatol, vol. 33, pp. 443-4, May-Jun 2015.
[62] F. Kausar, K. Mustafa, G. Sweis, R. Sawaqed, K. Alawneh, R. Salloum, et al., “Ocrelizumab: a step forward in the evolution of B cell therapy,” Expert Opin Biol Ther, vol. 9, pp. 889-95, Jul 2009.
[63] W. Stohl, J. Gomez-Reino, E. Olech, J. Dudler, R. M. Fleischmann, C. A. Zerbini, et al., “Safety and efficacy of ocrelizumab in combination with methotrexate in MTX-naive subjects with rheumatoid arthritis: the phase III FILM trial,” Ann Rheum Dis, vol. 71, pp. 1289-96, Aug 2012.
[64] R. Kurrasch, J. C. Brown, M. Chu, J. Craigen, P. Overend, B. Patel, et al., “Subcutaneously administered ofatumumab in rheumatoid arthritis: a phase I/II study of safety, tolerability, pharmacokinetics, and pharmacodynamics,” J Rheumatol, vol. 40, pp. 1089-96, Jul 2013.
[65] P. C. Taylor, E. Quattrocchi, S. Mallett, R. Kurrasch, J. Petersen, and D. J. Chang, “Ofatumumab, a fully human anti-CD20 monoclonal antibody, in biological-naive, rheumatoid arthritis patients with an inadequate response to methotrexate:
a randomised, double-blind, placebo-controlled clinical trial,” Ann Rheum Dis, vol. 70, pp. 2119-25, Dec 2011.
[66] Nitschke, “The role of CD22 and other inhibitory co-receptors in B cell activation,” Curr Opin Immunol, vol. 17, pp. 290-7, Jun 2005.
[67] J. P. Leonard and D. M. Goldenberg, “Preclinical and clinical evaluation of epratuzumab (anti-CD22 IgG) in B cell malignancies,” Oncogene, vol. 26, pp. 3704-13, May 28 2007.
[68] S. D. Steinfeld, L. Tant, G. R. Burmester, N. K. Teoh, W. A. Wegener, D. M. Goldenberg, et al., “Epratuzumab (humanised anti-CD22 antibody) in primary Sjogren’s syndrome: an open-label phase I/II study,” Arthritis Res Ther, vol. 8, p. R129, 2006.
[69] P. Szodoray and R. Jonsson, “The BAFF/APRIL system in systemic autoimmune diseases with a special emphasis on Sjogren’s syndrome,” Scand J Immunol, vol. 62, pp. 421-8, Nov 2005.
[70] M. Varin, L. Le Pottier, P. Youinou, D. Saulep, F. Mackay, and J. O. Pers, “B cell tolerance breakdown in Sjogren’s syndrome: focus on BAFF,” Autoimmun Rev, vol. 9, pp. 604-8, Jul 2010.
[71] J. Groom, S. L. Kalled, A. H. Cutler, C. Olson, S. A. Woodcock, P. Schneider, et al., “Association of BAFF/BLyS overexpression and altered B cell differentiation with Sjogren’s syndrome,” J Clin Invest, vol. 109, pp. 59-68, Jan 2002.
[72] F. Mackay, S. A. Woodcock, P. Lawton, C. Ambrose, M. Baetscher, P. Schneider,
et al., “Mice transgenic for BAFF develop lymphocytic disorders along with autoimmune manifestations,” J Exp Med, vol. 190, pp. 1697-710, Dec 6 1999.
[73] S. Walters, K. E. Webster, A. Sutherland, S. Gardam, J. Groom, D. Liuwantara, et al., “Increased CD4+Foxp3+ T cells in BAFF-transgenic mice suppress T cell effector responses,” J Immunol, vol. 182, pp. 793-801, Jan 15 2009.
[74] F. Lavie, C. Miceli-Richard, J. Quillard, S. Roux, P. Leclerc, and X. Mariette, “Expression of BAFF (BLyS) in T cells infiltrating labial salivary glands from patients with Sjogren’s syndrome,” J Pathol, vol. 202, pp. 496-502, Apr 2004.
[75] C. A. Fletcher, J. R. Groom, B. Woehl, H. Leung, C. Mackay, and F. Mackay, “Development of autoimmune nephritis in genetically asplenic and splenectomized BAFF transgenic mice,” J Autoimmun, vol. 36, pp. 125-34, Mar 2011.
[76] V. Jonsson, P. Szodoray, S. Jellestad, R. Jonsson, and K. Skarstein, “Association between circulating levels of the novel TNF family members APRIL and BAFF and lymphoid organization in primary Sjogren’s syndrome,” J Clin Immunol, vol. 25, pp. 189-201, May 2005.
[77] G. Mumcu, M. Bicakcigil, N. Yilmaz, H. Ozay, U. Karacayli, H. Cimilli, et al., “Salivary and serum B cell activating factor (BAFF) levels after hydroxychloroquine treatment in primary Sjogren’s syndrome,” Oral Health Prev Dent, vol. 11, pp. 229-34, 2013.
[78] R. P. Pollard, W. H. Abdulahad, A. Vissink, N. Hamza, J. G. Burgerhof, J. M. Meijer, et al., “Serum levels of BAFF, but not APRIL, are increased after rituximab treatment in patients with primary Sjogren’s syndrome: data from a placebo-controlled clinical trial,” Ann Rheum Dis, vol. 72, pp. 146-8, Jan 2013.
[79] X. Mariette, R. Seror, L. Quartuccio, G. Baron, S. Salvin, M. Fabris, et al., “Efficacy and safety of belimumab in primary Sjogren’s syndrome: results of the BELISS open-label phase II study,” Ann Rheum Dis, vol. 74, pp. 526-31, Mar 2015.
[80] S. De Vita, L. Quartuccio, R. Seror, S. Salvin, P. Ravaud, M. Fabris, et al., “Efficacy and safety of belimumab given for 12 months in primary Sjogren’s syndrome: the BELISS open-label phase II study,” Rheumatology (Oxford), Aug 4 2015.
[81] D. Isenberg, C. Gordon, D. Licu, S. Copt, C. P. Rossi, and D. Wofsy, “Efficacy and safety of atacicept for prevention of flares in patients with moderate-to-severe systemic lupus erythematosus (SLE): 52-week data (APRIL-SLE randomised trial),” Ann Rheum Dis, Jun 20 2014.
[82] R. F. van Vollenhoven, N. Kinnman, E. Vincent, S. Wax, and J. Bathon, “Atacicept in patients with rheumatoid arthritis and an inadequate response to methotrexate: results of a phase II, randomised, placebo-controlled trial,” Arthritis Rheum, vol. 63, pp. 1782-92, Jul 2011.
[83] S. De Vita, L. Quartuccio, S. Salvin, L. Picco, C. A. Scott, M. Rupolo, et al., “Sequential therapy with belimumab followed by rituximab in Sjogren’s syndrome associated with B cell lymphoproliferation and overexpression of BAFF: evidence for long-term efficacy,” Clin Exp Rheumatol, vol. 32, pp. 490-4, Jul-Aug 2014.
[84] Singh and P. L. Cohen, “The T cell in Sjogren’s syndrome: force majeure, not spectateur,” J Autoimmun, vol. 39, pp. 229-33, Sep 2012.
[85] D. A. Isenberg, D. Rowe, A. Tookman, A. Hopp, M. Griffiths, E. Paice, et al., “An immunohistological study of secondary Sjogren’s syndrome,” Ann Rheum Dis, vol. 43, pp. 470-6, Jun 1984.
[86] R. I. Fox, T. C. Adamson, 3rd, S. Fong, C. Young, and F. V. Howell, “Characterization of the phenotype and function of lymphocytes infiltrating the salivary gland in patients with primary Sjogren syndrome,” Diagn Immunol, vol. 1, pp. 233-9, 1983.
[87] T. C. Adamson, 3rd, R. I. Fox, D. M. Frisman, and F. V. Howell, “Immunohistologic analysis of lymphoid infiltrates in primary Sjogren’s syndrome using monoclonal antibodies,” J Immunol, vol. 130, pp. 203-8, Jan 1983.
[88] Youinou and J. O. Pers, “Disturbance of cytokine networks in Sjogren’s syndrome,” Arthritis Res Ther, vol. 13, p. 227, 2011.
[89] N. Turkcapar, S. D. Sak, M. Saatci, M. Duman, and U. Olmez, “Vasculitis and expression of vascular cell adhesion molecule-1, intercellular adhesion molecule-1, and E-selectin in salivary glands of patients with Sjogren’s syndrome,” J Rheumatol, vol. 32, pp. 1063-70, Jun 2005.
[90] J. Lamey, F. T. Lundy, and I. Al-Hashimi, “Sjogren’s syndrome: a condition with features of chronic graft-versus-host disease: does duct cell adhesion or permeability play a role in pathogenesis?,” Med Hypotheses, vol. 62, pp. 825-9, 2004.
[91] G. Herrero-Beaumont, M. J. Martinez Calatrava, and S. Castaneda, “Abatacept mechanism of action: concordance with its clinical profile,” Reumatol Clin, vol. 8, pp. 78-83, Mar-Apr 2012.
[92] Downie-Doyle, N. Bayat, M. Rischmueller, and S. Lester, “Influence of CTLA4 haplotypes on susceptibility and some extra-glandular manifestations in primary Sjogren’s syndrome,” Arthritis Rheum, vol. 54, pp. 2434-40, Aug 2006.
[93] J. E. Gottenberg, P. Loiseau, M. Azarian, C. Chen, N. Cagnard, E. Hachulla, et al., “CTLA-4 +49A/G and CT60 gene polymorphisms in primary Sjogren syndrome,” Arthritis Res Ther, vol. 9, p. R24, 2007.
[94] Adler, M. Korner, F. Forger, D. Huscher, M. D. Caversaccio, and P. M. Villiger, “Evaluation of histologic, serologic, and clinical changes in response to abatacept treatment of primary Sjogren’s syndrome: a pilot study,” Arthritis Care Res (Hoboken), vol. 65, pp. 1862-8, Nov 2013.
[95] P. M. Meiners, A. Vissink, F. G. Kroese, F. K. Spijkervet, N. S. Smitt-Kamminga, W. H. Abdulahad, et al., “Abatacept treatment reduces disease activity in early primary Sjogren’s syndrome (open-label proof of concept ASAP study),” Ann Rheum Dis, vol. 73, pp. 1393-6, Jul 2014.
[96] P. R. Sada, D. Isenberg, and C. Ciurtin, “Biologic treatment in Sjogren’s syndrome,” Rheumatology (Oxford), vol. 54, pp. 219-30, Feb 2015.
[97] H. Tsuboi, I. Matsumoto, S. Hagiwara, T. Hirota, H. Takahashi, H. Ebe, et al., “Efficacy and safety of abatacept for patients with Sjogren’s syndrome associated with rheumatoid arthritis: rheumatoid arthritis with orencia trial toward Sjogren’s syndrome Endocrinopathy (ROSE) trial-an open-label, one-year, prospective study-Interim analysis of 32 patients for 24 weeks,” Mod Rheumatol, vol. 25, pp. 187-93, Mar 2015.
[98] M. Ramos-Casals and P. Brito-Zeron, “Emerging biological therapies in primary Sjogren’s syndrome,” Rheumatology (Oxford), vol. 46, pp. 1389-96, Sep 2007.
[99] E. A. Georgakopoulou, D. Andreadis, E. Arvanitidis, and P. Loumou, “Biologic agents and oral diseases -- an update on clinical applications,” Acta Dermatovenerol Croat, vol. 21, pp. 24-34, 2013.
[100] R. K. Sivamani, G. Correa, Y. Ono, M. P. Bowen, S. P. Raychaudhuri, and E. Maverakis, “Biological therapy of psoriasis,” Indian J Dermatol, vol. 55, pp. 161-70, Apr-Jun 2010.
[101] N. Scheinfeld, “Alefacept: a safety profile,” Expert Opin Drug Saf, vol. 4, pp. 975-85, Nov 2005.
[102] E. Guttman-Yassky, Y. Vugmeyster, M. A. Lowes, F. Chamian, T. Kikuchi, M. Kagen, et al., “Blockade of CD11a by efalizumab in psoriasis patients induces a unique state of T cell hyporesponsiveness,” J Invest Dermatol, vol. 128, pp. 1182-91, May 2008.
[103] A. Miller and E. St Onge, “Otelixizumab: a novel agent for the prevention of type 1 diabetes mellitus,” Expert Opin Biol Ther, vol. 11, pp. 1525-32, Nov 2011.
[104] P. Wiczling, M. Rosenzweig, L. Vaickus, and W. J. Jusko, “Pharmacokinetics and pharmacodynamics of a chimeric/humanised anti-CD3 monoclonal antibody, otelixizumab (TRX4), in subjects with psoriasis and with type 1 diabetes mellitus,” J Clin Pharmacol, vol. 50, pp. 494-506, May 2010.
[105] N. Roescher, P. P. Tak, and G. G. Illei, “Cytokines in Sjogren’s syndrome: potential therapeutic targets,” Ann Rheum Dis, vol. 69, pp. 945-8, Jun 2010.
[106] S. Y. Lee, S. J. Han, S. M. Nam, S. C. Yoon, J. M. Ahn, T. I. Kim, et al., “Analysis of tear cytokines and clinical correlations in Sjogren syndrome dry eye patients and non-Sjogren syndrome dry eye patients,” Am J Ophthalmol, vol. 156, pp. 247-253 e1, Aug 2013.
[107] H. Koski, A. Janin, M. G. Humphreys-Beher, T. Sorsa, M. Malmstrom, and Y. T. Konttinen, “Tumor necrosis factor-alpha and receptors for it in labial salivary glands in Sjogren’s syndrome,” Clin Exp Rheumatol, vol. 19, pp. 131-7, Mar-Apr 2001.
[108] R. Matsumura, K. Umemiya, M. Kagami, H. Tomioka, E. Tanabe, T. Sugiyama, et al., “Expression of TNF-related apoptosis inducing ligand (TRAIL) on infiltrating cells and of TRAIL receptors on salivary glands in patients with Sjogren’s syndrome,” Clin Exp Rheumatol, vol. 20, pp. 791-8, Nov-Dec 2002.
[109] S. D. Steinfeld, P. Demols, I. Salmon, R. Kiss, and T. Appelboom, “Infliximab in patients with primary Sjogren’s syndrome: a pilot study,” Arthritis Rheum, vol. 44, pp. 2371-5, Oct 2001.
[110] S. D. Steinfeld, P. Demols, and T. Appelboom, “Infliximab in primary Sjogren’s syndrome: one-year followup,” Arthritis Rheum, vol. 46, pp. 3301-3, Dec 2002.
[111] X. Mariette, P. Ravaud, S. Steinfeld, G. Baron, J. Goetz, E. Hachulla, et al., “Inefficacy of infliximab in primary Sjogren’s syndrome: results of the randomised, controlled Trial of Remicade in Primary Sjogren’s Syndrome (TRIPSS),” Arthritis Rheum, vol. 50, pp. 1270-6, Apr 2004.
[112] S. D. Steinfeld, P. Demols, I. Salmon, R. Kiss, and T. Appelboom, “Notice of retraction of two articles (“Infliximab in patients with primary Sjogren’s syndrome: a pilot study” and “Infliximab in patients with primary Sjogren’s syndrome: one-year followup”),” Arthritis Rheum, vol. 65, p. 814, Mar 2013.
[113] M. M. Zandbelt, P. de Wilde, P. van Damme, C. B. Hoyng, L. van de Putte, and F. van den Hoogen, “Etanercept in the treatment of patients with primary Sjogren’s syndrome: a pilot study,” J Rheumatol, vol. 31, pp. 96-101, Jan 2004.
[114] Sankar, M. T. Brennan, M. R. Kok, R. A. Leakan, J. A. Smith, J. Manny, et al., “Etanercept in Sjogren’s syndrome: a twelve-week randomised, double-blind, placebo-controlled pilot clinical trial,” Arthritis Rheum, vol. 50, pp. 2240-5, Jul 2004.
[115] C. P. Mavragani, T. B. Niewold, N. M. Moutsopoulos, S. R. Pillemer, S. M. Wahl, and M. K. Crow, “Augmented interferon-alpha pathway activation in patients with Sjogren’s syndrome treated with etanercept,” Arthritis Rheum, vol. 56, pp. 3995-4004, Dec 2007.
[116] Z. Brkic and M. A. Versnel, “Type I IFN signature in primary Sjogren’s syndrome patients,” Expert Rev Clin Immunol, vol. 10, pp. 457-67, Apr 2014.
[117] Z. Brkic, N. I. Maria, C. G. van Helden-Meeuwsen, J. P. van de Merwe, P. L. van Daele, V. A. Dalm, et al., “Prevalence of interferon type I signature in CD14 monocytes of patients with Sjogren’s syndrome and association with disease activity and BAFF gene expression,” Ann Rheum Dis, vol. 72, pp. 728-35, May 2013.
[118] G. F. Ferraccioli, F. Salaffi, S. De Vita, L. Casatta, C. Avellini, M. Carotti, et al., “Interferon alpha-2 (IFN alpha 2) increases lacrimal and salivary function in Sjogren’s syndrome patients. Preliminary results of an open pilot trial versus OH-chloroquine,” Clin Exp Rheumatol, vol. 14, pp. 367-71, Jul-Aug 1996.
[119] J. K. Smith, A. A. Siddiqui, L. A. Modica, R. Dykes, C. Simmons, J. Schmidt, et al., “Interferon-alpha upregulates gene expression of aquaporin-5 in human parotid glands,” J Interferon Cytokine Res, vol. 19, pp. 929-35, Aug 1999.
[120] J. A. Ship, P. C. Fox, J. E. Michalek, M. J. Cummins, and A. B. Richards, “Treatment of primary Sjogren’s syndrome with low-dose natural human interferon-alpha administered by the oral mucosal route: a phase II clinical trial. IFN Protocol Study Group,” J Interferon Cytokine Res, vol. 19, pp. 943-51, Aug 1999.
[121] V. Khurshudian, “A pilot study to test the efficacy of oral administration of interferon-alpha lozenges to patients with Sjogren’s syndrome,” Oral Surg Oral Med Oral Pathol Oral Radiol Endod, vol. 95, pp. 38-44, Jan 2003.
[122] M. J. Cummins, A. Papas, G. M. Kammer, and P. C. Fox, “Treatment of primary Sjogren’s syndrome with low-dose human interferon alfa administered by the oromucosal route: combined phase III results,” Arthritis Rheum, vol. 49, pp. 585-93, Aug 15 2003.
[123] T. Komai, H. Shoda, K. Yamaguchi, K. Sakurai, M. Shibuya, K. Kubo, et al., “Neuromyelitis optica spectrum disorder complicated with Sjogren syndrome successfully treated with tocilizumab: A case report,” Mod Rheumatol, Dec 9 2013.
[124] S. Rist, J. Sellam, E. Hachulla, C. Sordet, X. Puechal, P. Y. Hatron, et al., “Experience of intravenousIgtherapy in neuropathy associated with primary Sjogren’s syndrome: a national multicentric retrospective study,” Arthritis Care Res (Hoboken), vol. 63, pp. 1339-44, Sep 2011.
[125] S. Morozumi, Y. Kawagashira, M. Iijima, H. Koike, N. Hattori, M. Katsuno, et al., “IntravenousIgtreatment for painful sensory neuropathy associated with Sjogren’s syndrome,” J Neurol Sci, vol. 279, pp. 57-61, Apr 15 2009.
[126] N. Martinez-Sanchez, A. Robles-Marhuenda, R. Alvarez-Doforno, A. Viejo, E. Antolin-Alvarado, L. Deiros-Bronte, et al., “The effect of a triple therapy on maternal anti-Ro/SS-A levels associated to fetal cardiac manifestations,” Autoimmun Rev, vol. 14, pp. 423-8, May 2015.
[127] B. S. Choung and W. H. Yoo, “Successful treatment with intravenousIgof severe thrombocytopenia complicated in primary Sjogren’s syndrome,” Rheumatol Int, vol. 32, pp. 1353-5, May 2012.
[128] C. Yao, X. Li, K. Murdiastuti, C. Kosugi-Tanaka, T. Akamatsu, N. Kanamori, et al., “Lipopolysaccharide-induced elevation and secretion of interleukin-1beta in the submandibular gland of male mice,” Immunology, vol. 116, pp. 213-22, Oct 2005.
[129] D. Zoukhri, R. R. Hodges, D. Byon, and C. L. Kublin, “Role of proinflammatory cytokines in the impaired lacrimation associated with autoimmune xerophthalmia,” Invest Ophthalmol Vis Sci, vol. 43, pp. 1429-36, May 2002.
[130] J. J. Dubost, S. Perrier, M. Afane, J. L. Viallard, P. Roux-Lombard, M. Baudet-Pommel, et al., “IL1 receptor antagonist in saliva; characterization in normal saliva and reduced concentration in Sjogren’s syndrome (SS),” Clin Exp Immunol, vol. 106, pp. 237-42, Nov 1996.
[131] K. B. Norheim, E. Harboe, L. G. Goransson, and R. Omdal, “Interleukin-1 inhibition and fatigue in primary Sjogren’s syndrome--a double-blind, randomised clinical trial,” PLoS One, vol. 7, p. e30123, 2012.
[132] Yamada, R. Arakaki, Y. Kudo, and N. Ishimaru, “Targeting IL1 in Sjogren’s syndrome,” Expert Opin Ther Targets, vol. 17, pp. 393-401, Apr 2013.
[133] K. Yanagi, N. Haneji, H. Hamano, M. Takahashi, H. Higashiyama, and Y. Hayashi, “In vivo role of IL10 and IL12 during development of Sjogren’s syndrome in MRL/lpr mice,” Cell Immunol, vol. 168, pp. 243-50, Mar 15 1996.
[134] S. M. Brookes, S. B. Cohen, E. J. Price, L. M. Webb, M. Feldmann, R. N. Maini, et al., “T cell clones from a Sjogren’s syndrome salivary gland biopsy produce high levels of IL10,” Clin Exp Immunol, vol. 103, pp. 268-72, Feb 1996.
[135] J. M. Anaya, P. A. Correa, M. Herrera, J. Eskdale, and G. Gallagher, “Interleukin 10 (IL10) influences autoimmune response in primary Sjogren’s syndrome and is linked to IL10 gene polymorphism,” J Rheumatol, vol. 29, pp. 1874-6, Sep 2002.
[136] X. Li, L. Qian, G. Wang, H. Zhang, X. Wang, K. Chen, et al., “T regulatory cells are markedly diminished in diseased salivary glands of patients with primary Sjogren’s syndrome,” J Rheumatol, vol. 34, pp. 2438-45, Dec 2007.
[137] M. F. Liu, L. H. Lin, C. T. Weng, and M. Y. Weng, “Decreased CD4+CD25+bright T cells in peripheral blood of patients with primary Sjogren’s syndrome,” Lupus, vol. 17, pp. 34-9, Jan 2008.
[138] C. Q. Nguyen, H. Yin, B. H. Lee, W. C. Carcamo, J. A. Chiorini, and A. B. Peck, “Pathogenic effect of interleukin-17A in induction of Sjogren’s syndrome-like disease using adenovirus-mediated gene transfer,” Arthritis Res Ther, vol. 12, p. R220, 2010.
[139] Y. Fei, W. Zhang, D. Lin, C. Wu, M. Li, Y. Zhao, et al., “Clinical parameter and Th17 related to lymphocytes infiltrating degree of labial salivary gland in primary Sjogren’s syndrome,” Clin Rheumatol, vol. 33, pp. 523-9, Apr 2014.
[140] L. Zheng, Z. Zhang, C. Yu, and C. Yang, “Expression of Toll-like receptors 7, 8, and 9 in primary Sjogren’s syndrome,” Oral Surg Oral Med Oral Pathol Oral Radiol Endod, vol. 109, pp. 844-50, Jun 2010.
[141] N. Amft, S. J. Curnow, D. Scheel-Toellner, A. Devadas, J. Oates, J. Crocker, et al., “Ectopic expression of the B cell-attracting chemokine BCA-1 (CXCL13) on endothelial cells and within lymphoid follicles contributes to the establishment of germinal center-like structures in Sjogren’s syndrome,” Arthritis Rheum, vol. 44, pp. 2633-41, Nov 2001.
[142] C. Croia, E. Astorri, W. Murray-Brown, A. Willis, K. A. Brokstad, N. Sutcliffe, et al., “Implication of Epstein-Barr Virus Infection in Disease-Specific Autoreactive B Cell Activation in Ectopic Lymphoid Structures of Sjogren’s Syndrome,” Arthritis Rheumatol, vol. 66, pp. 2545-57, Sep 2014.
[143] G. J. Tobon, A. Saraux, J. E. Gottenberg, L. Quartuccio, M. Fabris, R. Seror, et al., “Role of Fms-like tyrosine kinase 3 ligand as a potential biologic marker of lymphoma in primary Sjogren’s syndrome,” Arthritis Rheum, vol. 65, pp. 3218-27, Dec 2013.
[144] R. Alonso, C. Buors, C. Le Dantec, S. Hillion, J. O. Pers, A. Saraux, et al., “Aberrant expression of CD6 on B cell subsets from patients with Sjogren’s syndrome,” J Autoimmun, vol. 35, pp. 336-41, Dec 2010.
[145] R. A. Fava, S. M. Kennedy, S. G. Wood, A. I. Bolstad, J. Bienkowska, A. Papandile, et al., “Lymphotoxin-beta receptor blockade reduces CXCL13 in lacrimal glands and improves corneal integrity in the NOD model of Sjogren’s syndrome,” Arthritis Res Ther, vol. 13, p. R182, 2011.
[146] M. K. Gatumu, K. Skarstein, A. Papandile, J. L. Browning, R. A. Fava, and A. I. Bolstad, “Blockade of lymphotoxin-beta receptor signaling reduces aspects of Sjogren’s syndrome in salivary glands of non-obese diabetic mice,” Arthritis Res Ther, vol. 11, p. R24, 2009.
[147] Devauchelle-Pensec, N. Cagnard, J. O. Pers, P. Youinou, A. Saraux, and G. Chiocchia, “Gene expression profile in the salivary glands of primary Sjogren’s syndrome patients before and after treatment with rituximab,” Arthritis Rheum, vol. 62, pp. 2262-71, Aug 2010.
[148] J. Pijpe, W. W. Kalk, H. Bootsma, F. K. Spijkervet, C. G. Kallenberg, and A. Vissink, “Progression of salivary gland dysfunction in patients with Sjogren’s syndrome,” Ann Rheum Dis, vol. 66, pp. 107-12, Jan 2007.
[149] H. F. Cay, I. Sezer, S. Dogan, R. Felek, and M. Aslan, “Polymorphism in the TNF-alpha gene promoter at position -1031 is associated with increased circulating levels of TNF-alpha, myeloperoxidase and nitrotyrosine in primary Sjogren’s syndrome,” Clin Exp Rheumatol, vol. 30, pp. 843-9, Nov-Dec 2012.

Chapter 5

[1] Silman, S. Jannini, D. Symmons, and P. Bacon, “An epidemiological study of scleroderma in the West Midlands,” Br J Rheumatol, vol. 27, pp. 286-90, Aug 1988.
[2] R. J. Allcock, I. Forrest, P. A. Corris, P. R. Crook, and I. D. Griffiths, “A study of the prevalence of systemic sclerosis in northeast England,” Rheumatology (Oxford), vol. 43, pp. 596-602, May 2004.
[3] M. Hoffmann-Vold, O. Midtvedt, O. Molberg, T. Garen, and J. T. Gran, “Prevalence of systemic sclerosis in south-east Norway,” Rheumatology (Oxford), vol. 51, pp. 1600-5, Sep 2012.
[4] H. El Adssi, D. Cirstea, J. M. Virion, F. Guillemin, and J. D. de Korwin, “Estimating the prevalence of systemic sclerosis in the Lorraine region, France, by the capture-recapture method,” Semin Arthritis Rheum, vol. 42, pp. 530-8, Apr 2013.
[5] E. C. LeRoy, C. Black, R. Fleischmajer, S. Jablonska, T. Krieg, T. A. Medsger, Jr., et al., “Scleroderma (systemic sclerosis): classification, subsets and pathogenesis,” J Rheumatol, vol. 15, pp. 202-5, Feb 1988.
[6] E. C. LeRoy and T. A. Medsger, Jr., “Criteria for the classification of early systemic sclerosis,” J Rheumatol, vol. 28, pp. 1573-6, Jul 2001.
[7] F. van den Hoogen, D. Khanna, J. Fransen, S. R. Johnson, M. Baron, A. Tyndall, et al., “2013 classification criteria for systemic sclerosis: an American College of Rheumatology/European League against Rheumatism collaborative initiative,” Arthritis Rheum, vol. 65, pp. 2737-47, Nov 2013.
[8] T. A. Medsger, Jr., “Natural history of systemic sclerosis and the assessment of disease activity, severity, functional status, and psychologic well-being,” Rheum Dis Clin North Am, vol. 29, pp. 255-73, vi, May 2003.
[9] L. Shand, M. Lunt, S. Nihtyanova, M. Hoseini, A. Silman, C. M. Black, et al., “Relationship between change in skin score and disease outcome in diffuse cutaneous systemic sclerosis: application of a latent linear trajectory model,” Arthritis Rheum, vol. 56, pp. 2422-31, Jul 2007.
[10] S. I. Nihtyanova, B. E. Schreiber, V. H. Ong, D. Rosenberg, P. Moinzadeh, J. G. Coghlan, et al., “Prediction of pulmonary complications and long-term survival in systemic sclerosis,” Arthritis Rheumatol, vol. 66, pp. 1625-35, Jun 2014.
[11] R. K. Hoyles, R. W. Ellis, J. Wellsbury, B. Lees, P. Newlands, N. S. Goh, et al., “A multicenter, prospective, randomised, double-blind, placebo-controlled trial of corticosteroids and intravenous cyclophosphamide followed by oral azathioprine for the treatment of pulmonary fibrosis in scleroderma,” Arthritis Rheum, vol. 54, pp. 3962-70, Dec 2006.
[12] D. P. Tashkin, R. Elashoff, P. J. Clements, J. Goldin, M. D. Roth, D. E. Furst, et al., “Cyclophosphamide versus placebo in scleroderma lung disease,” N Engl J Med, vol. 354, pp. 2655-66, Jun 22 2006.
[13] D. P. Tashkin, R. Elashoff, P. J. Clements, M. D. Roth, D. E. Furst, R. M. Silver, et al., “Effects of 1-year treatment with cyclophosphamide on outcomes at 2 years in scleroderma lung disease,” Am J Respir Crit Care Med, vol. 176, pp. 1026-34, Nov 15 2007.
[14] D. T. Philip J. Clements, Michael Roth, Dinesh Khanna, Daniel E. Furst, Chi-hong Tseng, Elizabeth R. Volkmann and Robert Elashoff, “The Scleroderma Lung Study II (SLS II) Shows That Both Oral Cyclophosphamide (CYC) and Mycophenolate Mofitil (MMF) Are Efficacious in Treating Progressive Interstitial Lung Disease (ILD) in Patients with Systemic Sclerosis (SSc),” Arthritis Rheumatol, vol. 67 Suppl 10, p. ABSTRACT NUMBER: 1075, Oct 2015.
[15] F. H. van den Hoogen, A. M. Boerbooms, A. J. Swaak, J. J. Rasker, H. J. van Lier, and L. B. van de Putte, “Comparison of methotrexate with placebo in the treatment of systemic sclerosis: a 24 week randomised double-blind trial, followed by a 24 week observational trial,” Br J Rheumatol, vol. 35, pp. 364-72, Apr 1996.
[16] J. E. Pope, N. Bellamy, J. R. Seibold, M. Baron, M. Ellman, S. Carette, et al., “A randomised, controlled trial of methotrexate versus placebo in early diffuse scleroderma,” Arthritis Rheum, vol. 44, pp. 1351-8, Jun 2001.
[17] R. K. Burt, S. J. Shah, K. Dill, T. Grant, M. Gheorghiade, J. Schroeder, et al., “Autologous non-myeloablative haemopoietic stem-cell transplantation compared with pulse cyclophosphamide once per month for systemic sclerosis (ASSIST): an open-label, randomised phase 2 trial,” Lancet, vol. 378, pp. 498-506, Aug 6 2011.
[18] J. M. van Laar, D. Farge, J. K. Sont, K. Naraghi, Z. Marjanovic, J. Larghero, et al., “Autologous hematopoietic stem cell transplantation vs intravenous pulse cyclophosphamide in diffuse cutaneous systemic sclerosis: a randomised clinical trial,” Jama, vol. 311, pp. 2490-8, Jun 25 2014.
[19] R. K. Burt, S. J. Shah, M. Gheorghiade, E. Ruderman, and J. Schroeder, “Hematopoietic stem cell transplantation for systemic sclerosis: if you are confused, remember: “it is a matter of the heart”,” J Rheumatol, vol. 39, pp. 206-9, Feb 2012.
[20] R. K. Burt, M. C. Oliveira, S. J. Shah, D. A. Moraes, B. Simoes, M. Gheorghiade, et al., “Cardiac involvement and treatment-related mortality after non-myeloablative haemopoietic stem-cell transplantation with unselected autologous peripheral blood for patients with systemic sclerosis: a retrospective analysis,” Lancet, vol. 381, pp. 1116-24, Mar 30 2013.
[21] R. K. Burt, M. C. Oliveira, and S. J. Shah, “Cardiac assessment before stem cell transplantation for systemic sclerosis,” Jama, vol. 312, p. 1803, Nov 5 2014.
[22] J. Pope, D. McBain, L. Petrlich, S. Watson, L. Vanderhoek, F. de Leon, et al., “Imatinib in active diffuse cutaneous systemic sclerosis: Results of a six-month, randomised, double-blind, placebo-controlled, proof-of-concept pilot study at a single center,” Arthritis Rheum, vol. 63, pp. 3547-51, Nov 2011.
[23] S. Prey, K. Ezzedine, A. Doussau, A. S. Grandoulier, D. Barcat, E. Chatelus, et al., “Imatinib mesylate in scleroderma-associated diffuse skin fibrosis: a phase II multicentre randomised double-blinded controlled trial,” Br J Dermatol, vol. 167, pp. 1138-44, Nov 2012.
[24] O. Kowal-Bielecka, R. Landewe, J. Avouac, S. Chwiesko, I. Miniati, L. Czirjak, et al., “EULAR recommendations for the treatment of systemic sclerosis: a report from the EULAR Scleroderma Trials and Research group (EUSTAR),” Ann Rheum Dis, vol. 68, pp. 620-8, May 2009.
[25] P. Denton, “Systemic sclerosis: from pathogenesis to targeted therapy,” Clin Exp Rheumatol, vol. 33, pp. 3-7, Sep-Oct 2015.
[26] J. Abraham, T. Krieg, J. Distler, and O. Distler, “Overview of pathogenesis of systemic sclerosis,” Rheumatology (Oxford), vol. 48 Suppl 3, pp. iii3-7, Jun 2009.
[27] J. Henault, M. Tremblay, I. Clement, Y. Raymond, and J. L. Senecal, “Direct binding of anti-DNA topoisomerase I autoantibodies to the cell surface of fibroblasts in patients with systemic sclerosis,” Arthritis Rheum, vol. 50, pp. 3265-74, Oct 2004.
[28] P. Q. Hu, N. Fertig, T. A. Medsger, Jr., and T. M. Wright, “Correlation of serum anti-DNA topoisomerase I antibody levels with disease severity and activity in systemic sclerosis,” Arthritis Rheum, vol. 48, pp. 1363-73, May 2003.
[29] Yoshizaki, “B lymphocytes in systemic sclerosis: Abnormalities and therapeutic targets,” J Dermatol, vol. 43, pp. 39-45, Jan 2016.
[30] L. I. Sakkas and D. P. Bogdanos, “Systemic sclerosis: New evidence re-enforces the role of B cells,” Autoimmun Rev, Oct 21 2015.
[31] S. O’Reilly, T. Hugle, and J. M. van Laar, “T cells in systemic sclerosis: a reappraisal,” Rheumatology (Oxford), vol. 51, pp. 1540-9, Sep 2012.
[32] M. Gizinski and D. A. Fox, “T cell subsets and their role in the pathogenesis of rheumatic disease,” Curr Opin Rheumatol, vol. 26, pp. 204-10, Mar 2014.
[33] K. Khan, S. Xu, S. Nihtyanova, E. Derrett-Smith, D. Abraham, C. P. Denton, et al., “Clinical and pathological significance of interleukin 6 overexpression in systemic sclerosis,” Ann Rheum Dis, vol. 71, pp.
[34] V. H. Ong and C. P. Denton, “Innovative therapies for systemic sclerosis,” Curr Opin Rheumatol, vol. 22, pp. 264-72, May 2010.
[35] F. A. Wollheim, “Is rituximab a potential new therapy in systemic sclerosis? New evidence indicates the presence of CD20-positive B-lymphocytes in scleroderma skin,” J Clin Rheumatol, vol. 10, p. 155, Jun 2004.
[36] M. Fujimoto and S. Sato, “B lymphocytes and systemic sclerosis,” Curr Opin Rheumatol, vol. 17, pp. 746-51, Nov 2005.
[37] Leask, “B cell block: is rituximab a new possible treatment for systemic sclerosis?” J Cell Commun Signal, vol. 4, pp. 201-2, Dec 2010.
[38] M. Hasegawa, “B lymphocytes: shedding new light on the pathogenesis of systemic sclerosis,” J Dermatol, vol. 37, pp. 3-10, Jan 2010.
[39] S. Bosello, G. De Luca, B. Tolusso, G. Lama, C. Angelucci, G. Sica, et al., “B cells in systemic sclerosis: a possible target for therapy,” Autoimmun Rev, vol. 10, pp. 624-30, Aug 2011.
[40] Daoussis, S. N. Liossis, A. C. Tsamandas, C. Kalogeropoulou, A. Kazantzi, P. Korfiatis, et al., “Is there a role for B cell depletion as therapy for scleroderma? A case report and review of the literature,” Semin Arthritis Rheum, vol. 40, pp. 127-36, Oct 2010.
[41] M. Haroon, P. McLaughlin, M. Henry, and S. Harney, “Cyclophosphamide-refractory scleroderma-associated interstitial lung disease: remarkable clinical and radiological response to a single course of rituximab combined with high-dose corticosteroids,” Ther Adv Respir Dis, vol. 5, pp. 299-304, Oct 2011.
[42] W. H. Yoo, “Successful treatment of steroid and cyclophosphamide-resistant diffuse scleroderma-associated interstitial lung disease with rituximab,” Rheumatol Int, vol. 32, pp. 795-8, Mar 2012.
[43] R. de Paula, F. B. Klem, P. G. Lorencetti, C. Muller, and V. F. Azevedo, “Rituximab-induced regression of CREST-related calcinosis,” Clin Rheumatol, vol. 32, pp. 281-3, Feb 2013.
[44] H. Sumida, Y. Asano, Z. Tamaki, N. Aozasa, T. Taniguchi, T. Takahashi, et al., “Successful experience of rituximab therapy for systemic sclerosis-associated interstitial lung disease with concomitant systemic lupus erythematosus,” J Dermatol, vol. 41, pp. 418-20, May 2014.
[45] C. G. Khor, X. L. Chen, T. S. Lin, C. H. Lu, and S. C. Hsieh, “Rituximab for refractory digital infarcts and ulcers in systemic sclerosis,” Clin Rheumatol, vol. 33, pp. 1019-20, Jul 2014.
[46] R. Lafyatis, E. Kissin, M. York, G. Farina, K. Viger, M. J. Fritzler, et al., “B cell depletion with rituximab in patients with diffuse cutaneous systemic sclerosis,” Arthritis Rheum, vol. 60, pp. 578-83, Feb 2009.
[47] S. Bosello, M. De Santis, G. Lama, C. Spano, C. Angelucci, B. Tolusso, et al., “B cell depletion in diffuse progressive systemic sclerosis: safety, skin score modification and IL-6 modulation in an up to thirty-six months follow-up open-label trial,” Arthritis Res Ther, vol. 12, p. R54, 2010.
[48] S. L. Bosello, G. De Luca, M. Rucco, G. Berardi, M. Falcione, F. M. Danza, et al., “Long-term efficacy of B cell depletion therapy on lung and skin involvement in diffuse systemic sclerosis,” Semin Arthritis Rheum, vol. 44, pp. 428-36, Feb 2015.
[49] D. Daoussis, S. N. Liossis, A. C. Tsamandas, C. Kalogeropoulou, F. Paliogianni, C. Sirinian, et al., “Effect of long-term treatment with rituximab on pulmonary function and skin fibrosis in patients with diffuse systemic sclerosis,” Clin Exp Rheumatol, vol. 30, pp. S17-22, Mar-Apr 2012.
[50] V. Smith, J. T. Van Praet, B. Vandooren, B. Van der Cruyssen, J. M. Naeyaert, S. Decuman, et al., “Rituximab in diffuse cutaneous systemic sclerosis: an open-label clinical and histopathological study,” Ann Rheum Dis, vol. 69, pp. 193-7, Jan 2010.
[51] V. Smith, Y. Piette, J. T. van Praet, S. Decuman, E. Deschepper, D. Elewaut, et al., “Two-year results of an open pilot study of a 2-treatment course with rituximab in patients with early systemic sclerosis with diffuse skin involvement,” J Rheumatol, vol. 40, pp. 52-7, Jan 2013.
[52] J. Keir, T. M. Maher, D. M. Hansell, C. P. Denton, V. H. Ong, S. Singh, et al., “Severe interstitial lung disease in connective tissue disease: rituximab as rescue therapy,” Eur Respir J, vol. 40, pp. 641-8, Sep 2012.
[53] J. Keir, T. M. Maher, D. Ming, R. Abdullah, A. de Lauretis, M. Wickremasinghe, et al., “Rituximab in severe, treatment-refractory interstitial lung disease,” Respirology, vol. 19, pp. 353-9, Apr 2014.
[54] L. Maslyanskiy, S. V. Lapin, E. P. Kolesova, I. N. Penin, M. D. Cheshuina, E. Feist, et al., “Effects of rituximab therapy on elastic properties of vascular wall in patients with progressive systemic sclerosis,” Clin Exp Rheumatol, vol. 32, pp. S-228, Nov-Dec 2014.
[55] F. C. Moazedi-Fuerst, S. M. Kielhauser, J. Hermann, M. Meilinger, U. Demel, M. H. Stradner, et al., “Decrease in autoantibody titres during long-term treatment of scleroderma with rituximab: a promising surveillance marker of therapy?,” Scand J Rheumatol, vol. 44, pp. 519-20, Nov 2015.
[56] F. C. Moazedi-Fuerst, S. M. Kielhauser, K. Bodo, and W. B. Graninger, “Dosage of rituximab in systemic sclerosis: 2-year results of five cases,” Clin Exp Dermatol, vol. 40, pp. 211-2, Mar 2015.
[57] D. Giuggioli, F. Lumetti, M. Colaci, P. Fallahi, A. Antonelli, and C. Ferri, “Rituximab in the treatment of patients with systemic sclerosis. Our experience and review of the literature,” Autoimmun Rev, vol. 14, pp. 1072-8, Nov 2015.
[58] S. Jordan, J. H. Distler, B. Maurer, D. Huscher, J. M. van Laar, Y. Allanore, et al., “Effects and safety of rituximab in systemic sclerosis: an analysis from the European Scleroderma Trial and Research (EUSTAR) group,” Ann Rheum Dis, vol. 74, pp. 1188-94, Jun 2015.
[59] D. Daoussis, S. N. Liossis, A. C. Tsamandas, C. Kalogeropoulou, A. Kazantzi, C. Sirinian, et al., “Experience with rituximab in scleroderma: results from a 1-year, proof-of-principle study,” Rheumatology (Oxford), vol. 49, pp. 271-80, Feb 2010.
[60] M. O. Becker, C. Bruckner, H. U. Scherer, N. Wassermann, J. Y. Humrich, L. G. Hanitsch, et al., “The monoclonal anti-CD25 antibody basiliximab for the treatment of progressive systemic sclerosis: an open-label study,” Ann Rheum Dis, vol. 70, pp. 1340-1, Jul 2011.
[61] U. Scherer, G. R. Burmester, and G. Riemekasten, “Targeting activated T cells: successful use of anti-CD25 monoclonal antibody basiliximab in a patient with systemic sclerosis,” Ann Rheum Dis, vol. 65, pp. 1245-7, Sep 2006.
[62] D. Isaacs, B. L. Hazleman, K. Chakravarty, J. W. Grant, G. Hale, and H. Waldmann, “Monoclonal antibody therapy of diffuse cutaneous scleroderma with CAMPATH-1H,” J Rheumatol, vol. 23, pp. 1103-6, Jun 1996.
[63] M. Elhai, M. Meunier, M. Matucci-Cerinic, B. Maurer, G. Riemekasten, T. Leturcq, et al., “Outcomes of patients with systemic sclerosis-associated polyarthritis and myopathy treated with tocilizumab or abatacept: a EUSTAR observational study,” Ann Rheum Dis, vol. 72, pp. 1217-20, Jul 2013.
[64] F. V. de Paoli, B. D. Nielsen, F. Rasmussen, B. Deleuran, and K. Sondergaard, “Abatacept induces clinical improvement in patients with severe systemic sclerosis,” Scand J Rheumatol, vol. 43, pp. 342-5, 2014.
[65] E. F. Chakravarty, V. Martyanov, D. Fiorentino, T. A. Wood, D. J. Haddon, J. A. Jarrell, et al., “Gene expression changes reflect clinical response in a placebo-controlled randomised trial of abatacept in patients with diffuse cutaneous systemic sclerosis,” Arthritis Res Ther, vol. 17, p. 159, 2015.
[66] E. P. Balaban, R. G. Sheehan, P. E. Lipsky, and E. P. Frenkel, “Treatment of cutaneous sclerosis and aplastic anemia with antithymocyte globulin,” Ann Intern Med, vol. 106, pp. 56-8, Jan 1987.
[67] E. P. Balaban, S. J. Zashin, T. D. Geppert, P. E. Lipsky, and R. M. Condie, “Treatment of systemic sclerosis with antithymocyte globulin,” Arthritis Rheum, vol. 34, pp. 244-5, Feb 1991.
[68] E. L. Matteson, M. I. Shbeeb, T. G. McCarthy, K. T. Calamia, L. E. Mertz, and J. J. Goronzy, “Pilot study of antithymocyte globulin in systemic sclerosis,” Arthritis Rheum, vol. 39, pp. 1132-7, Jul 1996.
[69] R. J. Stratton, H. Wilson, and C. M. Black, “Pilot study of anti-thymocyte globulin plus mycophenolate mofetil in recent-onset diffuse scleroderma,” Rheumatology (Oxford), vol. 40, pp. 84-8, Jan 2001.
[70] C. P. Denton, P. A. Merkel, D. E. Furst, D. Khanna, P. Emery, V. M. Hsu, et al., “Recombinant human anti-transforming growth factor beta1 antibody therapy in systemic sclerosis: a multicenter, randomised, placebo-controlled phase I/II trial of CAT-192,” Arthritis Rheum, vol. 56, pp. 323-33, Jan 2007.
[71] L. M. Rice, C. M. Padilla, S. R. McLaughlin, A. Mathes, J. Ziemek, S. Goummih, et al., “Fresolimumab treatment decreases biomarkers and improves clinical symptoms in systemic sclerosis patients,” J Clin Invest, vol. 125, pp. 2795-807, Jul 1 2015.
[72] S. Kitaba, H. Murota, M. Terao, H. Azukizawa, F. Terabe, Y. Shima, et al., “Blockade of interleukin-6 receptor alleviates disease in mouse model of scleroderma,” Am J Pathol, vol. 180, pp. 165-76, Jan 2012.
[73] De Lauretis, P. Sestini, P. Pantelidis, R. Hoyles, D. M. Hansell, N. S. Goh, et al., “Serum interleukin 6 is predictive of early functional decline and mortality in interstitial lung disease associated with systemic sclerosis,” J Rheumatol, vol. 40, pp. 435-46, Apr 2013.
[74] Y. Shima, Y. Kuwahara, H. Murota, S. Kitaba, M. Kawai, T. Hirano, et al., “The skin of patients with systemic sclerosis softened during the treatment with anti-IL-6 receptor antibody tocilizumab,” Rheumatology (Oxford), vol. 49, pp. 2408-12, Dec 2010.
[75] Y. Shima, N. Hosen, T. Hirano, J. Arimitsu, S. Nishida, K. Hagihara, et al., “Expansion of range of joint motion following treatment of systemic sclerosis with tocilizumab,” Mod Rheumatol, vol. 25, pp. 134-7, Jan 2015.
[76] M. Fernandes das Neves, S. Oliveira, M. C. Amaral, and J. Delgado Alves, “Treatment of systemic sclerosis with tocilizumab,” Rheumatology (Oxford), vol. 54, pp. 371-2, Feb 2015.
[77] D. Khanna, C. P. Denton, J. M. van Laar, A. Jahreis, S. Cheng, H. Spotswood, et al., “Safety and Efficacy of Subcutaneous Tocilizumab in Adults with Systemic Sclerosis: Week 24 Data from a Phase 2/3 Trial,” Arthritis Rheum, vol. 66 Supplement 10, p. Abstract 874., 2014.
[78] D. Khanna, C. P. Denton, A. Jahreis, J. M. van Laar, T. M. Frech, M. E. Anderson, et al., “Safety and efficacy of subcutaneous tocilizumab in adults with systemic sclerosis: week 48 results from the randomised controlled faSScinate trial,” Lancet, 2016.
[79] H. Distler, G. Schett, S. Gay, and O. Distler, “The controversial role of tumor necrosis factor alpha in fibrotic diseases,” Arthritis Rheum, vol. 58, pp. 2228-35, Aug 2008.
[80] H. Distler, S. Jordan, P. Airo, J. J. Alegre-Sancho, Y. Allanore, A. Balbir Gurman, et al., “Is there a role for TNFalpha antagonists in the treatment of SSc? EUSTAR expert consensus development using the Delphi technique,” Clin Exp Rheumatol, vol. 29, pp. S40-5, Mar-Apr 2011.
[81] Ellman MH, McDonald PA, and H. FA., “Etanercept as treatment for diffuse scleroderma: a pilot study [abstract].” Arthritis Rheum, vol. 43(Suppl), p. s392, 2000.
[82] S. Bosello, M. De Santis, B. Tolusso, A. Zoli, and G. Ferraccioli, “Tumor necrosis factor-alpha inhibitor therapy in erosive polyarthritis secondary to systemic sclerosis,” Ann Intern Med, vol. 143, pp. 918-20, Dec 20 2005.
[83] G. K. Lam, L. K. Hummers, A. Woods, and F. M. Wigley, “Efficacy and safety of etanercept in the treatment of scleroderma-associated joint disease,” J Rheumatol, vol. 34, pp. 1636-7, Jul 2007.
[84] M. Antoniou, M. Mamoulaki, K. Malagari, H. D. Kritikos, D. Bouros, N. M. Siafakas, et al., “Infliximab therapy in pulmonary fibrosis associated with collagen vascular disease,” Clin Exp Rheumatol, vol. 25, pp. 23-8, Jan-Feb 2007.
[85] C. P. Denton, M. Engelhart, N. Tvede, H. Wilson, K. Khan, X. Shiwen, et al., “An open-label pilot study of infliximab therapy in diffuse cutaneous systemic sclerosis,” Ann Rheum Dis, vol. 68, pp. 1433-9, Sep 2009.
[86] Y. Allanore, G. Devos-Francois, C. Caramella, P. Boumier, V. Jounieaux, and A. Kahan, “Fatal exacerbation of fibrosing alveolitis associated with systemic sclerosis in a patient treated with adalimumab,” Ann Rheum Dis, vol. 65, pp. 834-5, Jun 2006.
[87] S. Sen, C. Peltz, K. Jordan, and T. J. Boes, “Infliximab-induced nonspecific interstitial pneumonia,” Am J Med Sci, vol. 344, pp. 75-8, Jul 2012.
[88] R. Caccaro, E. Savarino, R. D’Inca, and G. C. Sturniolo, “Noninfectious interstitial lung disease during infliximab therapy: case report and literature review,” World J Gastroenterol, vol. 19, pp. 5377-80, Aug 28 2013.
[89] S. Kakavas, E. Balis, V. Lazarou, M. Kouvela, and G. Tatsis, “Respiratory failure due to infliximab induced interstitial lung disease,” Heart Lung, vol. 42, pp. 480-2, Nov-Dec 2013.
[90] K. Serban, M. Muzoora, C. A. Hage, and T. Lahm, “Distinct immunologic and radiographic patterns in etanercept-induced lung injury,” Respir Med Case Rep, vol. 8, pp. 18-20, 2013.
[91] T. Nakashita, K. Ando, N. Kaneko, K. Takahashi, and S. Motojima, “Potential risk of TNF inhibitors on the progression of interstitial lung disease in patients with rheumatoid arthritis,” BMJ Open, vol. 4, p. e005615, 2014.
[92] Watad, M. Perelman, R. Mansour, Y. Shoenfeld, and H. Amital, “Etanercept-Induced Pneumonitis: Severe Complication of Tumor Necrosis Factor-Alpha Blocker Treatment,” Isr Med Assoc J, vol. 17, pp. 130-2, Feb 2015.
[93] Grassegger, G. Schuler, G. Hessenberger, B. Walder-Hantich, J. Jabkowski, W. MacHeiner, et al., “Interferon-gamma in the treatment of systemic sclerosis: a randomised controlled multicentre trial,” Br J Dermatol, vol. 139, pp. 639-48, Oct 1998.
[94] M. Black, A. J. Silman, A. I. Herrick, C. P. Denton, H. Wilson, J. Newman, et al., “Interferon-alpha does not improve outcome at one year in patients with diffuse cutaneous scleroderma: results of a randomised, double-blind, placebo-controlled trial,” Arthritis Rheum, vol. 42, pp. 299-305, Feb 1999.
[95] Y. Levy, Y. Sherer, P. Langevitz, M. Lorber, P. Rotman, F. Fabrizzi, et al., “Skin score decrease in systemic sclerosis patients treated with intravenous immunoglobulin--a preliminary report,” Clin Rheumatol, vol. 19, pp. 207-11, 2000.
[96] Y. Levy, H. Amital, P. Langevitz, F. Nacci, A. Righi, L. Conforti, et al., “Intravenous immunoglobulin modulates cutaneous involvement and reduces skin fibrosis in systemic sclerosis: an open-label study,” Arthritis Rheum, vol. 50, pp. 1005-7, Mar 2004.
[97] F. Nacci, A. Righi, M. L. Conforti, I. Miniati, G. Fiori, D. Martinovic, et al., “Intravenous immunoglobulins improve the function and ameliorate joint involvement in systemic sclerosis: a pilot study,” Ann Rheum Dis, vol. 66, pp. 977-9, Jul 2007.
[98] L. Poelman, L. K. Hummers, F. M. Wigley, C. Anderson, F. Boin, and A. A. Shah, “Intravenous immunoglobulin may be an effective therapy for refractory, active diffuse cutaneous systemic sclerosis,” J Rheumatol, vol. 42, pp. 236-42, Feb 2015.
[99] K. Takehara, H. Ihn, and S. Sato, “A randomised, double-blind, placebo-controlled trial: intravenous immunoglobulin treatment in patients with diffuse cutaneous systemic sclerosis,” Clin Exp Rheumatol, vol. 31, pp. 151-6, Mar-Apr 2013.
[100] J. Raja, S. I. Nihtyanova, C. D. Murray, C. P. Denton, and V. H. Ong, “Sustained benefit from intravenous immunoglobulin therapy for gastrointestinal involvement in systemic sclerosis,” Rheumatology (Oxford), Aug 28 2015.
[101] K. M. McKown, L. D. Carbone, J. Bustillo, J. M. Seyer, A. H. Kang, and A. E. Postlethwaite, “Induction of immune tolerance to human type I collagen in patients with systemic sclerosis by oral administration of bovine type I collagen,” Arthritis Rheum, vol. 43, pp. 1054-61, May 2000.
[102] E. Postlethwaite, W. K. Wong, P. Clements, S. Chatterjee, B. J. Fessler, A. H. Kang, et al., “A multicenter, randomised, double-blind, placebo-controlled trial of oral type I collagen treatment in patients with diffuse cutaneous systemic sclerosis: I. oral type I collagen does not improve skin in all patients, but may improve skin in late-phase disease,” Arthritis Rheum, vol. 58, pp. 1810-22, Jun 2008.
[103] S. Samuel, T. D. Hewitson, E. N. Unemori, and M. L. Tang, “Drugs of the future: the hormone relaxin,” Cell Mol Life Sci, vol. 64, pp. 1539-57, Jun 2007.
[104] R. G. Bennett, “Relaxin and its role in the development and treatment of fibrosis,” Transl Res, vol. 154, pp. 1-6, Jul 2009.
[105] J. R. Seibold, J. H. Korn, R. Simms, P. J. Clements, L. W. Moreland, M. D. Mayes, et al., “Recombinant human relaxin in the treatment of scleroderma. A randomised, double-blind, placebo-controlled trial,” Ann Intern Med, vol. 132, pp. 871-9, Jun 6 2000.
[106] Khanna, P. J. Clements, D. E. Furst, J. H. Korn, M. Ellman, N. Rothfield, et al., “Recombinant human relaxin in the treatment of systemic sclerosis with diffuse cutaneous involvement: a randomised, double-blind, placebo-controlled trial,” Arthritis Rheum, vol. 60, pp. 1102-11, Apr 2009.
[107] P. Quillinan, D. McIntosh, J. Vernes, S. Haq, and C. P. Denton, “Treatment of diffuse systemic sclerosis with hyperimmune caprine serum (AIMSPRO): a phase II double-blind placebo-controlled trial,” Ann Rheum Dis, vol. 73, pp. 56-61, Jan 2014.
[108] S. I. Nihtyanova, E. C. Tang, J. G. Coghlan, A. U. Wells, C. M. Black, and C. P. Denton, “Improved survival in systemic sclerosis is associated with better ascertainment of internal organ disease: a retrospective cohort study,” Qjm, vol. 103, pp. 109-15, Feb 2010.
[109] C. Moazedi-Fuerst, S. M. Kielhauser, K. Brickmann, J. Hermann, A. Lutfi, M. Meilinger, et al., “Rituximab for systemic sclerosis: arrest of pulmonary disease progression in five cases. Results of a lower dosage and shorter interval regimen,” Scand J Rheumatol, vol. 43, pp. 257-8, 2014.
[110] Saito, S. Sato, S. Nogi, N. Sasaki, N. Chinen, K. Honda, et al., “A case of rheumatoid arthritis and limited systemic sclerosis overlap successfully treated with tocilizumab for arthritis and concomitant generalised lymphadenopathy and primary biliary cirrhosis,” Case Rep Rheumatol, vol. 2014, p. 386328, 2014.

Chapter 6

[1] J. C. Jennette, R. J. Falk, P. A. Bacon, N. Basu, M. C. Cid, F. Ferrario,
et al., “2012 revised international chapel hill consensus conference nomenclature of vasculitides,” Arthritis Rheum, vol. 65, pp. 1-11, 2013.
[2] J. C. Jennette, R. J. Falk, K. Andrassy, P. A. Bacon, J. Churg, W. L. Gross, et al., “Nomenclature of systemic vasculitides. Proposal of an international consensus conference,” Arthritis Rheum., vol. 37, pp. 187-92., 1994.
[3] S. Ozen, A. Pistorio, S. M. Iusan, A. Bakkaloglu, T. Herlin, R. Brik,
et al., “EULAR/PRINTO/PRES criteria for Henoch-Schonlein purpura, childhood polyarteritis nodosa, childhood Wegener granulomatosis and childhood Takayasu arteritis: Ankara 2008. Part II: Final classification criteria,” Ann, vol. 69, pp. 798-806., 2010.
[4] P. W. Mathieson, S. P. Cobbold, G. Hale, M. R. Clark, D. B. Oliveira, C. M. Lockwood, et al., “Monoclonal-antibody therapy in systemic vasculitis,” N Engl J Med., vol. 323, pp. 250-4., 1990.
[5] E. Ntatsaki, R. A. Watts, and D. G. Scott, “Epidemiology of ANCA-associated vasculitis,” Rheum Dis Clin North Am, vol. 36, pp. 447-61, 2010.
[6] M. A. Little, P. Nightingale, C. A. Verburgh, T. Hauser, K. De Groot, C. Savage, et al., “Early mortality in systemic vasculitis: relative contribution of adverse events and active vasculitis,” Ann Rheum Dis, vol. 69, pp. 1036-43, 2010.
[7] E. W. Walton, “Giant-cell granuloma of the respiratory tract (Wegener's granulomatosis),” Br Med J., vol. 2, pp. 265-70., 1958.
[8] P. Eriksson, L. Jacobsson, A. Lindell, J. A. Nilsson, and T. Skogh, “Improved outcome in Wegener's granulomatosis and microscopic polyangiitis? A retrospective analysis of 95 cases in two cohorts,” J Intern Med. 2009 Apr;265(4):496-506.
[9] E. Ntatsaki, D. Carruthers, K. Chakravarty, D. D'Cruz, L. Harper, D. Jayne, et al., “BSR and BHPR guideline for the management of adults with ANCA-associated vasculitis,” Rheumatology, vol. 53, pp. 2306-9, 2013.
[10] Miller, M. Chan, A. Wiik, S. A. Misbah, and R. A. Luqmani, “An approach to the diagnosis and management of systemic vasculitis,” Clin Exp Immunol, vol. 160, pp. 143-60, 2010.
[11] J. S. McLaren, R. H. Stimson, E. R. McRorie, J. E. Coia, and R. A. Luqmani, “The diagnostic value of anti-neutrophil cytoplasmic antibody testing in a routine clinical setting,” QJM, vol. 94, pp. 615-21., 2001.
[12] L. R. Bacon P, “Assessment of disease activity and damage,” in Vasculitis, B. S. Ball GV, Ed., 2nd Ed Oxford: Oxford University Press, 2002, pp. 297-308.
[13] R. A. Luqmani, P. A. Bacon, R. J. Moots, B. A. Janssen, A. Pall, P. Emery, et al., “Birmingham Vasculitis Activity Score (BVAS) in systemic necrotizing vasculitis,” Qjm., vol. 87, pp. 671-8., 1994.
[14] E. Reinhold-Keller, J. Kekow, A. Schnabel, W. H. Schmitt, M. Heller, A. Beigel, et al., “Influence of disease manifestation and antineutrophil cytoplasmic antibody titer on the response to pulse cyclophosphamide therapy in patients with Wegener's granulomatosis,” Arthritis Rheum., vol. 37, pp. 919-24., 1994.
[15] R. Suppiah, C. Mukhtyar, O. Flossmann, F. Alberici, B. Baslund, R. Batra, et al., “A cross-sectional study of the Birmingham Vasculitis Activity Score version 3 in systemic vasculitis,” Rheumatology, vol. 50, pp. 899-905. Epub 2010 Dec 13. 2011.
[16] K. Bhamra and R. Luqmani, “Damage assessment in ANCA-associated vasculitis,” Curr Rheumatol Rep, vol. 14, pp. 494-500, 2012.
[17] C. Mukhtyar, L. Guillevin, M. C. Cid, B. Dasgupta, K. de Groot, W. Gross, et al., “EULAR recommendations for the management of primary small and medium vessel vasculitis,” Ann Rheum Dis., vol. 68, pp. 310-7. doi: 10.1136/ard.2008.088096. Epub 2008 Apr 15. 2009.
[18] R. J. Looney, “B cells as a therapeutic target in autoimmune diseases other than rheumatoid arthritis,” Rheumatology (Oxford). 2005 May; 44 Suppl 2:ii13-ii17., 2005.
[19] C. G. Kallenberg, “Pathogenesis and treatment of ANCA-associated vasculitides,” Clin, vol. 33, pp. S11-4. Epub 2015 Oct 12, 2015.
[20] G. S. Kerr, T. A. Fleisher, C. W. Hallahan, R. Y. Leavitt, A. S. Fauci, and G. S. Hoffman, “Limited prognostic value of changes in antineutrophil cytoplasmic antibody titer in patients with Wegener's granulomatosis,” Arthritis Rheum. 1993 Mar;36(3):365-71., 1993.
[21] G. J. Silverman and S. Weisman, “Rituximab therapy and autoimmune disorders: prospects for anti-B cell therapy,” Arthritis Rheum., vol. 48, pp. 1484-92, 2003.
[22] R. B. Jones, J. W. Tervaert, T. Hauser, R. Luqmani, M. D. Morgan, C. A. Peh, et al., “Rituximab vs. cyclophosphamide in ANCA-associated renal vasculitis,” N Engl J Med, vol. 363, pp. 211-20, Jul 15 2010.
[23] J. H. Stone, P. A. Merkel, R. Spiera, P. Seo, C. A. Langford, G. S. Hoffman, et al., “Rituximab vs. cyclophosphamide for ANCA-associated vasculitis,” N Engl J Med, vol. 363, pp. 221-32, Jul 15 2010.
[24] (2013). Clinical Commissioning Policy; Ritixumab for ANCA- associated vasculitis www.england.nhs.uk/wp-content/uploads/2013/04/a13-p-a.pdf.
[25] NICE, “Rituximab in combination with glucocorticoids for treating anti-neutrophil cytoplasmic antibody-associated vasculitis,” N. t. a. g. [TA308], Ed., ed, 2014.
[26] P. M. Lutalo and D. P. D'Cruz, “Biological drugs in ANCA-associated vasculitis,” Int Immunopharmacol, vol. 27, pp. 209-12, 2015.
[27] P. Charles, B. Bienvenu, B. Bonnotte, P. Gobert, P. Godmer, E. Hachulla, et al., “Rituximab: Recommendations of the French Vasculitis Study Group (FVSG) for induction and maintenance treatments of adult, antineutrophil cytoplasm antibody-associated necrotizing vasculitides,” Presse Med, vol. 42, pp. 1317-30, 2013.
[28] R. Jones and M. Walsh, “A Randomised Trial of Mycophenolate Mofetil vs. Cyclophosphamide for Remission Induction in ANCA-Associated Vasculitis: MYCYC [abstract]” J Am Soc Nephrol, vol. 23, p. 3B, 2012 2012.
[29] L. Guillevin, “Ritximab vs. azathioprine for maintenance in ANCA-associated vasculitis. A prospective study in 117 patients.” Presse Med, vol. 42, p. 679, 2013.
[30] M. de Menthon, P. Cohen, C. Pagnoux, M. Buchler, J. Sibilia, F. Detree, et al., “Infliximab or rituximab for refractory Wegener's granulomatosis: long-term follow up. A prospective randomised multicentre study on 17 patients,” Clin Exp Rheumatol, vol. 29, pp. S63-71, Jan-Feb 2011.
[31] R. B. Jones, A. J. Ferraro, A. N. Chaudhry, P. Brogan, A. D. Salama, K. G. Smith, et al., “A multicenter survey of rituximab therapy for refractory antineutrophil cytoplasmic antibody-associated vasculitis,” Arthritis Rheum., vol. 60, pp. 2156-68. doi: 10.1002/art.24637., 2009.
[32] D. Eleftheriou, M. Melo, S. D. Marks, K. Tullus, J. Sills, G. Cleary, et al., “Biologic therapy in primary systemic vasculitis of the young,” Rheumatology (Oxford). 2009 Aug;48(8):978-86. doi: 10.1093/rheumatology/kep148. Epub 2009 Jun 17, 2009.
[33] P. M. Aries, B. Hellmich, J. Voswinkel, M. Both, B. Nolle, K. Holl-Ulrich, et al., “Lack of efficacy of rituximab in Wegener’s granulomatosis with refractory granulomatous manifestations,” Ann Rheum Dis. 2006 Jul;65(7):853-8. Epub 2005 Nov 3, 2006.
[34] S. R. Taylor, A. D. Salama, L. Joshi, C. D. Pusey, and S. L. Lightman, “Rituximab is effective in the treatment of refractory ophthalmic Wegener’s granulomatosis,” Arthritis Rheum., vol. 60, pp. 1540-7. doi: 10.1002/art.24454., 2009.
[35] C. S. Henderson SR1, Pusey CD, Ind PW, Salama AD., “Prolonged B cell depletion with rituximab is effective in treating refractory pulmonary granulomatous inflammation in granulomatosis with polyangiitis (GPA),” Medicine (Baltimore), vol. 93, p. e229. doi: 10.1097/MD.0000000000000229., Dec 2014.
[36] R. M. Tarzi and C. D. Pusey, “Current and future prospects in the management of granulomatosis with polyangiitis (Wegener’s granulomatosis),” Ther, vol. 10:279-93, p. 10.2147/TCRM.S41598., 2014.
[37] S. McAdoo, “Ofatumumab for B Cell Depletion Therapy in ANCA-Associated Vasculitis,” presented at the 17th International Vasculitis and ANCA Workshop London, April 19–22, 2015, London, April 19–22, 2015, 2015.
[38] W. F. Pendergraft, 3rd, F. B. Cortazar, J. Wenger, A. P. Murphy, E. P. Rhee, K. A. Laliberte, et al., “Long-term maintenance therapy using rituximab-induced continuous B-cell depletion in patients with ANCA vasculitis,” Clin J Am Soc Nephrol. 2014 Apr;9(4):736-44. doi: 10.2215/CJN.07340713. Epub 2014 Mar 13, 2014.
[39] P. Jarrot and G. Kaplanski, “Anti-TNF-Alpha Therapy and Systemic Vasculitis,” Mediators Inflamm, vol. 2014, 2014.
[40] Lenert and P. Lenert, “Current and emerging treatment options for ANCA-associated vasculitis: potential role of belimumab and other BAFF/APRIL targeting agents,” Drug Des Devel Ther. 2015 Jan 7;9:333-47. doi: 10.2147/DDDT.S67264. eCollection 2015., 2015.
[41] L. Lally and R. Spiera, “B-cell-targeted therapy in systemic vasculitis,” Curr Opin Rheumatol, vol. 28, pp. 15-20, 2016.
[42] S. Hamour, A. D. Salama, and C. D. Pusey, “Management of ANCA-associated vasculitis: Current trends and future prospects,” Ther, vol. 6, pp. 253-64., 2010.
[43] Booth, L. Harper, T. Hammad, P. Bacon, M. Griffith, J. Levy, et al., “Prospective study of TNFalpha blockade with infliximab in anti-neutrophil cytoplasmic antibody-associated systemic vasculitis,” J Am Soc Nephrol., vol. 15, pp. 717-21., 2004.
[44] WGET and R. Group, “Etanercept plus standard therapy for Wegener's granulomatosis,” N Engl J Med, vol. 352, pp. 351-61, Jan 27 2005.
[45] S. Laurino, A. Chaudhry, A. Booth, G. Conte, and D. Jayne, “Prospective study of TNFalpha blockade with adalimumab in ANCA-associated systemic vasculitis with renal involvement,” Nephrol Dial Transplant. 2010 Oct;25(10):3307-14. doi: 10.1093/ndt/gfq187. Epub 2010 Apr 5, 2010.
[46] Berti, G. Cavalli, C. Campochiaro, B. Guglielmi, E. Baldissera, S. Cappio, et al., “Interleukin-6 in ANCA-associated vasculitis: Rationale for successful treatment with tocilizumab,” Semin Arthritis Rheum. 2015 Aug;45(1):48-54. doi: 10.1016/
j.semarthrit.2015.02.002. Epub 2015 Feb 20,
2015.
[47] F. Moosig, W. L. Gross, K. Herrmann, J. P. Bremer, and B. Hellmich, “Targeting interleukin-5 in refractory and relapsing Churg-Strauss syndrome Extended follow-up after stopping mepolizumab in relapsing/refractory Churg-Strauss syndrome,” Ann Intern Med, vol. 155, pp. 341-3, 2011.
[48] S. Kim, G. Marigowda, E. Oren, E. Israel, and M. E. Wechsler, “Mepolizumab as a steroid-sparing treatment option in patients with Churg-Strauss syndrome,” J Allergy Clin Immunol, vol. 125, pp. 1336-43, 2010.
[49] E. Iglesias, M. Camacho Lovillo, I. Delgado Pecellin, M. J. Lirola Cruz, M. D. Falcon Neyra, J. C. Salazar Quero, et al., “Successful management of Churg-Strauss syndrome using omalizumab as adjuvant immunomodulatory therapy: first documented pediatric case,” Pediatr Pulmonol, vol. 49, p. 8, 2013.
[50] Detoraki, L. Di Capua, G. Varricchi, A. Genovese, G. Marone, and G. Spadaro, “Omalizumab in patients with eosinophilic granulomatosis with polyangiitis: a 36-month follow-up study,” J Asthma, vol. 17, pp. 1-6, 2015.
[51] M. Walsh, A. Chaudhry, and D. Jayne, “Long-term follow-up of relapsing/refractory anti-neutrophil cytoplasm antibody associated vasculitis treated with the lymphocyte depleting antibody alemtuzumab (CAMPATH-1H),” Ann Rheum Dis., vol. 67, pp. 1322-7. Epub 2007 Nov 29, 2008.
[52] C. A. Langford, P. A. Monach, U. Specks, P. Seo, D. Cuthbertson, C. A. McAlear, et al., “An open-label trial of abatacept (CTLA4-IG) in non-severe relapsing granulomatosis with polyangiitis (Wegener's),” Ann Rheum Dis. 2014 Jul;73(7):1376-9. doi: 10.1136/annrheumdis-2013-204164. Epub 2013 Dec 9, 2014.
[53] Schreiber, H. Xiao, J. C. Jennette, W. Schneider, F. C. Luft, and R. Kettritz, “C5a receptor mediates neutrophil activation and ANCA-induced glomerulonephritis,” J Am Soc Nephrol., vol. 20, pp. 289-98. doi: 10.1681/ASN.2008050497. Epub 2008 Dec 10, 2009.
[54] J. Yuan, S. J. Gou, J. Huang, J. Hao, M. Chen, and M. H. Zhao, “C5a and its receptors in human anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis,” Arthritis Res Ther. 2012 Jun 12;14(3):R140. doi: 10.1186/ar3873., 2015.
[55] D. Jayne, A. Bruchfeld, and M. Schaier, “Phase 2 randomised trial of oral C5a receptor antagonist CCX168 in ANCA-associated renal vasculitis.,” Nephrol Dial Transplant. 2010 Oct;25(10):3307-14. doi: 10.1093/ndt/gfq187. Epub 2010 Apr 5, vol. 29(Suppl 3), pp. iii27–iii29, 2014.
[56] P. Bekker, D. Jayne, A. Bruchfeld3, M. Schaier, K. Ciechanowski, L. Harper, et al., “CCX168, an Orally Administered C5aR Inhibitor for Treatment of Patients with Antineutrophil Cytoplasmic Antibody-Associated Vasculitis,” presented at the 2014 ACR/ARHP ANNUAL MEETING, Boston, MA, 2014.
[57] R. M. Smith, R. B. Jones, and D. R. Jayne, “Progress in treatment of ANCA-associated vasculitis,” Arthritis Res Ther, vol. 14, 2012.
[58] D. R. Jayne, V. L. Esnault, and C. M. Lockwood, “ANCA anti-idiotype antibodies and the treatment of systemic vasculitis with intravenous immunoglobulin,” J Autoimmun., vol. 6, pp. 207-19., 1993.
[59] F. Rossi, B. Bellon, M. C. Vial, P. Druet, and M. D. Kazatchkine, “Beneficial effect of human therapeutic intravenous immunoglobulins (IVIg) in mercuric-chloride-induced autoimmune disease of Brown-Norway rats,” Clin Exp Immunol., vol. 84, pp. 129-33., 1991.
[60] P. M. Fortin, A. M. Tejani, K. Bassett, and V. M. Musini, “Intravenous immunoglobulin as adjuvant therapy for Wegener's granulomatosis,” Cochrane Database Syst Rev., p. CD007057. doi: 10.1002/14651858.CD007057.pub2., 2009.
[61] J. C. Jennette, R. J. Falk, K. Andrassy, P. A. Bacon, J. Churg, W. L. Gross, et al., “Nomenclature of systemic vasculitides. Proposal of an international consensus conference,” Arthritis Rheum, vol. 37, pp. 187-92, Feb 1994.
[62] J. Hernandez-Rodriguez and G. S. Hoffman, “Updating single-organ vasculitis,” Curr Opin Rheumatol, vol. 24, pp. 38-45, Jan 2012.
[63] Mahr, L. Guillevin, M. Poissonnet, and S. Ayme, “Prevalences of polyarteritis nodosa, microscopic polyangiitis, Wegener's granulomatosis, and Churg-Strauss syndrome in a French urban multiethnic population in 2000: a capture-recapture estimate,” Arthritis Rheum, vol. 51, pp. 92-9, Feb 15 2004.
[64] J. Hernandez-Rodriguez, M. A. Alba, S. Prieto-Gonzalez, and M. C. Cid, “Diagnosis and classification of polyarteritis nodosa,” J Autoimmun, vol. 48-49, pp. 84-9, Feb-Mar 2014.
[65] L. Forbess and S. Bannykh, “Polyarteritis nodosa,” Rheum Dis Clin North Am, vol. 41, pp. 33-46, vii, 2015.
[66] M. Kouchi, S. Sato, M. Kamono, A. Taoda, K. Iijima, A. Mizuma, et al., “A case of polyarteritis nodosa associated with cytomegalovirus infection,” Case Rep Rheumatol, vol. 2014, p. 604874, 2014.
[67] J. Morgan and R. A. Schwartz, “Cutaneous polyarteritis nodosa: a comprehensive review,” Int J Dermatol, vol. 49, pp. 750-6, Jul 2010.
[68] M. A. Gonzalez-Gay, C. Garcia-Porrua, J. Guerrero, P. Rodriguez-Ledo, and J. Llorca, “The epidemiology of the primary systemic vasculitides in northwest Spain: Implications of the Chapel Hill Consensus Conference definitions,” Arthritis Care and Research, vol. 49, pp. 388-393, 2003.
[69] D. Selga, A. Mohammad, G. Sturfelt, and M. Segelmark, “Polyarteritis nodosa when applying the Chapel Hill nomenclature—a descriptive study on ten patients,” Rheumatology, vol. 45, pp. 1276-1281, October 1, 2006 2006.
[70] J. Mohammad, L. T. Jacobsson, A. D. Mahr, G. Sturfelt, and M. Segelmark, “Prevalence of Wegener's granulomatosis, microscopic polyangiitis, polyarteritis nodosa and Churg-Strauss syndrome within a defined population in southern Sweden,” Rheumatology (Oxford), vol. 46, pp. 1329-37, Aug 2007.
[71] Ribi, P. Cohen, C. Pagnoux, A. Mahr, J. P. Arene, X. Puechal, et al., “Treatment of polyarteritis nodosa and microscopic polyangiitis without poor-prognosis factors: A prospective randomised study of one hundred twenty-four patients,” Arthritis Rheum, vol. 62, pp. 1186-97, Apr 2010.
[72] Bourgarit, P. Le Toumelin, C. Pagnoux, P. Cohen, A. Mahr, V. Le Guern, et al., “Deaths occurring during the first year after treatment onset for polyarteritis nodosa, microscopic polyangiitis, and Churg-Strauss syndrome: a retrospective analysis of causes and factors predictive of mortality based on 595 patients,” Medicine (Baltimore), vol. 84, pp. 323-30, Sep 2005.
[73] L. Guillevin, C. Pagnoux, R. Seror, A. Mahr, L. Mouthon, and P. Le Toumelin, “The Five-Factor Score revisited: assessment of prognoses of systemic necrotizing vasculitides based on the French Vasculitis Study Group (FVSG) cohort,” Medicine (Baltimore), vol. 90, pp. 19-27, Jan 2011.
[74] L. Guillevin, P. Cohen, A. Mahr, J. P. Arene, L. Mouthon, X. Puechal, et al., “Treatment of polyarteritis nodosa and microscopic polyangiitis with poor prognosis factors: a prospective trial comparing glucocorticoids and six or twelve cyclophosphamide pulses in sixty-five patients,” Arthritis Rheum, vol. 49, pp. 93-100, Feb 15 2003.
[75] E. Ribeiro, T. Cressend, P. Duffau, M. Grenouillet-Delacre, M. Rouanet-Lariviere, A. Vital, et al., “Rituximab Efficacy during a Refractory Polyarteritis Nodosa Flare,” Case Rep Med, vol. 2009, p. 738293, 2009.
[76] L. Guillevin, A. Mahr, P. Callard, P. Godmer, C. Pagnoux, E. Leray, et al., “Hepatitis B virus-associated polyarteritis nodosa: clinical characteristics, outcome, and impact of treatment in 115 patients,” Medicine (Baltimore), vol. 84, pp. 313-22, Sep 2005.
[77] K. Wu and D. Throssell, “A new treatment for polyarteritis nodosa,” Nephrol Dial Transplant, vol. 21, pp. 1710-2, Jun 2006.
[78] J. C. Burns and M. P. Glode, “Kawasaki syndrome,” Lancet, vol. 364, pp. 533-44, Aug 7-13 2004.
[79] H. Kato, T. Sugimura, T. Akagi, N. Sato, K. Hashino, Y. Maeno, et al., “Long-term consequences of Kawasaki disease. A 10- to 21-year follow-up study of 594 patients,” Circulation, vol. 94, pp. 1379-85, Sep 15 1996.
[80] J. W. Newburger, M. Takahashi, J. C. Burns, A. S. Beiser, K. J. Chung, C. E. Duffy, e
t al., “The treatment of Kawasaki syndrome with intravenous gamma globulin,” N Engl J Med, vol. 315, pp. 341-7, Aug 7 1986.
[81] Y. Nakamura, M. Yashiro, R. Uehara, A. Sadakane, S. Tsuboi, Y. Aoyama, et al., “Epidemiologic features of Kawasaki disease in Japan: results of the 2009-2010 nationwide survey,” J Epidemiol, vol. 22, pp. 216-21, 2012.
[82] T. Heuclin, F. Dubos, V. Hue, F. Godart, C. Francart, P. Vincent, et al., “Increased detection rate of Kawasaki disease using new diagnostic algorithm, including early use of echocardiography,” J Pediatr, vol. 155, pp. 695-9.e1, Nov 2009.
[83] J. W. Newburger, M. Takahashi, A. S. Beiser, J. C. Burns, J. Bastian, K. J. Chung,
et al., “A single intravenous infusion of gamma globulin as compared with four infusions in the treatment of acute Kawasaki syndrome,” N Engl J Med, vol. 324, pp. 1633-9, Jun 6 1991.
[84] T. Kontopoulou, D. G. Kontopoulos, E. Vaidakis, and G. P. Mousoulis, “Adult Kawasaki disease in a European patient: a case report and review of the literature,” J Med Case Rep, vol. 9, p. 75, 2015.
[85] J. B. Fraison, P. Seve, C. Dauphin, A. Mahr, E. Gomard-Mennesson, L. Varron, et al., “Kawasaki disease in adults: Observations in France and literature review,” Autoimmun Rev, Nov 26 2015.
[86] J. W. Newburger, M. Takahashi, M. A. Gerber, M. H. Gewitz, L. Y. Tani, J. C. Burns, et al., “Diagnosis, treatment, and long-term management of Kawasaki disease: a statement for health professionals from the Committee on Rheumatic Fever, Endocarditis and Kawasaki Disease, Council on Cardiovascular Disease in the Young, American Heart Association,” Circulation, vol. 110, pp. 2747-71, Oct 26 2004.
[87] R. M. Patel and S. T. Shulman, “Kawasaki disease: a comprehensive review of treatment options,” J Clin Pharm Ther, Nov 7 2015.
[88] H. Tremoulet, S. Jain, P. Jaggi, S. Jimenez-Fernandez, J. M. Pancheri, X. Sun, et al., “Infliximab for intensification of primary therapy for Kawasaki disease: a phase 3 randomised, double-blind, placebo-controlled trial,” Lancet, vol. 383, pp. 1731-8, May 17 2014.
[89] J. E. Weiss, B. A. Eberhard, D. Chowdhury, and B. S. Gottlieb, “Infliximab as a novel therapy for refractory Kawasaki disease,” J Rheumatol, vol. 31, pp. 808-10, Apr 2004.
[90] J. C. Burns, B. M. Best, A. Mejias, L. Mahony, D. E. Fixler, H. S. Jafri, et al., “Infliximab treatment of intravenous immunoglobulin-resistant Kawasaki disease,” J Pediatr, vol. 153, pp. 833-8, Dec 2008.
[91] M. B. Son, K. Gauvreau, J. C. Burns, E. Corinaldesi, A. H. Tremoulet, V. E. Watson,
et al., “Infliximab for intravenous immunoglobulin resistance in Kawasaki disease:
a retrospective study,” J Pediatr, vol. 158, pp. 644-649.e1, Apr 2011.
[92] N. F. Choueiter, A. K. Olson, D. D. Shen, and M. A. Portman, “Prospective open-label trial of etanercept as adjunctive therapy for kawasaki disease,” J Pediatr, vol. 157, pp. 960-966.e1, Dec 2010.
[93] M. A. Portman, A. Olson, B. Soriano, N. Dahdah, R. Williams, and E. Kirkpatrick, “Etanercept as adjunctive treatment for acute Kawasaki disease: study design and rationale,” Am Heart J, vol. 161, pp. 494-9, Mar 2011.
[94] E. Sauvaget, B. Bonello, M. David, B. Chabrol, J. C. Dubus, and E. Bosdure, “Resistant Kawasaki disease treated with anti-CD20,” J Pediatr, vol. 160, pp. 875-6, May 2012.
[95] S. Chang and W. Carr, “Urticarial vasculitis,” Allergy Asthma Proc, vol. 28, pp. 97-100, Jan-Feb 2007.
[96] L. J. Jara, C. Navarro, G. Medina, O. Vera-Lastra, and M. A. Saavedra, “Hypocomplementemic urticarial vasculitis syndrome,” Curr Rheumatol Rep, vol. 11, pp. 410-5, Dec 2009.
[97] M. A. Kinney and J. L. Jorizzo, “Small-vessel vasculitis,” Dermatologic Therapy, vol. 25, pp. 148-157, 2012.
[98] M. N. Ghazanfar and S. F. Thomsen, “Omalizumab for Urticarial Vasculitis: Case Report and Review of the Literature,” Case Rep Dermatol Med, vol. 2015, p. 576893, 2015.
[99] Buck, J. Christensen, and M. McCarty, “Hypocomplementemic Urticarial Vasculitis Syndrome: A Case Report and Literature Review,” J Clin Aesthet Dermatol, vol. 5, pp. 36-46, Jan 2012.
[100] F. C. McDuffie, W. M. Sams, Jr., J. E. Maldonado, P. H. Andreini, D. L. Conn, and E. A. Samayoa, “Hypocomplementemia with cutaneous vasculitis and arthritis. Possible immune complex syndrome,” Mayo Clin Proc, vol. 48, pp. 340-8, May 1973.
[101] M. Jachiet, B. Flageul, A. Deroux, A. Le Quellec, F. Maurier, F. Cordoliani, et al., “The clinical spectrum and therapeutic management of hypocomplementemic urticarial vasculitis: data from a French nationwide study of fifty-seven patients,” Arthritis Rheumatol, vol. 67, pp. 527-34, Feb 2015.
[102] T. Zuberbier, W. Aberer, R. Asero, C. Bindslev-Jensen, Z. Brzoza, G. W. Canonica,
et al., “The EAACI/GA(2) LEN/EDF/WAO Guideline for the definition, classification, diagnosis, and management of urticaria: the 2013 revision and update,” Allergy, vol. 69, pp. 868-87, Jul 2014.
[103] Mukhtyar, S. Misbah, J. Wilkinson, and P. Wordsworth, “Refractory urticarial vasculitis responsive to anti-B-cell therapy,” Br J Dermatol, vol. 160, pp. 470-2, Feb 2009.
[104] Botsios, P. Sfriso, L. Punzi, and S. Todesco, “Non-complementaemic urticarial vasculitis: successful treatment with the IL-1 receptor antagonist, anakinra,” Scand J Rheumatol, vol. 36, pp. 236-7, May-Jun 2007.
[105] Grattan, et al., “Schnitzler’s syndrome: diagnosis, treatment, and follow-up,” Allergy, vol. 68, pp. 562-8, 2013.
[106] M. Ramos-Casals, P. Brito-Zeron, S. Munoz, N. Soria, D. Galiana, L. Bertolaccini,
et al., “Autoimmune diseases induced by TNF-targeted therapies: analysis of 233 cases,” Medicine (Baltimore), vol. 86, pp. 242-51, Jul 2007.
[107] H. A. Brandling-Bennett and M. G. Liang, “Urticarial Vasculitis,” in Harper's Textbook of Pediatric Dermatology, Ed: Wiley-Blackwell, 2011, pp. 163.1-163.7.
[108] W. Fadahunsi, M. Garcia-Rosell, and D. Pattanaik, “Hypocomplementemic Urticarial Vasculitis Syndrome Possibly Secondary to Etanercept Use,” J Clin Rheumatol, vol. 21, pp. 274-5, Aug 2015.
[109] K. Krause, A. Mahamed, K. Weller, M. Metz, T. Zuberbier, and M. Maurer, “Efficacy and safety of canakinumab in urticarial vasculitis: an open-label study,” J Allergy Clin Immunol, vol. 132, pp. 751-754.e5, Sep 2013.
[110] J. M. Gardner-Medwin, P. Dolezalova, C. Cummins, and T. R. Southwood, “Incidence of Henoch-Schonlein purpura, Kawasaki disease, and rare vasculitides in children of different ethnic origins,” Lancet, vol. 360, pp. 1197-202, Oct 19 2002.
[111] F. T. Saulsbury, “Clinical update: Henoch-Schonlein purpura,” Lancet, vol. 369, pp. 976-8, Mar 24 2007.
[112] S. Shrestha, N. Sumingan, J. Tan, H. Alhous, L. McWilliam, and F. Ballardie, “Henoch Schonlein purpura with nephritis in adults: adverse prognostic indicators in a UK population,” Qjm, vol. 99, pp. 253-65, Apr 2006.
[113] Pillebout, F. Rocha, L. Fardet, M. Rybojad, J. Verine, and D. Glotz, “Successful outcome using rituximab as the only immunomodulation in Henoch-Schonlein purpura: case report,” Nephrol Dial Transplant, vol. 26, pp. 2044-6, Jun 2011.
[114] Audemard-Verger, E. Pillebout, L. Guillevin, E. Thervet, and B. Terrier, “IgA vasculitis (Henoch-Shonlein purpura) in adults: Diagnostic and therapeutic aspects,” Autoimmun Rev, vol. 14, pp. 579-85, Jul 2015.
[115] H. Ishiguro, T. Hashimoto, M. Akata, S. Suzuki, K. Azushima, Y. Kobayashi, et al., “Rituximab treatment for adult purpura nephritis with nephrotic syndrome,” Intern Med, vol. 52, pp. 1079-83, 2013.
[116] T. Pindi Sala, J. M. Michot, R. Snanoudj, M. Dollat, E. Esteve, B. Marie, et al., “Successful outcome of a corticodependent henoch-schonlein purpura adult with rituximab,” Case Rep Med, vol. 2014, p. 619218, 2014.
[117] El-Husseini, A. Ahmed, A. Sabucedo, and E. Fabulo, “Refractory Henoch–Schönlein Purpura: Atypical Aetiology and Management,” Journal of Renal Care, vol. 39, pp. 77-81, 2013.
[118] K. J. Donnithorne, T. P. Atkinson, C. H. Hinze, J. B. Nogueira, S. A. Saeed, D. J. Askenazi, et al., “Rituximab therapy for severe refractory chronic Henoch-Schonlein purpura,” J Pediatr, vol. 155, pp. 136-9, Jul 2009.
[119] Lee, R. Kasama, A. Evangelisto, B. Elfenbein, and G. Falasca, “Henoch-Schonlein purpura after etanercept therapy for psoriasis,” J Clin Rheumatol, vol. 12, pp. 249-51, Oct 2006.
[120] T. N. Duffy, M. Genta, S. Moll, P. Y. Martin, and C. Gabay, “Henoch Schonlein purpura following etanercept treatment of rheumatoid arthritis,” Clin Exp Rheumatol, vol. 24, p. S106, Mar-Apr 2006.
[121] S. Nobile, C. Catassi, and L. Felici, “Herpes zoster infection followed by Henoch-Schonlein purpura in a girl receiving infliximab for ulcerative colitis,” J Clin Rheumatol, vol. 15, p. 101, Mar 2009.
[122] Marques, A. Lagos, J. Reis, A. Pinto, and B. Neves, “Reversible Henoch-Schonlein purpura complicating adalimumab therapy,” J Crohns Colitis, vol. 6, pp. 796-9, Aug 2012.
[123] Z. Rahman, G. K. Takhar, O. Roy, A. Shepherd, S. L. Bloom, and S. A. McCartney, “Henoch-Schonlein purpura complicating adalimumab therapy for Crohn's disease,” World J Gastrointest Pharmacol Ther, vol. 1, pp. 119-22, Oct 6 2010.
[124] C. Ferri, M. Sebastiani, D. Giuggioli, M. Cazzato, G. Longombardo, A. Antonelli,
et al., “Mixed cryoglobulinemia: demographic, clinical, and serologic features and survival in 231 patients,” Semin Arthritis Rheum, vol. 33, pp. 355-74, Jun 2004.
[125] D. Giuggioli, A. Manfredi, F. Lumetti, M. Sebastiani, and C. Ferri, “Cryoglobulinemic vasculitis and skin ulcers. Our therapeutic strategy and review of the literature,” Semin Arthritis Rheum, vol. 44, pp. 518-26, Apr 2015.
[126] P. Cacoub, B. Terrier, and D. Saadoun, “Hepatitis C virus-induced vasculitis: therapeutic options,” Ann Rheum Dis, vol. 73, pp. 24-30, Jan 2014.
[127] D. Saadoun, M. Resche-Rigon, V. Thibault, J. C. Piette, and P. Cacoub, “Antiviral therapy for hepatitis C virus--associated mixed cryoglobulinemia vasculitis: a long-term followup study,” Arthritis Rheum, vol. 54, pp. 3696-706, Nov 2006.
[128] B. Terrier, D. Saadoun, D. Sene, J. Sellam, L. Perard, B. Coppere, et al., “Efficacy and tolerability of rituximab with or without PEGylated interferon alfa-2b plus ribavirin in severe hepatitis C virus-related vasculitis: a long-term followup study of thirty-two patients,” Arthritis Rheum, vol. 60, pp. 2531-40, Aug 2009.
[129] Kaplanski, V. Marin, T. Maisonobe, A. Sbai, C. Farnarier, P. Ghillani, et al., “Increased soluble p55 and p75 tumour necrosis factor-α receptors in patients with hepatitis C-associated mixed cryoglobulinaemia,” Clinical and Experimental Immunology, vol. 127, pp. 123-130, 2002.
[130] M. O. Chandesris, S. Gayet, N. Schleinitz, B. Doudier, J. R. Harle, and G. Kaplanski, “Infliximab in the treatment of refractory vasculitis secondary to hepatitis C-associated mixed cryoglobulinaemia,” Rheumatology (Oxford), vol. 43, pp. 532-3, Apr 2004.
[131] P. Bartolucci, J. Ramanoelina, P. Cohen, A. Mahr, P. Godmer, C. Le Hello, et al., “Efficacy of the anti-TNF-alpha antibody infliximab against refractory systemic vasculitides: an open pilot study on 10 patients,” Rheumatology (Oxford), vol. 41, pp. 1126-32, Oct 2002.
[132] C. Ferri, P. Cacoub, C. Mazzaro, D. Roccatello, P. Scaini, M. Sebastiani, et al., “Treatment with rituximab in patients with mixed cryoglobulinemia syndrome: results of multicenter cohort study and review of the literature,” Autoimmun Rev, vol. 11, pp. 48-55, Nov 2011.
[133] M. C. Sneller, Z. Hu, and C. A. Langford, “A randomised controlled trial of rituximab following failure of antiviral therapy for hepatitis C virus-associated cryoglobulinemic vasculitis,” Arthritis Rheum, vol. 64, pp. 835-42, Mar 2012.
[134] S. De Vita, L. Quartuccio, M. Isola, C. Mazzaro, P. Scaini, M. Lenzi, et al., “A randomised controlled trial of rituximab for the treatment of severe cryoglobulinemic vasculitis,” Arthritis and Rheumatism, vol. 64, pp. 843-853, 2012.
[135] B. Terrier, E. Krastinova, I. Marie, D. Launay, A. Lacraz, P. Belenotti, et al., “Management of noninfectious mixed cryoglobulinemia vasculitis: data from 242 cases included in the CryoVas survey,” Blood, vol. 119, pp. 5996-6004, Jun 21 2012.
[136] P. Peto and A. D. Salama, “Update on antiglomerular basement membrane disease,” Curr Opin Rheumatol, vol. 23, pp. 32-7, 2011.
[137] Bandak, B. A. Jones, J. Li, J. Yee, and K. Umanath, “Rituximab for the treatment of refractory simultaneous anti-glomerular basement membrane (anti-GBM) and membranous nephropathy,” Clin Kidney J, vol. 7, pp. 53-6, 2014.
[138] M. Touzot, J. Poisson, S. Faguer, D. Ribes, P. Cohen, L. Geffray, et al., “Rituximab in anti-GBM disease: A retrospective study of 8 patients,” J Autoimmun, vol. 60, pp. 74-9, 2015.
[139] R. M. Tarzi, H. T. Cook, and C. D. Pusey, “Crescentic glomerulonephritis: new aspects of pathogenesis,” Semin Nephrol, vol. 31, pp. 361-8, 2011.

Chapter 7

[1] J. Jennette, R. Falk, P. Bacon, N. Basu, M. Cid, F. Ferrario, et al., “2012 Revised International Chapel Hill Consensus Conference Nomenclature of Vasculitides,” Arthritis Rheum, vol. 65, no. 1, pp. 1-11, 2012.
[2] C. Mukhtyar, L. Guillevin, M. Cid, B. Dasgupta, K. de Groot, W. Gross, et al., “EULAR recommendations for the management of large vessel vasculitis”, Ann Rheum Dis, vol. 68, no. 3, pp. 318-323, 2009.
[3] C. Salvarani, F. Cantini and G. Hunder, “Polymyalgia rheumatica and giant-cell arteritis”, Lancet, vol. 372(9634), pp. 234–245, 2008.
[4] P. Liang and G. S. Hoffman, “Advances in the medical and surgical treatment of Takayasu arteritis,” Curr Opin Rheumatol, vol. 17, no. 1, pp. 16–24, 2005.
[5] T. Adizie and B. Dasgupta, “PMR and GCA: steroids or bust,” Int J Clin Pract, vol. 66, no. 6, pp. 524-527, 2012.
[6] J. Loricera, R. Blanco, J. Hernández, T. Pina, M. González-Vela and M. González-Gay, “Biologic therapy in ANCA-negative vasculitis,” Intern Immunopharm, vol. 27, no. 2, pp. 213-219, 2015.
[7] L. Smeeth, C. Cook and A. Hall, “Incidence of diagnosed polymyalgia rheumatica and temporal arteritis in the United Kingdom, 1990-2001”, Ann Rheum Dis, vol. 65, no. 8, pp. 1093-1098, 2006.
[8] N. Hassan, B. Dasgupta and K. Barraclough, “Easily missed? Giant cell arteritis”, BMJ, vol. 342, pp.1206-1209, 2011.
[9] E. Tombetti, M. Chiara Di Chio, S. Sartorelli, E. Bozzolo, M. Grazia Sabbadini, et al., “Anti-cytokine treatment for Takayasu arteritis: State of the art”, Intractable Rare Dis Res, vol. 3, no. 1, pp. 29-33, 2014.
[10] J. Stone, V. Patel, G. Oliveira and J. Stone, “Case 38-2012: A 60-Year-Old Man with Abdominal Pain and Aortic Aneurysms,” N Engl J Med, vol. 367, no. 24, pp. 2335-2346, 2012. doi: 10.1056/NEJMcpc1209330.
[11] R. Talarico, L. Boiardi, N. Pipitone, A. d'Ascanio, C. Stagnaro, C. Ferrari, et al., “Isolated aortitis versus giant cell arteritis: are they really two sides of the same coin?”, Clin Exp Rheumatol, vol. 32, (3 Suppl 82), pp. S55-58, 2014.
[12] D. Christidis, S. Jain and B. Gupta, “Successful use of tocilizumab in polymyalgic onset biopsy positive GCA with large vessel involvement,” BMJ Case Reports, doi: 10.1136/bcr.04.2011.4135, 2011.
[13] P. Macchioni, L. Boiardi, M. Catanoso, L. Pulsatelli, N. Pipitone, R. Meliconi, et al., “Tocilizumab for polymyalgia rheumatica: Report of two cases and review of the literature,” Semin Arthritis Rheum, vol. 43, no. 1, pp. 113-118, 2013.
[14] C. Dejaco, C. Duftner, F. Buttgereit, L. Eric, E. Matteson and B. Dasgupta, “Giant cell arteritis and Polymyalgia arteritica – an old concept revisited,” Rheumatol, 2016: Submitted (Personal communication).
[15] B. Hamrin, “Polymyalgia arteritica,” Acta Med Scand, vol. 533, pp. 1-131, 1972.
[16] F. Buttgereit, G. Burmester, R. Straub, M. Seibel and H. Zhou, “Exogenous and endogenous glucocorticoids in rheumatic diseases,” Arthritis Rheum, vol. 63, no. 1, pp. 1-9, 2010.
[17] G. Pazzola, F. Muratore, N. Pipitone and C. Salvarani, “Biologics in vasculitides: Where do we stand, where do we go from now?” Presse Méd, vol. 44, no. 6, pp. e231-e239, 2015.
[18] G. Hoffman, M. Cid, D. Hellmann, L. Guillevin, J. Stone, J. Schousboe, et al., “A multicenter, randomised, double-blind, placebo-controlled trial of adjuvant methotrexate treatment for giant cell arteritis,” Arthritis Rheum, vol. 46, no. 5, pp. 1309-1318, 2002.
[19] J. Jover, C. Hernández-García, I. Morado, E. Vargas, B. Bañares, et al., “Combined Treatment of Giant-Cell Arteritis with Methotrexate and Prednisone. A randomised, double-blind, placebo-controlled trial,” Ann Intern Med, vol. 134, no. 2, pp. 106-114, 2001.
[20] A. Mahr, J. Jover, R. Spiera, C. Hernández-García, B. Fernández-Gutiérrez, M. LaValley, et al., “Adjunctive methotrexate for treatment of giant cell arteritis: An individual patient data meta-analysis,” Arthritis Rheum, vol. 56, no. 8, pp. 2789-2797, 2007.
[21] R. Spiera, H. Mitnick, M. Kupersmith, M. Richmond, H. Spiera, M. Peterson, et al., “A prospective, double-blind, randomised, placebo controlled trial of MTX in the treatment of giant cell arteritis (GCA)”, Clin Exp Rheumatol, vol. 19, no. 5, pp. 495–501, 2001.
[22] V. Schäfer and J. Zwerina, “Biologic treatment of large-vessel vasculitides,” Curr Opin Rheumatol, vol. 24, no. 1, pp. 31-37, 2012.
[23] C. Salvarani, F. Cantini, L. Niccoli, P. Macchioni, D. Consonni, G. Bajocchi, et al., “Acute-phase reactants and the risk of relapse/recurrence in polymyalgia rheumatica: A prospective followup study,” Arthritis Rheum, vol. 53, no. 1, pp. 33-38, 2005.
[24] H. Kremers, M. Reinalda, C. Crowson, A. Zinsmeiste, G. Hunder and E. Gabriel, “Relapse in a population based cohort of patients with polymyalgia rheumatica”, J Rheumatol, vol. 32, no. 1, pp. 65–73, 2005.
[25] L. Pulsatelli, L. Boiardi, E. Pignotti, P. Dolzani, T. Silvestri, P. Macchioni, et al., “Serum interleukin-6 receptor in polymyalgia rheumatica: A potential marker of relapse/recurrence risk,” Arthritis Rheum, vol. 59, no. 8, pp. 1147-1154, 2008.
[26] S. Unizony, J. Stone and J. Stone, “New treatment strategies in large-vessel vasculitis”, Curr Opin Rheumatol, vol. 25, no. 1, pp. 3-9, 2013.
[27] I. Kötter, J. Henes, A. Wagner, J. Loock and W. Gross, “Does glucocorticosteroid-resistant large-vessel vasculitis (giant cell arteritis and Takayasu arteritis) exist and how can remission be achieved? A critical review of the literature,” Clin Exp Rheumatol, vol. 30, (1 Suppl 70), pp. S114-129, 2012.
[28] S. Gabriel, J. Sunku, C. Salvarani, W. O'Fallon and G. Hunder, “Adverse outcomes of antiinflammatory therapy among patients with polymyalgia rheumatic,” Arthritis Rheum, vol. 40, no. 10, pp. 1873-1878, 1997.
[29] M. van der Goes, J. Jacobs, M. Boers, T. Andrews, M. Blom-Bakkers, F. Buttgereit,
et al., “Patient and rheumatologist perspectives on glucocorticoids: an exercise to improve the implementation of the European League Against Rheumatism (EULAR) recommendations on the management of systemic glucocorticoid therapy in rheumatic diseases,” Ann Rheum Dis, vol. 69, no. 6, pp. 1015-1021, 2010.
[30] A. Proven, S. Gabriel, C. Orces, W. O'Fallon and G. Hunder, “Glucocorticoid therapy in giant cell arteritis: Duration and adverse outcomes”, Arthritis Rheum, vol. 49, no. 5, pp. 703-708, 2003.
[31] C. Dejaco, Y. Singh, P. Perel, A. Hutchings, D. Camellino, S. Mackie, E. Matteson and B. Dasgupta, “Current evidence for therapeutic interventions and prognostic factors in polymyalgia rheumatica: a systematic literature review informing the 2015 European League Against Rheumatism/American College of Rheumatology recommendations for the management of polymyalgia rheumatic,” Ann Rheum Dis, vol. 74, no. 10, pp. 1808-1817, 2015.
[32] B. Dasgupta, A. Dolan, G. Panayi and L. Fernandes, “An initially double-blind controlled 96 week trial of depot methylprednisolone against oral prednisolone in the treatment of polymyalgia rheumatic,” Br J Rheumatol, vol. 37, no. 2, pp. 189-195, 1998.
[33] A. Diamantopoulos, G. Haugeberg, H. Hetland, D. Soldal, R. Bie and G. Myklebust, “Diagnostic Value of Color Doppler Ultrasonography of Temporal Arteries and Large Vessels in Giant Cell Arteritis: A Consecutive Case Series,” Arthritis Care Res, vol. 66, no. 1, pp. 113-119, 2013.
[34] W. Schmidt, H. Kraft, K. Vorpahl, L. Völker and E. Gromnica-Ihle, “Color Duplex Ultrasonography in the Diagnosis of Temporal Arteritis,” N Engl J Med, vol. 337, no. 19, pp. 1336-1342, 1997.
[35] P. Falsetti, C. Acciai, A. Volpe and L. Lenzi, “Ultrasonography in early assessment of elderly patients with polymyalgic symptoms: a role in predicting diagnostic outcome?” Scand J Rheumatol, vol. 40, no. 1, pp. 57-63, 2011.
[36] T. Bley, O. Weiben, M. Uhl, P. Vaith, D. Schmidt, K. Warnatz, et al., “Assessment of the cranial involvement pattern of giant cell arteritis with 3t magnetic resonance imaging,” Arthritis Rheum, vol. 52, no. 8, pp. 2470-2477, 2005.
[37] J. Cabero Moyano, M. Andreu Magarolas, E. Castañer González, X. Gallardo Cistaré and E. Belmonte Castan, “Nonurgent aortic disease: Clinical-radiological diagnosis of aortitis,” Radiología (English Edition), vol. 55, no. 6, pp. 469-482, 2013.
[38] E. Rodríguez-Caulo, C. Velázquez, M. García-Borbolla and J. Barquero, “Mega-Aorta Syndrome Development in Giant Cell Arteritis. A Same Entity?” Ann Vasc Surg, vol. 25, no. 8, p. 1141.e1-1141.e3, 2011.
[39] O. Espitia, A. Neel, C. Leux, J. Connault, A. Espitis-Thibault, T. Ponge, et al., “Giant Cell Arteritis with or without Aortitis at Diagnosis. A Retrospective Study of 22 Patients with Longterm Followup,” J Rheumatol, vol. 39, no. 11, pp. 2157-2162, 2012.
[40] T. Neumann, P. Oelzner, M. Freesmeyer, A. Hansch, T. Opfermann, G. Hein, et al., “Diagnosis of Large-Vessel Vasculitis by [18F] Fluorodeoxyglucose-Positron Emission Tomography,” Circulation, vol. 119, no. 2, pp. 338-339, 2009.
[41] M. Gotthardt, C. Bleeker-Rovers, O. Boerman and W. Oyen, “Imaging of Inflammation by PET, Conventional Scintigraphy, and Other Imaging Techniques,” J Nuc Med, vol. 51, no. 12, pp. 1937-1949, 2010.
[42] N. Papathanasiou, Y. Du, L. Menezes, A. Almuhaideb, M. Shastry, H. Beynon and J. Bomanji, “18 F-Fludeoxyglucose PET/CT in the evaluation of large-vessel vasculitis: diagnostic performance and correlation with clinical and laboratory parameters,” Br J Radiol, vol. 85, no. 1014, pp. e188-e194, 2012.
[43] P. Patil, C. Dejaco and B. Dasgupta, “A pragmatic approach to imaging in large vessel vasculitis,” Expert Opinion on Orphan Drugs, vol. 3, no. 7, pp. 767-775, 2015.
[44] M. Soussan, P. Nicolas, C. Schramm, S. Katsahian, G. Pop, O. Fain, et al., “Management of Large-Vessel Vasculitis With FDG-PET”, Medicine (Baltimore), vol. 94, no. 14, p. e622, 2015.
[45] H. Adams, P. Raijmakers and Y. Smulders, “Polymyalgia Rheumatica and Interspinous FDG Uptake on PET/CT,” Clin Nucl Med, vol. 37, no. 5, pp. 502-505, 2012.
[46] K. Le, L. Bools, A. Lynn, T. Clancy, W. Hooks and W. Hope, “The effect of temporal artery biopsy on the treatment of temporal arteritis,” Am J Surg, vol. 209, no. 2, pp. 338-341, 2015.
[47] M. Kaiser, C. Weyand, J. Björnsson and J. Goronzy, “Platelet-derived growth factor, intimal hyperplasia, and ischemic complications in giant cell arteritis,” Arthritis Rheum, vol. 41, no. 4, pp. 623-633, 1998.
[48] A. Rodríguez-Pla, J. Bosch-Gil, J. Rosselló-Urgell, P. Huguet-Redecilla, J. Stone and M. Vilardell-Tarres, “Metalloproteinase-2 and -9 in Giant Cell Arteritis: Involvement in Vascular Remodeling,” Circulation, vol. 112, no. 2, pp. 264-269, 2005.
[49] M. Cid, M. Cebrián, C. Font, B. Coll-Vinent, J. Hernández-Rodríguez, J. Esparza, et al., “Cell adhesion molecules in the development of inflammatory infiltrates in giant cell arteritis: Inflammation-induced angiogenesis as the preferential site of leukocyte-endothelial cell interactions,” Arthritis Rheum, vol. 43, no. 1, pp. 184-194, 2000.
[50] A. Borchers and M. Gershwin, “Giant cell arteritis: A review of classification, pathophysiology, geoepidemiology and treatment”, Autoimmun Rev, vol. 11, no. 6-7, pp. A544-A554, 2012.
[51] J. Gillot, E. Masy, M. Davril, E. Hachulla, P. Hatron and B. Devulder, et al., “Elastase derived elastin peptides: putative autoimmune targets in giant cell arteritis,” J Rheumatol., vol. 24, no. 4, pp. 677-682, 1997.
[52] I. Wilkinson and R. Russell, “Arteries of the head and neck in giant cell arteritis. A pathological study to show the pattern of arterial involvement”, Arch Neurol, vol. 27, no. 5, pp. 378-391, 1972.
[53] C. Weyand, W. Ma-Krupa and J. Goronzy, “Immunopathways in giant cell arteritis and polymyalgia rheumatic,” Autoimmun Rev, vol. 3, no. 1, pp. 46-53, 2004.
[54] C. Weyand and J. Goronzy, “Pathogenic principles in giant cell arteritis”, Int J Cardiol, vol. 75, pp. S9-S15, 2000.
[55] C. Ponte, A. Rodrigues, L. O'Neill and R. Luqmani, “Giant cell arteritis: Current treatment and management,” World J Clin Cases, vol. 3, no. 6, pp. 484-494, 2015.
[56] M. Park, S. Lee, Y. Park and S. Lee, “Serum cytokine profiles and their correlations with disease activity in Takayasu's arteritis,” Rheumatology (Oxford), vol. 45, no. 5, pp. 545-548, 2006.
[57] G. Hoffman, P. Merkel, R. Brasington, D. Lenschow and P. Liang, “Anti-tumor necrosis factor therapy in patients with difficult to treat Takayasu arteritis,” Arthritis Rheum, vol. 50, no. 7, pp. 2296-2304, 2004.
[58] I. Molloy, C. Langford, T. Clark, C. Gota and G. Hoffman, “Anti-tumour necrosis factor therapy in patients with refractory Takayasu arteritis: long-term follow-up”, Ann Rheum Di., vol. 67, no. 11, pp. 1567-1569, 2008.
[59] C. Comarmond, E. Plaisier, K. Dahan, T. Mirault, J. Emmerich, Z. Amoura, P. Cacoub and D. Saadoun, “Anti TNFα in refractory Takayasu's arteritis: Cases series and review of the literature,” Autoimmun Rev, vol. 11, no. 9, pp. 678-684, 2012.
[60] S. Maffei, M. Di Renzo, S. Santoro, L. Puccetti and A. Pasqui, “Refractory Takayasu arteritis successfully treated with infliximab,” Eur Rev Med Pharmacol Sci, vol. 13, no. 1, pp. 63-65, 2009.
[61] L. Quartuccio, F. Schiavon, F. Zuliani, V. Carraro, E. Catarsi and A. Tavoni, et al., “Long-term efficacy and improvement of health-related quality of life in patients with Takayasu's arteritis treated with infliximab,” Clin Exp Rheumatol, vol. 30, pp. 922-928, 2012.
[62] A. Clifford and G. Hoffman, “Recent advances in the medical management of Takayasu arteritis”, Curr Opin Rheumatol, vol. 26, no. 1, pp. 7-15, 2014.
[63] N. Aikawa, R. Pereira, L. Lage, E. Bonfá and J. Carvalho, “Anti-TNF therapy for polymyalgia rheumatica: report of 99 cases and review of the literature,” Clin Rheumatol, vol. 31, no. 3, pp. 575-579, 2012.
[64] A. Migliore, U. Massafra, E. Carloni, C. Padalino, S. Martin and F. Lasaracina, et al., “TNF-alpha blockade induce clinical remission in patients affected by polymyalgia rheumatica associated to diabetes mellitus and/or osteoporosis: a seven cases report,” Eur Rev Med Pharmacol Sci, vol. 9, no. 6, pp. 373-378, 2005.
[65] F. Kreiner and H. Galbo, “Effect of etanercept in polymyalgia rheumatica: a randomised controlled trial”, Arthritis Res Ther, vol. 12, no. 5, p. R176, 2010.
[66] G. Hoffman, M. Cid, K. Rendt-Zagar, P. Merkel, C. Weyand and J. Stone, et al., “Infliximab for maintenance of glucocorticosteroid-induced remission of giant cell arteritis: a randomised trial,” Ann Intern Med, vol. 146, no. 9, pp. 621-630, 2007.
[67] M. Osman, S. Aaron, M. Noga and E. Yacyshyn, “Takayasu's arteritis progression on anti-TNF biologics: a case series”, Clin Rheumatol, vol. 30, no. 5, pp. 703-706, 2011, doi: 10.1007/s10067-010-1658-1.
[68] N. Mariani, A. So and B. Aubry-Rozier, “Two cases of Takayasu's arteritis occurring under anti-TNF therapy,” Joint Bone Spine, vol. 80, no. 2, pp. 211-213, 2013, doi: 10.1016/j.jbspin.2012.07.015.
[69] C. Dejaco, Y. Singh, P. Perel, A. Hutchings, D. Camellino, S. Mackie, et al., “2015 Recommendations for the management of polymyalgia rheumatica: a European League Against Rheumatism/American College of Rheumatology collaborative initiative,” Ann Rheum Dis, vol. 74, no. 10, pp. 1799-1807, 2015. doi:10.1136/annrheumdis-2015-207492.
[70] T. Barnes, M. Anderson and R. Moots, “The Many Faces of Interleukin-6: The Role of IL6 in Inflammation, Vasculopathy, and Fibrosis in Systemic Sclerosis,” Int J Rheumatol, Rheumatology, vol. 2011, pp. 1-6, 2011. http://dx.doi.org/10.1155/
2011/721608.
[71] O. Dienz and M. Rincon, “The effects of IL6 on CD4 T cell responses”, Clin Immunol, vol. 130, no. 1, pp. 27-33, 2009.
[72] M. Mihara, Y. Moriya, T. Kishimoto and Y. Ohsugi, “Interleukin-6 (IL6) induces the proliferation of synovial fibroblastic cells in the presence of soluble IL6 receptor,” Br J Rheumatol, vol. 34, no. 4, pp. 321-325, 1995.
[73] B. Dasgupta and G. Panayi, “Interleukin-6 in serum of patients with polymyalgia rheumatica and giant cell arteritis,” Br J Rheumatol, vol. 29, no. 6, pp. 456-458, 1990.
[74] L. Alvarez-Rodriguez, M. Lopez-Hoyos, C. Mata, M. Marin, J. Calvo-Alen, R. Blanco, et al., “Circulating cytokines in active polymyalgia rheumatic,” Ann Rheum Dis, vol. 69, no. 1, pp. 263-269, 2010. doi:10.1136/ard.2008.103663
[75] F. Alibaz-Oner, S. Yentür, G. Saruhan-Direskeneli and H. Direskeneli, “Serum cytokine profiles in Takayasu's arteritis: search for biomarkers”, Clin Exp Rheumatol, vol. 33, no. 2 (Suppl 89), pp. 32-35, 2015.
[76] A. Vaglio, M. Catanoso, L. Spaggiari, L. Magnani, N. Pipitone and P. Macchioni, et al., “Interleukin-6 as an inflammatory mediator and target of therapy in chronic periaortitis,” Arthritis Rheum, vol. 65, no. 9, pp. 2469-2475, 2013.
[77] D. Emilie, E. Liozon, M. Crevon, C. Lavignac, A. Portier and F. Liozon, et al., “Production of interleukin 6 by granulomas of giant cell arteritis,” Hum Immunol, vol. 39, no. 1, pp. 17-24, 1994.
[78] T. Gout, A. Östör and M. Nisar, “Lower gastrointestinal perforation in rheumatoid arthritis patients treated with conventional DMARDs or tocilizumab: a systematic literature review,” Clin Rheumatol, vol. 30, no. 11, pp. 1471-1474, 2011.
[79] J. Zavada, M. Lunt, R. Davies, A. Low, L. Mercer, J. Galloway, K. Watson, D. Symmons and K. Hyrich, “The risk of gastrointestinal perforations in patients with rheumatoid arthritis treated with anti-TNF therapy: results from the BSRBR-RA,” Ann Rheum Dis, vol. 73, no. 1, pp. 252-255, 2013.
[80] C. Salvarani, L. Magnani, M. Catanoso, N. Pipitone, A. Versari, L. Dardani, et al., “Tocilizumab: a novel therapy for patients with large-vessel vasculitis,” Rheumatology, vol. 51, no. 1, pp. 151-156, 2011.
[81] F. Oliveira, R. Butendieck, W. Ginsburg, K. Parikh and A. Abril, “Tocilizumab, an effective treatment for relapsing giant cell arteritis,” Clin Exp Rheumatol, vol. 32, no. 3 (Suppl 82), pp. S76-78, 2014.
[82] M. Seitz, S. Reichenbach, H. Bonel, S. Adler, F. Wermelinger and P. Villiger, “Rapid induction of remission in large vessel vasculitis by IL6 blockade,” Swiss Med Wkly, vol. 141, w13156, 2011.
[83] S. Sciascia, D. Rossi and D. Roccatello, “Interleukin 6 Blockade as Steroid-sparing Treatment for 2 Patients with Giant Cell Arteritis,” J Rheumatol, vol. 38, no. 9, pp. 2080-2081, 2011.
[84] C. Beyer, R. Axmann, E. Sahinbegovic, J. Distler, B. Manger, G. Schett and J. Zwerina, “Anti-interleukin 6 receptor therapy as rescue treatment for giant cell arteritis,” Ann Rheum Dis, vol. 70, no. 10, pp. 1874-1875, 2011.
[85] J. Schmidt, T. Kermani, A. Bacani, C. Crowson, E. Matteson and K. Warrington, “Tumor necrosis factor inhibitors in patients with Takayasu arteritis: Experience from a referral center with long-term follow-up,” Arthritis Care Res. (Hoboken), vol. 64, pp. 1079-1083, 2012.
[86] A. Mekinian, A. Neel, J. Sibilia, P. Cohen, J. Connault, M. Lambert, et al., “Efficacy and tolerance of infliximab in refractory Takayasu arteritis: French multicentre study,” Rheumatology (Oxford), vol. 51, no. 5, pp. 882-886, 2012
[87] K. Izumi, H. Kuda, M. Ushikubo, M. Kuwana, T. Takeuchi and H. Oshima, “Tocilizumab is effective against polymyalgia rheumatica: experience in 13 intractable cases,” RMD Open. vol. 1, no. 1, p. e000162, 2015.
[88] A. Al Rashidi, M. Hegazi, S. Mohammad and A. Varghese, “Effective control of polymyalgia rheumatica with tocilizumab,” J Clin Rheumatol, vol. 19, no. 7, pp. 400-401, 2013.
[89] K. Takenaka, T. Ohba, K. Suhara, Y. Sato and K. Nagasaka, “Successful treatment of refractory aortitis in antineutrophil cytoplasmic antibody-associated vasculitis using tocilizumab,” Clin Rheumatol, vol. 33, no. 2, pp. 287-289, 2014.
[90] S. Unizony, L. Arias-Urdaneta, E. Miloslavsky, S. Arvikar, A. Khosroshahi and B. Keroack, et al., “Tocilizumab for the treatment of large-vessel vasculitis (giant cell arteritis, Takayasu arteritis) and polymyalgia rheumatic,” Arthritis Care Res (Hoboken), vol. 64, no. 11, pp. 1720-1729, 2012. doi: 10.1002/acr.21750.
[91] N. Abisror, A. Mekinian, C. Lavigne, M. Vandenhende, M. Soussan and O. Fain, “Tocilizumab in refractory Takayasu arteritis: A case series and updated literature review,” Autoimmun Rev, vol. 12, no. 12, pp. 1143-1149, 2013.
[92] M. Bredemeier, C. Rocha, M. Barbosa and E. Pitrez, “One-year clinical and radiological evolution of a patient with refractory Takayasu's arteritis under treatment with Tocilizumab,” Clin Exp Rheumatol, vol. 30 pp. S98–S100, 2012.
[93] T. Xenitidis, M. Horger, G. Zeh, L. Kanz and J. Henes, “Sustained inflammation of the aortic wall despite tocilizumab treatment in two cases of Takayasu arteritis,” Rheumatology, vol. 52, no. 9, pp. 1729-1731, 2013.
[94] C. Garlanda, C. Dinarello and A. Mantovani, “The Interleukin-1 Family: Back to the Future”, Immunity, vol. 39, no. 6, pp. 1003-1018, 2013. doi: 10.1016/j.immuni.
2013.11.010.
[95] C. Dinarello, “Immunological and Inflammatory Functions of the Interleukin-1 Family,” Annu Rev Immunol, vol. 27, no. 1, pp. 519-550, 2009. doi:10.1146/
annurev.immunol.021908.132612.
[96] J. Lukens, J. Gross and T. Kanneganti, “IL1 family cytokines trigger sterile inflammatory disease,” Front Immunol, vol. 3, p. 315, 2012. doi: 10.3389/
fimmu.2012.00315.
[97] W. Arend, M. Malyak, C. Guthridge and C. Gabay, “Interleukin-1 receptor antagonist: Role in biology,” Annu Rev Immunol, vol. 16, no. 1, pp. 27-55, 1998.
[98] J. Deng, B. Younge, R. Olshen, J. Goronzy and C. Weyand, “Th17 and Th1 T-Cell Responses in Giant Cell Arteritis,” Circulation, vol. 121, no. 7, pp. 906-915, 2010.
[99] G. Cavalli and C. Dinarello, “Treating rheumatological diseases and co-morbidities with interleukin-1 blocking therapies”, Rheumatology (Oxford), vol. 54, no. 12, pp. 2134-2144, 2015. doi: 10.1093/rheumatology/kev269.
[100] T. Bardin, Canakinumab for the Patient With Difficult-to-Treat Gouty Arthritis: Review of the Clinical Evidence. Joint Bone Spine, 2015: Oct;82 Suppl 1, eS9-eS16. doi: 10.1016/S1297-319X(15)30003-8.
[101] C. Cavelti-Weder, A. Babians-Brunner, C. Keller, M. Stahel, M. Kurz-Levin and H. Zayed, et al., “Effects of gevokizumab on glycemia and inflammatory markers in type 2 diabetes,” Diabetes Care, vol. 35, no. 8, pp.1654-1662, 2012. doi: 10.2337/dc11-2219.
[102] K. Ly, J. Stirnemann, E. Liozon, M. Michel, O. Fain and A. Fauchais, “Interleukin-1 blockade in refractory giant cell arteritis,” Joint Bone Spine, vol. 81, no.1, pp. 76-78, 2014.
[103] XOMA (US) LLCA, “Randomised-Withdrawal, Double-Masked, Placebo-Controlled Study of the Efficacy and Safety of Gevokizumab in Treating Subjects With Behcet's Disease Uveitis,” ClinicalTrials.gov identifier: NCT02258867.
[104] A. Miller, “Role of IL33 in inflammation and disease,” J Inflamm (Lond), vol 8, p. 22, 2011.
[105] E. Lee, M. So, S. Hong, Y. Kim, B. Yoo and C. Lee, “Interleukin-33 acts as a transcriptional repressor and extracellular cytokine in fibroblast-like synoviocytes in patients with rheumatoid arthritis,” Cytokine, vol. 77, pp. 35-43, 2016.
[106] F. Ciccia, R. Alessandro, A. Rizzo, S. Raimondo, A. Giardina and F. Raiata, et al., “IL33 is over expressed in the inflamed arteries of patients with giant cell arteritis,” Ann Rheum Dis, vol. 72, no. 2, pp. 258-264, 2015.
[107] A. Márquez, R. Solans, J. Hernández-Rodríguez, M. Cid, S. Castañeda and M. Ramentol, et al., “A candidate gene approach identifies an IL33 genetic variant as a novel genetic risk factor for GCA,” PLoS One, vol 9, no. 11, pp. e113476, 2014. doi: 10.1371/journal.pone.0113476. eCollection 2014.
[108] C. Weyand and J. Goronzy, “Pathogenic principles in giant cell arteritis”, Int J Cardiol, vol. 75, (Suppl 1), pp. S9-S15; discussion S17-9, 2000.
[109] C. Weyand, Liao Y and J. Goronzy, “The Immunopathology of Giant Cell Arteritis: Diagnostic and Therapeutic Implications,” J Neuroophthalmol, vol. 32, no.3, pp. 259–265, 2012. doi: 10.1097/WNO.0b013e318268aa9b.
[110] W. Ma-Krupa, M. Jeon, S. Spoerl, F. Thomas, T. Tedder and J. Jörg, et al., “Activation of Arterial Wall Dendritic Cells and Breakdown of Self-tolerance in Giant Cell Arteritis,” J Exp Med, vol. 199, no.2, pp. 173–183, 2004. doi: 10.1084/jem.20030850.
[111] W. Krupa, M. Dewan, M. Jeon, P. Kurtin, B. Younge and J. Goronzy, et al., “Trapping of misdirected dendritic cells in the granulomatous lesions of giant cell arteritis”, Am J Pathol, vol. 161, no. 5, pp.1815-1823, 2002.
[112] S. Mohan, J. Liao, J. Kim, J. Goronzy and C. Weyand, “Giant cell arteritis: immune and vascular aging as disease risk factors,” Arthritis Res Ther, vol. 13, no. 4, pp. 231, 2011. doi: 10.1186/ar3358.
[113] C. Cid, E. Campo, G. Ercilla, A. Palacin, J. Vilaseca and J. Villalta, et al., “Immunohistochemical analysis of lymphoid and macrophage cell subsets and their immunologic activation markers in temporal arteritis. Influence of corticosteroid treatment,” Arthritis Rheum, vol. 32, no. 7, pp. 884-893, 1989.
[114] R. Meliconi, L. Pulsatelli, M. Uguccioni, C. Salvarani, P. Macchioni and C. Melchiorri,
et al., “Leukocyte infiltration in synovial tissue from the shoulder of patients with polymyalgia rheumatica. Quantitative analysis and influence of corticosteroid treatment,” Arthritis Rheum, vol. 39, no. 7, pp. 1199-207, 1996.
[115] K. van der Geest, W. Abdulahad, A. Rutgers, G. Horst, J. Bijzet and S. Arends, et al., “Serum markers associated with disease activity in giant cell arteritis and polymyalgia rheumatic,” Rheumatology (Oxford), vol. 54, no. 8, pp. 1397-1402, 2015. doi: 10.1093/rheumatology/keu526.
[116] A. Sutherland, L. Ng, C. Fletcher, B. Shum, R. Newton and S. Grey, et al., “BAFF augments certain Th1-associated inflammatory responses”, J Immunol, vol. 174, no. 9, pp. 5537-5544, 2005.
[117] A. Lenert and P. Lenert, “Current and emerging treatment options for ANCA-associated vasculitis: potential role of belimumab and other BAFF/APRIL targeting agents,” Drug Des Devel Ther, vol.9, pp. 333-347, 2015.
[118] K. van der Geest, W. Abdulahad, P. Chalan, A. Rutgers, G. Horst and M. Huitema,
et al., “Disturbed B cell homeostasis in newly diagnosed giant cell arteritis and polymyalgia rheumatic,” Arthritis Rheum, vol. 66, no. 7, pp.1927-1938, 2014. doi: 10.1002/art.38625.
[119] Y. Nishino, M. Tamai, A. Kawakami, T. Koga, J. Makiyama J and Y. Maeda, et al., “Serum levels of BAFF for assessing the disease activity of Takayasu arteritis”, Clin Exp Rheumatol, vol. 28, no. 1 (Suppl 57), pp. 14-17, 2010.
[120] F. Cantini, L. Niccoli, C. Salvarani, A. Padula and I. Olivieri, “Treatment of longstanding active giant cell arteritis with infliximab: report of four cases,” Arthritis Rheum, vol. 44, no. 12, pp. 2933–2935, 2001.
[121] V. Martínez-Taboada, V. Rodríguez-Valverde, L. Carreño, J. López-Longo, M. Figueroa M and J. Belzunegui, et al., “A double-blind placebo controlled trial of etanercept in patients with giant cell arteritis and corticosteroid side effects,” Ann. Rheum. Dis, vol. 67, no. 5, pp. 625-630, 2008.
[122] B. Dasgupta and G. Panayi, “Interleukin-6 in serum of patients with polymyalgia rheumatica and giant cell arteritis,” Br J Rheumatol, vol. 29, pp. 456-458, 1990.
[123] J. Loricera, R. Blanco, J. Hernandez, S. Castaneda, A. Mera and E. Perez-Pampin,
et al., “Tocilizumab in giant cell arteritis: Multicenter open-label study of 22 patients,” Semin Arthritis Rheum, vol. 44, no.6, pp. 717-723, 2015.
[124] S. Unizony, L. Arias-Urdaneta, E. Miloslavsky, S. Arvikar, A. Khosroshahi and B. Keroack, et al., “Tocilizumab for the treatment of large-vessel vasculitis (Giant cell arteritis, Takayasu arteritis) and Polymyalgia rheumatic,” Arthritis Care Res (Hoboken), vol. 64, no. 11, pp. 1720-1729, 2012.
[125] S. Sciascia, D. Rossi and D. Roccatello, “Interleukin 6 blockade as steroid-sparing treatment for 2 patients with giant cell arteritis,” J Rheumatol, vol. 38, no. 9, pp. 2080-2081, 2011.
[126] S. Adler, S. Reichenbach, S. Kuchen, F. Wermelinger, D. Dan and P. Villiger, et al., “Tocilizumab for the Treatment of Giant Cell Arteritis – a Randomised Placebo-Controlled Trial [abstract]”, http://acrabstracts.org/abstract/tocilizumab-for-the-treatment-of-giant-cell-arteritis-a-randomised-placebo-controlled-trial.
[127] A. Regent, S. Redeker, A. Deroux, P. Kieffer, K. Ly and Dougados M, et al., “A Multicentre Open-Label Study in France [abstract]”, Arthritis Rheumatol, vol. 67, (suppl 10), 2015. http://acrabstracts.org/abstract/tocilizumab-in-giant-cell-arteritis-a-multicentre-open-label-study-in-france.
[128] V. Devauchelle, A. Saraux, JM. Berthelot, D. Cornec, Y. Renaudineau and S. Jousse-Joulin, et al., “Dramatic Efficacy of Tocilizumab As First Line Therapy in Patients with Recent Polymyalgia Rheumatica (PMR): Results of the First Longitudinal Prospective Study [abstract],” Arthritis Rheumatol, vol. 67, suppl 10, 2015. http://acrabstracts.org/abstract/
dramatic-efficacy-of-tocilizumab-as-first-line-therapy-in-patients-with-recent-polymyalgia-rheumatica-pmr-results-of-the-first-longitudinal-prospective-study.
[129] L. Lally, L. Forbess, C. Hatzis and R. Spiera, “Efficacy and Safety of Tocilizumab for Polymyalgia Rheumatica [abstract],” Arthritis Rheumatol, vol 67, (suppl 10), 2015.
[130] J. Evans, L. Steel, F. Borg and B. Dasgupta, “Long-term efficacy and safety of tocilizumab in giant cell arteritis and large vessel vasculitis”, RMD Open, vol. 2, no.1, e000137, 2016. doi: 10.1136/rmdopen-2015-000137.
[131] S. Unizony, B. Dasgupta, E. Fisheleva, L. Rowell, G. Schett, and R. Spiera, et al., “Design of the Tocilizumab in Giant Cell Arteritis Trial.” Int J Rheumatol, vol. 2013, 2013 Article ID 912562, http://dx.doi.org/10.1155/2013/912562.
[132] N. Palmou-Fontana, J. Loricera, R. Blanco, J. Hernández, S. Castañeda and N. Ortego, “FRI0270 Tocilizumab Compared to Anti-TNFα Agents in Refractory Aortitis,” Ann Rheum Dis, vol. 74, p. 522, 2015.
[133] R. Seror, G. Baron, E. Hachulla, M. Debandt, C. Larroche and X. Puéchal, “Adalimumab for steroid sparing in patients with giant-cell arteritis: results of a multicentre randomised controlled trial”, Ann Rheum Dis, vol. 73, no.12, pp. 2074-2081, 2014. doi: 10.1136/annrheumdis-2013-203586.
[134] R. Tarzi, J. Mason and C. Pusey, “Issues in trial design for ANCA-associated and large-vessel vasculitis.”

Nat Rev Rheumatol, vol. 10, no. 8, pp.502-510, 2014. doi: 10.1038/nrrheum.2014.67.
[135] H. Direskeneli, S. Aydin, T. Kermani, E. Matteson, M. Boers and K. Herlyn, et al., “Development of outcome measures for large-vessel vasculitis for use in clinical trials: opportunities, challenges, and research agenda”, J Rheumatol, vol. 38, no.7, pp. 1471-1479, 2011. doi: 10.3899/jrheum.110275.
[136] R. Misra, D. Danda, S. Rajappa, A. Ghosh, R. Gupta and K. Mahendranath, et al., “Development and initial validation of the Indian Takayasu Clinical Activity Score (ITAS2010),” Rheumatology (Oxford), vol. 52, no. 10, pp. 1795-1801, 2013. doi: 10.1093/rheumatology/ket128. Accessed December 13, 2015.
[137] L. Campbell, C. Chen C, S. Bhagat, R. Parker and A. Östor, “Risk of adverse events including serious infections in rheumatoid arthritis patients treated with tocilizumab: a systematic literature review and meta-analysis of randomised controlled trials,” Rheumatology, vol. 50, no. 3, pp. 552–562, 2011.
[138] W. Dixon, K. Watson, M. Lunt, K. Hyrich, A. Silman and D. Symmons, “Rates of serious infection, including site specific and bacterial intracellular infection, in rheumatoid arthritis patients receiving anti-tumor necrosis factor therapy: results from the British Society for Rheumatology Biologics Register.” Arthritis Rheum, vol. 54, no. 8, pp. 2368-2376, 2006.
[139] A. Patel and L. Moreland, “Interleukin-6 inhibition for treatment of rheumatoid arthritis: a review of tocilizumab therapy,” Drug Des Dev Ther, vol. 4, pp. 263–278, 2010.
[140] V. Lang, M. Englbrecht, J. Rech, H. Nüsslein, K. Manger and F. Schuch F, et al., “Risk of infections in rheumatoid arthritis patients treated with tocilizumab”, Rheumatology, vol. 51, no. 5, pp. 852–857, 2012.
[141] R. Davies and E. Choy, “Clinical experience of IL6 blockade in rheumatic diseases-Implications on IL6 biology and disease pathogenesis,” Seminars in Immunology, vol. 26, no. 1, pp. 97-104, 2014.
[142] A. Wagner, H. Gérard, T. Fresemann, W. Schmidt, E. Gromnica-Ihle and A. Hudson, et al., “Detection of Chlamydia pneumoniae in giant cell vasculitis and correlation with the topographic arrangement of tissue-infiltrating dendritic cells,” Arthritis Rheum, vol. 43, no. 7, pp. 1543-1551, 2000.
[143] D. Gilden and M. Nagel, “Varicella Zoster Virus in Temporal Arteries of Patients With Giant Cell Arteritis,” J Infect Dis, vol. 212, no. Suppl 1, pp. S37-39, 2015.
[144] R. Alvarez-Lafuente, B. Fernández-Gutiérrez, J. Jover, E. Júdez, E. Loza and D. Clemente, et al., “Human parvovirus B19, varicella zoster virus, and human herpes virus 6 in temporal artery biopsy specimens of patients with giant cell arteritis: analysis with quantitative real time polymerase chain reaction.” Ann Rheum Dis, vol. 64, no. 5, pp. 780-782, 2005.
[145] P. Vaith, E. Röther, A. Vogt and H. Peter, “Polymyalgia rheumatica following Borrelia infection.” Immun Infekt vol. 16, no. 2, pp. 71-73, 1988.
[146] A. Duzova, O. Türkmen, A. Cinar, S. Cekirge, U. Saatci, and S. Ozen, “Takayasu's arteritis and tuberculosis: a case report,” Clin Rheumatol, vol. 19, no. 6, pp. 486-489, 2000.
[147] L. Guillevin, “Infections in vasculitis,” Best Pract Res Clin. Rheumatol, vol. 27, no. 1, pp. 19-31, 2013.

[148] C. Langford, D. Cuthbertson, S. Ytterberg, N. Khalidi, P. Monach and S. Carette, et al., “A Randomised Double-Blind Trial of Abatacept and Glucocorticoids for the Treatment of Giant Cell Arteritis [abstract]”. Arthritis Rheumatol, vol. 67, no. (suppl. 10), 2015. http://acrabstracts.org/abstract/a-randomised-double-blind-trial-of-abatacept-and-glucocorticoids-for-the-treatment-of-giant-cell-arteritis/.
[149] C. Salvarani, P. Macchioni, C. Manzini, G. Paolazzi, A. Trotta and P. Manganelli, et al., “Infliximab plus prednisone or placebo plus prednisone for the initial treatment of polymyalgia rheumatica: a randomised trial,” Ann Intern Med, vol. 146, no. 9, pp. 631-639, 2007.

Chapter 8

[1] Sakane, T; Takeno, M; Suzuki, N; Inaba, G. “Behçet's Disease,” New England Journal of Medicine, vol. 341, pp. 1284-1291, 1999.
[2] Feigenbaum, A. “Description of Behcet’s syndrome in the Hippocratic third book of endemic diseases,” Br J Ophthalmol, vol. 40, pp. 355-7, Jun 1956.
[3] Adamantiades, B. “A case of relapsing iritis with hypopyon (in Greek),” Proceedings of the Medicial Society of Athens, pp. 586-93, 1930.
[4] Zouboulis, CC; Keitel, W. “A Historical Review of Early Descriptions of Adamantiades-Behcet's Disease,” vol. 119, pp. 201-205, 2002.
[5] Katzenellenbogen, I. “Recurrent aphthous ulceration of oral mucous membrane and genitals associated with recurrent hypopyon iritis (Behcet’s Syndrome), report of three cases,” British Journal of Dermatology, vol. 58, pp. 161-172, 1946.
[6] Mason, RM; Barnes, CG. “Behcet’s syndrome with arthritis,” Ann Rheum Dis, vol. 28, pp. 95-103, 1969.
[7] Saylan, T. “Life story of Dr. Hulusi Behçet,” Yonsei Med J, vol. 38, pp. 327-332, 1997.
[8] Zouboulis, CC. “Benediktos Adamantiades and his forgotten contributions to medicine,” Eur J Dermatol, vol. 12, pp. 471-4, 2002.
[9] Curth, HO. “Recurrent genito-oral aphthosis and uveitis with hypopyon (Behcet's syndrome),” Arch Derm Syphilol, vol. 54, pp. 179-96, 1946.
[10] Davatchi, F. “The International Criteria for Behcet’s Disease (ICBD): a collaborative study of 27 countries on the sensitivity and specificity of the new criteria,” J Eur Acad Dermatol Venereol, vol. 28, pp. 338-47, Mar 2014.
[11] International Study Group for Behçet's, D. “Criteria for diagnosis of Behcet's disease,” The Lancet, vol. 335, pp. 1078-1080, 1990.
[12] Wechsler, B; Davatchi, F; Mizushima, Y; Hamza, M; Dilsen, N; Kansu, E; et al., “Evaluation of Diagnostic (‘Classification’) Criteria in Behçet's Disease—Towards Internationally Agreed Criteria,” Rheumatology, vol. 31, pp. 299-308, May 1, 1992 1992.
[13] Ohno, S; Ohguchi, M; Hirose, S; Matsuda, H; Wakisaka, A; Aizawa, M; “Close association of HLA-bw51 with Behçet’s disease,” Archives of Ophthalmology, vol. 100, pp. 1455-1458, 1982.
[14] Mizuki, N; Meguro, A; Ota, M: Ohno, S; Shiota, T; Kawagoe, T; et al., “Genome-wide association studies identify IL23R-IL12RB2 and IL10 as Behcet’s disease susceptibility loci,” Nature Genetics, vol. 42, pp. 703-706, 2010.
[15] Remmers, EF; Cosan, F; Kirino, Y; Ombrello, MJ; Abaci, N; Satorius, C; et al., “Genome-wide association study identifies variants in the MHC class I, IL10, and IL23R-IL12RB2 regions associated with Behcet’s disease,” Nature Genetics, vol. 42, pp. 698-702, 2010.
[16] Kirino, Y; Bertsias, G; Ishigatsubo, Y; Mizuki, N; Tugal-Tutkun, I; Seyahi, E; et al., “Genome-wide association analysis identifies new susceptibility loci for Behcet’s disease and epistasis between HLA-B*51 and ERAP1,” Nat Genet, vol. 45, pp. 202-7, Feb 2013.
[17] Zierhut, M; Mizuki, N; Ohno, S; Inoko, H; Gul, A; Onoe, K; et al., “Immunology and functional genomics of Behcet’s disease,” Cellular and Molecular Life Sciences, vol. 60, pp. 1903-22, Sep 2003.
[18] Mendes, D; Correia, M; Barbedo, M; Vaio, T; Mota, M; Gonçalves, O; et al., “Behçet’s disease – a contemporary review,” J Autoimmun, vol. 32, pp. 178-188, 2009.
[19] Ben Ahmed, M; Houman, H; Miled, M; Dellagi, K; Louzir, H. “Involvement of chemokines and Th1 cytokines in the pathogenesis of mucocutaneous lesions of Behcet’s disease,” Arthritis Rheum, vol. 50, pp. 2291-5, Jul 2004.
[20] Hamuryudan, V; Mat, C; Saip, S; Ozyazgan, Y; Siva, A; Yurdakul, S; et al., “Thalidomide in the Treatment of the Mucocutaneous Lesions of the Behcet SyndromeA Randomised, Double-Blind, Placebo-Controlled Trial,” Annals of Internal Medicine, vol. 128, pp. 443-450, 1998.
[21] Schmidt, H; Rush, B; Simonian, G; Murphy, T; Hsieh, J; Condon, M. “Thalidomide Inhibits TNF Response and Increases Survival Following Endotoxin Injection in Rats,” Journal of Surgical Research, vol. 63, pp. 143-146, 1996.
[22] Saenz, A; Ausejo, M; Shea, B; Wells George, A; Welch, V; Tugwell, P. (1998), Pharmacotherapy for Behcet’s syndrome. Cochrane Database of Systematic Reviews (2). Available: http://onlinelibrary.wiley.com/doi/ 10.1002/14651858. CD001084/ abstract.
[23] Taylor, J; Glenny, AM; Walsh, T; Brocklehurst, P; Riley, P; Gorodkin, R; et al. (2014). Interventions for the management of oral ulcers in Behçet’s disease. Cochrane Database of Systematic Reviews, (9). Available: http://onlinelibrary. wiley.com/doi/10.1002/14651858. CD011018.pub2/abstract.
[24] Nava, F; Ghilotti, F; Maggi, L; Hatemi, G; Del Bianco, A; Merlo, C; et al. (2014, Biologics, colchicine, corticosteroids, immunosuppressants and interferon-alpha for Neuro-Behçet’s Syndrome. Cochrane Database of Systematic Reviews, (12). Available: http://onlinelibrary.wiley.com/ doi/10.1002/14651858.CD010729.pub2/abstract.
[25] Hatemi, G; Silman, A; Bang, D; Bodaghi, B; Chamberlain, AM; Gul, A; et al., “EULAR recommendations for the management of Behçet disease,” Annals of the Rheumatic Diseases, vol. 67, pp. 1656-1662, December 1, 2008 2008.
[26] Hatemi, G; Melikoglu, M; Tunc, R; Korkmaz, C; Turgut Ozturk, B; Mat, C; et al., “Apremilast for Behcet’s syndrome--a phase 2, placebo-controlled study,” N Engl J Med, vol. 372, pp. 1510-8, Apr 16 2015.
[27] Lightman, S; Taylor, SR; Bunce, C; Longhurst, H; Lynn, W; Moots, R; et al., “Pegylated interferon-alpha-2b reduces corticosteroid requirement in patients with Behcet’s disease with upregulation of circulating regulatory T cells and reduction of Th17,” Ann Rheum Dis, vol. 74, pp. 1138-44, Jun 2015.
[28] Melikoglu, M; Fresko, I; Mat, C; Ozyazgan, Y; Gogus, F; Yurdakul, S; et al., “Short-term trial of etanercept in Behçet’s disease: a double blind, placebo controlled study,” The Journal of Rheumatology, vol. 32, pp. 98-105, January 1, 2005 2005.
[29] Almoznino, G; Ben-Chetrit, E. “Infliximab for the treatment of resistant oral ulcers in Behcet’s disease: a case report and review of the literature,” Clinical and Experimental Rheumatology, vol. 25, pp. S99-102, Jul-Aug 2007.
[30] Haugeberg, G; Velken, M; Johnsen, V. “Successful treatment of genital ulcers with infliximab in Behçet’s disease,” Annals of the Rheumatic Diseases, vol. 63, pp. 744-745, June 1, 2004 2004.
[31] Ryu, HJ; Seo, MR; Choi, HJ; Baek, HJ. “Infliximab for refractory oral ulcers,” Am J Otolaryngol, vol. 35, pp. 664-8, Sep-Oct 2014.
[32] Olivieri, I; Padula, DASA; Leccese, P; Mennillo, GA. “Successful treatment of recalcitrant genital ulcers of Behcet’s disease with adalimumab after failure of infliximab and etanercept,” Clinical and Experimental Rheumatology, vol. 27, p. S112, Mar-Apr 2009.
[33] Estrach, C; Mpofu, S; Moots, RJ. “Behçet’s syndrome: response to infliximab after failure of etanercept,” Rheumatology, vol. 41, pp. 1213-1214, October 1, 2002 2002.
[34] Atzeni, F; Leccese, P; D’Angelo, S; Sarzi-Puttini, P; Olivieri, I. “Successful treatment of leg ulcers in Behcet’s disease using adalimumab plus methotrexate after the failure of infliximab,” Clinical and Experimental Rheumatology, vol. 28, p. S94, Jul-Aug 2010.
[35] Aikawa, NE; Goncalves, C; Silva, CA; Goncalves, C; Bonfa, E; de Carvalho, JF. “Late response to anti-TNF-alpha therapy in refractory mucocutaneous lesions of Behcet’s disease,” Rheumatol Int, vol. 31, pp. 1097-9, Aug 2011.
[36] Vitale, A; Rigante, D; Caso, F; Brizi, MG; Galeazzi, M; Costa, L; et al., “Inhibition of interleukin-1 by canakinumab as a successful mono-drug strategy for the treatment of refractory Behcet’s disease: a case series,” Dermatology, vol. 228, pp. 211-4, 2014.
[37] Tugal-Tutkun, I; Onal, S; Altan-Yaycioglu, R; Huseyin Altunbas, H; Urgancioglu, M. “Uveitis in Behcet disease: an analysis of 880 patients,” Am J Ophthalmol, vol. 138, pp. 373-80, Sep 2004.
[38] Vallet, H; Riviere, S; Sanna, A; Deroux, A; Moulis, G; Addimanda, O; et al., “Efficacy of anti-TNF alpha in severe and/or refractory Behcet’s disease: Multicenter study of 124 patients,” J Autoimmun, vol. 62, pp. 67-74, Aug 2015.
[39] Sfikakis, PP; Theodossiadis, PG; Katsiari, CG; Kaklamanis, P; Markomichelakis, NN. “Effect of infliximab on sight-threatening panuveitis in Behcet’s disease,” The Lancet, vol. 358, pp. 295-296, 2001.
[40] Markomichelakis, N; Delicha, E; Masselos, S; Fragiadaki, K; Kaklamanis, P; Sfikakis, PP. “A single infliximab infusion vs corticosteroids for acute panuveitis attacks in Behcet’s disease: a comparative 4-week study,” Rheumatology (Oxford), vol. 50, pp. 593-7, Mar 2011.
[41] Markomichelakis, N; Delicha, E; Masselos, S; Sfikakis, PP. “Intravitreal infliximab for sight-threatening relapsing uveitis in Behcet disease: a pilot study in 15 patients,” Am J Ophthalmol, vol. 154, pp. 534-541 e1, Sep 2012.
[42] Tognon, S; Graziani, G; Marcolongo, R. “Anti-TNF-alpha therapy in seven patients with Behcet’s uveitis: advantages and controversial aspects,” Ann N Y Acad Sci, vol. 1110, pp. 474-84, Sep 2007.
[43] Al Rashidi, S; Al Fawaz, A; Kangave, D; Abu El-Asrar, AM. “Long-term clinical outcomes in patients with refractory uveitis associated with Behcet disease treated with infliximab,” Ocul Immunol Inflamm, vol. 21, pp. 468-74, Dec 2013.
[44] Tabbara, KF; Al-Hemidan, AI. “Infliximab effects compared to conventional therapy in the management of retinal vasculitis in Behcet disease,” Am J Ophthalmol, vol. 146, pp. 845-50 e1, Dec 2008.
[45] Bawazeer, A; Raffa, LH; Nizamuddin, SH. “Clinical experience with adalimumab in the treatment of ocular Behcet disease,” Ocul Immunol Inflamm, vol. 18, pp. 226-32, Jun 2010.
[46] Mushtaq, B; Saeed, T; Situnayake, RD; Murray, PI. “Adalimumab for sight-threatening uveitis in Behcet’s disease,” Eye (Lond), vol. 21, pp. 824-5, Jun 2007.
[47] Interlandi, E; Leccese, P; Olivieri, I; Latanza, L. “Adalimumab for treatment of severe Behcet’s uveitis: a retrospective long-term follow-up study,” Clinical and Experimental Rheumatology, vol. 32, pp. S58-62, Jul-Aug 2014.
[48] Mesquida, M; Victoria Hernandez, M; Llorenc, V; Pelegrin, L; Espinosa, G; Dick, AD; et al., “Behcet disease-associated uveitis successfully treated with golimumab,” Ocul Immunol Inflamm, vol. 21, pp. 160-2, Apr 2013.
[49] Calvo-Rio, V; Blanco, R; Beltran, E; Sanchez-Burson, J; Mesquida, M; Adan, A; et al., “Anti-TNF-alpha therapy in patients with refractory uveitis due to Behcet’s disease: a 1-year follow-up study of 124 patients,” Rheumatology (Oxford), vol. 53, pp. 2223-31, Dec 2014.
[50] Gul, A; Tugal-Tutkun, I; Dinarello, CA; Reznikov, L; Esen, BA; Mirza, A; et al., “Interleukin-1beta-regulating antibody XOMA 052 (gevokizumab) in the treatment of acute exacerbations of resistant uveitis of Behcet’s disease: an open-label pilot study,” Ann Rheum Dis, vol. 71, pp. 563-6, Apr 2012.
[51] Chi, W; Zhu, X; Yang, P; Liu, X; Lin, X; Zhou, H; et al., “Upregulated IL-23 and IL-17 in Behcet patients with active uveitis,” Investigative Ophthalmology and Visual Science, vol. 49, pp. 3058-64, Jul 2008.
[52] Dick, AD; Tugal-Tutkun, I; Foster, S; Zierhut, M; Melissa Liew, SH; Bezlyak, V; et al., “Secukinumab in the treatment of noninfectious uveitis: results of three randomised, controlled clinical trials,” Ophthalmology, vol. 120, pp. 777-87, Apr 2013.
[53] Papo, M; Bielefeld, P; Vallet, H; Seve, P; Wechsler, B; Cacoub, P; et al., “Tocilizumab in severe and refractory non-infectious uveitis,” Clinical and Experimental Rheumatology, vol. 32, pp. S75-9, Jul-Aug 2014.
[54] Buggage, RR; Levy-Clarke, G; Sen, HN; Ursea, R; Srivastava, SK; Suhler, EB; et al., “A double-masked, randomised study to investigate the safety and efficacy of daclizumab to treat the ocular complications related to Behcet’s disease,” Ocul Immunol Inflamm, vol. 15, pp. 63-70, Mar-Apr 2007.
[55] Sobaci, G; Erdem, U; Durukan, AH; Erdurman, C; Bayer, A; Koksal, S; et al., “Safety and effectiveness of interferon alpha-2a in treatment of patients with Behcet’s uveitis refractory to conventional treatments,” Ophthalmology, vol. 117, pp. 1430-5, Jul 2010.
[56] Erdurman, FC; Durukan, AH; Mumcuoglu, T; Hurmeric, V. “Intravitreal bevacizumab treatment of macular edema due to optic disc vasculitis,” Ocul Immunol Inflamm, vol. 17, pp. 56-8, Jan-Feb 2009.
[57] Mirshahi, A; Namavari, A; Djalilian, A; Moharamzad, Y; Chams, H. “Intravitreal bevacizumab (Avastin) for the treatment of cystoid macular edema in Behcet disease,” Ocul Immunol Inflamm, vol. 17, pp. 59-64, Jan-Feb 2009.
[58] Levy-Clarke, G; Jabs, DA; Read, RW; Rosenbaum, JT; Vitale, A; Van Gelder, RN. “Expert panel recommendations for the use of anti-tumor necrosis factor biologic agents in patients with ocular inflammatory disorders,” Ophthalmology, vol. 121, pp. 785-96 e3, Mar 2014.
[59] Kakkassery, V; Mergler, S; Pleyer, U. “Anti-TNF-alpha treatment: a possible promoter in endogenous uveitis? observational report on six patients: occurrence of uveitis following etanercept treatment,” Current eye research, vol. 35, pp. 751-6, Aug 2010.
[60] Hisamatsu, T; Ueno, F; Matsumoto, T; Kobayashi, K; Koganei, K; Kunisaki, R; et al., “The 2nd edition of consensus statements for the diagnosis and management of intestinal Behcet’s disease: indication of anti-TNFalpha monoclonal antibodies,” J Gastroenterol, vol. 49, pp. 156-62, Jan 2014.
[61] Travis, SPL; Czajkowski, M; McGovern, DPB; Watson, RGP; Bell, AL. “Treatment of intestinal Behçet’s syndrome with chimeric tumour necrosis factor α antibody,” Gut, vol. 49, pp. 725-728, November 1, 2001 2001.
[62] Hassard, PV; Binder‡, SW; Nelson‡, V; Vasiliauskas, EA. “Anti–tumor necrosis factor monoclonal antibody therapy for gastrointestinal Behçet’s disease: A case report,” Gastroenterology, vol. 120, pp. 995-999, 2001.
[63] Ma, D; Zhang, CJ; Wang, RP; Wang, L; Yang, H. “Etanercept in the treatment of intestinal Behcet’s disease,” Cell Biochem Biophys, vol. 69, pp. 735-9, Jul 2014.
[64] Tanida, S; Inoue, N; Kobayashi, K; Naganuma, M; Hirai, F; Iizuka, B; et al., “Adalimumab for the treatment of Japanese patients with intestinal Behcet’s disease,” Clin Gastroenterol Hepatol, vol. 13, pp. 940-8 e3, May 2015.
[65] Kidd, D. “The prevalence of headache in Behcet’s syndrome,” Rheumatology (Oxford), vol. 45, pp. 621-3, May 2006.
[66] Kalra, S; Silman, A; Akman-Demir, G; Bohlega, S; Borhani-Haghighi, A; Constantinescu, CS; et al., “Diagnosis and management of Neuro-Behcet's disease: international consensus recommendations,” J Neurol, vol. 261, pp. 1662-76, Sep 2014.
[67] Hirohata, S; Kikuchi, H; Sawada, T; Nagafuchi, H; Kuwana, M; Takeno, M; et al., “Retrospective analysis of long-term outcome of chronic progressive neurological manifestations in Behcet's disease,” J Neurol Sci, vol. 349, pp. 143-8, Feb 15 2015.
[68] Licata, G; Pinto, A; Tuttolomondo, A; Banco, A; Ciccia, F; Ferrante, A; et al., “Anti-tumour necrosis factor α monoclonal antibody therapy for recalcitrant cerebral vasculitis in a patient with Behçet’s syndrome,” Annals of the Rheumatic Diseases, vol. 62, pp. 280-281, March 1, 2003 2003.
[69] Ribi, C; Sztajzel, R; Delavelle, J; Chizzolini, C. “Efficacy of TNFα blockade in cyclophosphamide resistant neuro-Behçet disease,” Journal of Neurology, Neurosurgery and Psychiatry, vol. 76, pp. 1733-1735, December 1, 2005 2005.
[70] Pipitone, N; Olivieri, I; Padula, A; D'Angelo, S; Nigro, A; Zuccoli, G; et al., “Infliximab for the treatment of Neuro-Behcet’s disease: a case series and review of the literature,” Arthritis Rheum, vol. 59, pp. 285-90, Feb 15 2008.
[71] Alty, JE; Monaghan, TM; Bamford, JM. “A patient with neuro-Behçet’s disease is successfully treated with etanercept: Further evidence for the value of TNFα blockade,” Clin Neurol Neurosurg, vol. 109, pp. 279-281, 2007.
[72] Belzunegui, J; Lopez, L; Paniagua, I; Intxausti, JJ; Maiz, O. “Efficacy of infliximab and adalimumab in the treatment of a patient with severe neuro-Behcet’s disease,” Clinical and Experimental Rheumatology, vol. 26, pp. S133-4, Jul-Aug 2008.
[73] Leccese, P; D’Angelo, S; Angela, P; Coniglio, G; Olivieri, I. “Switching to adalimumab is effective in a case of neuro-Behcet’s disease refractory to infliximab,” Clinical and Experimental Rheumatology, vol. 28, p. S102, Jul-Aug 2010.
[74] Al-Araji, A; Kidd, DP. “Neuro-Behçet’s disease: epidemiology, clinical characteristics, and management,” The Lancet Neurology, vol. 8, pp. 192-204, 2009.
[75] Kuroda, R; Suzuki, J; Muramatsu, M; Tasaki, A; Yano, M; Imai, N; et al., “Efficacy of infliximab in neuro-Behcet’s disease presenting with isolated longitudinally extensive transverse myelitis,” J Neurol, vol. 260, pp. 3167-70, Dec 2013.
[76] Shapiro, LS; Farrell, J; Borhani Haghighi, A. “Tocilizumab treatment for neuro-Behcet’s disease, the first report,” Clin Neurol Neurosurg, vol. 114, pp. 297-8, Apr 2012.
[77] Urbaniak, P; Hasler, P; Kretzschmar, S. “Refractory neuro-Behcet treated by tocilizumab: a case report,” Clinical and Experimental Rheumatology, vol. 30, pp. S73-5, May-Jun 2012.
[78] Addimanda, O; Pipitone, N; Pazzola, G; Salvarani, C. “Tocilizumab for severe refractory neuro-Behcet: three cases IL-6 blockade in neuro-Behcet,” Semin Arthritis Rheum, vol. 44, pp. 472-5, Feb 2015.
[79] Cantarini, L; Lopalco, G; Vitale, A; Coladonato, L; Rigante, D; Lucherini, OM; et al., “Paradoxical mucocutaneous flare in a case of Behcet's disease treated with tocilizumab,” Clin Rheumatol, vol. 34, pp. 1141-3, Jun 2015.
[80] Terreaux, W; Mestrallet, S; Fauconier, M; Pennaforte, JL; Penalba, C; Eschard, JP; et al., “Failure of tocilizumab therapy in a patient with mouth and genital ulcers with inflamed cartilage syndrome complicated by aortic aneurysm,” Rheumatology (Oxford), vol. 54, pp. 2111-3, Nov 2015.
[81] Hamuryudan, V; Yurdakul, S; Moral, F; Numan, F; Tuzun, H; Tuzuner, N; et al., “Pulmonary arterial aneurysms in Behcet’s syndrome: a report of 24 cases,” Br J Rheumatol, vol. 33, pp. 48-51, 1994.
[82] Ahn, J; Lee, Y; Jeon, C; Koh, EM; Cha, HS. “Treatment of venous thrombosis associated with Behçet’s disease: immunosuppressive therapy alone versus immunosuppressive therapy plus anticoagulation,” Clinical Rheumatology, vol. 27, pp. 201-205, 2008.
[83] Desbois, AC; Wechsler, B; Resche-Rigon, M; Piette, JC; Huong Dle, T; Amoura, Z; et al., “Immunosuppressants reduce venous thrombosis relapse in Behcet's disease,” Arthritis Rheum, vol. 64, pp. 2753-60, 2012.
[84] Alibaz-Oner, F; Karadeniz, A; Ylmaz, S; Balkarl, A; Kimyon, G; Yazc, A; et al., “Behcet disease with vascular involvement: effects of different therapeutic regimens on the incidence of new relapses,” Medicine (Baltimore), vol. 94, p. e494, Feb 2015.
[85] Mehta, P; Laffan, M; Haskard, DO. “Thrombosis and Behçet’s syndrome in non-endemic regions,” Rheumatology, vol. 49, pp. 2003-2004, November 1, 2010 2010.
[86] Davies, R; Galloway, JB; Watson, KD; Lunt, M; Symmons, DP; Hyrich, KL; et al., “Venous thrombotic events are not increased in patients with rheumatoid arthritis treated with anti-TNF therapy: results from the British Society for Rheumatology Biologics Register,” Ann Rheum Dis, vol. 70, pp. 1831-4, Oct 2011.
[87] Seyahi, E; Hamuryudan, V; Hatemi, G; Melikoglu, M; Celik, S; Fresko, I; et al., “Infliximab in the treatment of hepatic vein thrombosis (Budd-Chiari syndrome) in three patients with Behçet’s syndrome,” Rheumatology, vol. 46, pp. 1213-1214, July 1, 2007 2007.
[88] Yoshida, S; Takeuchi, T; Yoshikawa, A; Ozaki, T; Fujiki, Y; Hata, K; et al., “Good response to infliximab in a patient with deep vein thrombosis associated with Behçet disease,” Modern Rheumatology, pp. 1-5, 2012.
[89] Baki, K; Villiger, PM; Jenni, D; Meyer, T; Beer, JH. “Behcet’s disease with life-threatening haemoptoe and pulmonary aneurysms: complete remission after infliximab treatment,” Ann Rheum Dis, vol. 65, pp. 1531-2, Nov 2006.
[90] Lee, SW; Lee, SY; Kim, KN; Jung, JK; Chung, WT. “Adalimumab treatment for life threatening pulmonary artery aneurysm in Behcet disease: a case report,” Clin Rheumatol, vol. 29, pp. 91-3, Jan 2010.
[91] Hamuryudan, V; Oz, B; Tuzun, H; Yazici, H. “The menacing pulmonary artery aneurysms of Behcet’s syndrome,” Clin Exp Rheumatol, vol. 22, pp. S1-3, 2004.
[92] Adler, S; Baumgartner, I; Villiger, PM. “Behcet's disease: successful treatment with infliximab in 7 patients with severe vascular manifestations. A retrospective analysis,” Arthritis Care Res (Hoboken), vol. 64, pp. 607-11, Apr 2012.
[93] Davatchi, F; Shams, H; Rezaipoor, M; Sadeghi-Abdollahi, B; Shahram, F; Nadji, A; et al., “Rituximab in intractable ocular lesions of Behcet’s disease; randomised single-blind control study (pilot study),” International Journal of Rheumatic Diseases, vol. 13, pp. 246-252, 2010.
[94] Zhao, BH; Oswald, AE. “Improved clinical control of a challenging case of Behçet’s disease with rituximab therapy,” Clinical Rheumatology, vol. 33, pp. 149-150, 2013.
[95] Ardelean, DS; Gonska, T; Wires, S; Cutz, E; Griffiths, A; Harvey, E; et al., “Severe ulcerative colitis after rituximab therapy,” Pediatrics, vol. 126, pp. e243-6, Jul 2010.
[96] Manetti, R; Parronchi, P; Giudizi, MG; Piccinni, MP; Maggi, E; Trinchieri, G; et al., “Natural killer cell stimulatory factor (interleukin 12 [IL-12]) induces T helper type 1 (Th1)-specific immune responses and inhibits the development of IL-4-producing Th cells,” The Journal of Experimental Medicine, vol. 177, pp. 1199-1204, April 1, 1993 1993.
[97] Baerveldt, EM; Kappen, JH; Thio, HB; van Laar, JA; van Hagen, PM; Prens, EP. “Successful long-term triple disease control by ustekinumab in a patient with Behcet’s disease, psoriasis and hidradenitis suppurativa,” Ann Rheum Dis, vol. 72, pp. 626-7, Apr 2013.
[98] Lockwood, CM; Hale, G; Waldman, H; Jayne, DR. “Remission induction in Behcet’s disease following lymphocyte depletion by the anti-CD52 antibody CAMPATH 1-H,” Rheumatology (Oxford), vol. 42, pp. 1539-44, Dec 2003.
[99] Sugita, S; Kawazoe, Y; Imai, A; Kawaguchi, T; Horie, S; Keino, H; et al., “Role of IL-22- and TNF-alpha-producing Th22 cells in uveitis patients with Behcet’s disease,” J Immunol, vol. 190, pp. 5799-808, Jun 1 2013.
[100] Arida, A; Fragiadaki, K; Giavri, E; Sfikakis, PP. “Anti-TNF Agents for Behçet's Disease: Analysis of Published Data on 369 Patients,” Seminars in Arthritis and Rheumatism, vol. 41, pp. 61-70, 2011.
[101] Hatemi, G; Merkel, PA; Hamuryudan, V; Boers, M; Direskeneli, H; Aydin, SZ; et al., “Outcome Measures Used in Clinical Trials for Behçet Syndrome: A Systematic Review,” The Journal of Rheumatology, vol. 41, pp. 599-612, 2014.

Chapter 9

[1] Gibofsky, A. “Overview of epidemiology, pathophysiology, and diagnosis of rheumatoid arthritis.,” Am. J. Manag. Care, vol. 18, no. 13 Suppl, pp. S295–302, Dec. 2012.
[2] Makrygiannakis, D; Hermansson, M; Ulfgren, AK; Nicholas, AP; Zendman, AJW; Eklund, A; Grunewald, J; Skold, CM; Klareskog, L; Catrina, AI. “Smoking increases peptidylarginine deiminase 2 enzyme expression in human lungs and increases citrullination in BAL cells.,” Ann. Rheum. Dis., vol. 67, no. 10, pp. 1488–92, Oct. 2008.
[3] Wegner, N; Lundberg, K; Kinloch, A; Fisher, B; Malmström, V; Feldmann, M; Venables, PJ. “Autoimmunity to specific citrullinated proteins gives the first clues to the etiology of rheumatoid arthritis.,” Immunol. Rev., vol. 233, no. 1, pp. 34–54, Jan. 2010.
[4] Burska, AN; Hunt, L; Boissinot, M; Strollo, R; Ryan, BJ; Vital, E; Nissim, A; Winyard, PG; Emery, P; Ponchel, F. “Autoantibodies to posttranslational modifications in rheumatoid arthritis.,” Mediators Inflamm., vol. 2014, p. 492873, Jan. 2014.
[5] McInnes, IB; Schett, G. “The pathogenesis of rheumatoid arthritis.,” N. Engl. J. Med., vol. 365, no. 23, pp. 2205–19, Dec. 2011.
[6] van Venrooij, WJ; van Beers, JJBC; Pruijn, GJM. “Anti-CCP antibodies: the past, the present and the future.,” Nat. Rev. Rheumatol., vol. 7, no. 7, pp. 391–8, Jul. 2011.
[7] Hitchon, CA; El-Gabalawy, HS. “The synovium in rheumatoid arthritis.,” Open Rheumatol. J., vol. 5, pp. 107–14, Jan. 2011.
[8] de Hair, MJH; van de Sande, MGH; Ramwadhdoebe, TH; Hansson, M; Landewé, R; van der Leij, C; Maas, M; Serre, G; van Schaardenburg, D; Klareskog, L; Gerlag, DM; van Baarsen, LGM; Tak, PP. “Features of the synovium of individuals at risk of developing rheumatoid arthritis: implications for understanding preclinical rheumatoid arthritis.,” Arthritis Rheumatol. (Hoboken, N.J.), vol. 66, no. 3, pp. 513–22, Mar. 2014.
[9] Schett, G; Gravallese, E. “Bone erosion in rheumatoid arthritis: mechanisms, diagnosis and treatment.,” Nat. Rev. Rheumatol., vol. 8, no. 11, pp. 656–64, Nov. 2012.
[10] Quinn, MA; Conaghan, PG; O’Connor, PJ; Karim, Z; Greenstein, A; Brown, A; Brown, C; Fraser, A; Jarret, S; Emery, P. “Very early treatment with infliximab in addition to methotrexate in early, poor-prognosis rheumatoid arthritis reduces magnetic resonance imaging evidence of synovitis and damage, with sustained benefit after infliximab withdrawal: results from a twelve-m,” Arthritis Rheum., vol. 52, no. 1, pp. 27–35, Jan. 2005.
[11] Saxne, T; Palladino, MA; Heinegård, D; Talal, N; Wollheim, FA. “Detection of tumor necrosis factor alpha but not tumor necrosis factor beta in rheumatoid arthritis synovial fluid and serum.,” Arthritis Rheum., vol. 31, no. 8, pp. 1041–5, Aug. 1988.
[12] Arend, WP; Dayer, JM. “Cytokines and cytokine inhibitors or antagonists in rheumatoid arthritis.,” Arthritis Rheum., vol. 33, no. 3, pp. 305–15, Mar. 1990.
[13] Brennan, FM; Chantry, D; Jackson, A; Maini, R; Feldmann, M. “Inhibitory effect of TNF alpha antibodies on synovial cell interleukin-1 production in rheumatoid arthritis.,” Lancet (London, England), vol. 2, no. 8657, pp. 244–7, Jul. 1989.
[14] Knight, DM; Trinh, H; Le, J; Siegel, S; Shealy, D; McDonough, M; Scallon, B; Moore, MA; Vilcek, J; Daddona, P. “Construction and initial characterization of a mouse-human chimeric anti-TNF antibody.,” Mol. Immunol., vol. 30, no. 16, pp. 1443–53, Nov. 1993.
[15] Keffer, J; Probert, L; Cazlaris, H; Georgopoulos, S; Kaslaris, E; Kioussis, D; Kollias, G. “Transgenic mice expressing human tumour necrosis factor: a predictive genetic model of arthritis.,” EMBO J., vol. 10, no. 13, pp. 4025–31, Dec. 1991.
[16] Elliott, MJ; Maini, RN; Feldmann, M; Long-Fox, A; Charles, P; Katsikis, P; Brennan, FM; Walker, J; Bijl, H; Ghrayeb, J. “Treatment of rheumatoid arthritis with chimeric monoclonal antibodies to tumor necrosis factor alpha.,” Arthritis Rheum., vol. 36, no. 12, pp. 1681–90, Dec. 1993.
[17] Elliott, MJ; Maini, RN; Feldmann, M; Long-Fox, A; Charles, P; Bijl, H; Woody, JN. “Repeated therapy with monoclonal antibody to tumour necrosis factor alpha (cA2) in patients with rheumatoid arthritis.,” Lancet (London, England), vol. 344, no. 8930, pp. 1125–7, Oct. 1994.
[18] Juhász, K; Buzás, K; Duda, E. “Importance of reverse signaling of the TNF superfamily in immune regulation.,” Expert Rev. Clin. Immunol., vol. 9, no. 4, pp. 335–48, Apr. 2013.
[19] KR; Salfeld, J; Kaymakçalan, Z; Tracey, D; Roberts, A. “Generation of fully human anti-TNF antibody D2E7 [abstract],” Arthritis Rheum, vol. 41, no. Suppl, p. S57, 1998.
[20] “British National Formulary (BNF),” no. 70.
[21] WDMU, “Certolizumab pegol use in pregnancy: low levels detected in cord blood [abstract],” Arthritis Rheum, vol. 62, no. Suppl. 10, p. 299, 2010.
[22] Luqmani, R; Hennell, S; Estrach, C; Birrell, F; Bosworth, A; Davenport, G; Fokke, C; Goodson, N; Jeffreson, P; Lamb, E; Mohammed, R; Oliver, S; Stableford, Z; Walsh, D; Washbrook, C; Webb, F. “British Society for Rheumatology and british health professionals in Rheumatology guideline for the management of rheumatoid arthritis (the first two years).,” Rheumatology (Oxford)., vol. 45, no. 9, pp. 1167–9, Sep. 2006.
[23] “Rheumatoid arthritis in adults: management | Guidance and guidelines | NICE.”
[24] Smolen, JS; Landewé, R; Breedveld, FC; Buch, M; Burmester, G; Dougados, M; Emery, P; Gaujoux-Viala, C; Gossec, L; Nam, J; Ramiro, S; Winthrop, K; de Wit, M; Aletaha, D; Betteridge, N; Bijlsma, JWJ; Boers, M; Buttgereit, F; Combe, B; Cutolo, M; Damjanov, N; Hazes, JMW; Kouloumas, M; Kvien, TK; Mariette, X; Pavelka, K; van Riel, PLCM; Rubbert-Roth, A; Scholte-Voshaar, M; Scott, DL; Sokka-Isler, T; Wong, JB; van der Heijde, D. “EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update.,” Ann. Rheum. Dis., vol. 73, no. 3, pp. 492–509, Mar. 2014.
[25] Singh, JA; Saag, KG; Bridges, SL; Akl, EA; Bannuru, RR; Sullivan, MC; Vaysbrot, E; McNaughton, C; Osani, M; Shmerling, RH; Curtis, JR; Furst, DE; Parks, D; Kavanaugh, A; O’Dell, J; King, C; Leong, A; Matteson, EL; Schousboe, JT; Drevlow, B; Ginsberg, S; Grober, J; St Clair, EW; Tindall, E; Miller, AS; McAlindon, T. “2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis.,” Arthritis Care Res. (Hoboken)., vol. 68, no. 1, pp. 1–25, Jan. 2016.
[26] Bombardieri, S; Ruiz, AA; Fardellone, P; Geusens, P; McKenna, F; Unnebrink, K; Oezer, U; Kary, S; Kupper, H; Burmester, GR. “Effectiveness of adalimumab for rheumatoid arthritis in patients with a history of TNF-antagonist therapy in clinical practice.,” Rheumatology (Oxford)., vol. 46, no. 7, pp. 1191–9, Jul. 2007.
[27] Buch, MH; Bingham, SJ; Bejarano, V; Bryer, D; White, J; Reece, R; Quinn, M; Emery, P. “Therapy of patients with rheumatoid arthritis: outcome of infliximab failures switched to etanercept.,” Arthritis Rheum., vol. 57, no. 3, pp. 448–53, Apr. 2007.
[28] Hyrich, KL; Lunt, M; Watson, KD; Symmons, DPM; Silman, AJ. “Outcomes after switching from one anti-tumor necrosis factor alpha agent to a second anti-tumor necrosis factor alpha agent in patients with rheumatoid arthritis: results from a large UK national cohort study.,” Arthritis Rheum., vol. 56, no. 1, pp. 13–20, Jan. 2007.
[29] Hyrich, KL; Lunt, M; Dixon, WG; Watson, KD; Symmons, DPM. “Effects of switching between anti-TNF therapies on HAQ response in patients who do not respond to their first anti-TNF drug.,” Rheumatology (Oxford)., vol. 47, no. 7, pp. 1000–5, Jul. 2008.
[30] Karlsson, JA; Kristensen, LE; Kapetanovic, MC; Gülfe, A; Saxne, T; Geborek, P. “Treatment response to a second or third TNF-inhibitor in RA: results from the South Swedish Arthritis Treatment Group Register.,” Rheumatology (Oxford)., vol. 47, no. 4, pp. 507–13, Apr. 2008.
[31] Finckh, A; Ciurea, A; Brulhart, L; Möller, B; Walker, UA; Courvoisier, D; Kyburz, D; Dudler, J; Gabay, C. “Which subgroup of patients with rheumatoid arthritis benefits from switching to rituximab vs. alternative anti-tumour necrosis factor (TNF) agents after previous failure of an anti-TNF agent?,” Ann. Rheum. Dis., vol. 69, no. 2, pp. 387–93, Feb. 2010.
[32] Virkki, LM; Valleala, H; Takakubo, Y; Vuotila, J; Relas, H; Komulainen, R; Koivuniemi, R; Yli-Kerttula, U; Mali, M; Sihvonen, S; Krogerus, ML; Jukka, E; Nyrhinen, S; Konttinen, YT; Nordström, DC. “Outcomes of switching anti-TNF drugs in rheumatoid arthritis--a study based on observational data from the Finnish Register of Biological Treatment (ROB-FIN).,” Clin. Rheumatol., vol. 30, no. 11, pp. 1447–54, Nov. 2011.
[33] Maini, R; St Clair, EW; Breedveld, F; Furst, D; Kalden, J; Weisman, M; Smolen, J; Emery, P; Harriman, G; Feldmann, M; Lipsky, P. “Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) vs. placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. ATTRACT Study Group.,” Lancet (London, England), vol. 354, no. 9194, pp. 1932–9, Dec. 1999.
[34] Lipsky, PE; van der Heijde, DMFM; St. Clair, EW; Furst, DE; Breedveld, FC; Kalden, JR; Smolen, JS; Weisman, M; Emery, P; Feldmann, M; Harriman, GR; Maini, RN. “Infliximab and Methotrexate in the Treatment of Rheumatoid Arthritis,” N. Engl. J. Med., vol. 343, no. 22, pp. 1594–1602, Nov. 2000.
[35] Kavanaugh, A; St Clair, EW; McCune, WJ; Braakman, T; Lipsky, P. “Chimeric anti-tumor necrosis factor-alpha monoclonal antibody treatment of patients with rheumatoid arthritis receiving methotrexate therapy.,” J. Rheumatol., vol. 27, no. 4, pp. 841–50, Apr. 2000.
[36] Maini, RN; Breedveld, FC; Kalden, JR; Smolen, JS; Davis, D; Macfarlane, JD; Antoni, C; Leeb, B; Elliott, MJ; Woody, JN; Schaible, TF; Feldmann, M. “Therapeutic efficacy of multiple intravenous infusions of anti-tumor necrosis factor alpha monoclonal antibody combined with low-dose weekly methotrexate in rheumatoid arthritis.,” Arthritis Rheum., vol. 41, no. 9, pp. 1552–63, Sep. 1998.
[37] van der Heijde, D. “How to read radiographs according to the Sharp/van der Heijde method.,” J. Rheumatol., vol. 27, no. 1, pp. 261–3, Jan. 2000.
[38] Felson, DT; Anderson, JJ; Boers, M; Bombardier, C; Chernoff, M; Fried, B; Furst, D; Goldsmith, C; Kieszak, S; Lightfoot, R. “The American College of Rheumatology preliminary core set of disease activity measures for rheumatoid arthritis clinical trials. The Committee on Outcome Measures in Rheumatoid Arthritis Clinical Trials.,” Arthritis Rheum., vol. 36, no. 6, pp. 729–40, Jun. 1993.
[39] SAME; Lopez-Olivo, M; Ortiz, Z; Pak, CH; Cox, V; Kimmel, B; Kendall-Roundtree, A; Skidmore, B. “A META-ANALYSIS ON THE TIMING OF THERAPEUTIC INTRODUCTION OF INFLIXIMAB (IFX) AND ETANERCEPT (ETN) [abstract],” Ann Rheum Dis, vol. 65, no. Suppl II, p. 329, 2006.
[40] Smolen, JS; Van Der Heijde, DMFM; St Clair, EW; Emery, P; Bathon, JM; Keystone, E; Maini, RN; Kalden, JR; Schiff, M; Baker, D; Han, C; Han, J; Bala, M. “Predictors of joint damage in patients with early rheumatoid arthritis treated with high-dose methotrexate with or without concomitant infliximab: results from the ASPIRE trial.,” Arthritis Rheum., vol. 54, no. 3, pp. 702–10, Mar. 2006.
[41] St Clair, EW; van der Heijde, DMFM; Smolen, JS; Maini, RN; Bathon, JM; Emery, P; Keystone, E; Schiff, M; Kalden, JR; Wang, B; Dewoody, K; Weiss, R; Baker, D. “Combination of infliximab and methotrexate therapy for early rheumatoid arthritis: a randomised, controlled trial.,” Arthritis Rheum., vol. 50, no. 11, pp. 3432–43, Nov. 2004.
[42] Goekoop-Ruiterman, YPM; de Vries-Bouwstra, JK; Allaart, CF; van Zeben, D; Kerstens, PJSM; Hazes, JMW; Zwinderman, AH; Ronday, HK; Han, KH; Westedt, ML; Gerards, AH; van Groenendael, JHLM; Lems, WF; van Krugten, MV; Breedveld, FC; Dijkmans, BAC. “Clinical and radiographic outcomes of four different treatment strategies in patients with early rheumatoid arthritis (the BeSt study): a randomised, controlled trial.,” Arthritis Rheum., vol. 52, no. 11, pp. 3381–90, Nov. 2005.
[43] van der Bijl, AE; Goekoop-Ruiterman, YPM; de Vries-Bouwstra, JK; Ten Wolde, S; Han, KH; van Krugten, MV; Allaart, CF; Breedveld, FC; Dijkmans, BAC. “Infliximab and methotrexate as induction therapy in patients with early rheumatoid arthritis.,” Arthritis Rheum., vol. 56, no. 7, pp. 2129–34, Jul. 2007.
[44] Nadkarni, S; Mauri, C; Ehrenstein, MR. “Anti-TNF-alpha therapy induces a distinct regulatory T cell population in patients with rheumatoid arthritis via TGF-beta.,” J. Exp. Med., vol. 204, no. 1, pp. 33–9, Jan. 2007.
[45] Keystone, EC; Kavanaugh, AF; Sharp, JT; Tannenbaum, H; Hua, Y; Teoh, LS; Fischkoff, SA; Chartash, EK. “Radiographic, clinical, and functional outcomes of treatment with adalimumab (a human anti-tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy: a randomised, placebo-controlled,” Arthritis Rheum., vol. 50, no. 5, pp. 1400–11, May 2004.
[46] van de Putte, LBA; Atkins, C; Malaise, M; Sany, J; Russell, AS; van Riel, PLCM; Settas, L; Bijlsma, JW; Todesco, S; Dougados, M; Nash, P; Emery, P; Walter, N; Kaul, M; Fischkoff, S; Kupper, H. “Efficacy and safety of adalimumab as monotherapy in patients with rheumatoid arthritis for whom previous disease modifying antirheumatic drug treatment has failed.,” Ann. Rheum. Dis., vol. 63, no. 5, pp. 508–16, May 2004.
[47] Weinblatt, ME; Keystone, EC; Furst, DE; Moreland, LW; Weisman, MH; Birbara, CA; Teoh, LA; Fischkoff, SA; Chartash, EK. “Adalimumab, a fully human anti-tumor necrosis factor alpha monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: the ARMADA trial.,” Arthritis Rheum., vol. 48, no. 1, pp. 35–45, Jan. 2003.
[48] Weinblatt, ME; Keystone, EC; Furst, DE; Kavanaugh, AF; Chartash, EK; Segurado, OG. “Long term efficacy and safety of adalimumab plus methotrexate in patients with rheumatoid arthritis: ARMADA 4 year extended study.,” Ann. Rheum. Dis., vol. 65, no. 6, pp. 753–9, Jul. 2006.
[49] Breedveld, FC; Weisman, MH; Kavanaugh, AF; Cohen, SB; Pavelka, K; van Vollenhoven, R; Sharp, J; Perez, JL; Spencer-Green, GT. “The PREMIER study: A multicenter, randomised, double-blind clinical trial of combination therapy with adalimumab plus methotrexate vs. methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previo,” Arthritis Rheum., vol. 54, no. 1, pp. 26–37, Jan. 2006.
[50] Jamal, S; Patra, K; Keystone, EC. “Adalimumab response in patients with early vs. established rheumatoid arthritis: DE019 randomised controlled trial subanalysis.,” Clin. Rheumatol., vol. 28, no. 4, pp. 413–9, May 2009.
[51] “Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed | Guidance and guidelines | NICE.”
[52] De, MA; Machado, Á; Maciel, AA; de Lemos, LLP; Costa, JO; Kakehasi, AM; Andrade, EIG; Cherchiglia, ML; de, F; Acurcio, A; Sampaio-Barros, PD. “Adalimumab in rheumatoid arthritis treatment: a systematic review and meta-analysis of randomised clinical trials.,” Rev. Bras. Reumatol., vol. 53, no. 5, pp. 419–30, Jan.
[53] Wiens, A; Venson, R; Correr, CJ; Otuki, MF; Pontarolo, R. “Meta-analysis of the efficacy and safety of adalimumab, etanercept, and infliximab for the treatment of rheumatoid arthritis.,” Pharmacotherapy, vol. 30, no. 4, pp. 339–53, May 2010.
[54] Bruce, B; Fries, JF. “The Stanford Health Assessment Questionnaire: a review of its history, issues, progress, and documentation.,” J. Rheumatol., vol. 30, no. 1, pp. 167–78, Jan. 2003.
[55] Bathon, JM; Martin, RW; Fleischmann, RM; Tesser, JR; Schiff, MH; Keystone, EC; Genovese, MC; Wasko, MC; Moreland, LW; Weaver, AL; Markenson, J; Finck, BK. “A comparison of etanercept and methotrexate in patients with early rheumatoid arthritis.,” N. Engl. J. Med., vol. 343, no. 22, pp. 1586–93, Nov. 2000.
[56] Klareskog, L; van der Heijde, D; de Jager, JP; Gough, A; Kalden, J; Malaise, M; Martín Mola, E; Pavelka, K; Sany, J; Settas, L; Wajdula, J; Pedersen, R; Fatenejad, S; Sanda, M. “Therapeutic effect of the combination of etanercept and methotrexate compared with each treatment alone in patients with rheumatoid arthritis: double-blind randomised controlled trial.,” Lancet (London, England), vol. 363, no. 9410, pp. 675–81, Feb. 2004.
[57] van Riel, PLCM; Taggart, AJ; Sany, J; Gaubitz, M; Nab, HW; Pedersen, R; Freundlich, B; MacPeek, D. “Efficacy and safety of combination etanercept and methotrexate vs. etanercept alone in patients with rheumatoid arthritis with an inadequate response to methotrexate: the ADORE study.,” Ann. Rheum. Dis., vol. 65, no. 11, pp. 1478–83, Nov. 2006.
[58] Weinblatt, ME; Kremer, JM; Bankhurst, AD; Bulpitt, KJ; Fleischmann, RM; Fox, RI; Jackson, CG; Lange, M; Burge, DJ. “A trial of etanercept, a recombinant tumor necrosis factor receptor: Fc fusion protein, in patients with rheumatoid arthritis receiving methotrexate.,” N. Engl. J. Med., vol. 340, no. 4, pp. 253–9, Jan. 1999.
[59] Combe, B; Codreanu, C; Fiocco, U; Gaubitz, M; Geusens, PP; Kvien, TK; Pavelka, K; Sambrook, PN; Smolen, JS; Wajdula, J; Fatenejad, S. “Etanercept and sulfasalazine, alone and combined, in patients with active rheumatoid arthritis despite receiving sulfasalazine: a double-blind comparison.,” Ann. Rheum. Dis., vol. 65, no. 10, pp. 1357–62, Oct. 2006.
[60] Prevoo, ML; van’t Hof, MA; Kuper, HH; van Leeuwen, MA; van de Putte, LB; van Riel, PL. “Modified disease activity scores that include twenty-eight-joint counts. Development and validation in a prospective longitudinal study of patients with rheumatoid arthritis.,” Arthritis Rheum., vol. 38, no. 1, pp. 44–8, Jan. 1995.
[61] Emery, P; Breedveld, FC; Hall, S; Durez, P; Chang, DJ; Robertson, D; Singh, A; Pedersen, RD; Koenig, AS; Freundlich, B. “Comparison of methotrexate monotherapy with a combination of methotrexate and etanercept in active, early, moderate to severe rheumatoid arthritis (COMET): a randomised, double-blind, parallel treatment trial.,” Lancet (London, England), vol. 372, no. 9636, pp. 375–82, Aug. 2008.
[62] Emery, P; Kvien, TK; Combe, B; Freundlich, B; Robertson, D; Ferdousi, T; Bananis, E; Pedersen, R; Koenig, AS. “Combination etanercept and methotrexate provides better disease control in very early (<=4 months) vs. early rheumatoid arthritis (>4 months and <2 years): post hoc analyses from the COMET study.,” Ann. Rheum. Dis., vol. 71, no. 6, pp. 989–92, Jul. 2012.
[63] Buch, MH; Conaghan, PG; Quinn, MA; Bingham, SJ; Veale, D; Emery, P. “True infliximab resistance in rheumatoid arthritis: a role for lymphotoxin alpha?,” Ann. Rheum. Dis., vol. 63, no. 10, pp. 1344–6, Oct. 2004.
[64] Keystone, E; van der Heijde, D; Mason, D; Landewé, R; Van Vollenhoven, R; Combe, B; Emery, P; Strand, V; Mease, P; Desai, C; Pavelka, K. “Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis: findings of a fifty-two-week, phase III, multicenter, randomised, double-blind, placebo-controlled, parallel-group study.,” Arthritis Rheum., vol. 58, no. 11, pp. 3319–29, Nov. 2008.
[65] Smolen, J; Landewé, RB; Mease, P; Brzezicki, J; Mason, D; Luijtens, K; van Vollenhoven, RF; Kavanaugh, A; Schiff, M; Burmester, GR; Strand, V; Vencovs.ky, J; van der Heijde, D. “Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study. A randomised controlled trial.,” Ann. Rheum. Dis., vol. 68, no. 6, pp. 797–804, Jun. 2009.
[66] Weinblatt, ME; Fleischmann, R; Huizinga, TWJ; Emery, P; Pope, J; Massarotti, EM; van Vollenhoven, RF; Wollenhaupt, J; Bingham, CO; Duncan, B; Goel, N; Davies, OR; Dougados, M. “Efficacy and safety of certolizumab pegol in a broad population of patients with active rheumatoid arthritis: results from the REALISTIC phase IIIb study.,” Rheumatology (Oxford)., vol. 51, no. 12, pp. 2204–14, Dec. 2012.
[67] Smolen, JS; Emery, P; Ferraccioli, GF; Samborski, W; Berenbaum, F; Davies, OR; Koetse, W; Purcaru, O; Bennett, B; Burkhardt, H. “Certolizumab pegol in rheumatoid arthritis patients with low to moderate activity: the CERTAIN double-blind, randomised, placebo-controlled trial.,” Ann. Rheum. Dis., vol. 74, no. 5, pp. 843–50, May 2015.
[68] Fleischmann, R; Vencovs.ky, J; van Vollenhoven, RF; Borenstein, D; Box, J; Coteur, G; Goel, N; Brezinschek, HP; Innes, A; Strand, V. “Efficacy and safety of certolizumab pegol monotherapy every 4 weeks in patients with rheumatoid arthritis failing previous disease-modifying antirheumatic therapy: the FAST4WARD study.,” Ann. Rheum. Dis., vol. 68, no. 6, pp. 805–11, Jun. 2009.
[69] Patel, AM; Moreland, LW. “Certolizumab pegol: a new biologic targeting rheumatoid arthritis.,” Expert Rev. Clin. Immunol., vol. 6, no. 6, pp. 855–66, Nov. 2010.
[70] Emery, P; Fleischmann, RM; Moreland, LW; Hsia, EC; Strusberg, I; Durez, P; Nash, P; Amante, EJB; Churchill, M; Park, W; Pons-Estel, BA; Doyle, MK; Visvanathan, S; Xu, W; Rahman, MU. “Golimumab, a human anti-tumor necrosis factor alpha monoclonal antibody, injected subcutaneously every four weeks in methotrexate-naïve patients with active rheumatoid arthritis: twenty-four-week results of a phase III, multicenter, randomised, double-bli,” Arthritis Rheum., vol. 60, no. 8, pp. 2272–83, Aug. 2009.
[71] Kay, J; Matteson, EL; Dasgupta, B; Nash, P; Durez, P; Hall, S; Hsia, EC; Han, J; Wagner, C; Xu, Z; Visvanathan, S; Rahman, MU. “Golimumab in patients with active rheumatoid arthritis despite treatment with methotrexate: a randomised, double-blind, placebo-controlled, dose-ranging study.,” Arthritis Rheum., vol. 58, no. 4, pp. 964–75, Apr. 2008.
[72] Keystone, EC; Genovese, MC; Klareskog, L; Hsia, EC; Hall, ST; Miranda, PC; Pazdur, J; Bae, SC; Palmer, W; Zrubek, J; Wiekowski, M; Visvanathan, S; Wu, Z; Rahman, MU. “Golimumab, a human antibody to tumour necrosis factor {alpha} given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate therapy: the GO-FORWARD Study.,” Ann. Rheum. Dis., vol. 68, no. 6, pp. 789–96, Jun. 2009.
[73] Keystone, E; Genovese, MC; Klareskog, L; Hsia, EC; Hall, S; Miranda, PC; Pazdur, J; Bae, SC; Palmer, W; Xu, S; Rahman, MU. “Golimumab in patients with active rheumatoid arthritis despite methotrexate therapy: 52-week results of the GO-FORWARD study.,” Ann. Rheum. Dis., vol. 69, no. 6, pp. 1129–35, Jun. 2010.
[74] Smolen, JS; Kay, J; Doyle, MK; Landewé, R; Matteson, EL; Wollenhaupt, J; Gaylis, N; Murphy, FT; Neal, JS; Zhou, Y; Visvanathan, S; Hsia, EC; Rahman, MU; “Golimumab in patients with active rheumatoid arthritis after treatment with tumour necrosis factor alpha inhibitors (GO-AFTER study): a multicentre, randomised, double-blind, placebo-controlled, phase III trial.,” Lancet (London, England), vol. 374, no. 9685, pp. 210–21, Jul. 2009.
[75] Singh, JA; Noorbaloochi, S; Singh, G. “Golimumab for rheumatoid arthritis.,” Cochrane database Syst. Rev., no. 1, p. CD008341, Jan. 2010.
[76] Kristensen, LE; Christensen, R; Bliddal, H; Geborek, P; Danneskiold-Samsøe, B; Saxne, T. “The number needed to treat for adalimumab, etanercept, and infliximab based on ACR50 response in three randomised controlled trials on established rheumatoid arthritis: a systematic literature review.,” Scand. J. Rheumatol., vol. 36, no. 6, pp. 411–7, Jan.
[77] Singh, JA; Christensen, R; Wells, GA; Suarez-Almazor, ME; Buchbinder, R; Lopez-Olivo, MA; Tanjong Ghogomu, E; and Tugwell, P. “Biologics for rheumatoid arthritis: an overview of Cochrane reviews.,” Cochrane database Syst. Rev., no. 4, p. CD007848, Jan. 2009.
[78] Alonso-Ruiz, A; Pijoan, JI; Ansuategui, E; Urkaregi, A; Calabozo, M; Quintana, A. “Tumor necrosis factor alpha drugs in rheumatoid arthritis: systematic review and metaanalysis of efficacy and safety.,” BMC Musculoskelet. Disord., vol. 9, p. 52, Jan. 2008.
[79] Launois, R; Avouac, B; Berenbaum, F; Blin, O; Bru, I; Fautrel, B; Joubert, JM; Sibilia, J; Combe, B. “Comparison of certolizumab pegol with other anticytokine agents for treatment of rheumatoid arthritis: a multiple-treatment Bayesian metaanalysis.,” J. Rheumatol., vol. 38, no. 5, pp. 835–45, May 2011.
[80] Aaltonen, KJ; Virkki, LM; Malmivaara, A; Konttinen, YT; Nordström, DC; Blom, M. “Systematic review and meta-analysis of the efficacy and safety of existing TNF blocking agents in treatment of rheumatoid arthritis.,” PLoS One, vol. 7, no. 1, p. e30275, Jan. 2012.
[81] Devine, EB; Alfonso-Cristancho, R; Sullivan, SD. “Effectiveness of biologic therapies for rheumatoid arthritis: an indirect comparisons approach.,” Pharmacotherapy, vol. 31, no. 1, pp. 39–51, Jan. 2011.
[82] Schmitz, S; Adams, R; Walsh, CD; Barry, M; FitzGerald, O. “A mixed treatment comparison of the efficacy of anti-TNF agents in rheumatoid arthritis for methotrexate non-responders demonstrates differences between treatments: a Bayesian approach.,” Ann. Rheum. Dis., vol. 71, no. 2, pp. 225–30, Feb. 2012.
[83] Brennan, A; Bansback, N; Nixon, R; Madan, J; Harrison, M; Watson, K; Symmons, D. “Modelling the cost-effectiveness of TNF-alpha antagonists in the management of rheumatoid arthritis: results from the British Society for Rheumatology Biologics Registry.,” Rheumatology (Oxford)., vol. 46, no. 8, pp. 1345–54, Aug. 2007.
[84] Tanno, M; Nakamura, I; Ito, K; Tanaka, H; Ohta, H; Kobayashi, M; Tachihara, A; Nagashima, M; Yoshino, S; Nakajima, A. “Modeling and cost-effectiveness analysis of etanercept in adults with rheumatoid arthritis in Japan: a preliminary analysis.,” Mod. Rheumatol., vol. 16, no. 2, pp. 77–84, Jan. 2006.
[85] Bansback, NJ; Brennan, A; Ghatnekar, O. “Cost-effectiveness of adalimumab in the treatment of patients with moderate to severe rheumatoid arthritis in Sweden.,” Ann. Rheum. Dis., vol. 64, no. 7, pp. 995–1002, Jul. 2005.
[86] Scottish, MC. “Cost-effectiveness of Biologics.”
[87] Joensuu, JT; Huoponen, S; Aaltonen, KJ; Konttinen, YT; Nordström, D; Blom, M. “The cost-effectiveness of biologics for the treatment of rheumatoid arthritis: a systematic review.,” PLoS One, vol. 10, no. 3, p. e0119683, Jan. 2015.
[88] Woodrick, RS; Ruderman, EM. “Safety of biologic therapy in rheumatoid arthritis.,” Nat. Rev. Rheumatol., vol. 7, no. 11, pp. 639–52, Dec. 2011.
[89] Galloway, JB; Hyrich, KL; Mercer, LK; Dixon, WG; Fu, B; Ustianowski, AP; Watson, KD; Lunt, M; Symmons, DPM. “Anti-TNF therapy is associated with an increased risk of serious infections in patients with rheumatoid arthritis especially in the first 6 months of treatment: updated results from the British Society for Rheumatology Biologics Register with special emph,” Rheumatology (Oxford)., vol. 50, no. 1, pp. 124–31, Jan. 2011.
[90] Greenberg, JD; Reed, G; Kremer, JM; Tindall, E; Kavanaugh, A; Zheng, C; Bishai, W; Hochberg, MC. “Association of methotrexate and tumour necrosis factor antagonists with risk of infectious outcomes including opportunistic infections in the CORRONA registry.,” Ann. Rheum. Dis., vol. 69, no. 2, pp. 380–6, Mar. 2010.
[91] Mohan, VP; Scanga, CA; Yu, K; Scott, HM; Tanaka, KE; Tsang, E; Tsai, MM; Flynn, JL; Chan, J. “Effects of tumor necrosis factor alpha on host immune response in chronic persistent tuberculosis: possible role for limiting pathology.,” Infect. Immun., vol. 69, no. 3, pp. 1847–55, Mar. 2001.
[92] Scanga, CA; Mohan, VP; Yu, K; Joseph, H; Tanaka, K; Chan, J; Flynn, JL. “Depletion of CD4(+) T cells causes reactivation of murine persistent tuberculosis despite continued expression of interferon gamma and nitric oxide synthase 2.,” J. Exp. Med., vol. 192, no. 3, pp. 347–58, Aug. 2000.
[93] Keane, J; Gershon, S; Wise, RP; Mirabile-Levens, E; Kasznica, J; Schwieterman, WD; Siegel, JN; Braun, MM. “Tuberculosis associated with infliximab, a tumor necrosis factor alpha-neutralizing agent.,” N. Engl. J. Med., vol. 345, no. 15, pp. 1098–104, Oct. 2001.
[94] Tubach, F; Salmon, D; Ravaud, P; Allanore, Y; Goupille, P; Bréban, M; Pallot-Prades, B; Pouplin, S; Sacchi, A; Chichemanian, RM; Bretagne, S; Emilie, D; Lemann, M; Lortholary, O; Lorthololary, O; Mariette, X. “Risk of tuberculosis is higher with anti-tumor necrosis factor monoclonal antibody therapy than with soluble tumor necrosis factor receptor therapy: The three-year prospective French Research Axed on Tolerance of Biotherapies registry.,” Arthritis Rheum., vol. 60, no. 7, pp. 1884–94, Jul. 2009.
[95] Ding, T; Ledingham, J; Luqmani, R; Westlake, S; Hyrich, K; Lunt, M; Kiely, P; Bukhari, M; Abernethy, R; Bosworth, A; Ostor, A; Gadsby, K; McKenna, F; Finney, D; Dixey, J; Deighton, C. “BSR and BHPR rheumatoid arthritis guidelines on safety of anti-TNF therapies.,” Rheumatology (Oxford)., vol. 49, no. 11, pp. 2217–9, Dec. 2010.
[96] Winthrop, KL; Chang, E; Yamashita, S; Iademarco, MF; LoBue, PA. “Nontuberculous Mycobacteria Infections and Anti–Tumor Necrosis Factor-α Therapy,” Emerg. Infect. Dis., vol. 15, no. 10, pp. 1556–1561, Oct. 2009.
[97] García-Doval, I; Pérez-Zafrilla, B; Descalzo, MA; Roselló, R; Hernández, MV; Gómez-Reino, JJ; Carmona, L. “Incidence and risk of hospitalisation due to shingles and chickenpox in patients with rheumatic diseases treated with TNF antagonists.,” Ann. Rheum. Dis., vol. 69, no. 10, pp. 1751–5, Oct. 2010.
[98] Strangfeld, A; Listing, J; Herzer, P; Liebhaber, A; Rockwitz, K; Richter, C; Zink, A. “Risk of herpes zoster in patients with rheumatoid arthritis treated with anti-TNF-alpha agents.,” JAMA, vol. 301, no. 7, pp. 737–44, Mar. 2009.
[99] Kim, YJ; Bae, SC; Sung, YK; Kim, TH; Jun, JB; Yoo, DH; Kim, TY; Sohn, JH; Lee, HS. “Possible reactivation of potential hepatitis B virus occult infection by tumor necrosis factor-alpha blocker in the treatment of rheumatic diseases.,” J. Rheumatol., vol. 37, no. 2, pp. 346–50, Mar. 2010.
[100] Cepeda, EJ; Williams, FM; Ishimori, ML; Weisman, MH; Reveille, JD. “The use of anti-tumour necrosis factor therapy in HIV-positive individuals with rheumatic disease.,” Ann. Rheum. Dis., vol. 67, no. 5, pp. 710–2, May 2008.
[101] Mariette, X; Matucci-Cerinic, M; Pavelka, K; Taylor, P; van Vollenhoven, R; Heatley, R; Walsh, C; Lawson, R; Reynolds, A; Emery, P. “Malignancies associated with tumour necrosis factor inhibitors in registries and prospective observational studies: a systematic review and meta-analysis.,” Ann. Rheum. Dis., vol. 70, no. 11, pp. 1895–904, Dec. 2011.
[102] Setoguchi, S; Solomon, DH; Weinblatt, ME; Katz, JN; Avorn, J; Glynn, RJ; Cook, EF; Carney, G; Schneeweiss, S. “Tumor necrosis factor alpha antagonist use and cancer in patients with rheumatoid arthritis.,” Arthritis Rheum., vol. 54, no. 9, pp. 2757–64, Oct. 2006.
[103] Wolfe, F; Michaud, K. “Biologic treatment of rheumatoid arthritis and the risk of malignancy: analyses from a large US observational study.,” Arthritis Rheum., vol. 56, no. 9, pp. 2886–95, Oct. 2007.
[104] Chakravarty, EF; Michaud, K; Wolfe, F. “Skin cancer, rheumatoid arthritis, and tumor necrosis factor inhibitors.,” J. Rheumatol., vol. 32, no. 11, pp. 2130–5, Dec. 2005.
[105] Goncalves, DP; Laurindo, I; Scheinberg, MA. “The appearance of pustular psoriasis during antitumor necrosis factor therapy.,” J. Clin. Rheumatol., vol. 12, no. 5, p. 262, Oct. 2006.
[106] Lee, HH; Song, IH; Friedrich, M; Gauliard, A; Detert, J; Röwert, J; Audring, H; Kary, S; Burmester, GR; Sterry, W; Worm, M. “Cutaneous side-effects in patients with rheumatic diseases during application of tumour necrosis factor-alpha antagonists.,” Br. J. Dermatol., vol. 156, no. 3, pp. 486–91, Mar. 2007.
[107] Anker, SD; Coats, AJS. “How to RECOVER from RENAISSANCE? The significance of the results of RECOVER, RENAISSANCE, RENEWAL and ATTACH.,” Int. J. Cardiol., vol. 86, no. 2–3, pp. 123–30, Dec. 2002.
[108] Chung, ES; Packer, M; Lo, KH; Fasanmade, AA; Willerson, JT. “Randomised, double-blind, placebo-controlled, pilot trial of infliximab, a chimeric monoclonal antibody to tumor necrosis factor-alpha, in patients with moderate-to-severe heart failure: results of the anti-TNF Therapy Against Congestive Heart Failure (AT,” Circulation, vol. 107, no. 25, pp. 3133–40, Jul. 2003.
[109] Listing, J; Strangfeld, A; Kekow, J; Schneider, M; Kapelle, A; Wassenberg, S; Zink, A. “Does tumor necrosis factor alpha inhibition promote or prevent heart failure in patients with rheumatoid arthritis?,” Arthritis Rheum., vol. 58, no. 3, pp. 667–77, Mar. 2008.
[110] Danila, MI; Patkar, NM; Curtis, JR; Saag, KG; Teng, GG. “Biologics and heart failure in rheumatoid arthritis: are we any wiser?,” Curr. Opin. Rheumatol., vol. 20, no. 3, pp. 327–33, May 2008.
[111] SDPM; Dixon, WG; Watson, KD; Lunt, M; Hyrich, KL. “RHEUMATOID ARTHRITIS, INTERSTITIAL LUNG DISEASE, MORTALITY AND ANTI-TNF THERAPY: RESULTS FROM THE BSR BIOLOGICS REGISTER (BSRBR),” Ann Rheum Dis, vol. 66, no. Suppl II, p. 55, 2007.
[112] Stübgen, JP. “Tumor necrosis factor-alpha antagonists and neuropathy.,” Muscle Nerve, vol. 37, no. 3, pp. 281–92, Mar. 2008.
[113] Isaacs, JD. “The changing face of rheumatoid arthritis: sustained remission for all?,” Nat. Rev. Immunol., vol. 10, no. 8, pp. 605–11, Aug. 2010.

Chapter 10

[1] Muraguchi, A; Hirano, T; Tang, B; Matsuda, T; Horii, Y; Nakajima, K; Kishimoto, T. “The essential role of B cell stimulatory factor 2 (BSF-2/IL-6) for the terminal differentiation of B cells.,” J. Exp. Med., vol. 167, no. 2, pp. 332–44, Mar. 1988.
[2] Dienz, O; Eaton, SM; Bond, JP; Neveu, W; Moquin, D; Noubade, R; Briso, EM; Charland, C; Leonard, WJ; Ciliberto, G; Teuscher, C; Haynes, L; Rincon, M. “The induction of antibody production by IL-6 is indirectly mediated by IL-21 produced by CD4+ T cells.,” J. Exp. Med., vol. 206, no. 1, pp. 69–78, Jan. 2009.
[3] Jego, G; Bataille, R; Pellat-Deceunynck, C. “Interleukin-6 is a growth factor for nonmalignant human plasmablasts.,” Blood, vol. 97, no. 6, pp. 1817–22, Mar. 2001.
[4] Madhok, R; Crilly, A; Watson, J; Capell, HA. “Serum interleukin 6 levels in rheumatoid arthritis: correlations with clinical and laboratory indices of disease activity.,” Ann. Rheum. Dis., vol. 52, no. 3, pp. 232–4, Mar. 1993.
[5] Connolly, DT; Heuvelman, DM; Nelson, R; Olander, JV; Eppley, BL; Delfino, JJ; Siegel, NR; Leimgruber, RM; Feder, J. “Tumor vascular permeability factor stimulates endothelial cell growth and angiogenesis.,” J. Clin. Invest., vol. 84, no. 5, pp. 1470–8, Dec. 1989.
[6] Keck, PJ; Hauser, SD; Krivi, G; Sanzo, K; Warren, T; Feder, J; Connolly, DT. “Vascular permeability factor, an endothelial cell mitogen related to PDGF.,” Science, vol. 246, no. 4935, pp. 1309–12, Dec. 1989.
[7] Walsh, NC; Crotti, TN; Goldring, SR; Gravallese, EM. “Rheumatic diseases: the effects of inflammation on bone.,” Immunol. Rev., vol. 208, pp. 228–51, Dec. 2005.
[8] Ganz, T. “Hepcidin, a key regulator of iron metabolism and mediator of anemia of inflammation.,” Blood, vol. 102, no. 3, pp. 783–8, Aug. 2003.
[9] Boe, A; Baiocchi, M; Carbonatto, M; Papoian, R; Serlupi-Crescenzi, O. “Interleukin 6 knock-out mice are resistant to antigen-induced experimental arthritis.,” Cytokine, vol. 11, no. 12, pp. 1057–64, Dec. 1999.
[10] “British National Formulary (BNF),” no. 70.
[11] Smolen, JS; Beaulieu, A; Rubbert-Roth, A; Ramos-Remus, C; Rovensky, J; Alecock, E; Woodworth, T; Alten, R. “Effect of interleukin-6 receptor inhibition with tocilizumab in patients with rheumatoid arthritis (OPTION study): a double-blind, placebo-controlled, randomised trial.,” Lancet (London, England), vol. 371, no. 9617, pp. 987–97, Mar. 2008.
[12] Fleischmann, RM; Halland, AM; Brzosko, M; Burgos-Vargas, R; Mela, C; Vernon, E; Kremer, JM. “Tocilizumab inhibits structural joint damage and improves physical function in patients with rheumatoid arthritis and inadequate responses to methotrexate: LITHE study 2-year results.,” J. Rheumatol., vol. 40, no. 2, pp. 113–26, Feb. 2013.
[13] Genovese, MC; McKay, JD; Nasonov, EL; Mysler, EF; da Silva, NA; Alecock, E; Woodworth, T; Gomez-Reino, JJ. “Interleukin-6 receptor inhibition with tocilizumab reduces disease activity in rheumatoid arthritis with inadequate response to disease-modifying antirheumatic drugs: the tocilizumab in combination with traditional disease-modifying antirheumatic drug the,” Arthritis Rheum., vol. 58, no. 10, pp. 2968–80, Oct. 2008.
[14] Navarro, G; Taroumian, S; Barroso, N; Duan, L; Furst, D. “Tocilizumab in rheumatoid arthritis: a meta-analysis of efficacy and selected clinical conundrums.,” Semin. Arthritis Rheum., vol. 43, no. 4, pp. 458–69, Feb. 2014.
[15] Emery, P; Keystone, E; Tony, HP; Cantagrel, A; van Vollenhoven, R; Sanchez, A; Alecock, E; Lee, J; Kremer, J. “IL-6 receptor inhibition with tocilizumab improves treatment outcomes in patients with rheumatoid arthritis refractory to anti-tumour necrosis factor biologicals: results from a 24-week multicentre randomised placebo-controlled trial.,” Ann. Rheum. Dis., vol. 67, no. 11, pp. 1516–23, Nov. 2008.
[16] Jones, G; Sebba, A; Gu, J; Lowenstein, MB; Calvo, A; Gomez-Reino, JJ; Siri, DA; Tomsic, M; Alecock, E; Woodworth, T; Genovese, MC. “Comparison of tocilizumab monotherapy vs. methotrexate monotherapy in patients with moderate to severe rheumatoid arthritis: the AMBITION study.,” Ann. Rheum. Dis., vol. 69, no. 1, pp. 88–96, Jan. 2010.
[17] Nishimoto, N; Miyasaka, N; Yamamoto, K; Kawai, S; Takeuchi, T; Azuma, J; Kishimoto, T. “Study of active controlled tocilizumab monotherapy for rheumatoid arthritis patients with an inadequate response to methotrexate (SATORI): significant reduction in disease activity and serum vascular endothelial growth factor by IL-6 receptor inhibition t,” Mod. Rheumatol., vol. 19, no. 1, pp. 12–9, Jan. 2009.
[18] Nishimoto, N; Miyasaka, N; Yamamoto, K; Kawai, S; Takeuchi, T; Azuma, J. “Long-term safety and efficacy of tocilizumab, an anti-IL-6 receptor monoclonal antibody, in monotherapy, in patients with rheumatoid arthritis (the STREAM study): evidence of safety and efficacy in a 5-year extension study.,” Ann. Rheum. Dis., vol. 68, no. 10, pp. 1580–4, Oct. 2009.
[19] Singh, JA; Beg, S; Lopez-Olivo, MA. “Tocilizumab for rheumatoid arthritis: a Cochrane systematic review.,” J. Rheumatol., vol. 38, no. 1, pp. 10–20, Jan. 2011.
[20] Maini, RN; Taylor, PC; Szechinski, J; Pavelka, K; Bröll, J; Balint, G; Emery, P; Raemen, F; Petersen, J; Smolen, J; Thomson, D; Kishimoto, T. “Double-blind randomised controlled clinical trial of the interleukin-6 receptor antagonist, tocilizumab, in European patients with rheumatoid arthritis who had an incomplete response to methotrexate.,” Arthritis Rheum., vol. 54, no. 9, pp. 2817–29, Oct. 2006.
[21] Dougados, M; Kissel, K; Sheeran, T; Tak, PP; Conaghan, PG; Mola, EM; Schett, G; Amital, H; Navarro-Sarabia, F; Hou, A; Bernasconi, C; Huizinga, TWJ. “Adding tocilizumab or switching to tocilizumab monotherapy in methotrexate inadequate responders: 24-week symptomatic and structural results of a 2-year randomised controlled strategy trial in rheumatoid arthritis (ACT-RAY).,” Ann. Rheum. Dis., vol. 72, no. 1, pp. 43–50, Jan. 2013.
[22] Gabay, C; Emery, P; van Vollenhoven, R; Dikranian, A; Alten, R; Pavelka, K; Klearman, M; Musselman, D; Agarwal, S; Green, J; Kavanaugh, A. “Tocilizumab monotherapy vs. adalimumab monotherapy for treatment of rheumatoid arthritis (ADACTA): a randomised, double-blind, controlled Phase 4 trial.,” Lancet (London, England), vol. 381, no. 9877, pp. 1541–50, May 2013.
[23] Gabay, C; Riek, M; Hetland, ML; Hauge, EM; Pavelka, K; Tomšič, M; Canhao, H; Chatzidionysiou, K; Lukina, G; Nordström, DC; Lie, E; Ancuta, I; Hernández, MV; van Riel, PLMC; van Vollenhoven, R; Kvien, TK. “Effectiveness of tocilizumab with and without synthetic disease-modifying antirheumatic drugs in rheumatoid arthritis: results from a European collaborative study.,” Ann. Rheum. Dis., pp. annrheumdis–2015–207760–, Sep. 2015.
[24] Salliot, C; Finckh, A; Katchamart, W; Lu, Y; Sun, Y; Bombardier, C; Keystone, E. “Indirect comparisons of the efficacy of biological antirheumatic agents in rheumatoid arthritis in patients with an inadequate response to conventional disease-modifying antirheumatic drugs or to an anti-tumour necrosis factor agent: a meta-analysis.,” Ann. Rheum. Dis., vol. 70, no. 2, pp. 266–71, Feb. 2011.
[25] Bergman, GJD; Hochberg, MC; Boers, M; Wintfeld, N; Kielhorn, A; Jansen, JP. “Indirect comparison of tocilizumab and other biologic agents in patients with rheumatoid arthritis and inadequate response to disease-modifying antirheumatic drugs.,” Semin. Arthritis Rheum., vol. 39, no. 6, pp. 425–41, Jun. 2010.
[26] Ogata, A; Tanimura, K; Sugimoto, T; Inoue, H; Urata, Y; Matsubara, T; Kondo, M; Ueki, Y; Iwahashi, M; Tohma, S; Ohta, S; Saeki, Y; Tanaka, T. “Phase III study of the efficacy and safety of subcutaneous vs. intravenous tocilizumab monotherapy in patients with rheumatoid arthritis.,” Arthritis Care Res. (Hoboken)., vol. 66, no. 3, pp. 344–54, Mar. 2014.
[27] McLaughlin, M; Östör, A. “Safety of subcutaneous vs. intravenous tocilizumab in combination with traditional disease-modifying antirheumatic drugs in patients with rheumatoid arthritis.,” Expert Opin. Drug Saf., vol. 14, no. 3, pp. 429–37, Mar. 2015.
[28] Nishimoto, N; Kishimoto, T. “Interleukin 6: from bench to bedside.,” Nat. Clin. Pract. Rheumatol., vol. 2, no. 11, pp. 619–26, Nov. 2006.
[29] Morel, RM. Jacques, Duzanski, Marie-Odile, Bardin, Thomas, Cantagrel, Alain G., Combe, Bernard, Dougados, Maxime, Flipo, “Prospective Follow-up of Tocilizumab Treatment in 764 Patients with Refractory Rheumatoid Arthritis: Tolerance and Efficacy Data From the French Registry Regate (REGistry –RoAcTEmra) [abstract],” Arthritis Rheum, vol. 64, no. Suppl 10, p. 351, 2012.
[30] Weinblatt, ME; Keystone, EC; Furst, DE; Kavanaugh, AF; Chartash, EK; Segurado, OG. “Long term efficacy and safety of adalimumab plus methotrexate in patients with rheumatoid arthritis: ARMADA 4 year extended study.,” Ann. Rheum. Dis., vol. 65, no. 6, pp. 753–9, Jul. 2006.
[31] Lang, VR; Englbrecht, M; Rech, J; Nüsslein, H; Manger, K; Schuch, F; Tony, HP; Fleck, M; Manger, B; Schett, G; Zwerina, J. “Risk of infections in rheumatoid arthritis patients treated with tocilizumab.,” Rheumatology (Oxford)., vol. 51, no. 5, pp. 852–7, May 2012.
[32] Edwards, CJ. “IL-6 inhibition and infection: treating patients with tocilizumab.,” Rheumatology (Oxford)., vol. 51, no. 5, pp. 769–70, May 2012.
[33] Campbell, L; Chen, C; Bhagat, SS; Parker, RA; Östör, AJK. “Risk of adverse events including serious infections in rheumatoid arthritis patients treated with tocilizumab: a systematic literature review and meta-analysis of randomised controlled trials.,” Rheumatology (Oxford)., vol. 50, no. 3, pp. 552–62, Mar. 2011.
[34] Schiff, MH; Kremer, JM; Jahreis, A; Vernon, E; Isaacs, JD; van Vollenhoven, RF. “Integrated safety in tocilizumab clinical trials.,” Arthritis Res. Ther., vol. 13, no. 5, p. R141, Jan. 2011.
[35] JR. Van Vollenhoven, Ronald F., Keystone, Edward C., Furie, R., Blesch, A., Wang, C., Curtis, “Gastrointestinal Safety In Patients With Rheumatoid Arthritis Treated With Tocilizumab: Data From Roche Clinical Trials [abstract],” Arthritis Rheum., vol. 60, no. Suppl 10, p. 1613, 2009.
[36] Gout, T; Ostör, AJK; Nisar, MK. “Lower gastrointestinal perforation in rheumatoid arthritis patients treated with conventional DMARDs or tocilizumab: a systematic literature review.,” Clin. Rheumatol., vol. 30, no. 11, pp. 1471–4, Nov. 2011.
[37] Tanaka, E; Inoue, E; Hoshi, D; Shimizu, Y; Kobayashi, A; Sugimoto, N; Shidara, K; Sato, E; Seto, Y; Nakajima, A; Momohara, S; Taniguchi, A; Yamanaka, H. “Cost-effectiveness of tocilizumab, a humanised anti-interleukin-6 receptor monoclonal antibody, vs. methotrexate in patients with rheumatoid arthritis using real-world data from the IORRA observational cohort study.,” Mod. Rheumatol., vol. 25, no. 4, pp. 503–13, Jul. 2015.
[38] Soini, EJ; Hallinen, TA; Puolakka, K; Vihervaara, V; Kauppi, MJ. “Cost-effectiveness of adalimumab, etanercept, and tocilizumab as first-line treatments for moderate-to-severe rheumatoid arthritis.,” J. Med. Econ., vol. 15, no. 2, pp. 340–51, Jan. 2012.
[39] Scottish, MC. “Cost-effectiveness of Biologics.”.
[40] “Rheumatoid arthritis in adults: management | Guidance and guidelines | NICE.”
[41] Smolen, JS; Landewé, R; Breedveld, FC; Buch, M; Burmester, G; Dougados, M; Emery, P; Gaujoux-Viala, C; Gossec, L; Nam, J; Ramiro, S; Winthrop, K; de Wit, M; Aletaha, D; Betteridge, N; Bijlsma, JWJ; Boers, M; Buttgereit, F; Combe, B; Cutolo, M; Damjanov, N; Hazes, JMW; Kouloumas, M; Kvien, TK; Mariette, X; Pavelka, K; van Riel, PLCM; Rubbert-Roth, A; Scholte-Voshaar, M; Scott, DL; Sokka-Isler, T; Wong, JB; van der Heijde, D. “EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update.,” Ann. Rheum. Dis., vol. 73, no. 3, pp. 492–509, Mar. 2014.
[42] Singh, JA; Saag, KG; Bridges, SL; Akl, EA; Bannuru, RR; Sullivan, MC; Vaysbrot, E; McNaughton, C; Osani, M; Shmerling, RH; Curtis, JR; Furst, DE; Parks, D; Kavanaugh, A; O’Dell, J; King, C; Leong, A; Matteson, EL; Schousboe, JT; Drevlow, B; Ginsberg, S; Grober, J; St Clair, EW; Tindall, E; Miller, AS; McAlindon, T. “2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis.,” Arthritis Care Res. (Hoboken)., vol. 68, no. 1, pp. 1–25, Jan. 2016.
[43] Yamada, A; Salama, AD; Sayegh, MH. “The role of novel T cell costimulatory pathways in autoimmunity and transplantation.,” J. Am. Soc. Nephrol., vol. 13, no. 2, pp. 559–75, Feb. 2002.
[44] Herrero-Beaumont, G; Martínez Calatrava, MJ; Castañeda, S. “Abatacept mechanism of action: concordance with its clinical profile.,” Reumatol. Clin., vol. 8, no. 2, pp. 78–83, Jan.
[45] Webb, LM; Walmsley, MJ; Feldmann, M. “Prevention and amelioration of collagen-induced arthritis by blockade of the CD28 co-stimulatory pathway: requirement for both B7-1 and B7-2.,” Eur. J. Immunol., vol. 26, no. 10, pp. 2320–8, Oct. 1996.
[46] Westhovens, R; Robles, M; Ximenes, AC; Nayiager, S; Wollenhaupt, J; Durez, P; Gomez-Reino, J; Grassi, W; Haraoui, B; Shergy, W; Park, SH; Genant, H; Peterfy, C; Becker, JC; Covucci, A; Helfrick, R; Bathon, J. “Clinical efficacy and safety of abatacept in methotrexate-naïve patients with early rheumatoid arthritis and poor prognostic factors.,” Ann. Rheum. Dis., vol. 68, no. 12, pp. 1870–7, Dec. 2009.
[47] HR; BJ; Westhovens, R; Robles, M; Nayiager, S; Wollenhaupt, J; Durez, P; Gómez-Reino, J; Grassi, W; Haraoui, B; Shergy, W; Park, SH; Genant, H; Peterfy, C; Becker, JC; Covucci, A. “Disease Remission Is Achieved within Two Years in Over Half of Methotrexate Naïve Patients with Early Erosive Rheumatoid Arthritis (RA) Treated with Abatacept Plus MTX: Results From the AGREE Trial [abstract],” Arthritis Rheum, vol. 60, no. Suppl, p. 239, 2009.
[48] Emery, P; Durez, P; Dougados, M; Legerton, CW; Becker, JC; Vratsanos, G; Genant, HK; Peterfy, C; Mitra, P; Overfield, S; Qi, K; Westhovens, R. “Impact of T cell costimulation modulation in patients with undifferentiated inflammatory arthritis or very early rheumatoid arthritis: a clinical and imaging study of abatacept (the ADJUST trial).,” Ann. Rheum. Dis., vol. 69, no. 3, pp. 510–6, Mar. 2010.
[49] Kremer, JM; Genant, HK; Moreland, LW; Russell, AS; Emery, P; Abud-Mendoza, C; Szechinski, J; Li, T; Ge, Z; Becker, JC; Westhovens, R. “Effects of abatacept in patients with methotrexate-resistant active rheumatoid arthritis: a randomised trial.,” Ann. Intern. Med., vol. 144, no. 12, pp. 865–76, Jun. 2006.
[50] Kremer, JM; Westhovens, R; Leon, M; Di Giorgio, E; Alten, R; Steinfeld, S; Russell, A; Dougados, M; Emery, P; Nuamah, IF; Williams, GR; Becker, JC; Hagerty, DT; Moreland, LW. “Treatment of Rheumatoid Arthritis by Selective Inhibition of T cell Activation with Fusion Protein CTLA4Ig,” N. Engl. J. Med., vol. 349, no. 20, pp. 1907–1915, Nov. 2003.
[51] Kremer, JM; Dougados, M; Emery, P; Durez, P; Sibilia, J; Shergy, W; Steinfeld, S; Tindall, E; Becker, JC; Li, T; Nuamah, IF; Aranda, R; Moreland, LW. “Treatment of rheumatoid arthritis with the selective costimulation modulator abatacept: twelve-month results of a Phase iib, double-blind, randomised, placebo-controlled trial.,” Arthritis Rheum., vol. 52, no. 8, pp. 2263–71, Aug. 2005.
[52] Schiff, M; Keiserman, M; Codding, C; Songcharoen, S; Berman, A; Nayiager, S; Saldate, C; Li, T; Aranda, R; Becker, JC; Lin, C; Cornet, PLN; Dougados, M. “Efficacy and safety of abatacept or infliximab vs. placebo in ATTEST: a Phase III, multi-centre, randomised, double-blind, placebo-controlled study in patients with rheumatoid arthritis and an inadequate response to methotrexate.,” Ann. Rheum. Dis., vol. 67, no. 8, pp. 1096–103, Aug. 2008.
[53] Westhovens, R; Kremer, JM; Moreland, LW; Emery, P; Russell, AS; Li, T; Aranda, R; Becker, JC; Qi, K; Dougados, M. “Safety and efficacy of the selective costimulation modulator abatacept in patients with rheumatoid arthritis receiving background methotrexate: a 5-year extended Phase IIB study.,” J. Rheumatol., vol. 36, no. 4, pp. 736–42, Apr. 2009.
[54] DM; Westhovens, R; Kremer, J; Emery, P; Russell, AS; Li, T; Aranda, R; Becker, JC; Zhao, C. “Consistent safety and sustained improvement in disease activity and treatment response over 7 years of abatacept treatment in biologic-naïve patients with RA [abstract],” Ann Rheum Dis, vol. 67, no. Suppl II, p. 341, 2008.
[55] Genovese, MC; Becker, JC; Schiff, M; Luggen, M; Sherrer, Y; Kremer, J; Birbara, C; Box, J; Natarajan, K; Nuamah, I; Li, T; Aranda, R; Hagerty, DT; Dougados, M. “Abatacept for rheumatoid arthritis refractory to tumor necrosis factor alpha inhibition.,” N. Engl. J. Med., vol. 353, no. 11, pp. 1114–23, Sep. 2005.
[56] Genovese, MC; Schiff, M; Luggen, M; Becker, JC; Aranda, R; Teng, J; Li, T; Schmidely, N; Le Bars, M; Dougados, M. “Efficacy and safety of the selective co-stimulation modulator abatacept following 2 years of treatment in patients with rheumatoid arthritis and an inadequate response to anti-tumour necrosis factor therapy.,” Ann. Rheum. Dis., vol. 67, no. 4, pp. 547–54, Apr. 2008.
[57] Emery, P; Burmester, GR; Bykerk, VP; Combe, BG; Furst, DE; Barré, E; Karyekar, CS; Wong, DA; Huizinga, TWJ. “Evaluating drug-free remission with abatacept in early rheumatoid arthritis: results from the Phase IIIb, multicentre, randomised, active-controlled AVERT study of 24 months, with a 12-month, double-blind treatment period.,” Ann. Rheum. Dis., vol. 74, no. 1, pp. 19–26, Jan. 2015.
[58] Takeuchi, Y. Tsutomu, Matsubara, Tsukasa, Ohta, Shuji, Mukai, Masaya, Amano, Koichi, Tohma, Shigeto, Tanaka, “Abatacept Biologic-Free Remission Study In Established Rheumatoid Arthritis Patients. Orion Study [abstract],” Arthritis Rheum 2012, vol. 64, no. Suppl 10, p. 1289, 2010.
[59] Genovese, MC; Covarrubias, A; Leon, G; Mysler, E; Keiserman, M; Valente, R; Nash, P; Simon-Campos, JA; Porawska, W; Box, J; Legerton, C; Nasonov, E; Durez, P; Aranda, R; Pappu, R; Delaet, I; Teng, J; Alten, R. “Subcutaneous abatacept vs. intravenous abatacept: a Phase IIIb noninferiority study in patients with an inadequate response to methotrexate.,” Arthritis Rheum., vol. 63, no. 10, pp. 2854–64, Oct. 2011.
[60] Weinblatt, ME; Schiff, M; Valente, R; van der Heijde, D; Citera, G; Zhao, C; Maldonado, M; Fleischmann, R. “Head-to-head comparison of subcutaneous abatacept vs. adalimumab for rheumatoid arthritis: findings of a Phase IIIb, multinational, prospective, randomised study.,” Arthritis Rheum., vol. 65, no. 1, pp. 28–38, Jan. 2013.
[61] Maxwell, L; Singh, JA. “Abatacept for rheumatoid arthritis.,” Cochrane database Syst. Rev., no. 4, p. CD007277, Jan. 2009.
[62] Guyot, P; Taylor, P; Christensen, R; Pericleous, L; Poncet, C; Lebmeier, M; Drost, P; Bergman, G. “Abatacept with methotrexate vs. other biologic agents in treatment of patients with active rheumatoid arthritis despite methotrexate: a network meta-analysis.,” Arthritis Res. Ther., vol. 13, no. 6, p. R204, Jan. 2011.
[63] ML; Kremer, JM; Westhovens, R; Leon, M; Di Giorgio, E; Alten, R; Steinfeld, S; Russell, A; Dougados, M; Emery, P; Nuamah, IF; Williams, GR; Becker, JC; Hagerty, DT. “Treatment of rheumatoid arthritis by selective inhibition of T cell activation with fusion protein CTLA4Ig,” N Engl J Med, vol. 20, no. 349, pp. 1907–15, 2003.
[64] Genant, HK; Peterfy, CG; Westhovens, R; Becker, JC; Aranda, R; Vratsanos, G; Teng, J; Kremer, JM. “Abatacept inhibits progression of structural damage in rheumatoid arthritis: results from the long-term extension of the AIM trial.,” Ann. Rheum. Dis., vol. 67, no. 8, pp. 1084–9, Aug. 2008.
[65] Manders, SHM; Kievit, W; Adang, E; Brus, HL; Moens, HJB; Hartkamp, A; Hendriks, L; Brouwer, E; Visser, H; Vonkeman, HE; Hendrikx, J; Jansen, TL; Westhovens, R; van de Laar, MAFJ; van Riel, PLCM. “Cost-effectiveness of abatacept, rituximab, and TNFi treatment after previous failure with TNFi treatment in rheumatoid arthritis: a pragmatic multi-centre randomised trial.,” Arthritis Res. Ther., vol. 17, p. 134, Jan. 2015.
[66] Moreland, LW; Alten, R; Van den Bosch, F; Appelboom, T; Leon, M; Emery, P; Cohen, S; Luggen, M; Shergy, W; Nuamah, I; Becker, JC. “Costimulatory blockade in patients with rheumatoid arthritis: a pilot, dose-finding, double-blind, placebo-controlled clinical trial evaluating CTLA-4Ig and LEA29Y eighty-five days after the first infusion.,” Arthritis Rheum., vol. 46, no. 6, pp. 1470–9, Jul. 2002.
[67] Alten, R; Kaine, J; Keystone, E; Nash, P; Delaet, I; Genovese, MC. “Long-term safety of subcutaneous abatacept in rheumatoid arthritis: integrated analysis of clinical trial data representing more than four years of treatment.,” Arthritis Rheumatol. (Hoboken, N.J.), vol. 66, no. 8, pp. 1987–97, Aug. 2014.
[68] Kim, HJ; Berek, C. “B cells in rheumatoid arthritis.,” Arthritis Res., vol. 2, no. 2, pp. 126–31, Jan. 2000.
[69] De Vita, S; Zaja, F; Sacco, S; De Candia, A; Fanin, R; Ferraccioli, G. “Efficacy of selective B cell blockade in the treatment of rheumatoid arthritis: evidence for a pathogenetic role of B cells.,” Arthritis Rheum., vol. 46, no. 8, pp. 2029–33, Aug. 2002.
[70] Edwards, JCW; Szczepanski, L; Szechinski, J; Filipowicz-Sosnowska, A; Emery, P; Close, DR; Stevens, RM; Shaw, T. “Efficacy of B cell-targeted therapy with rituximab in patients with rheumatoid arthritis.,” N. Engl. J. Med., vol. 350, no. 25, pp. 2572–81, Jun. 2004.
[71] Cambridge, G; Stohl, W; Leandro, MJ; Migone, TS; Hilbert, DM; Edwards, JCW. “Circulating levels of B lymphocyte stimulator in patients with rheumatoid arthritis following rituximab treatment: relationships with B cell depletion, circulating antibodies, and clinical relapse.,” Arthritis Rheum., vol. 54, no. 3, pp. 723–32, Mar. 2006.
[72] Leandro, MJ; Cambridge, G; Ehrenstein, MR; Edwards, JCW. “Reconstitution of peripheral blood B cells after depletion with rituximab in patients with rheumatoid arthritis.,” Arthritis Rheum., vol. 54, no. 2, pp. 613–20, Feb. 2006.
[73] Roll, P; Palanichamy, A; Kneitz, C; Dorner, T; Tony, HP. “Regeneration of B cell subsets after transient B cell depletion using anti-CD20 antibodies in rheumatoid arthritis.,” Arthritis Rheum., vol. 54, no. 8, pp. 2377–86, Aug. 2006.
[74] Thurlings, RM; Vos, K; Wijbrandts, CA; Zwinderman, AH; Gerlag, DM; Tak, PP. “Synovial tissue response to rituximab: mechanism of action and identification of biomarkers of response.,” Ann. Rheum. Dis., vol. 67, no. 7, pp. 917–25, Jul. 2008.
[75] Shaw, T; Quan, J; Totoritis, MC. “B cell therapy for rheumatoid arthritis: the rituximab (anti-CD20) experience.,” Ann. Rheum. Dis., vol. 62 Suppl 2, pp. ii55–9, Nov. 2003.
[76] Clynes, RA; Towers, TL; Presta, LG; Ravetch, JV. “Inhibitory Fc receptors modulate in vivo cytotoxicity against tumor targets.,” Nat. Med., vol. 6, no. 4, pp. 443–6, Apr. 2000.
[77] Protheroe, A; Edwards, JC; Simmons, A; Maclennan, K; Selby, P. “Remission of inflammatory arthropathy in association with anti-CD20 therapy for non-Hodgkin’s lymphoma.,” Rheumatology (Oxford)., vol. 38, no. 11, pp. 1150–2, Nov. 1999.
[78] Leandro, MJ; Edwards, JCW; Cambridge, G. “Clinical outcome in 22 patients with rheumatoid arthritis treated with B lymphocyte depletion.,” Ann. Rheum. Dis., vol. 61, no. 10, pp. 883–8, Oct. 2002.
[79] JM, T. “Successful treatment of infliximab-refractory rheumatoid arthritis with rituximab. LB11 [abstract],” Arthritis Rheum, vol. 46, p. 3420, 2002.
[80] Emery, P; Fleischmann, R; Filipowicz-Sosnowska, A; Schechtman, J; Szczepanski, L; Kavanaugh, A; Racewicz, AJ; van Vollenhoven, RF; Li, NF; Agarwal, S; Hessey, EW; Shaw, TM. “The efficacy and safety of rituximab in patients with active rheumatoid arthritis despite methotrexate treatment: results of a Phase IIB randomised, double-blind, placebo-controlled, dose-ranging trial.,” Arthritis Rheum., vol. 54, no. 5, pp. 1390–400, May 2006.
[81] Cohen, SB; Emery, P; Greenwald, MW; Dougados, M; Furie, RA; Genovese, MC; Keystone, EC; Loveless, JE; Burmester, GR; Cravets, MW; Hessey, EW; Shaw, T; Totoritis, MC. “Rituximab for rheumatoid arthritis refractory to anti–tumor necrosis factor therapy: Results of a multicenter, randomised, double-blind, placebo-controlled, Phase III trial evaluating primary efficacy and safety at twenty-four weeks,” Arthritis Rheum., vol. 54, no. 9, pp. 2793–2806, Sep. 2006.
[82] Emery, P; Deodhar, A; Rigby, WF; Isaacs, JD; Combe, B; Racewicz, AJ; Latinis, K; Abud-Mendoza, C; Szczepanski, LJ; Roschmann, RA; Chen, A; Armstrong, GK; Douglass, W; Tyrrell, H. “Efficacy and safety of different doses and retreatment of rituximab: a randomised, placebo-controlled trial in patients who are biological naïve with active rheumatoid arthritis and an inadequate response to methotrexate (Study Evaluating Rituximab’s Effi,” Ann. Rheum. Dis., vol. 69, no. 9, pp. 1629–35, Sep. 2010.
[83] Owczarczyk, K; Hellmann, M; Fliedner, G; Röhrs, T; Maizus, K; Passon, D; Hallek, M; Rubbert, A. “Clinical outcome and B cell depletion in patients with rheumatoid arthritis receiving rituximab monotherapy in comparison with patients receiving concomitant methotrexate.,” Ann. Rheum. Dis., vol. 67, no. 11, pp. 1648–9, Nov. 2008.
[84] Loveless, M. James, Olech, E., Pritchard, Charles H., Cha, A., Kelman, Ariella, Klearman, “An Open-Label, Prospective Study (SUNDIAL) Of The Safety Of Rituximab In Combination With Disease-Modifying Anti-Rheumatic Drugs In Patients With Active Rheumatoid Arthritis (SUNDIAL) [abstract],” Arthritis Rheum, vol. 60, no. Suppl 10, p. 1660, 2009.
[85] Greenwald, MW; Shergy, WJ; Kaine, JL; Sweetser, MT; Gilder, K; Linnik, MD. “Evaluation of the safety of rituximab in combination with a tumor necrosis factor inhibitor and methotrexate in patients with active rheumatoid arthritis: results from a randomised controlled trial.,” Arthritis Rheum., vol. 63, no. 3, pp. 622–32, Mar. 2011.
[86] Rigby, WFC; Mease, PJ; Olech, E; Ashby, M; Tole, S. “Safety of rituximab in combination with other biologic disease-modifying antirheumatic drugs in rheumatoid arthritis: an open-label study.,” J. Rheumatol., vol. 40, no. 5, pp. 599–604, May 2013.
[87] Finckh, A; Ciurea, A; Brulhart, L; Kyburz, D; Möller, B; Dehler, S; Revaz, S; Dudler, J; Gabay, C. “B cell depletion may be more effective than switching to an alternative anti-tumor necrosis factor agent in rheumatoid arthritis patients with inadequate response to anti-tumor necrosis factor agents.,” Arthritis Rheum., vol. 56, no. 5, pp. 1417–23, May 2007.
[88] Chatzidionysiou, K; van Vollenhoven, RF. “Rituximab vs. anti-TNF in patients who previously failed one TNF inhibitor in an observational cohort.,” Scand. J. Rheumatol., vol. 42, no. 3, pp. 190–5, Jan. 2013.
[89] Rubbert-Roth, A; Tak, PP; Zerbini, C; Tremblay, JL; Carreño, L; Armstrong, G; Collinson, N; Shaw, TM. “Efficacy and safety of various repeat treatment dosing regimens of rituximab in patients with active rheumatoid arthritis: results of a Phase III randomised study (MIRROR).,” Rheumatology (Oxford)., vol. 49, no. 9, pp. 1683–93, Sep. 2010.
[90] Keystone, E; Fleischmann, R; Emery, P; Furst, DE; van Vollenhoven, R; Bathon, J; Dougados, M; Baldassare, A; Ferraccioli, G; Chubick, A; Udell, J; Cravets, MW; Agarwal, S; Cooper, S; Magrini, F. “Safety and efficacy of additional courses of rituximab in patients with active rheumatoid arthritis: an open-label extension analysis.,” Arthritis Rheum., vol. 56, no. 12, pp. 3896–908, Dec. 2007.
[91] Mease, PJ; Cohen, S; Gaylis, NB; Chubick, A; Kaell, AT; Greenwald, M; Agarwal, S; Yin, M; Kelman, A. “Efficacy and safety of retreatment in patients with rheumatoid arthritis with previous inadequate response to tumor necrosis factor inhibitors: results from the SUNRISE trial.,” J. Rheumatol., vol. 37, no. 5, pp. 917–27, May 2010.
[92] Popa, C; Leandro, MJ; Cambridge, G; Edwards, JCW. “Repeated B lymphocyte depletion with rituximab in rheumatoid arthritis over 7 yrs.,” Rheumatology (Oxford)., vol. 46, no. 4, pp. 626–30, Apr. 2007.
[93] Teng, YKO; Tekstra, J; Breedveld, FC; Lafeber, F; Bijlsma, JWJ; van Laar, JM. “Rituximab fixed retreatment vs. on-demand retreatment in refractory rheumatoid arthritis: comparison of two B cell depleting treatment strategies.,” Ann. Rheum. Dis., vol. 68, no. 6, pp. 1075–7, Jun. 2009.
[94] Thurlings, RM; Vos, K; Gerlag, DM; Tak, PP. “Disease activity-guided rituximab therapy in rheumatoid arthritis: the effects of re-treatment in initial nonresponders vs. initial responders.,” Arthritis Rheum., vol. 58, no. 12, pp. 3657–64, Dec. 2008.
[95] Vander Cruyssen, B; Durez, P; Westhovens, R; Kaiser, MJ; Hoffman, I; De Keyser, F. “The Belgian MIRA (MabThera In Rheumatoid Arthritis) registry: clues for the optimization of rituximab treatment strategies.,” Arthritis Res. Ther., vol. 12, no. 5, p. R169, Jan. 2010.
[96] Lopez-Olivo, MA; Amezaga Urruela, M; McGahan, L; Pollono, EN; Suarez-Almazor, ME. “Rituximab for rheumatoid arthritis.,” Cochrane database Syst. Rev., vol. 1, p. CD007356, Jan. 2015.
[97] Hernández-Cruz, B; García-Arias, M; Ariza Ariza, R; Martín Mola, E. “[Rituximab in rheumatoid arthritis: a systematic review of efficacy and safety].,” Reumatol. Clin., vol. 7, no. 5, pp. 314–22, Jan.
[98] Volkmann, E; Agrawal, H; Maranian, P; Furst, D. “Rituximab for rheumatoid arthritis: a meta-analysis and systematic review.” Centre for Reviews and Dissemination (UK), 2010.
[99] Mease, PJ; Revicki, DA; Szechinski, J; Greenwald, M; Kivitz, A; Barile-Fabris, L; Kalsi, J; Eames, J; Leirisalo-Repo, M. “Improved health-related quality of life for patients with active rheumatoid arthritis receiving rituximab: Results of the Dose-Ranging Assessment: International Clinical Evaluation of Rituximab in Rheumatoid Arthritis (DANCER) Trial.,” J. Rheumatol., vol. 35, no. 1, pp. 20–30, Jan. 2008.
[100] Keystone, E; Burmester, GR; Furie, R; Loveless, JE; Emery, P; Kremer, J; Tak, PP; Broder, MS; Yu, E; Cravets, M; Magrini, F; Jost, F. “Improvement in patient-reported outcomes in a rituximab trial in patients with severe rheumatoid arthritis refractory to anti-tumor necrosis factor therapy.,” Arthritis Rheum., vol. 59, no. 6, pp. 785–93, Jun. 2008.
[101] Strand, V; Balbir-Gurman, A; Pavelka, K; Emery, P; Li, N; Yin, M; Lehane, PB; Agarwal, S. “Sustained benefit in rheumatoid arthritis following one course of rituximab: improvements in physical function over 2 years.,” Rheumatology (Oxford)., vol. 45, no. 12, pp. 1505–13, Dec. 2006.
[102] Keystone, E; Emery, P; Peterfy, CG; Tak, PP; Cohen, S; Genovese, MC; Dougados, M; Burmester, GR; Greenwald, M; Kvien, TK; Williams, S; Hagerty, D; Cravets, MW; Shaw, T. “Rituximab inhibits structural joint damage in patients with rheumatoid arthritis with an inadequate response to tumour necrosis factor inhibitor therapies.,” Ann. Rheum. Dis., vol. 68, no. 2, pp. 216–21, Feb. 2009.
[103] Tak, PP; Rigby, WF; Rubbert-Roth, A; Peterfy, CG; van Vollenhoven, RF; Stohl, W; Hessey, E; Chen, A; Tyrrell, H; Shaw, TM. “Inhibition of joint damage and improved clinical outcomes with rituximab plus methotrexate in early active rheumatoid arthritis: the IMAGE trial.,” Ann. Rheum. Dis., vol. 70, no. 1, pp. 39–46, Jan. 2011.
[104] Tak, PP; Rigby, W; Rubbert-Roth, A; Peterfy, C; van Vollenhoven, RF; Stohl, W; Healy, E; Hessey, E; Reynard, M; Shaw, T. “Sustained inhibition of progressive joint damage with rituximab plus methotrexate in early active rheumatoid arthritis: 2-year results from the randomised controlled trial IMAGE.,” Ann. Rheum. Dis., vol. 71, no. 3, pp. 351–7, Mar. 2012.
[105] Peterfy, C; Emery, P; Tak, PP; Østergaard, M; DiCarlo, J; Otsa, K; Navarro Sarabia, F; Pavelka, K; Bagnard, MA; Gylvin, LH; Bernasconi, C; Gabriele, A. “MRI assessment of suppression of structural damage in patients with rheumatoid arthritis receiving rituximab: results from the randomised, placebo-controlled, double-blind RA-SCORE study.,” Ann. Rheum. Dis., vol. 75, no. 1, pp. 170–7, Jan. 2016.
[106] Lindgren, P; Geborek, P; Kobelt, G. “Modeling the cost-effectiveness of treatment of rheumatoid arthritis with rituximab using registry data from Southern Sweden.,” Int. J. Technol. Assess. Health Care, vol. 25, no. 2, pp. 181–9, Apr. 2009.
[107] Joensuu, JT; Huoponen, S; Aaltonen, KJ; Konttinen, YT; Nordström, D; Blom, M. “The cost-effectiveness of biologics for the treatment of rheumatoid arthritis: a systematic review.,” PLoS One, vol. 10, no. 3, p. e0119683, Jan. 2015.
[108] Kielhorn, A; Porter, D; Diamantopoulos, A; Lewis, G. “UK cost-utility analysis of rituximab in patients with rheumatoid arthritis that failed to respond adequately to a biologic disease-modifying antirheumatic drug.,” Curr. Med. Res. Opin., vol. 24, no. 9, pp. 2639–50, Sep. 2008.
[109] Tan, CS; Koralnik, IJ. “Progressive multifocal leukoencephalopathy and other disorders caused by JC virus: clinical features and pathogenesis.,” Lancet. Neurol., vol. 9, no. 4, pp. 425–37, Apr. 2010.
[110] emc, “Rituximab Summary of Product Characteristics.”.
[111] Molloy, ES; Calabrese, LH. “Progressive multifocal leukoencephalopathy: a national estimate of frequency in systemic lupus erythematosus and other rheumatic diseases.,” Arthritis Rheum., vol. 60, no. 12, pp. 3761–5, Dec. 2009.
[112] Luqmani, R; Hennell, S; Estrach, C; Birrell, F; Bosworth, A; Davenport, G; Fokke, C; Goodson, N; Jeffreson, P; Lamb, E; Mohammed, R; Oliver, S; Stableford, Z; Walsh, D; Washbrook, C; Webb, F. “British Society for Rheumatology and british health professionals in Rheumatology guideline for the management of rheumatoid arthritis (the first two years).,” Rheumatology (Oxford)., vol. 45, no. 9, pp. 1167–9, Sep. 2006.
[113] Bresnihan, B; Cobby, M. “Clinical and radiological effects of anakinra in patients with rheumatoid arthritis.,” Rheumatology (Oxford)., vol. 42 Suppl 2, pp. ii22–8, May 2003.
[114] Fleischmann, RM; Tesser, J; Schiff, MH; Schechtman, J; Burmester, GR; Bennett, R; x Modafferi, R; Zhou, L; Bell, D; Appleton, B. “Safety of extended treatment with anakinra in patients with rheumatoid arthritis.,” Ann. Rheum. Dis., vol. 65, no. 8, pp. 1006–12, Aug. 2006.
[115] Fleischmann, RM; Schechtman, J; Bennett, R; Handel, ML; Burmester, GR; Tesser, J; Modafferi, D; Poulakos, J; Sun, G. “Anakinra, a recombinant human interleukin-1 receptor antagonist (r-metHuIL-1ra), in patients with rheumatoid arthritis: A large, international, multicenter, placebo-controlled trial.,” Arthritis Rheum., vol. 48, no. 4, pp. 927–34, Apr. 2003.
[116] Bendele, A; McAbee, T; Sennello, G; Frazier, J; Chlipala, E; McCabe, D. “Efficacy of sustained blood levels of interleukin-1 receptor antagonist in animal models of arthritis: comparison of efficacy in animal models with human clinical data.,” Arthritis Rheum., vol. 42, no. 3, pp. 498–506, Mar. 1999.
[117] Bresnihan, B; Alvaro-Gracia, JM; Cobby, M; Doherty, M; Domljan, Z; Emery, P; Nuki, G; Pavelka, K; Rau, R; Rozman, B; Watt, I; Williams, B; Aitchison, R; McCabe, D; Musikic, P. “Treatment of rheumatoid arthritis with recombinant human interleukin-1 receptor antagonist.,” Arthritis Rheum., vol. 41, no. 12, pp. 2196–204, Dec. 1998.
[118] Cohen, SB; Moreland, LW; Cush, JJ; Greenwald, MW; Block, S; Shergy, WJ; Hanrahan, PS; Kraishi, MM; Patel, A; Sun, G; Bear, MB. “A multicentre, double-blind, randomised, placebo controlled trial of anakinra (Kineret), a recombinant interleukin 1 receptor antagonist, in patients with rheumatoid arthritis treated with background methotrexate.,” Ann. Rheum. Dis., vol. 63, no. 9, pp. 1062–8, Sep. 2004.
[119] Thaler, K; Chandiramani, DV;. Hansen, RA; Gartlehner, G. “Efficacy and safety of anakinra for the treatment of rheumatoid arthritis: an update of the Oregon Drug Effectiveness Review Project.,” Biologics, vol. 3, pp. 485–98, Jan. 2009.
[120] Nixon, R; Bansback, N; Brennan, A. “The efficacy of inhibiting tumour necrosis factor alpha and interleukin 1 in patients with rheumatoid arthritis: a meta-analysis and adjusted indirect comparisons.,” Rheumatology (Oxford)., vol. 46, no. 7, pp. 1140–7, Jul. 2007.
[121] Singh, JA; Christensen, R; Wells, GA; Suarez-Almazor, ME; Buchbinder, R; Lopez-Olivo, MA; Tanjong Ghogomu, E; Tugwell, P. “Biologics for rheumatoid arthritis: an overview of Cochrane reviews.,” Cochrane database Syst. Rev., no. 4, p. CD007848, Jan. 2009.
[122] Genovese, MC; Cohen, S; Moreland, L; Lium, D; Robbins, S; Newmark, R; Bekker, P. “Combination therapy with etanercept and anakinra in the treatment of patients with rheumatoid arthritis who have been treated unsuccessfully with methotrexate.,” Arthritis Rheum., vol. 50, no. 5, pp. 1412–9, May 2004.
[123] Dinarello, CA; Simon, A; van der Meer, JWM. “Treating inflammation by blocking interleukin-1 in a broad spectrum of diseases.,” Nat. Rev. Drug Discov., vol. 11, no. 8, pp. 633–52, Aug. 2012.
[124] Schett, G; Dayer, JM; Manger, B. “Interleukin-1 function and role in rheumatic disease,” Nat. Rev. Rheumatol., vol. 12, no. 1, pp. 14–24, Dec. 2015.
[125] Mertens, M; Singh, JA. “Anakinra for rheumatoid arthritis.,” Cochrane database Syst. Rev., no. 1, p. CD005121, Jan. 2009.
[126] Salliot, C; Dougados, M; Gossec, L. “Risk of serious infections during rituximab, abatacept and anakinra treatments for rheumatoid arthritis: meta-analyses of randomised placebo-controlled trials.,” Ann. Rheum. Dis., vol. 68, no. 1, pp. 25–32, Jan. 2009.
[127] Perrin, F; Néel, A; Graveleau, J; Ruellan, AL; Masseau, A; Hamidou, M. “Two cases of anakinra-induced neutropenia during auto-inflammatory diseases: drug reintroduction can be successful.,” Press. meìdicale (Paris, Fr. 1983), vol. 43, no. 3, pp. 319–21, Mar. 2014.
[128] Kontzias, A; Kotlyar, A; Laurence, A; Changelian, P; O’Shea, JJ. “Jakinibs: a new class of kinase inhibitors in cancer and autoimmune disease.,” Curr. Opin. Pharmacol., vol. 12, no. 4, pp. 464–70, Aug. 2012.
[129] Meyer, DM; Jesson, MI; Li, X; Elrick, MM; Funckes-Shippy, CL; Warner, JD; Gross, CJ; Dowty, ME; Ramaiah, SK; Hirsch, JL; Saabye, MJ; Barks, JL; Kishore, N; Morris, DL. “Anti-inflammatory activity and neutrophil reductions mediated by the JAK1/JAK3 inhibitor, CP-690,550, in rat adjuvant-induced arthritis.,” J. Inflamm. (Lond)., vol. 7, p. 41, Jan. 2010.
[130] Fleischmann, R; Kremer, J; Cush, J; Schulze-Koops, H; Connell, CA; Bradley, JD; Gruben, D; Wallenstein, GV; Zwillich, SH; Kanik, KS. “Placebo-controlled trial of tofacitinib monotherapy in rheumatoid arthritis.,” N. Engl. J. Med., vol. 367, no. 6, pp. 495–507, Aug. 2012.
[131] Vaddi, K; Luchi, M. “JAK inhibition for the treatment of rheumatoid arthritis: a new era in oral DMARD therapy.,” Expert Opin. Investig. Drugs, vol. 21, no. 7, pp. 961–73, Jul. 2012.
[132] Lee, EB; Fleischmann, R; Hall, S; Wilkinson, B; Bradley, JD; Gruben, D; Koncz, T; Krishnaswami, S; Wallenstein, GV; Zang, C; Zwillich, SH; van Vollenhoven, RF. “Tofacitinib vs. methotrexate in rheumatoid arthritis.,” N. Engl. J. Med., vol. 370, no. 25, pp. 2377–86, Jun. 2014.
[133] Burmester, GR; Blanco, R; Charles-Schoeman, C; Wollenhaupt, J; Zerbini, C; Benda, B; Gruben, D; Wallenstein, G; Krishnaswami, S; Zwillich, SH; Koncz, T; Soma, K; Bradley, J; Mebus, C. “Tofacitinib (CP-690,550) in combination with methotrexate in patients with active rheumatoid arthritis with an inadequate response to tumour necrosis factor inhibitors: a randomised Phase III trial.,” Lancet (London, England), vol. 381, no. 9865, pp. 451–60, Feb. 2013.
[134] van Vollenhoven, RF; Fleischmann, R; Cohen, S; Lee, EB; García Meijide, JA; Wagner, S; Forejtova, S; Zwillich, SH; Gruben, D; Koncz, T; Wallenstein, GV; Krishnaswami, S; Bradley, JD; Wilkinson, B. “Tofacitinib or adalimumab vs. placebo in rheumatoid arthritis.,” N. Engl. J. Med., vol. 367, no. 6, pp. 508–19, Aug. 2012.
[135] van der Heijde, D; Tanaka, Y; Fleischmann, R; Keystone, E; Kremer, J; Zerbini, C; Cardiel, MH; Cohen, S; Nash, P; Song, YW; Tegzová, D; Wyman, BT; Gruben, D; Benda, B; Wallenstein, G; Krishnaswami, S; Zwillich, SH; Bradley, JD; Connell, CA. “Tofacitinib (CP-690,550) in patients with rheumatoid arthritis receiving methotrexate: twelve-month data from a twenty-four-month Phase III randomised radiographic study.,” Arthritis Rheum., vol. 65, no. 3, pp. 559–70, Mar. 2013.
[136] Kremer, J; Li, ZG; Hall, S; Fleischmann, R; Genovese, M; Martin-Mola, E; Isaacs, JD; Gruben, D; Wallenstein, G; Krishnaswami, S; Zwillich, SH; Koncz, T; Riese, R; Bradley, J. “Tofacitinib in combination with nonbiologic disease-modifying antirheumatic drugs in patients with active rheumatoid arthritis: a randomised trial.,” Ann. Intern. Med., vol. 159, no. 4, pp. 253–61, Aug. 2013.
[137] Kawalec, P; Mikrut, A; Wiśniewska, N; Pilc, A. “The effectiveness of tofacitinib, a novel Janus kinase inhibitor, in the treatment of rheumatoid arthritis: a systematic review and meta-analysis.,” Clin. Rheumatol., vol. 32, no. 10, pp. 1415–24, Oct. 2013.
[138] Kaur, K; Kalra, S; Kaushal, S. “Systematic review of tofacitinib: a new drug for the management of rheumatoid arthritis.,” Clin. Ther., vol. 36, no. 7, pp. 1074–86, Jul. 2014.
[139] “European Medicines Agency. Refusal of the marketing authorisation for Xeljanz (tofacitinib),” 2013.

Chapter 11

[1] Østergaard, M; Baslund, B; Rigby, W; Rojkovich, B; Jorgensen, C; Dawes, PT; Wiell, C; Wallace, DJ; Tamer, SC; Kastberg, H; Petersen, J; Sierakowski, S. “Ofatumumab, a human anti-CD20 monoclonal antibody, for treatment of rheumatoid arthritis with an inadequate response to one or more disease-modifying antirheumatic drugs: results of a randomised, double-blind, placebo-controlled, phase I/II study.,” Arthritis Rheum., vol. 62, no. 8, pp. 2227–38, Aug. 2010.
[2] Taylor, PC; Quattrocchi, E; Mallett, S; Kurrasch, R; Petersen, J; Chang, DJ. “Ofatumumab, a fully human anti-CD20 monoclonal antibody, in biological-naive, rheumatoid arthritis patients with an inadequate response to methotrexate: a randomised, double-blind, placebo-controlled clinical trial.,” Ann. Rheum. Dis., vol. 70, no. 12, pp. 2119–25, Dec. 2011.
[3] Beum, PV; Lindorfer, MA; Beurskens, F; Stukenberg, PT; Lokhorst, HM; Pawluczkowycz, AW; Parren, PWHI; van de Winkel, JGJ; Taylor, RP. “Complement activation on B lymphocytes opsonized with rituximab or ofatumumab produces substantial changes in membrane structure preceding cell lysis.,” J. Immunol., vol. 181, no. 1, pp. 822–32, Jul. 2008.
[4] GlaxoSmithKline, “Investigating Clinical Efficacy of Ofatumumab in Adult Rheumatoid Arthritis (RA) Patients Who Had an Inadequate Response to MTX Therapy.”
[5] GlaxoSmithKline, “Investigating Clinical Efficacy of Ofatumumab in Adult Rheumatoid Arthritis (RA) Patients Who Had an Inadequate Response to TNF-α Antagonist Therapy.”
[6] Kurrasch, R; Brown, JC; Chu, M; Craigen, J; Overend, P; Patel, B; Wolfe, S; Chang, DJ. “Subcutaneously administered ofatumumab in rheumatoid arthritis: a phase I/II study of safety, tolerability, pharmacokinetics, and pharmacodynamics.,” J. Rheumatol., vol. 40, no. 7, pp. 1089–96, Jul. 2013.
[7] Rigby, W; Tony, HP; Oelke, K; Combe, B; Laster, A; von Muhlen, CA; Fisheleva, E; Martin, C; Travers, H; Dummer, W. “Safety and efficacy of ocrelizumab in patients with rheumatoid arthritis and an inadequate response to methotrexate: results of a forty-eight-week randomised, double-blind, placebo-controlled, parallel-group phase III trial.,” Arthritis Rheum., vol. 64, no. 2, pp. 350–9, Feb. 2012.
[8] Tak, PP; Mease, PJ; Genovese, MC; Kremer, J; Haraoui, B; Tanaka, Y; Bingham, CO; Ashrafzadeh, A; Travers, H; Safa-Leathers, S; Kumar, S; Dummer, W. “Safety and efficacy of ocrelizumab in patients with rheumatoid arthritis and an inadequate response to at least one tumor necrosis factor inhibitor: results of a forty-eight–week randomised, double-blind, placebo-controlled, parallel-group phase III trial,” Arthritis Rheum., vol. 64, no. 2, pp. 360–70, Feb. 2012.
[9] Harigai, M; Tanaka, Y; Maisawa, S. “Safety and efficacy of various dosages of ocrelizumab in Japanese patients with rheumatoid arthritis with an inadequate response to methotrexate therapy: a placebo-controlled double-blind parallel-group study.,” J. Rheumatol., vol. 39, no. 3, pp. 486–95, Mar. 2012.
[10] C. go. I. NCT01390545, “VELVET, a Dose Range Finding Trial of Veltuzumab in Subjects With Moderate to Severe Rheumatoid Arthritis - Full Text View - ClinicalTrials.gov.”
[11] Helling, B; König, M; Dälken, B; Engling, A; Krömer, W; Heim, K; Wallmeier, H; Haas, J; Wildemann, B; Fritz, B; Jonuleit, H; Kubach, J; Dingermann, T; Radeke, HH; Osterroth, F; Uherek, C; Czeloth, N; Schüttrumpf, J. “A specific CD4 epitope bound by tregalizumab mediates activation of regulatory T cells by a unique signaling pathway.,” Immunol. Cell Biol., vol. 93, no. 4, pp. 396–405, Apr. 2015.
[12] et al. Rudnev, Anatoliy; Ragavan, Sukanya; Trollmo, Christina; Malmstroem, Vivianne; Becker, Christian; Jonuleit, Helmut. “Selective Activation of Naturally Occurring Regulatory T Cells (Tregs) by the Monoclonal Antibody (mAb) BT-061. Markers of Clinical Activity and Early Phase II Results in Patients with Rheumatoid Arthritis (RA),” Arthritis Rheum, vol. 62, no. Suppl 10, p. 1125, 2010.
[13] “Study to Investigate the Safety and Efficacy of Tregalizumab in Subjects (MTX-IR) With Active Rheumatoid Arthritis.”
[14] Isaacs, JD; Manna, VK; Rapson, N; Bulpitt, KJ; Hazleman, BL; Matteson, EL; St Clair, EW; Schnitzer, TJ; Johnston, JM. “CAMPATH-1H in rheumatoid arthritis--an intravenous dose-ranging study.,” Br. J. Rheumatol., vol. 35, no. 3, pp. 231–40, Mar. 1996.
[15] Weinblatt, ME; Maddison, PJ; Bulpitt, KJ; Hazleman, BL; Urowitz, MB; Sturrock, RD; Coblyn, JS; Maier, AL; Spreen, WR; Manna, VK; Johnston, JM. “Campath-1h, a humanised monoclonal antibody, in refractory rheumatoid arthritis,” Arthritis Rheum., vol. 38, no. 11, pp. 1589–1594, Nov. 1995.
[16] Anderson, AE; Lorenzi, AR; Pratt, A; Wooldridge, T; Diboll, J; Hilkens, CMU; Isaacs, JD. “Immunity 12 years after alemtuzumab in RA: CD5+ B cell depletion, thymus-dependent T cell reconstitution and normal vaccine responses.,” Rheumatology (Oxford)., vol. 51, no. 8, pp. 1397–406, Aug. 2012.
[17] Coclet-Ninin, J; Dayer, JM; Burger, D. “Interferon-beta not only inhibits interleukin-1beta and tumor necrosis factor-alpha but stimulates interleukin-1 receptor antagonist production in human peripheral blood mononuclear cells.,” Eur. Cytokine Netw., vol. 8, no. 4, pp. 345–9, Dec. 1997.
[18] Palmer, G; Mezin, F; Juge-Aubry, CE; Plater-Zyberk, C; Gabay, C; Guerne, PA. “Interferon beta stimulates interleukin 1 receptor antagonist production in human articular chondrocytes and synovial fibroblasts.,” Ann. Rheum. Dis., vol. 63, no. 1, pp. 43–9, Jan. 2004.
[19] van Holten, J; Pavelka, K; Vencovsky, J; Stahl, H; Rozman, B; Genovese, M; Kivitz, AJ; Alvaro, J; Nuki, G; Furst, DE; Herrero-Beaumont, G; McInnes, IB; Musikic, P; Tak, PP. “A multicentre, randomised, double blind, placebo controlled phase II study of subcutaneous interferon beta-1a in the treatment of patients with active rheumatoid arthritis.,” Ann. Rheum. Dis., vol. 64, no. 1, pp. 64–9, Jan. 2005.
[20] Burmester, GR; Weinblatt, ME; McInnes, IB; Porter, D; Barbarash, O; Vatutin, M; Szombati, I; Esfandiari, E; Sleeman, MA; Kane, CD; Cavet, G; Wang, B; Godwood, A; Magrini, F. “Efficacy and safety of mavrilimumab in subjects with rheumatoid arthritis.,” Ann. Rheum. Dis., vol. 72, no. 9, pp. 1445–52, Sep. 2013.
[21] Takeuchi, T; Tanaka, Y; Close, D; Godwood, A; Wu, CY; Saurigny, D. “Efficacy and safety of mavrilimumab in Japanese subjects with rheumatoid arthritis: findings from a Phase IIa study.,” Mod. Rheumatol., vol. 25, no. 1, pp. 21–30, Jan. 2015.
[22] MedImmuneLtd, “A Study of Mavrilimumab Versus Anti Tumor Necrosis Factor in Subjects With Rheumatoid Arthritis. ClinicalTrials.gov Identifier: NCT01715896.”
[23] Gaffen, SL; Jain, R; Garg, AV; Cua, DJ. “The IL-23-IL-17 immune axis: from mechanisms to therapeutic testing.,” Nat. Rev. Immunol., vol. 14, no. 9, pp. 585–600, Sep. 2014.
[24] Smolen, J; Agarwal, SK; Ilivanova, E; Xu, XL; Miao, Y; Mudivarthy, S; Xu, W; Radziszewski, W; Greenspan, A; Beutler, A; Baker, D. “OP0031 A Phase 2 Study Evaluating the Efficacy and Safety of Subcutaneously Administered Ustekinumab and Guselkumab in Patients with Active Rheumatoid Arthritis Despite Treatment with Methotrexate:,” Ann. Rheum. Dis., vol. 74, no. Suppl 2, pp. 76.2–77, Jun. 2015.
[25] Baslund, B; Tvede, N; Danneskiold-Samsoe, B; Larsson, P; Panayi, G; Petersen, J; Petersen, LJ; Beurskens, FJM; Schuurman, J; van de Winkel, JGJ; Parren, PWHI; Gracie, JA; Jongbloed, S; Liew, FY; McInnes, IB. “Targeting interleukin-15 in patients with rheumatoid arthritis: a proof-of-concept study.,” Arthritis Rheum., vol. 52, no. 9, pp. 2686–92, Oct. 2005.
[26] Nakae, S; Nambu, A; Sudo, K; Iwakura, Y. “Suppression of immune induction of collagen-induced arthritis in IL-17-deficient mice.,” J. Immunol., vol. 171, no. 11, pp. 6173–7, Dec. 2003.
[27] Lubberts, E; Koenders, MI; Oppers-Walgreen, B; van den Bersselaar, L; Coenen-de Roo, CJJ; Joosten, LAB; van den Berg, WB. “Treatment with a neutralizing anti-murine interleukin-17 antibody after the onset of collagen-induced arthritis reduces joint inflammation, cartilage destruction, and bone erosion,” Arthritis Rheum., vol. 50, no. 2, pp. 650–659, Feb. 2004.
[28] Plater-Zyberk, C; Joosten, LAB; Helsen, MMA; Koenders, MI; Baeuerle, PA; van den Berg, WB. “Combined blockade of granulocyte-macrophage colony stimulating factor and interleukin 17 pathways potently suppresses chronic destructive arthritis in a tumour necrosis factor alpha-independent mouse model.,” Ann. Rheum. Dis., vol. 68, no. 5, pp. 721–8, May 2009.
[29] Patel, DD; Lee, DM; Kolbinger, F; Antoni, C. “Effect of IL-17A blockade with secukinumab in autoimmune diseases.,” Ann. Rheum. Dis., vol. 72 Suppl 2, pp. ii116–23, Apr. 2013.
[30] Kellner, H. “Targeting interleukin-17 in patients with active rheumatoid arthritis: rationale and clinical potential.,” Ther. Adv. Musculoskelet. Dis., vol. 5, no. 3, pp. 141–52, Jun. 2013.
[31] Hueber, W; Patel, DD; Dryja, T; Wright, AM; Koroleva, I; Bruin, G; Antoni, C; Draelos, Z; Gold, MH; Durez, P; Tak, PP; Gomez-Reino, JJ; Foster, CS; Kim, RY; Samson, CM; Falk, NS; Chu, DS; Callanan, D; Nguyen, QD; Rose, K; Haider, A; Di Padova, F. “Effects of AIN457, a fully human antibody to interleukin-17A, on psoriasis, rheumatoid arthritis, and uveitis.,” Sci. Transl. Med., vol. 2, no. 52, p. 52ra72, Oct. 2010.
[32] Genovese, MC; Durez, P; Richards, HB; Supronik, J; Dokoupilova, E; Mazurov, V; Aelion, JA; Lee, SH; Codding, CE; Kellner, H; Ikawa, T; Hugot, S; Mpofu, S. “Efficacy and safety of secukinumab in patients with rheumatoid arthritis: a phase II, dose-finding, double-blind, randomised, placebo controlled study,” Ann. Rheum. Dis., vol. 72, no. 6, pp. 863–869, Jun. 2012.
[33] Novartis, “Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 1 Year of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Anti-Tumor Necrosis Factor α (Anti-TNFα) Agents. (NURTURE 1).”
[34] Novartis, “Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Anti-TNFα Agents (REASSURE).”
[35] Genovese, MC; Van den Bosch, F; Roberson, SA; Bojin, S; Biagini, IM; Ryan, P; Sloan-Lancaster, J. “LY2439821, a humanised anti-interleukin-17 monoclonal antibody, in the treatment of patients with rheumatoid arthritis: A phase I randomised, double-blind, placebo-controlled, proof-of-concept study.,” Arthritis Rheum., vol. 62, no. 4, pp. 929–39, Apr. 2010.
[36] Genovese, M; Greenwald, M; Cho, CS; Berman, A; Jin, L; Cameron, G; Wang, L; Xie, L; Braun, D; Berclaz, PY; Banerjee, S. “OP0021 A phase 2 study of multiple subcutaneous doses of LY2439821, an anti-IL-17 monoclonal antibody, in patients with rheumatoid arthritis in two populations: Naive to biologic therapy or inadequate responders to tumor necrosis factor alpha inhibitors,” Ann. Rheum. Dis., vol. 71, no. Suppl 3, pp. 59–59, Jan. 2014.
[37] Martin, DA; Churchill, M; Flores-Suarez, L; Cardiel, MH; Wallace, D; Martin, R; Phillips, K; Kaine, JL; Dong, H; Salinger, D; Stevens, E; Russell, CB; Chung, JB. “A phase Ib multiple ascending dose study evaluating safety, pharmacokinetics, and early clinical response of brodalumab, a human anti-IL-17R antibody, in methotrexate-resistant rheumatoid arthritis.,” Arthritis Res. Ther., vol. 15, no. 5, p. R164, Jan. 2013.
[38] Pavelka, K; Chon, Y; Newmark, R; Lin, SL; Baumgartner, S; Erondu, N. “A study to evaluate the safety, tolerability, and efficacy of brodalumab in subjects with rheumatoid arthritis and an inadequate response to methotrexate.,” J. Rheumatol., vol. 42, no. 6, pp. 912–9, Jun. 2015.
[39] Leung, BP; McInnes, IB; Esfandiari, E; Wei, XQ; Liew, FY. “Combined effects of IL-12 and IL-18 on the induction of collagen-induced arthritis.,” J. Immunol., vol. 164, no. 12, pp. 6495–502, Jun. 2000.
[40] McInnes, IB; Gracie, JA; Leung, BP; Wei, XQ; Liew, FY. “Interleukin 18: a pleiotropic participant in chronic inflammation.,” Immunol. Today, vol. 21, no. 7, pp. 312–5, Jul. 2000.
[41] Gracie, JA; Forsey, RJ; Chan, WL; Gilmour, A; Leung, BP; Greer, MR; Kennedy, K; Carter, R; Wei, XQ; Xu, D; Field, M; Foulis, A; Liew, FY; McInnes, IB. “A proinflammatory role for IL-18 in rheumatoid arthritis.,” J. Clin. Invest., vol. 104, no. 10, pp. 1393–401, Dec. 1999.
[42] Wei, XQ; Leung, BP; Arthur, HM; McInnes, IB; Liew, FY. “Reduced incidence and severity of collagen-induced arthritis in mice lacking IL-18.,” J. Immunol., vol. 166, no. 1, pp. 517–21, Jan. 2001.
[43] Bresnihan, B; Roux-Lombard, P; Murphy, E; Kane, D; FitzGerald, O; Dayer, JM. “Serum interleukin 18 and interleukin 18 binding protein in rheumatoid arthritis.,” Ann. Rheum. Dis., vol. 61, no. 8, pp. 726–9, Aug. 2002.
[44] Tak, PP; Bacchi, M; Bertolino, M. “Pharmacokinetics of IL-18 binding protein in healthy volunteers and subjects with rheumatoid arthritis or plaque psoriasis.,” Eur. J. Drug Metab. Pharmacokinet., vol. 31, no. 2, pp. 109–16, Jan.
[45] RJ; et al. Pavelka, K; Kuba, V. “Clinical effects of pralnacasan (PRAL), an orally active interleukin-1 beta converting enzyme (ICE) inhibitor in 285 patients PhII trial in rheumatoid arthritis 9abstract],” Am. Coll. Rheumatol. 66th Annu. Sci. Meet. New Orleans.
[46] Šenolt, L; Leszczynski, P; Dokoupilová, E; Göthberg, M; Valencia, X; Hansen, BB; Cañete, JD. “Efficacy and Safety of Anti-Interleukin-20 Monoclonal Antibody in Patients With Rheumatoid Arthritis: A Randomised Phase IIa Trial.,” Arthritis Rheumatol. (Hoboken, N.J.), vol. 67, no. 6, pp. 1438–48, Jul. 2015.
[47] Niu, X; He, D; Zhang, X; Yue, T; Li, N; Zhang, JZ; Dong, C; Chen, G. “IL-21 regulates Th17 cells in rheumatoid arthritis.,” Hum. Immunol., vol. 71, no. 4, pp. 334–41, May 2010.
[48] Yuan, FL; Hu, W; Lu, WG; Li, X; Li, JP; Xu, RS; Li, CW; Chen, FH; Jin, C. “Targeting interleukin-21 in rheumatoid arthritis.,” Mol. Biol. Rep., vol. 38, no. 3, pp. 1717–21, Mar. 2011.
[49] Jüngel, A; Distler, JHW; Kurowska-Stolarska, M; Seemayer, CA; Seibl, R; Forster, A; Michel, BA; Gay, RE; Emmrich, F; Gay, S; Distler, O. “Expression of interleukin-21 receptor, but not interleukin-21, in synovial fibroblasts and synovial macrophages of patients with rheumatoid arthritis.,” Arthritis Rheum., vol. 50, no. 5, pp. 1468–76, May 2004.
[50] Young, DA; Hegen, M; Ma, HLM; Whitters, MJ; Albert, LM; Lowe, L; Senices, M; Wu, PW; Sibley, B; Leathurby, Y; Brown, TP; Nickerson-Nutter, C; Keith, JC; Collins, M. “Blockade of the interleukin-21/interleukin-21 receptor pathway ameliorates disease in animal models of rheumatoid arthritis.,” Arthritis Rheum., vol. 56, no. 4, pp. 1152–63, May 2007.
[51] Novo Nordisk, “First-in-Man Trial of NNC114-0005 in Healthy Subjects and Subjects With Rheumatoid Arthritis.”
[52] Novo Nordisk, “A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy of NNC0114-0006 in Subjects With Active Rheumatoid Arthritis.”
[53] Novo Nordisk, “Safety and Tolerability of NNC0114-0006 at Increasing Dose Levels in Subjects With Rheumatoid Arthritis.”
[54] Genovese, MC; Jarosova, K; Cieślak, D; Alper, J; Kivitz, A; Hough, DR; Maes, P; Pineda, L; Chen, M; Zaidi, F. “Apremilast in Patients With Active Rheumatoid Arthritis: A Phase II, Multicenter, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study.,” Arthritis Rheumatol. (Hoboken, N.J.), vol. 67, no. 7, pp. 1703–10, Jul. 2015.
[55] Baylor Research Institute, “The Controlled Trial of Apremilast for Rheumatoid Arthritis Treatment (CARAT).”
[56] Keystone, EC; Taylor, PC; Drescher, E; Schlichting, DE; Beattie, SD; Berclaz, PY; Lee, CH; Fidelus-Gort, RK; Luchi, ME; Rooney, TP; Macias, WL; Genovese, MC. “Safety and efficacy of baricitinib at 24 weeks in patients with rheumatoid arthritis who have had an inadequate response to methotrexate.,” Ann. Rheum. Dis., vol. 74, no. 2, pp. 333–40, Feb. 2015.
[57] Genovese, MC; Kremer, J; Zamani, O; Ludivico, C; Krogulec, M; Xie, L; Beattie, S; Koch, AE; Cardillo, T; Rooney, T; Macias, W; Schlichting, D; Smolen, JS. “OP0029 Baricitinib, An Oral Janus Kinase (JAK)1/JAK2 Inhibitor, in Patients with Active Rheumatoid Arthritis (RA) and an Inadequate Response to TNF Inhibitors: Results of the Phase 3 RA-Beacon Study:,” Ann. Rheum. Dis., vol. 74, no. Suppl 2, pp. 75.3–76, Jun. 2015.
[58] Dougados, M; van der Heijde, D; Chen, YC; Greenwald, M; Drescher, E; Liu, J; Beattie, S; de la Torre, I; Rooney, T; Schlichting, D; de Bono, S; Emery, P. “LB0001 Baricitinib, an Oral Janus Kinase (JAK)1/JAK2 Inhibitor, in Patients with Active Rheumatoid Arthritis (RA) and An Inadequate Response to CDMARD Therapy: Results of the Phase 3 RA-Build Study:,” Ann. Rheum. Dis., vol. 74, no. Suppl 2, pp. 79.2–79, Jun. 2015.
[59] Lilly, “https://investor.lilly.com/releasedetail.cfm?ReleaseID=936515.”
[60] EL. Company, “An Extension Study in Participants With Moderate to Severe Rheumatoid Arthritis (RA-BEYOND). ClinicalTrials.gov Identifier: NCT01885078.”
[61] Fleischmann, RM; Damjanov, NS; Kivitz, AJ; Legedza, A; Hoock, T; Kinnman, N. “A randomised, double-blind, placebo-controlled, twelve-week, dose-ranging study of decernotinib, an oral selective JAK-3 inhibitor, as monotherapy in patients with active rheumatoid arthritis.,” Arthritis Rheumatol. (Hoboken, N.J.), vol. 67, no. 2, pp. 334–43, Feb. 2015.
[62] Genovese, MC; van Vollenhoven, RF; Pacheco-Tena, C; Zhang, Y; Kinnman, N. “VX-509 (Decernotinib), an Oral Selective JAK-3 Inhibitor, in Combination With Methotrexate in Patients With Rheumatoid Arthritis,” Arthritis Rheumatol., vol. 68, no. 1, pp. 46–55, Jan. 2016.
[63] Namour, F; Diderichsen, PM; Cox, E; Vayssière, B; Van der Aa, A; Tasset, C; Van’t Klooster, G. “Pharmacokinetics and Pharmacokinetic/ Pharmacodynamic Modeling of Filgotinib (GLPG0634), a Selective JAK1 Inhibitor, in Support of Phase IIB Dose Selection.,” Clin. Pharmacokinet., vol. 54, no. 8, pp. 859–74, Aug. 2015.
[64] Gomez-Puerta, JA; Mócsai, A. “Tyrosine kinase inhibitors for the treatment of rheumatoid arthritis.,” Curr. Top. Med. Chem., vol. 13, no. 6, pp. 760–73, Jan. 2013.
[65] OJD; Uckun, FM. “Targeting Spleen Tyrosine Kinase (Syk) for Treatment of Human Disease,” Pharm. Drug Deliv. Res.
[66] Weinblatt, ME; Genovese, MC; Ho, M; Hollis, S; Rosiak-Jedrychowicz, K; Kavanaugh, A; Millson, DS; Leon, G; Wang, M; van der Heijde, D. “Effects of fostamatinib, an oral spleen tyrosine kinase inhibitor, in rheumatoid arthritis patients with an inadequate response to methotrexate: results from a phase III, multicenter, randomised, double-blind, placebo-controlled, parallel-group study.,” Arthritis Rheumatol. (Hoboken, N.J.), vol. 66, no. 12, pp. 3255–64, Dec. 2014.
[67] Weinblatt, ME; Kavanaugh, A; Burgos-Vargas, R; Dikranian, AH; Medrano-Ramirez, G; Morales-Torres, JL; Murphy, FT; Musser, TK; Straniero, N; Vicente-Gonzales, AV; Grossbard, E. “Treatment of rheumatoid arthritis with a Syk kinase inhibitor: a twelve-week, randomised, placebo-controlled trial.,” Arthritis Rheum., vol. 58, no. 11, pp. 3309–18, Dec. 2008.
[68] Weinblatt, ME; Kavanaugh, A; Genovese, MC; Musser, TK; Grossbard, EB; Magilavy, DB. “An oral spleen tyrosine kinase (Syk) inhibitor for rheumatoid arthritis.,” N. Engl. J. Med., vol. 363, no. 14, pp. 1303–12, Oct. 2010.
[69] Herlaar, E; Brown, Z. “p38 MAPK signalling cascades in inflammatory disease.,” Mol. Med. Today, vol. 5, no. 10, pp. 439–47, Oct. 1999.
[70] Arthur, JSC; Ley, SC. “Mitogen-activated protein kinases in innate immunity.,” Nat. Rev. Immunol., vol. 13, no. 9, pp. 679–92, Sep. 2013.
[71] Damjanov, N; Kauffman, RS; Spencer-Green, GT. “Efficacy, pharmacodynamics, and safety of VX-702, a novel p38 MAPK inhibitor, in rheumatoid arthritis: results of two randomised, double-blind, placebo-controlled clinical studies.,” Arthritis Rheum., vol. 60, no. 5, pp. 1232–41, May 2009.
[72] Dörner, T; Kay, J. “Biosimilars in rheumatology: current perspectives and lessons learnt.,” Nat. Rev. Rheumatol., vol. 11, no. 12, pp. 713–24, Dec. 2015.
[73] “British Society for Rheumatology Position statement on biosimilar medicines (February 2015).”
[74] Dörner, T; Strand, V; Castañeda-Hernández, G; Ferraccioli, G; Isaacs, JD; Kvien, TK; Martin-Mola, E; Mittendorf, T; Smolen, JS; Burmester, GR. “The role of biosimilars in the treatment of rheumatic diseases.,” Ann. Rheum. Dis., vol. 72, no. 3, pp. 322–8, Mar. 2013.
[75] Haustein, R; de Millas, C; Ariane Höer, M; Professor Bertram Häussler, M. “Saving money in the European healthcare systems with biosimilars,” Generics Biosimilars Initiat. J., vol. 1, no. 3–4, pp. 120–126, Nov. 2012.
[76] Gulácsi, L; Brodszky, V; Baji, P; Kim, H; Kim, SY; Cho, YY; Péntek, M. “Biosimilars for the management of rheumatoid arthritis: economic considerations.,” Expert Rev. Clin. Immunol., vol. 11 Suppl 1, pp. S43–52, Jan. 2015.
[77] Yoo, DH; Hrycaj, P; Miranda, P; Ramiterre, E; Piotrowski, M; Shevchuk, S; Kovalenko, V; Prodanovic, N; Abello-Banfi, M; Gutierrez-Urena, S; Morales-Olazabal, L; Tee, M; Jimenez, R; Zamani, O; Lee, SJ; Kim, H; Park, W; Muller-Ladner, U. “A randomised, double-blind, parallel-group study to demonstrate equivalence in efficacy and safety of CT-P13 compared with innovator infliximab when coadministered with methotrexate in patients with active rheumatoid arthritis: the PLANETRA study,” Ann. Rheum. Dis., vol. 72, no. 10, pp. 1613–1620, May 2013.
[78] Park, W; Hrycaj, P; Jeka, S; Kovalenko, V; Lysenko, G; Miranda, P; Mikazane, H; Gutierrez-Ureña, S; Lim, M; Lee, YA; Lee, SJ; Kim, H; Yoo, DH; Braun, J. “A randomised, double-blind, multicentre, parallel-group, prospective study comparing the pharmacokinetics, safety, and efficacy of CT-P13 and innovator infliximab in patients with ankylosing spondylitis: the PLANETAS study.,” Ann. Rheum. Dis., vol. 72, no. 10, pp. 1605–12, Oct. 2013.
[79] Baji, P; Péntek, M; Czirják, L; Szekanecz, Z; Nagy, G; Gulácsi, L; Brodszky, V. “Efficacy and safety of infliximab-biosimilar compared to other biological drugs in rheumatoid arthritis: a mixed treatment comparison.,” Eur. J. Health Econ., vol. 15 Suppl 1, pp. S53–64, May 2014.
[80] Nikiphorou, E; Kautiainen, H; Hannonen, P; Asikainen, J; Kokko, A; Rannio, T; Sokka, T. “Clinical effectiveness of CT-P13 (Infliximab biosimilar) used as a switch from Remicade (infliximab) in patients with established rheumatic disease. Report of clinical experience based on prospective observational data.,” Expert Opin. Biol. Ther., vol. 15, no. 12, pp. 1677–83, Dec. 2015.
[81] PW; MLU; Yoo, D; Prodanovic, N; Jaworski, J; Miranda, P; Ramiterre, EB; Lanzon, A; Baranauskaite, A; Wiland, P; Abud-Mendoza, C; Oparanov, B; Smiyan, S; Son, YK. “Efficacy and Safety of CT-P13 (Infliximab biosimilar) over Two Years in Patients with Rheumatoid Arthritis: Comparison Between Continued CT-P13 and Switching from Infliximab to CT-P13,” Arthritis Rheum., vol. 65, no. 12, p. 3319, 2013.
[82] Diakonhjemmet Hospital, “The NOR-SWITCH Study,” p. ClinicalTrials.gov Identifier: NCT02148640.
[83] Isaacs, JD; Cutolo, M; Keystone, EC; Park, W; Braun, J. “Biosimilars in immune-mediated inflammatory diseases: initial lessons from the first approved biosimilar anti-tumour necrosis factor monoclonal antibody.,” J. Intern. Med., vol. 279, no. 1, pp. 41–59, Sep. 2015.
[84] WM; Kay, J; Chopra, A; Lassen, C; Shneyer, L. “BOW015, A biosimilar infliximab: disease activity and disability outcomes from a phase 3 active comparator study in patients with active rheumatoid arthritis on stable methotrexate doses,” Ann Rheum Dis, vol. 74, no. Suppl 2, p. 462, 2015.
[85] Bae, SC; Kim, JS; Choe, JY; Park, W; Lee, SR; Ahn, Y; Seo, Y. “OP0011 A Randomised, Double-Blind, Phase 3 Equivalence TRIAL Comparing the Etanercept Biosimilar, Hd203, with Enbrel(R), in Combination with Methotrexate (MTX) in Patients with Rheumatoid Arthritis (RA),” Ann. Rheum. Dis., vol. 73, no. Suppl 2, pp. 63–64, Jun. 2014.
[86] Jani, RH; Gupta, R; Bhatia, G; Rathi, G; Ashok Kumar, P; Sharma, R; Kumar, U; Gauri, LA; Jadhav, P; Bartakke, G; Haridas, V; Jain, D; Mendiratta, SK. “A prospective, randomised, double-blind, multicentre, parallel-group, active controlled study to compare efficacy and safety of biosimilar adalimumab (Exemptia; ZRC-3197) and adalimumab (Humira) in patients with rheumatoid arthritis.,” Int. J. Rheum. Dis., Jul. 2015.
[87] Jacobs, I; Yin, D; Melia, LA; Gumbiner, B; Suster, M; Thomas, D; Meng, X. “SAT0190 A Phase I Trial Comparing PF-05280586 (A Potential Biosimilar) and Rituximab in Patients with Active Rheumatoid Arthritis,” Ann. Rheum. Dis., vol. 74, no. Suppl 2, pp. 724.1–724, Jun. 2015.
[88] Polmar, SH. “New drugs for rheumatoid arthritis: The industry point of view.,” Reumatol. Clin., vol. 6, no. 1, pp. 3–4, Jan. 2010.

Chapter 12

[1] Dougados, M; Baeten, D. “Spondyloarthritis,” Lancet, vol. 377, pp. 2127-37, Jun 18 2011.
[2] Stolwijk, C; Boonen, A; van Tubergen, A; Reveille, JD. “Epidemiology of spondyloarthritis,” Rheum Dis Clin North Am, vol. 38, pp. 441-76, Aug 2012.
[3] Stolwijk, C; van Onna, M; Boonen, A; van Tubergen, A. “The global prevalence of spondyloarthritis: A systematic review and meta-regression analysis,” Arthritis Care Res (Hoboken), Dec 29 2015.
[4] Zink, A; Braun, J; Listing, J; Wollenhaupt, J. “Disability and handicap in rheumatoid arthritis and ankylosing spondylitis--results from the German rheumatological database. German Collaborative Arthritis Centers,” J Rheumatol, vol. 27, pp. 613-22, Mar 2000.
[5] van der Linden, S; Valkenburg, HA; Cats, A; “Evaluation of diagnostic criteria for ankylosing spondylitis. A proposal for modification of the New York criteria,” Arthritis Rheum, vol. 27, pp. 361-8, Apr 1984.
[6] Oostveen, J; Prevo, R; den Boer, J; van de Laar, M. “Early detection of sacroiliitis on magnetic resonance imaging and subsequent development of sacroiliitis on plain radiography. A prospective, longitudinal study,” J Rheumatol, vol. 26, pp. 1953-8, Sep 1999.
[7] Rudwaleit, M; van der Heijde, D; Landewe, R; Listing, J; Akkoc, N; Brandt, J; et al., “The development of Assessment of SpondyloArthritis international Society classification criteria for axial spondyloarthritis (part II): validation and final selection,” Ann Rheum Dis, vol. 68, pp. 777-83, Jun 2009.
[8] Rudwaleit, M; van der Heijde, D; Landewe, R; Akkoc, N; Brandt, J; Chou, CT; et al., “The Assessment of SpondyloArthritis International Society classification criteria for peripheral spondyloarthritis and for spondyloarthritis in general,” Ann Rheum Dis, vol. 70, pp. 25-31, Jan 2011.
[9] Benhamou, M; Gossec, L; Dougados, M. “Clinical relevance of C-reactive protein in ankylosing spondylitis and evaluation of the NSAIDs/coxibs' treatment effect on C-reactive protein,” Rheumatology (Oxford), vol. 49, pp. 536-41, Mar 2010.
[10] Wanders, A; Heijde, D; Landewe, R; Behier, JM; Calin, A; Olivieri, I; et al., “Nonsteroidal antiinflammatory drugs reduce radiographic progression in patients with ankylosing spondylitis: a randomised clinical trial,” Arthritis Rheum, vol. 52, pp. 1756-65, Jun 2005.
[11] Sieper, J; Listing, J; Poddubnyy, D; Song, IH; Hermann, KG; Callhoff, J; et al., “Effect of continuous vs. on-demand treatment of ankylosing spondylitis with diclofenac over 2 years on radiographic progression of the spine: results from a randomised multicentre trial (ENRADAS),” Ann Rheum Dis, Aug 4 2015.
[12] Poddubnyy, D; Rudwaleit, M; Haibel, H; Listing, J; Marker-Hermann, E; Zeidler, H; et al., “Effect of non-steroidal anti-inflammatory drugs on radiographic spinal progression in patients with axial spondyloarthritis: results from the German Spondyloarthritis Inception Cohort,” Ann Rheum Dis, vol. 71, pp. 1616-22, Oct 2012.
[13] Caso, F; Costa, L; Del Puente, A; Di Minno, MN; Lupoli, G; Scarpa, R; et al., “Pharmacological treatment of spondyloarthritis: exploring the effectiveness of nonsteroidal anti-inflammatory drugs, traditional disease-modifying antirheumatic drugs and biological therapies,” Ther Adv Chronic Dis, vol. 6, pp. 328-38, Nov 2015.
[14] Braun, J; Pham, T; Sieper, J; Davis, J; van der Linden, S; Dougados, M; et al., “International ASAS consensus statement for the use of anti-tumour necrosis factor agents in patients with ankylosing spondylitis,” Ann Rheum Dis, vol. 62, pp. 817-24, Sep 2003.
[15] Braun, J; van den Berg, R; Baraliakos, X; Boehm, H; Burgos-Vargas, R; Collantes-Estevez, E; et al., “2010 update of the ASAS/EULAR recommendations for the management of ankylosing spondylitis,” Ann Rheum Dis, vol. 70, pp. 896-904, Jun 2011.
[16] Callhoff, J; Sieper, J; Weiss, A; Zink, A; Listing, J; “Efficacy of TNF alpha blockers in patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis: a meta-analysis,” Ann Rheum Dis, vol. 74, pp. 1241-8, Jun 2015.
[17] Davis, JC; van der Heijde, DM; Braun, J; Dougados, M; Cush, J; Clegg, D; et al., “Sustained durability and tolerability of etanercept in ankylosing spondylitis for 96 weeks,” Ann Rheum Dis, vol. 64, pp. 1557-62, Nov 2005.
[18] Song, IH; Hermann, K; Haibel, H; Althoff, CE; Listing, J; Burmester, G; et al., “Effects of etanercept vs. sulfasalazine in early axial spondyloarthritis on active inflammatory lesions as detected by whole-body MRI (ESTHER): a 48-week randomised controlled trial,” Ann Rheum Dis, vol. 70, pp. 590-6, Apr 2011.
[19] Baraliakos, X; Haibel, H; Fritz, C; Listing, J; Heldmann, F; Braun, J; et al., “Long-term outcome of patients with active ankylosing spondylitis with etanercept-sustained efficacy and safety after seven years,” Arthritis Res Ther, vol. 15, p. R67, 2013.
[20] van der Heijde, D; Kivitz, A; Schiff, MH; Sieper, J; Dijkmans, BA; Braun, J; et al., “Efficacy and safety of adalimumab in patients with ankylosing spondylitis: results of a multicenter, randomised, double-blind, placebo-controlled trial,” Arthritis Rheum, vol. 54, pp. 2136-46, Jul 2006.
[21] Sieper, J; van der Heijde, D; Dougados, M; Mease, PJ; Maksymowych, WP; Brown, MA; et al., “Efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis: results of a randomised placebo-controlled trial (ABILITY-1),” Ann Rheum Dis, vol. 72, pp. 815-22, Jun 2013.
[22] Sieper, J; van der Heijde, D; Dougados, M; Brown, LS; Lavie, F; Pangan, AL. “Early response to adalimumab predicts long-term remission through 5 years of treatment in patients with ankylosing spondylitis,” Ann Rheum Dis, vol. 71, pp. 700-6, May 2012.
[23] Braun, J; Brandt, J; Listing, J; Zink, A; Alten, R; Golder, W; et al., “Treatment of active ankylosing spondylitis with infliximab: a randomised controlled multicentre trial,” Lancet, vol. 359, pp. 1187-93, Apr 6 2002.
[24] van der Heijde, D; Dijkmans, B; Geusens, P; Sieper, J; DeWoody, K; Williamson, P; et al., “Efficacy and safety of infliximab in patients with ankylosing spondylitis: results of a randomised, placebo-controlled trial (ASSERT),” Arthritis Rheum, vol. 52, pp. 582-91, Feb 2005.
[25] Barkham, N; Keen, HI; Coates, LC; O'Connor, P; Hensor, E; Fraser, AD; et al., “Clinical and imaging efficacy of infliximab in HLA-B27-Positive patients with magnetic resonance imaging-determined early sacroiliitis,” Arthritis Rheum, vol. 60, pp. 946-54, Apr 2009.
[26] Baraliakos, X; Listing, J; Fritz, C; Haibel, H; Alten, R; Burmester, GR; et al., “Persistent clinical efficacy and safety of infliximab in ankylosing spondylitis after 8 years--early clinical response predicts long-term outcome,” Rheumatology (Oxford), vol. 50, pp. 1690-9, Sep 2011.
[27] Inman, RD; Davis, JC; Jr., Heijde, D; Diekman, L; Sieper, J; Kim, SI; et al., “Efficacy and safety of golimumab in patients with ankylosing spondylitis: results of a randomised, double-blind, placebo-controlled, phase III trial,” Arthritis Rheum, vol. 58, pp. 3402-12, Nov 2008.
[28] Sieper, J; van der Heijde, D; Dougados, M; Maksymowych, WP; Scott, BB; Boice, JA; et al., “A randomised, double-blind, placebo-controlled, sixteen-week study of subcutaneous golimumab in patients with active nonradiographic axial spondyloarthritis,” Arthritis Rheumatol, vol. 67, pp. 2702-12, Oct 2015.
[29] Landewe, R; Braun, J; Deodhar, A; Dougados, M; Maksymowych, WP; Mease, PJ; et al., “Efficacy of certolizumab pegol on signs and symptoms of axial spondyloarthritis including ankylosing spondylitis: 24-week results of a double-blind randomised placebo-controlled Phase 3 study,” Ann Rheum Dis, vol. 73, pp. 39-47, Jan 2014.
[30] Sieper, RMJ; van der Heijde, D; Maksymowych, W; Dougados, M; Mease, PJ; et al., “SAT0351 Long-Term Safety and Efficacy of Certolizumab Pegol in Patients with Axial Spondyloarthritis, Including Ankylosing Spondylitis and Non-Radiographic Axial Spondyloarthritis: 96-Week Outcomes of the Rapid-Axspa Trial,” Ann Rheum Dis, vol. 73, pp. 719-720, 2014.
[31] Guignard, S; Gossec, L; Salliot, C; Ruyssen-Witrand, A; Luc, M; Duclos, M; et al., “Efficacy of tumour necrosis factor blockers in reducing uveitis flares in patients with spondylarthropathy: a retrospective study,” Ann Rheum Dis, vol. 65, pp. 1631-4, Dec 2006.
[32] van Denderen, JC; Visman, IM; Nurmohamed, MT; Suttorp-Schulten, MS; van der Horst-Bruinsma, IE. “Adalimumab significantly reduces the recurrence rate of anterior uveitis in patients with ankylosing spondylitis,” J Rheumatol, vol. 41, pp. 1843-8, Sep 2014.
[33] Braun, J; Baraliakos, X; Listing, J; Davis, J; van der Heijde, D; Haibel, H; et al., “Differences in the incidence of flares or new onset of inflammatory bowel diseases in patients with ankylosing spondylitis exposed to therapy with anti-tumor necrosis factor alpha agents,” Arthritis Rheum, vol. 57, pp. 639-47, May 15 2007.
[34] Sieper, J; Poddubnyy, D. “Inflammation, new bone formation and treatment options in axial spondyloarthritis,” Ann Rheum Dis, vol. 73, pp. 1439-41, Aug 2014.
[35] van der Heijde, D; Landewe, R; Baraliakos, X; Houben, H; van Tubergen, A; Williamson, P; et al., “Radiographic findings following two years of infliximab therapy in patients with ankylosing spondylitis,” Arthritis Rheum, vol. 58, pp. 3063-70, Oct 2008.
[36] Braun, J; Baraliakos, X; Hermann, KG; Deodhar, A; van der Heijde, D; Inman, R; et al., “The effect of two golimumab doses on radiographic progression in ankylosing spondylitis: results through 4 years of the GO-RAISE trial,” Ann Rheum Dis, vol. 73, pp. 1107-13, Jun 2014.
[37] van der Heijde, D; Salonen, D; Weissman, BN; Landewe, R; Maksymowych, WP; Kupper, H; et al., “Assessment of radiographic progression in the spines of patients with ankylosing spondylitis treated with adalimumab for up to 2 years,” Arthritis Res Ther, vol. 11, p. R127, 2009.
[38] van der Heijde, D; Landewe, R; Einstein, S; Ory, P; Vosse, D; Ni, L; et al., “Radiographic progression of ankylosing spondylitis after up to two years of treatment with etanercept,” Arthritis Rheum, vol. 58, pp. 1324-31, May 2008.
[39] Baraliakos, X; Haibel, H; Listing, J; Sieper, J; Braun, J. “Continuous long-term anti-TNF therapy does not lead to an increase in the rate of new bone formation over 8 years in patients with ankylosing spondylitis,” Ann Rheum Dis, vol. 73, pp. 710-5, Apr 2014.
[40] Haroon, N; Inman, RD; Learch, TJ; Weisman, MH; Lee, M; Rahbar, MH; et al., “The impact of tumor necrosis factor alpha inhibitors on radiographic progression in ankylosing spondylitis,” Arthritis Rheum, vol. 65, pp. 2645-54, Oct 2013.
[41] Machado, P. “Anti-tumor necrosis factor and new bone formation in ankylosing spondylitis: the controversy continues,” Arthritis Rheum, vol. 65, pp. 2537-40, Oct 2013.
[42] Fabbroni, M; Cantarini, L; Caso, F; Costa, L; Pagano, VA; Frediani, B; et al., “Drug retention rates and treatment discontinuation among anti-TNF-alpha agents in psoriatic arthritis and ankylosing spondylitis in clinical practice,” Mediators Inflamm, vol. 2014, p. 862969, 2014.
[43] Kang, JH; Park, DJ; Lee, JW; Lee, KE; Wen, L; Kim, TJ; et al., “Drug survival rates of tumor necrosis factor inhibitors in patients with rheumatoid arthritis and ankylosing spondylitis,” J Korean Med Sci, vol. 29, pp. 1205-11, Sep 2014.
[44] Carmona, L; Gomez-Reino, JJ; Group, B. “Survival of TNF antagonists in spondylarthritis is better than in rheumatoid arthritis. Data from the Spanish registry BIOBADASER,” Arthritis Res Ther, vol. 8, p. R72, 2006.
[45] Scire, CA; Caporali, R; Sarzi-Puttini, P; Frediani, B; Di Franco, M; Tincani, A; et al., “Drug survival of the first course of anti-TNF agents in patients with rheumatoid arthritis and seronegative spondyloarthritis: analysis from the MonitorNet database,” Clin Exp Rheumatol, vol. 31, pp. 857-63, Nov-Dec 2013.
[46] Rosales-Alexander, JL; Balsalobre Aznar, J; Perez-Vicente, S; Magro-Checa, C. “Drug survival of anti-tumour necrosis factor alpha therapy in spondyloarthropathies: results from the Spanish emAR II Study,” Rheumatology (Oxford), vol. 54, pp. 1459-63, Aug 2015.
[47] Hyrich, KL; Lunt, M; Watson, KD; Symmons, DP; Silman, AJ; British Society for Rheumatology Biologics, R. “Outcomes after switching from one anti-tumor necrosis factor alpha agent to a second anti-tumor necrosis factor alpha agent in patients with rheumatoid arthritis: results from a large UK national cohort study,” Arthritis Rheum, vol. 56, pp. 13-20, Jan 2007.
[48] Lie, E; van der Heijde, D; Uhlig, T; Mikkelsen, K; Rodevand, E; Koldingsnes, W; et al., “Effectiveness of switching between TNF inhibitors in ankylosing spondylitis: data from the NOR-DMARD register,” Ann Rheum Dis, vol. 70, pp. 157-63, Jan 2011.
[49] Haberhauer, G: Strehblow, C; Fasching, P. “Observational study of switching anti-TNF agents in ankylosing spondylitis and psoriatic arthritis vs. rheumatoid arthritis,” Wien Med Wochenschr, vol. 160, pp. 220-4, May 2010.
[50] Delaunay, C; Farrenq, V; Marini-Portugal, A; Cohen, JD; Chevalier, X; Claudepierre, P. “Infliximab to etanercept switch in patients with spondyloarthropathies and psoriatic arthritis: preliminary data,” J Rheumatol, vol. 32, pp. 2183-5, Nov 2005.
[51] Glintborg, B; Ostergaard, M; Krogh, NS; Tarp, U; Manilo, N; Loft, AG; et al., “Clinical response, drug survival and predictors thereof in 432 ankylosing spondylitis patients after switching tumour necrosis factor alpha inhibitor therapy: results from the Danish nationwide DANBIO registry,” Ann Rheum Dis, vol. 72, pp. 1149-55, Jul 2013.
[52] Konttinen, L; Tuompo, R; Uusitalo, T; Luosujarvi, R; Laiho, K; Lahteenmaki, J; et al., “Anti-TNF therapy in the treatment of ankylosing spondylitis: the Finnish experience,” Clin Rheumatol, vol. 26, pp. 1693-700, Oct 2007.
[53] Pradeep, DJ; Keat, AC; Gaffney, K; Brooksby, A; Leeder, J; Harris, C. “Switching anti-TNF therapy in ankylosing spondylitis,” Rheumatology (Oxford), vol. 47, pp. 1726-7, Nov 2008.
[54] Cantini, F; Niccoli, L; Benucci, M; Chindamo, D; Nannini, C; Olivieri, I; et al., “Switching from infliximab to once-weekly administration of 50 mg etanercept in resistant or intolerant patients with ankylosing spondylitis: results of a fifty-four-week study,” Arthritis Rheum, vol. 55, pp. 812-6, Oct 15 2006.
[55] Coates, LC; Cawkwell, LS; Ng, NW; Bennett, AN; Bryer, DJ; Fraser, AD; et al., “Real life experience confirms sustained response to long-term biologics and switching in ankylosing spondylitis,” Rheumatology (Oxford), vol. 47, pp. 897-900, Jun 2008.
[56] Conti, F; Ceccarelli, F; Marocchi, E; Magrini, L; Spinelli, FR; Spadaro, A; et al., “Switching tumour necrosis factor alpha antagonists in patients with ankylosing spondylitis and psoriatic arthritis: an observational study over a 5-year period,” Ann Rheum Dis, vol. 66, pp. 1393-7, Oct 2007.
[57] Paccou, J; Solau-Gervais, E; Houvenagel, E; Salleron, J; Luraschi, H; Philippe, P; et al., “Efficacy in current practice of switching between anti-tumour necrosis factor- alpha agents in spondyloarthropathies,” Rheumatology (Oxford), vol. 50, pp. 714-20, Apr 2011.
[58] Lord, PA; Farragher, TM; Lunt, M; Watson, KD; Symmons, DP; Hyrich, KL; et al., “Predictors of response to anti-TNF therapy in ankylosing spondylitis: results from the British Society for Rheumatology Biologics Register,” Rheumatology (Oxford), vol. 49, pp. 563-70, Mar 2010.
[59] Arends, S; Brouwer, E; van der Veer, E; Groen, H; Leijsma, MK; Houtman, PM; et al., “Baseline predictors of response and discontinuation of tumor necrosis factor-alpha blocking therapy in ankylosing spondylitis: a prospective longitudinal observational cohort study,” Arthritis Res Ther, vol. 13, p. R94, 2011.
[60] Kristensen, LE; Karlsson, JA; Englund, M; Petersson, IF; Saxne, T; Geborek, P. “Presence of peripheral arthritis and male sex predicting continuation of anti-tumor necrosis factor therapy in ankylosing spondylitis: an observational prospective cohort study from the South Swedish Arthritis Treatment Group Register,” Arthritis Care Res (Hoboken), vol. 62, pp. 1362-9, Oct 2010.
[61] Rudwaleit, M; Claudepierre, P; Wordsworth, P; Cortina, EL; Sieper, J; Kron, M; et al., “Effectiveness, safety, and predictors of good clinical response in 1250 patients treated with adalimumab for active ankylosing spondylitis,” J Rheumatol, vol. 36, pp. 801-8, Apr 2009.
[62] Vastesaeger, N; van der Heijde, D; Inman, RD; Wang, Y; Deodhar, A; Hsu, B; et al., “Predicting the outcome of ankylosing spondylitis therapy,” Ann Rheum Dis, vol. 70, pp. 973-81, Jun 2011.
[63] Rudwaleit, M; Listing, J; Brandt, J; Braun, J; Sieper, J. “Prediction of a major clinical response (BASDAI 50) to tumour necrosis factor alpha blockers in ankylosing spondylitis,” Ann Rheum Dis, vol. 63, pp. 665-70, Jun 2004.
[64] Rudwaleit, M; Schwarzlose, S; Hilgert, ES; Listing, J; Braun, J; Sieper, J. “MRI in predicting a major clinical response to anti-tumour necrosis factor treatment in ankylosing spondylitis,” Ann Rheum Dis, vol. 67, pp. 1276-81, Sep 2008.
[65] Lorenzin, M; Ortolan, A; Frallonardo, P; Oliviero, F; Punzi, L; Ramonda, R. “Predictors of response and drug survival in ankylosing spondylitis patients treated with infliximab,” BMC Musculoskelet Disord, vol. 16, p. 166, 2015.
[66] Lee, JW; Kang, JH; Yim, YR; Kim, JE; Wen, L; Lee, KE; et al., “Predictors of Switching Anti-Tumor Necrosis Factor Therapy in Patients with Ankylosing Spondylitis,” PLoS One, vol. 10, p. e0131864, 2015.
[67] Spadaro, A; Punzi, L; Marchesoni, A; Lubrano, E; Mathieu, A; Cantini, F; et al., “Switching from infliximab or etanercept to adalimumab in resistant or intolerant patients with spondyloarthritis: a 4-year study,” Rheumatology (Oxford), vol. 49, pp. 1107-11, Jun 2010.
[68] Bonafede, M; Fox, KM; Watson, C; Princic, N; Gandra, SR. “Treatment patterns in the first year after initiating tumor necrosis factor blockers in real-world settings,” Adv Ther, vol. 29, pp. 664-74, Aug 2012.
[69] Plasencia, C; Pascual-Salcedo, D; Garcia-Carazo, S; Lojo, L; Nuno, L; x Villalba, L; et al., “The immunogenicity to the first anti-TNF therapy determines the outcome of switching to a second anti-TNF therapy in spondyloarthritis patients,” Arthritis Res Ther, vol. 15, p. R79, 2013.
[70] Sethu, S; Govindappa, K; Alhaidari, M; Pirmohamed, M; Park, K; Sathish, J. “Immunogenicity to biologics: mechanisms, prediction and reduction,” Arch Immunol Ther Exp (Warsz), vol. 60, pp. 331-44, Oct 2012.
[71] Wolbink, GJ; Aarden, LA; Dijkmans, BA. “Dealing with immunogenicity of biologicals: assessment and clinical relevance,” Curr Opin Rheumatol, vol. 21, pp. 211-5, May 2009.
[72] Krieckaert, CL; Bartelds, GM; Lems, WF; Wolbink, GJ. “The effect of immunomodulators on the immunogenicity of TNF-blocking therapeutic monoclonal antibodies: a review,” Arthritis Res Ther, vol. 12, p. 217, 2010.
[73] van der Laken, CJ; Voskuyl, AE; Roos, JC; Stigter van Walsum, M; de Groot, ER; Wolbink, G; et al., “Imaging and serum analysis of immune complex formation of radiolabelled infliximab and anti-infliximab in responders and non-responders to therapy for rheumatoid arthritis,” Ann Rheum Dis, vol. 66, pp. 253-6, Feb 2007.
[74] Mok, CC; van der Kleij, D; Wolbink, GJ. “Drug levels, anti-drug antibodies, and clinical efficacy of the anti-TNFalpha biologics in rheumatic diseases,” Clin Rheumatol, vol. 32, pp. 1429-35, Oct 2013.
[75] Arstikyte, I; Kapleryte, G; Butrimiene, I; Venalis, A. “Influence of Immunogenicity on the Efficacy of Long-Term Treatment with TNF alpha Blockers in Rheumatoid Arthritis and Spondyloarthritis Patients,” Biomed Res Int, vol. 2015, p. 604872, 2015.
[76] Garces, S; Demengeot, J; Benito-Garcia, E. “The immunogenicity of anti-TNF therapy in immune-mediated inflammatory diseases: a systematic review of the literature with a meta-analysis,” Ann Rheum Dis, vol. 72, pp. 1947-55, Dec 2013.
[77] Soliman, MM; Ashcroft, DM; Watson, KD; Lunt, M; Symmons, DP; Hyrich, KL; et al., “Impact of concomitant use of DMARDs on the persistence with anti-TNF therapies in patients with rheumatoid arthritis: results from the British Society for Rheumatology Biologics Register,” Ann Rheum Dis, vol. 70, pp. 583-9, Apr 2011.
[78] Perez-Guijo, VC; Cravo, AR; Castro Mdel, C; Font, P; Munoz-Gomariz, E; Collantes-Estevez, E. “Increased efficacy of infliximab associated with methotrexate in ankylosing spondylitis,” Joint Bone Spine, vol. 74, pp. 254-8, May 2007.
[79] Breban, M; Ravaud, P; Claudepierre, P; Baron, G; Henry, YD; Hudry, C; et al., “Maintenance of infliximab treatment in ankylosing spondylitis: results of a one-year randomised controlled trial comparing systematic vs. on-demand treatment,” Arthritis Rheum, vol. 58, pp. 88-97, Jan 2008.
[80] Li, EK; Griffith, JF; Lee, VW; Wang, YX; Li, TK; Lee, KK; et al., “Short-term efficacy of combination methotrexate and infliximab in patients with ankylosing spondylitis: a clinical and magnetic resonance imaging correlation,” Rheumatology (Oxford), vol. 47, pp. 1358-63, Sep 2008.
[81] Mulleman, D; Lauferon, F; Wendling, D; Ternant, D; Ducourau, E; Paintaud, G; et al., “Infliximab in ankylosing spondylitis: alone or in combination with methotrexate? A pharmacokinetic comparative study,” Arthritis Res Ther, vol. 13, p. R82, 2011.
[82] Plasencia, C; Pascual-Salcedo, D; Nuno, L; Bonilla, G; Villalba, A; Peiteado, D; et al., “Influence of immunogenicity on the efficacy of longterm treatment of spondyloarthritis with infliximab,” Ann Rheum Dis, vol. 71, pp. 1955-60, Dec 2012.
[83] Ritchlin, C; Rahman, P; Kavanaugh, A; McInnes, IB; Puig, L; Li, S; et al., “Efficacy and safety of the anti-IL-12/23 p40 monoclonal antibody, ustekinumab, in patients with active psoriatic arthritis despite conventional non-biological and biological anti-tumour necrosis factor therapy: 6-month and 1-year results of the phase 3, multicentre, double-blind, placebo-controlled, randomised PSUMMIT 2 trial,” Ann Rheum Dis, vol. 73, pp. 990-9, Jun 2014.
[84] Smith, JA; Colbert, RA. “Review: The interleukin-23/interleukin-17 axis in spondyloarthritis pathogenesis: Th17 and beyond,” Arthritis Rheumatol, vol. 66, pp. 231-41, Feb 2014.
[85] Poddubnyy, D; Hermann, KG; Callhoff, J; Listing, J; Sieper, J. “Ustekinumab for the treatment of patients with active ankylosing spondylitis: results of a 28-week, prospective, open-label, proof-of-concept study (TOPAS),” Ann Rheum Dis, vol. 73, pp. 817-23, May 2014.
[86] Baeten, D; Baraliakos, X; Braun, J; Sieper, J; Emery, P; van der Heijde, D; et al., “Anti-interleukin-17A monoclonal antibody secukinumab in treatment of ankylosing spondylitis: a randomised, double-blind, placebo-controlled trial,” Lancet, vol. 382, pp. 1705-13, Nov 23 2013.
[87] Baeten, D; Sieper, J; Braun, J; Baraliakos, X; Dougados, M; Emery, P; et al., “Secukinumab, an Interleukin-17A Inhibitor, in Ankylosing Spondylitis,” N Engl J Med, vol. 373, pp. 2534-48, Dec 24 2015.
[88] Leonardi, C; Matheson, R; Zachariae, C; Cameron, G; Li, L; Edson-Heredia, E; et al., “Anti-interleukin-17 monoclonal antibody ixekizumab in chronic plaque psoriasis,” N Engl J Med, vol. 366, pp. 1190-9, Mar 29 2012.
[89] Rios Rodriguez, V; Poddubnyy, D. “Old and new treatment targets in axial spondyloarthritis,” RMD Open, vol. 1, p. e000054, 2015.
[90] Bal, A; Unlu, E; Bahar, G; Aydog, E; Eksioglu, E; Yorgancioglu, R. “Comparison of serum IL-1 beta, sIL-2R, IL-6, and TNF-alpha levels with disease activity parameters in ankylosing spondylitis,” Clin Rheumatol, vol. 26, pp. 211-5, Feb 2007.
[91] Francois, RJ; Neure, L; Sieper, J; Braun, J. “Immunohistological examination of open sacroiliac biopsies of patients with ankylosing spondylitis: detection of tumour necrosis factor alpha in two patients with early disease and transforming growth factor beta in three more advanced cases,” Ann Rheum Dis, vol. 65, pp. 713-20, Jun 2006.
[92] Cohen, JD; Ferreira, R; Jorgensen, C. “Ankylosing spondylitis refractory to tumor necrosis factor blockade responds to tocilizumab,” J Rheumatol, vol. 38, p. 1527, Jul 2011.
[93] Shima, Y; Tomita, T; Ishii, T; Morishima, A; Maeda, Y; Ogata, A; et al., “Tocilizumab, a humanised anti-interleukin-6 receptor antibody, ameliorated clinical symptoms and MRI findings of a patient with ankylosing spondylitis,” Mod Rheumatol, vol. 21, pp. 436-9, Aug 2011.
[94] Sieper, J; Porter-Brown, B; Thompson, L; Harari, O; Dougados, M. “Assessment of short-term symptomatic efficacy of tocilizumab in ankylosing spondylitis: results of randomised, placebo-controlled trials,” Ann Rheum Dis, vol. 73, pp. 95-100, Jan 2014.
[95] Sieper, J; Braun, J; Kay, J; Badalamenti, S; Radin, AR; Jiao, L; et al., “Sarilumab for the treatment of ankylosing spondylitis: results of a Phase II, randomised, double-blind, placebo-controlled study (ALIGN),” Ann Rheum Dis, vol. 74, pp. 1051-7, Jun 2015.
[96] Song, IH; Heldmann, F; Rudwaleit, M; Listing, J; Appel, H; Braun, J; et al., “Different response to rituximab in tumor necrosis factor blocker-naive patients with active ankylosing spondylitis and in patients in whom tumor necrosis factor blockers have failed: a twenty-four-week clinical trial,” Arthritis Rheum, vol. 62, pp. 1290-7, May 2010.
[97] Song, IH; Heldmann, F; Rudwaleit, M; Haibel, H; Weiss, A; Braun, J; et al., “Treatment of active ankylosing spondylitis with abatacept: an open-label, 24-week pilot study,” Ann Rheum Dis, vol. 70, pp. 1108-10, Jun 2011.
[98] Haibel, H; Rudwaleit, M; Listing, J; Sieper, J. “Open label trial of anakinra in active ankylosing spondylitis over 24 weeks,” Ann Rheum Dis, vol. 64, pp. 296-8, Feb 2005.
[99] Pathan, E; Abraham, S; Van Rossen, E; Withrington, R; Keat, A; Charles, PJ; et al., “Efficacy and safety of apremilast, an oral phosphodiesterase 4 inhibitor, in ankylosing spondylitis,” Ann Rheum Dis, vol. 72, pp. 1475-80, Sep 1 2013.
[100] Burmester, GR; Blanco, R; Charles-Schoeman, C; Wollenhaupt, J; Zerbini, C; Benda, B; et al., “Tofacitinib (CP-690,550) in combination with methotrexate in patients with active rheumatoid arthritis with an inadequate response to tumour necrosis factor inhibitors: a randomised phase 3 trial,” Lancet, vol. 381, pp. 451-60, Feb 9 2013.

Chapter 13

[1] Gelfand, JM; Gladman, DD; Mease, PJ; Smith, N; Margolis, DJ; Nijsten, T; et al., “Epidemiology of psoriatic arthritis in the population of the United States,” J Am Acad Dermatol, vol. 53, p. 573, Oct 2005.
[2] Gladman, DD. “Clinical Features and Diagnostic Considerations in Psoriatic Arthritis,” Rheum Dis Clin North Am, vol. 41, pp. 569-79, Nov 2015.
[3] Krueger, GG. “Clinical features of psoriatic arthritis,” Am J Manag Care, vol. 8, pp. S160-70, Apr 2002.
[4] Helliwell, PS; Taylor, WJ. “Classification and diagnostic criteria for psoriatic arthritis,” Ann Rheum Dis, vol. 64 Suppl 2, pp. ii3-8, Mar 2005.
[5] Lauter, SA; Vasey, FB; Espinoza, LR; Bombardier, C; Osterland, CK. “Homozygosity for HLA-B27 in psoriatic arthritis and spondylitis,” Arthritis Rheum, vol. 20, pp. 1569-70, Nov-Dec 1977.
[6] Gladman, DD; Anhorn, KA; Schachter, RK; Mervart, H. “HLA antigens in psoriatic arthritis,” J Rheumatol, vol. 13, pp. 586-92, Jun 1986.
[7] Gladman, DD; Antoni, C; Mease, P; Clegg, DO; Nash, P. “Psoriatic arthritis: epidemiology, clinical features, course, and outcome,” Ann Rheum Dis, vol. 64 Suppl 2, pp. ii14-7, Mar 2005.
[8] Gladman, DD; Mease, PJ. “Towards international guidelines for the management of psoriatic arthritis,” J Rheumatol, vol. 33, pp. 1228-30, Jul 2006.
[9] Rosen, CF; Mussani, F; Chandran, V; Eder, L; Thavaneswaran, A; Gladman, DD. “Patients with psoriatic arthritis have worse quality of life than those with psoriasis alone,” Rheumatology (Oxford), vol. 51, pp. 571-6, Mar 2012.
[10] Gossec, L; Smolen, JS; Gaujoux-Viala, C; Ash, Z; Marzo-Ortega, H; van der Heijde, D; et al., “European League Against Rheumatism recommendations for the management of psoriatic arthritis with pharmacological therapies,” Ann Rheum Dis, vol. 71, pp. 4-12, Jan 2012.
[11] Saad, AA; Ashcroft, DM; Watson, KD; Symmons, DP; Noyce, PR; Hyrich, KL. “Improvements in quality of life and functional status in patients with psoriatic arthritis receiving anti-tumor necrosis factor therapies,” Arthritis Care Res (Hoboken), vol. 62, pp. 345-53, Mar 2010.
[12] Strand, V; Sharp, V; Koenig, AS; Park, G; Shi, Y; Wang, B. et al., “Comparison of health-related quality of life in rheumatoid arthritis, psoriatic arthritis and psoriasis and effects of etanercept treatment,” Ann Rheum Dis, vol. 71, pp. 1143-50, Jul 2012.
[13] Ash, Z; Gaujoux-Viala, C; Gossec, L; Hensor, EM; FitzGerald, O; Winthrop, K; et al., “A systematic literature review of drug therapies for the treatment of psoriatic arthritis: current evidence and meta-analysis informing the EULAR recommendations for the management of psoriatic arthritis,” Ann Rheum Dis, vol. 71, pp. 319-26, Mar 2012.
[14] Bos, F; Capsoni, F; Molteni, S; Raeli, L; Diani, M; Altomare, A; et al., “Differential expression of interleukin-2 by anti-CD3-stimulated peripheral blood mononuclear cells in patients with psoriatic arthritis and patients with cutaneous psoriasis,” Clin Exp Dermatol, vol. 39, pp. 385-90, Apr 2014.
[15] Benham, H; Norris, P; Goodall, J; Wechalekar, MD; FitzGerald, O; Szentpetery, A; et al., “Th17 and Th22 cells in psoriatic arthritis and psoriasis,” Arthritis Res Ther, vol. 15, p. R136, 2013.
[16] Bovenschen, HJ; Seyger, MM; Van de Kerkhof, PC. “Plaque psoriasis vs. atopic dermatitis and lichen planus: a comparison for lesional T cell subsets, epidermal proliferation and differentiation,” Br J Dermatol, vol. 153, pp. 72-8, Jul 2005.
[17] Costello, PJ; Winchester, RJ; Curran, SA; Peterson, KS; Kane, DJ; Bresnihan, B; et al., “Psoriatic arthritis joint fluids are characterised by CD8 and CD4 T cell clonal expansions appear antigen driven,” J Immunol, vol. 166, pp. 2878-86, Feb 15 2001.
[18] Victor, FC; Gottlieb, AB. “TNF-alpha and apoptosis: implications for the pathogenesis and treatment of psoriasis,” J Drugs Dermatol, vol. 1, pp. 264-75, Dec 2002.
[19] Chamian, F; Lowes, MA; Lin, SL; Lee, E; Kikuchi, T; Gilleaudeau, P; et al., “Alefacept reduces infiltrating T cells, activated dendritic cells, and inflammatory genes in psoriasis vulgaris,” Proc Natl Acad Sci U S A, vol. 102, pp. 2075-80, Feb 8 2005.
[20] da Silva, AJ; Brickelmaier, M; Majeau, GR; Li, Z; Su, L; Hsu, YM; et al., “Alefacept, an immunomodulatory recombinant LFA-3/IgG1 fusion protein, induces CD16 signaling and CD2/CD16-dependent apoptosis of CD2(+) cells,” J Immunol, vol. 168, pp. 4462-71, May 1 2002.
[21] Vugmeyster, Y; Kikuchi, T; Lowes, MA; Chamian, F; Kagen, M; Gilleaudeau, P; et al., “Efalizumab (anti-CD11a)-induced increase in peripheral blood leukocytes in psoriasis patients is preferentially mediated by altered trafficking of memory CD8+ T cells into lesional skin,” Clin Immunol, vol. 113, pp. 38-46, Oct 2004.
[22] Di Meglio, P; Nestle, FO. “The role of IL-23 in the immunopathogenesis of psoriasis,” F1000 Biol Rep, vol. 2, 2010.
[23] Chan, JR; Blumenschein, W; Murphy, E; Diveu, C; Wiekowski, M; Abbondanzo, S; et al., “IL-23 stimulates epidermal hyperplasia via TNF and IL-20R2-dependent mechanisms with implications for psoriasis pathogenesis,” J Exp Med, vol. 203, pp. 2577-87, Nov 27 2006.
[24] Lee, E; Trepicchio, WL; Oestreicher, JL; Pittman, D; Wang, F; Chamian, F; et al., “Increased expression of interleukin 23 p19 and p40 in lesional skin of patients with psoriasis vulgaris,” J Exp Med, vol. 199, pp. 125-30, Jan 5 2004.
[25] Lowes, MA; Kikuchi, T; Fuentes-Duculan, J; Cardinale, I; Zaba, LC; Haider, AS; et al., “Psoriasis vulgaris lesions contain discrete populations of Th1 and Th17 T cells,” J Invest Dermatol, vol. 128, pp. 1207-11, May 2008.
[26] Menon, B; Gullick, NJ; Walter, GJ; Rajasekhar, M; Garrood, T; Evans, HG; et al., “Interleukin-17+CD8+ T cells are enriched in the joints of patients with psoriatic arthritis and correlate with disease activity and joint damage progression,” Arthritis Rheumatol, vol. 66, pp. 1272-81, May 2014.
[27] Ranganath, VK; Khanna, D; Paulus, HE. “ACR remission criteria and response criteria,” Clin Exp Rheumatol, vol. 24, pp. S-14-21, Nov-Dec 2006.
[28] Gottlieb, AB; Chaudhari, U; Baker, DG; Perate, M; Dooley, LT. “The National Psoriasis Foundation Psoriasis Score (NPF-PS) system vs. the Psoriasis Area Severity Index (PASI) and Physician's Global Assessment (PGA): a comparison,” J Drugs Dermatol, vol. 2, pp. 260-6, Jun 2003.
[29] Mease, PJ. “Measures of psoriatic arthritis: Tender and Swollen Joint Assessment, Psoriasis Area and Severity Index (PASI), Nail Psoriasis Severity Index (NAPSI), Modified Nail Psoriasis Severity Index (mNAPSI), Mander/Newcastle Enthesitis Index (MEI), Leeds Enthesitis Index (LEI), Spondyloarthritis Research Consortium of Canada (SPARCC), Maastricht Ankylosing Spondylitis Enthesis Score (MASES), Leeds Dactylitis Index (LDI), Patient Global for Psoriatic Arthritis, Dermatology Life Quality Index (DLQI), Psoriatic Arthritis Quality of Life (PsAQOL), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Psoriatic Arthritis Response Criteria (PsARC), Psoriatic Arthritis Joint Activity Index (PsAJAI), Disease Activity in Psoriatic Arthritis (DAPSA), and Composite Psoriatic Disease Activity Index (CPDAI),” Arthritis Care Res (Hoboken), vol. 63 Suppl 11, pp. S64-85, Nov 2011.
[30] Gladman, DD; Helliwell, P; Mease, PJ; Nash, P; Ritchlin, C; Taylor, W. “Assessment of patients with psoriatic arthritis: a review of currently available measures,” Arthritis Rheum, vol. 50, pp. 24-35, Jan 2004.
[31] Garrett, S; Jenkinson, T; Kennedy, LG; Whitelock, H; Gaisford, P; Calin, A. “A new approach to defining disease status in ankylosing spondylitis: the Bath Ankylosing Spondylitis Disease Activity Index,” J Rheumatol, vol. 21, pp. 2286-91, Dec 1994.
[32] Blome, C; Beikert, FC; Rustenbach, SJ; Augustin, M. “Mapping DLQI on EQ-5D in psoriasis: transformation of skin-specific health-related quality of life into utilities,” Arch Dermatol Res, vol. 305, pp. 197-204, Apr 2013.
[33] Mease, PJ; Goffe, BS; Metz, J; VanderStoep, A; Finck, B; Burge, DJ. “Etanercept in the treatment of psoriatic arthritis and psoriasis: a randomised trial,” Lancet, vol. 356, pp. 385-90, Jul 29 2000.
[34] Gottlieb, AB; Matheson, RT; Lowe, N; Krueger, GG; Kang, S; Goffe, BS; et al., “A randomised trial of etanercept as monotherapy for psoriasis,” Arch Dermatol, vol. 139, pp. 1627-32; discussion 1632, Dec 2003.
[35] Leonardi, CL; Powers, JL; Matheson, RT; Goffe, BS; Zitnik, R; Wang, A; et al., “Etanercept as monotherapy in patients with psoriasis,” N Engl J Med, vol. 349, pp. 2014-22, Nov 20 2003.
[36] Krueger, GG; Langley, RG; Finlay, AY; Griffiths, CE; Woolley, JM; Lalla, D; et al., “Patient-reported outcomes of psoriasis improvement with etanercept therapy: results of a randomised phase III trial,” Br J Dermatol, vol. 153, pp. 1192-9, Dec 2005.
[37] Reich, K; Nestle, FO; Papp, K; Ortonne, JP; Evans, R; Guzzo, C; et al., “Infliximab induction and maintenance therapy for moderate-to-severe psoriasis: a phase III, multicentre, double-blind trial,” Lancet, vol. 366, pp. 1367-74, Oct 15-21 2005.
[38] Tyring, S; Gottlieb, A; Papp, K; Gordon, K; Leonardi, C; Wang, A; et al., “Etanercept and clinical outcomes, fatigue, and depression in psoriasis: double-blind placebo-controlled randomised phase III trial,” Lancet, vol. 367, pp. 29-35, Jan 7 2006.
[39] van de Kerkhof, PC; Segaert, S; Lahfa, M; Luger, TA; Karolyi, Z; Kaszuba, A; et al., “Once weekly administration of etanercept 50 mg is efficacious and well tolerated in patients with moderate-to-severe plaque psoriasis: a randomised controlled trial with open-label extension,” Br J Dermatol, vol. 159, pp. 1177-85, Nov 2008.
[40] Reich, K; Segaert, S; Van de Kerkhof, P; Durian, C; Boussuge, MP; Paolozzi, L; et al., “Once-weekly administration of etanercept 50 mg improves patient-reported outcomes in patients with moderate-to-severe plaque psoriasis,” Dermatology, vol. 219, pp. 239-49, 2009.
[41] Mease, PJ; Kivitz, AJ; Burch, FX; Siegel, EL; Cohen, SB; Ory, P; et al., “Etanercept treatment of psoriatic arthritis: safety, efficacy, and effect on disease progression,” Arthritis Rheum, vol. 50, pp. 2264-72, Jul 2004.
[42] Mease, PJ; Kivitz, AJ; Burch, FX; Siegel, EL; Cohen, SB; Ory, P; et al., “Continued inhibition of radiographic progression in patients with psoriatic arthritis following 2 years of treatment with etanercept,” J Rheumatol, vol. 33, pp. 712-21, Apr 2006.
[43] Paller, AS; Siegfried, EC; Langley, RG; Gottlieb, AB; Pariser, D; Landells, I; et al., “Etanercept treatment for children and adolescents with plaque psoriasis,” N Engl J Med, vol. 358, pp. 241-51, Jan 17 2008.
[44] Siegfried, EC; Eichenfield, LF; Paller, AS; Pariser, D; Creamer, K; Kricorian, G. “Intermittent etanercept therapy in pediatric patients with psoriasis,” J Am Acad Dermatol, vol. 63, pp. 769-74, Nov 2010.
[45] Paller, AS; Siegfried, EC; Eichenfield, LF; Pariser, D; Langley, RG; Creamer, K; et al., “Long-term etanercept in pediatric patients with plaque psoriasis,” J Am Acad Dermatol, vol. 63, pp. 762-8, Nov 2010.
[46] Davis, Jr. JC; Van Der Heijde, D; Braun, J; Dougados, M; Cush, J; Clegg, DO; et al., “Recombinant human tumor necrosis factor receptor (etanercept) for treating ankylosing spondylitis: a randomised, controlled trial,” Arthritis Rheum, vol. 48, pp. 3230-6, Nov 2003.
[47] Lubrano, E; Spadaro, A; Marchesoni, A; Olivieri, I; Scarpa, R; D'Angelo, S; et al., “The effectiveness of a biologic agent on axial manifestations of psoriatic arthritis. A twelve months observational study in a group of patients treated with etanercept,” Clin Exp Rheumatol, vol. 29, pp. 80-4, Jan-Feb 2011.
[48] Sterry, W; Ortonne, JP; Kirkham, B; Brocq, O; Robertson, D; Pedersen, RD; et al., “Comparison of two etanercept regimens for treatment of psoriasis and psoriatic arthritis: PRESTA randomised double blind multicentre trial,” BMJ, vol. 340, p. c147, 2010.
[49] Ortonne, JP; Paul, C; Berardesca, E; Marino, V; Gallo, G; Brault, Y; et al., “A 24-week randomised clinical trial investigating the efficacy and safety of two doses of etanercept in nail psoriasis,” Br J Dermatol, vol. 168, pp. 1080-7, May 2013.
[50] Crowley, JJ; Weinberg, JM; Wu, JJ; Robertson, AD; Van Voorhees, AS; National Psoriasis, F. “Treatment of nail psoriasis: best practice recommendations from the Medical Board of the National Psoriasis Foundation,” JAMA Dermatol, vol. 151, pp. 87-94, Jan 2015.
[51] Kivelevitch, D; Mansouri, B; Menter, A. “Long term efficacy and safety of etanercept in the treatment of psoriasis and psoriatic arthritis,” Biologics, vol. 8, pp. 169-82, 2014.
[52] Menter, A; Gottlieb, A; Feldman, SR; Van Voorhees, AS; Leonardi, CL; Gordon, KB; et al., “Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics,” J Am Acad Dermatol, vol. 58, pp. 826-50, May 2008.
[53] Papp, KA; Poulin, Y; Bissonnette, R; Bourcier, M; Toth, D; Rosoph, L; et al., “Assessment of the long-term safety and effectiveness of etanercept for the treatment of psoriasis in an adult population,” J Am Acad Dermatol, vol. 66, pp. e33-45, Feb 2012.
[54] Kimball, AB; Pariser, D; Yamauchi, PS; Menter, A; Teller, CF; Shi, Y; et al., “OBSERVE-5 interim analysis: an observational postmarketing safety registry of etanercept for the treatment of psoriasis,” J Am Acad Dermatol, vol. 68, pp. 756-64, May 2013.
[55] Kimball, AB; Rothman, KJ; Kricorian, G; Pariser, D; Yamauchi, PS; Menter, A; et al., “OBSERVE-5: observational postmarketing safety surveillance registry of etanercept for the treatment of psoriasis final 5-year results,” J Am Acad Dermatol, vol. 72, pp. 115-22, Jan 2015.
[56] Wu, JJ; Poon, KY; Channual, JC; Shen, AY. “Association between tumor necrosis factor inhibitor therapy and myocardial infarction risk in patients with psoriasis,” Arch Dermatol, vol. 148, pp. 1244-50, Nov 2012.
[57] Stern, RS; Huibregtse, A. “Very severe psoriasis is associated with increased noncardiovascular mortality but not with increased cardiovascular risk,” J Invest Dermatol, vol. 131, pp. 1159-66, May 2011.
[58] Mallbris, L; Akre, O; Granath, F; Yin, L; Lindelof, B; Ekbom, A; et al., “Increased risk for cardiovascular mortality in psoriasis inpatients but not in outpatients,” Eur J Epidemiol, vol. 19, pp. 225-30, 2004.
[59] Menter, A; Griffiths, CE; Tebbey, PW; Horn, EJ; Sterry, W; International Psoriasis, C. “Exploring the association between cardiovascular and other disease-related risk factors in the psoriasis population: the need for increased understanding across the medical community,” J Eur Acad Dermatol Venereol, vol. 24, pp. 1371-7, Dec 2010.
[60] Menter, A; Tyring, SK; Gordon, K; Kimball, AB; Leonardi, CL; Langley, RG; et al., “Adalimumab therapy for moderate to severe psoriasis: A randomised, controlled phase III trial,” J Am Acad Dermatol, vol. 58, pp. 106-15, Jan 2008.
[61] Mease, PJ; Gladman, DD; Ritchlin, CT; Ruderman, EM; Steinfeld, SD; Choy, EH; et al., “Adalimumab for the treatment of patients with moderately to severely active psoriatic arthritis: results of a double-blind, randomised, placebo-controlled trial,” Arthritis Rheum, vol. 52, pp. 3279-89, Oct 2005.
[62] Genovese, MC; Mease, PJ; Thomson, GT; Kivitz, AJ; Perdok, RJ; Weinberg, MA; et al., “Safety and efficacy of adalimumab in treatment of patients with psoriatic arthritis who had failed disease modifying antirheumatic drug therapy,” J Rheumatol, vol. 34, pp. 1040-50, May 2007.
[63] Revicki, DA; Willian, MK; Menter, A; Gordon, KB; Kimball, AB; Leonardi, CL; et al., “Impact of adalimumab treatment on patient-reported outcomes: results from a Phase III clinical trial in patients with moderate to severe plaque psoriasis,” J Dermatolog Treat, vol. 18, pp. 341-50, 2007.
[64] Gladman, DD; Mease, PJ; Cifaldi, MA; Perdok, RJ; Sasso, E; Medich, J. “Adalimumab improves joint-related and skin-related functional impairment in patients with psoriatic arthritis: patient-reported outcomes of the Adalimumab Effectiveness in Psoriatic Arthritis Trial,” Ann Rheum Dis, vol. 66, pp. 163-8, Feb 2007.
[65] Saurat, JH; Stingl, G; Dubertret, L; Papp, K; Langley, RG; Ortonne, JP; et al., “Efficacy and safety results from the randomised controlled comparative study of adalimumab vs. methotrexate vs. placebo in patients with psoriasis (CHAMPION),” Br J Dermatol, vol. 158, pp. 558-66, Mar 2008.
[66] Karanikolas, GN; Koukli, EM; Katsalira, A; Arida, A; Petrou, D; Komninou, E; et al., “Adalimumab or cyclosporine as monotherapy and in combination in severe psoriatic arthritis: results from a prospective 12-month nonrandomised unblinded clinical trial,” J Rheumatol, vol. 38, pp. 2466-74, Nov 2011.
[67] Atteno, M; Peluso, R; Costa, L; Padula, S; Iervolino, S; Caso, F; et al., “Comparison of effectiveness and safety of infliximab, etanercept, and adalimumab in psoriatic arthritis patients who experienced an inadequate response to previous disease-modifying antirheumatic drugs,” Clin Rheumatol, vol. 29, pp. 399-403, Apr 2010.
[68] Fenix-Caballero, S; Alegre-del Rey, EJ; Castano-Lara, R; Puigventos-Latorre, F; Borrero-Rubio, JM; Lopez-Vallejo, JF. “Direct and indirect comparison of the efficacy and safety of adalimumab, etanercept, infliximab and golimumab in psoriatic arthritis,” J Clin Pharm Ther, vol. 38, pp. 286-93, Aug 2013.
[69] Thorlund, K; Druyts, E; Avina-Zubieta, JA; Mills, EJ. “Anti-tumor necrosis factor (TNF) drugs for the treatment of psoriatic arthritis: an indirect comparison meta-analysis,” Biologics, vol. 6, pp. 417-27, 2012.
[70] Fagerli, KM; Lie, E; van der Heijde, D; Heiberg, MS; Kalstad, S; Rodevand, E; et al., “Switching between TNF inhibitors in psoriatic arthritis: data from the NOR-DMARD study,” Ann Rheum Dis, vol. 72, pp. 1840-4, Nov 2013.
[71] Glintborg, B; Ostergaard, M; Krogh, NS; Andersen, MD; Tarp, U; Loft, AG; et al., “Clinical response, drug survival, and predictors thereof among 548 patients with psoriatic arthritis who switched tumor necrosis factor alpha inhibitor therapy: results from the Danish Nationwide DANBIO Registry,” Arthritis Rheum, vol. 65, pp. 1213-23, May 2013.
[72] Gladman, DD; Investigators, AS; Sampalis, JS; Illouz, O; Guerette, B. “Responses to adalimumab in patients with active psoriatic arthritis who have not adequately responded to prior therapy: effectiveness and safety results from an open-label study,” J Rheumatol, vol. 37, pp. 1898-906, Sep 2010.
[73] Van den Bosch, F; Manger, B; Goupille, P; McHugh, N; Rodevand, E; Holck, P; et al., “Effectiveness of adalimumab in treating patients with active psoriatic arthritis and predictors of good clinical responses for arthritis, skin and nail lesions,” Ann Rheum Dis, vol. 69, pp. 394-9, Feb 2010.
[74] Rigopoulos, D; Gregoriou, S; Lazaridou, E; Belyayeva, E; Apalla, Z; Makris, M; et al., “Treatment of nail psoriasis with adalimumab: an open label unblinded study,” J Eur Acad Dermatol Venereol, vol. 24, pp. 530-4, May 2010.
[75] Sieper, J; van der Heijde, D; Dougados, M; Mease, PJ; Maksymowych, WP; Brown, MA; et al., “Efficacy and safety of adalimumab in patients with non-radiographic axial spondyloarthritis: results of a randomised placebo-controlled trial (ABILITY-1),” Ann Rheum Dis, vol. 72, pp. 815-22, Jun 2013.
[76] van der Heijde, DM; Revicki, DA; Gooch, KL; Wong, RL; Kupper, H; Harnam, N; et al., “Physical function, disease activity, and health-related quality-of-life outcomes after 3 years of adalimumab treatment in patients with ankylosing spondylitis,” Arthritis Res Ther, vol. 11, p. R124, 2009.
[77] Wang, H; Zuo, D; Sun, M; Hua, Y; Cai, Z. “Randomised, placebo controlled and double-blind trials of efficacy and safety of adalimumab for treating ankylosing spondylitis: a meta-analysis,” Int J Rheum Dis, vol. 17, pp. 142-8, Feb 2014.
[78] Braun, J; Rudwaleit, M; Kary, S; Kron, M; Wong, RL; Kupper, H. “Clinical manifestations and responsiveness to adalimumab are similar in patients with ankylosing spondylitis with and without concomitant psoriasis,” Rheumatology (Oxford), vol. 49, pp. 1578-89, Aug 2010.
[79] Revicki, DA; Menter, A; Feldman, S; Kimel, M; Harnam, N; Willian, MK. “Adalimumab improves health-related quality of life in patients with moderate to severe plaque psoriasis compared with the United States general population norms: results from a randomised, controlled Phase III study,” Health Qual Life Outcomes, vol. 6, p. 75, 2008.
[80] Tsuji, S; Higashiyama, M; Inaoka, M; Tomita, T; Yokomi, A; Satoh, A; et al., “Effects of adalimumab therapy on musculoskeletal manifestations and health-related quality of life in patients with active psoriatic arthritis,” Mod Rheumatol, vol. 23, pp. 529-37, May 2013.
[81] Cohen Barak, E; Kerner, M; Rozenman, D; Ziv, M. “Combination therapy of cyclosporine and anti-tumor necrosis factor alpha in psoriasis: a case series of 10 patients,” Dermatol Ther, vol. 28, pp. 126-30, May-Jun 2015.
[82] Gordon, K; Papp, K; Poulin, Y; Gu, Y; Rozzo, S; Sasso, EH. “Long-term efficacy and safety of adalimumab in patients with moderate to severe psoriasis treated continuously over 3 years: results from an open-label extension study for patients from REVEAL,” J Am Acad Dermatol, vol. 66, pp. 241-51, Feb 2012.
[83] Schmeling, H; Minden, K; Foeldvari, I; Ganser, G; Hospach, T; Horneff, G. “Efficacy and safety of adalimumab as the first and second biologic agent in juvenile idiopathic arthritis: the German Biologics JIA Registry,” Arthritis Rheumatol, vol. 66, pp. 2580-9, Sep 2014.
[84] Rich, P; Griffiths, CE; Reich, K; Nestle, FO; Scher, RK; Li, S; et al., “Baseline nail disease in patients with moderate to severe psoriasis and response to treatment with infliximab during 1 year,” J Am Acad Dermatol, vol. 58, pp. 224-31, Feb 2008.
[85] Reich, K; Ortonne, JP; Kerkmann, U; Wang, Y; Saurat, JH; Papp, K; et al., “Skin and nail responses after 1 year of infliximab therapy in patients with moderate-to-severe psoriasis: a retrospective analysis of the EXPRESS Trial,” Dermatology, vol. 221, pp. 172-8, 2010.
[86] Menter, A; Feldman, SR; Weinstein, GD; Papp, K; Evans, R; Guzzo, C; et al., “A randomised comparison of continuous vs. intermittent infliximab maintenance regimens over 1 year in the treatment of moderate-to-severe plaque psoriasis,” J Am Acad Dermatol, vol. 56, pp. 31.e1-15, Jan 2007.
[87] Antoni, CE; Kavanaugh, A; Kirkham, B; Tutuncu, Z; Burmester, GR; Schneider, U; et al., “Sustained benefits of infliximab therapy for dermatologic and articular manifestations of psoriatic arthritis: results from the infliximab multinational psoriatic arthritis controlled trial (IMPACT),” Arthritis Rheum, vol. 52, pp. 1227-36, Apr 2005.
[88] Kavanaugh, A; Krueger, GG; Beutler, A; Guzzo, C; Zhou, B; Dooley, LT; et al., “Infliximab maintains a high degree of clinical response in patients with active psoriatic arthritis through 1 year of treatment: results from the IMPACT 2 trial,” Ann Rheum Dis, vol. 66, pp. 498-505, Apr 2007.
[89] van der Heijde, D; Kavanaugh, A; Gladman, DD; Antoni, C; Krueger, GG; Guzzo, C; et al., “Infliximab inhibits progression of radiographic damage in patients with active psoriatic arthritis through one year of treatment: Results from the induction and maintenance psoriatic arthritis clinical trial 2,” Arthritis Rheum, vol. 56, pp. 2698-707, Aug 2007.
[90] Kavanaugh, A; Antoni, C; Krueger, GG; Yan, S; Bala, M; Dooley, LT; et al., “Infliximab improves health related quality of life and physical function in patients with psoriatic arthritis,” Ann Rheum Dis, vol. 65, pp. 471-7, Apr 2006.
[91] Yang, HZ; Wang, K; Jin, HZ; Gao, TW; Xiao, SX; Xu, JH; et al., “Infliximab monotherapy for Chinese patients with moderate to severe plaque psoriasis: a randomised, double-blind, placebo-controlled multicenter trial,” Chin Med J (Engl), vol. 125, pp. 1845-51, Jun 2012.
[92] Torii, H; Nakagawa, H. “Infliximab monotherapy in Japanese patients with moderate-to-severe plaque psoriasis and psoriatic arthritis. A randomised, double-blind, placebo-controlled multicenter trial,” J Dermatol Sci, vol. 59, pp. 40-9, Jul 2010.
[93] Barker, J; Hoffmann, M; Wozel, G; Ortonne, JP; Zheng, H; van Hoogstraten, H; et al., “Efficacy and safety of infliximab vs. methotrexate in patients with moderate-to-severe plaque psoriasis: results of an open-label, active-controlled, randomised trial (RESTORE1),” Br J Dermatol, vol. 165, pp. 1109-17, Nov 2011.
[94] Baranauskaite, A; Raffayova, H; Kungurov, NV; Kubanova, A; Venalis, A; Helmle, L; et al., “Infliximab plus methotrexate is superior to methotrexate alone in the treatment of psoriatic arthritis in methotrexate-naive patients: the RESPOND study,” Ann Rheum Dis, vol. 71, pp. 541-8, Apr 2012.
[95] Gottlieb, AB; Kalb, RE; Blauvelt, A; Heffernan, MP; Sofen, HL; Ferris, LK; et al., “The efficacy and safety of infliximab in patients with plaque psoriasis who had an inadequate response to etanercept: results of a prospective, multicenter, open-label study,” J Am Acad Dermatol, vol. 67, pp. 642-50, Oct 2012.
[96] Wallis, RS; Broder, MS; Wong, JY; Hanson, ME; Beenhouwer, DO. “Granulomatous infectious diseases associated with tumor necrosis factor antagonists,” Clin Infect Dis, vol. 38, pp. 1261-5, May 1 2004.
[97] Wallis, RS; Broder, M; Wong, J; Lee, A; Hoq, L. “Reactivation of latent granulomatous infections by infliximab,” Clin Infect Dis, vol. 41 Suppl 3, pp. S194-8, Aug 1 2005.
[98] Gottlieb, AB; Kalb, RE; Langley, RG; Krueger, GG; de Jong, EM; Guenther, L; et al., “Safety observations in 12095 patients with psoriasis enrolled in an international registry (PSOLAR): experience with infliximab and other systemic and biologic therapies,” J Drugs Dermatol, vol. 13, pp. 1441-8, Dec 2014.
[99] Reich, K; Ortonne, JP; Gottlieb, AB; Terpstra, IJ; Coteur, G; Tasset, C; et al., “Successful treatment of moderate to severe plaque psoriasis with the PEGylated Fab' certolizumab pegol: results of a phase II randomised, placebo-controlled trial with a re-treatment extension,” Br J Dermatol, vol. 167, pp. 180-90, Jul 2012.
[100] Mease, PJ; Fleischmann, R; Deodhar, AA; Wollenhaupt, J; Khraishi, M; Kielar, D; et al., “Effect of certolizumab pegol on signs and symptoms in patients with psoriatic arthritis: 24-week results of a Phase 3 double-blind randomised placebo-controlled study (RAPID-PsA),” Ann Rheum Dis, vol. 73, pp. 48-55, Jan 2014.
[101] Mease, PJ; Fleischmann, R; Wollenhaupt, J; Deodhar, A; Gladman, D; Stach, C; et al., “210. Effect of Certolizumab Pegol Over 48 Weeks on Signs and Symptoms in Patients with Psoriatic Arthritis with and Without Prior Tumor Necrosis Factor Inhibitor Exposure,” Rheumatology, vol. 53, pp. i137-i138, April 1, 2014 2014.
[102] van der Heijde, D; Fleischmann, R; Wollenhaupt, J; Deodhar, A; Kielar, D; Woltering, F; et al., “Effect of different imputation approaches on the evaluation of radiographic progression in patients with psoriatic arthritis: results of the RAPID-PsA 24-week phase III double-blind randomised placebo-controlled study of certolizumab pegol,” Ann Rheum Dis, vol. 73, pp. 233-7, Jan 2014.
[103] Gladman, D; Fleischmann, R; Coteur, G; Woltering, F; Mease, PJ. “Effect of certolizumab pegol on multiple facets of psoriatic arthritis as reported by patients: 24-week patient-reported outcome results of a phase III, multicenter study,” Arthritis Care Res (Hoboken), vol. 66, pp. 1085-92, Jul 2014.
[104] Kavanaugh, A; Gladman, D; van der Heijde, D; Purcaru, O; Mease, P. “Improvements in productivity at paid work and within the household, and increased participation in daily activities after 24 weeks of certolizumab pegol treatment of patients with psoriatic arthritis: results of a phase 3 double-blind randomised placebo-controlled study,” Ann Rheum Dis, vol. 74, pp. 44-51, Jan 2015.
[105] Mease, P; Deodhar, A; Fleischmann, R; Wollenhaupt, J; Gladman, D; Leszczyński, P; et al., “Effect of certolizumab pegol over 96 weeks in patients with psoriatic arthritis with and without prior antitumour necrosis factor exposure,” RMD Open, vol. 1, June 1, 2015 2015.
[106] Singh, JA; Wells, GA; Christensen, R; Tanjong Ghogomu, E; Maxwell, L; Macdonald, JK; et al., “Adverse effects of biologics: a network meta-analysis and Cochrane overview,” Cochrane Database Syst Rev, p. Cd008794, 2011.
[107] Kavanaugh, A; McInnes, I; Mease, P; Krueger, GG; Gladman, D; Gomez-Reino, J; et al., “Golimumab, a new human tumor necrosis factor alpha antibody, administered every four weeks as a subcutaneous injection in psoriatic arthritis: Twenty-four-week efficacy and safety results of a randomised, placebo-controlled study,” Arthritis Rheum, vol. 60, pp. 976-86, Apr 2009.
[108] Kavanaugh, A; van der Heijde, D; McInnes, IB; Mease, P; Krueger, GG; Gladman, DD; et al., “Golimumab in psoriatic arthritis: one-year clinical efficacy, radiographic, and safety results from a phase III, randomised, placebo-controlled trial,” Arthritis Rheum, vol. 64, pp. 2504-17, Aug 2012.
[109] Kavanaugh, A; McInnes, IB; Mease, PJ; Krueger, GG; Gladman, DD; van der Heijde, D; et al., “Clinical efficacy, radiographic and safety findings through 2 years of golimumab treatment in patients with active psoriatic arthritis: results from a long-term extension of the randomised, placebo-controlled GO-REVEAL study,” Ann Rheum Dis, vol. 72, pp. 1777-85, Nov 2013.
[110] Kavanaugh, A; McInnes, IB; Mease, P; Krueger, GG; Gladman, D; van der Heijde, D; et al., “Clinical efficacy, radiographic and safety findings through 5 years of subcutaneous golimumab treatment in patients with active psoriatic arthritis: results from a long-term extension of a randomised, placebo-controlled trial (the GO-REVEAL study),” Ann Rheum Dis, April 19, 2014 2014.
[111] Kavanaugh, A; Mease, P. “Treatment of psoriatic arthritis with tumor necrosis factor inhibitors: longer-term outcomes including enthesitis and dactylitis with golimumab treatment in the Longterm Extension of a Randomised, Placebo-controlled Study (GO-REVEAL),” J Rheumatol Suppl, vol. 89, pp. 90-3, Jul 2012.
[112] Lemos, LL; de Oliveira Costa, J; Almeida, AM; Junior, HO; Barbosa, MM; Kakehasi, AM; et al., “Treatment of psoriatic arthritis with anti-TNF agents: a systematic review and meta-analysis of efficacy, effectiveness and safety,” Rheumatol Int, vol. 34, pp. 1345-60, Oct 2014.
[113] Saad, AA; Ashcroft, DM; Watson, KD; Symmons, DP; Noyce, PR; Hyrich, KL; et al., “Efficacy and safety of anti-TNF therapies in psoriatic arthritis: an observational study from the British Society for Rheumatology Biologics Register,” Rheumatology (Oxford), vol. 49, pp. 697-705, Apr 2010.
[114] Rodgers, M; Epstein, D; Bojke, L; Yang, H; Craig, D; Fonseca, T; et al., “Etanercept, infliximab and adalimumab for the treatment of psoriatic arthritis: a systematic review and economic evaluation,” Health Technol Assess, vol. 15, pp. i-xxi, 1-329, Feb 2011.
[115] Yang, H; Craig, D; Epstein, D; Bojke, L; Light, K; Bruce, IN; et al., “Golimumab for the treatment of psoriatic arthritis: a NICE single technology appraisal,” Pharmacoeconomics, vol. 30, pp. 257-70, Apr 2012.
[116] de Portu, S; Del Giglio, M; Altomare, G; Arcangeli, F; Berardesca, E; Calzavara-Pinton, P; et al., “Cost-effectiveness analysis of TNF-alpha blockers for the treatment of chronic plaque psoriasis in the perspective of the Italian health-care system,” Dermatol Ther, vol. 23 Suppl 1, pp. S7-13, Jan-Feb 2010.
[117] Schabert, VF; Watson, C; Joseph, GJ; Iversen, P; Burudpakdee, C; Harrison, DJ. “Costs of tumor necrosis factor blockers per treated patient using real-world drug data in a managed care population,” J Manag Care Pharm, vol. 19, pp. 621-30, Oct 2013.
[118] Leonardi, CL; Kimball, AB; Papp, KA; Yeilding, N; Guzzo, C; Wang, Y; et al., “Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 1),” Lancet, vol. 371, pp. 1665-74, May 17 2008.
[119] Papp, KA; Langley, RG; Lebwohl, M; Krueger, GG; Szapary, P; Yeilding, N; et al., “Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2),” Lancet, vol. 371, pp. 1675-84, May 17 2008.
[120] Rich, P; Bourcier, M; Sofen, H; Fakharzadeh, S; Wasfi, Y; Wang, Y; et al., “Ustekinumab improves nail disease in patients with moderate-to-severe psoriasis: results from PHOENIX 1,” Br J Dermatol, vol. 170, pp. 398-407, Feb 2014.
[121] Gottlieb, A; Menter, A; Mendelsohn, A; Shen, YK; Li, S; Guzzo, C; et al., “Ustekinumab, a human interleukin 12/23 monoclonal antibody, for psoriatic arthritis: randomised, double-blind, placebo-controlled, crossover trial,” Lancet, vol. 373, pp. 633-40, Feb 21 2009.
[122] McInnes, IB; Kavanaugh, A; Gottlieb, AB; Puig, L; Rahman, P; Ritchlin, C; et al., “Efficacy and safety of ustekinumab in patients with active psoriatic arthritis: 1 year results of the phase 3, multicentre, double-blind, placebo-controlled PSUMMIT 1 trial,” Lancet, vol. 382, pp. 780-9, Aug 31 2013.
[123] Ritchlin, C; Rahman, P; Kavanaugh, A; McInnes, IB; Puig, L; Li, S; et al., “Efficacy and safety of the anti-IL-12/23 p40 monoclonal antibody, ustekinumab, in patients with active psoriatic arthritis despite conventional non-biological and biological anti-tumour necrosis factor therapy: 6-month and 1-year results of the phase 3, multicentre, double-blind, placebo-controlled, randomised PSUMMIT 2 trial,” Ann Rheum Dis, vol. 73, pp. 990-9, Jun 2014.
[124] Kavanaugh, A; Puig, L; Gottlieb, A; Ritchlin, C; Li, S; Wang, Y; et al., “Efficacy and Safety of Ustekinumab in Patients with Active Psoriatic Arthritis: 2-Year Results from a Phase 3, Multicenter, Double-Blind, Placebo-Controlled Study,” presented at the 2013 ACR/ARHP Annual Meeting, San Diego, USA, 2013.
[125] Kavanaugh, A; Ritchlin, C; Rahman, P; Puig, L; Gottlieb, AB; Li, S; et al., “Ustekinumab, an anti-IL-12/23 p40 monoclonal antibody, inhibits radiographic progression in patients with active psoriatic arthritis: results of an integrated analysis of radiographic data from the phase 3, multicentre, randomised, double-blind, placebo-controlled PSUMMIT-1 and PSUMMIT-2 trials,” Ann Rheum Dis, vol. 73, pp. 1000-6, Jun 2014.
[126] Kavanaugh, A; Menter, A; Mendelsohn, A; Shen, YK; Lee, S; Gottlieb, AB. “Effect of ustekinumab on physical function and health-related quality of life in patients with psoriatic arthritis: a randomised, placebo-controlled, phase II trial,” Curr Med Res Opin, vol. 26, pp. 2385-92, Oct 2010.
[127] Zhu, X; Zheng, M; Song, M; Shen, YK; Chan, D; Szapary, PO; et al., “Efficacy and safety of ustekinumab in Chinese patients with moderate to severe plaque-type psoriasis: results from a phase 3 clinical trial (LOTUS),” J Drugs Dermatol, vol. 12, pp. 166-74, Feb 2013.
[128] Tsai, TF; Ho, JC; Song, M; Szapary, P; Guzzo, C; Shen, YK; et al., “Efficacy and safety of ustekinumab for the treatment of moderate-to-severe psoriasis: a phase III, randomised, placebo-controlled trial in Taiwanese and Korean patients (PEARL),” J Dermatol Sci, vol. 63, pp. 154-63, Sep 2011.
[129] Young, MS; Horn, EJ; Cather, JC. “The ACCEPT study: ustekinumab vs. etanercept in moderate-to-severe psoriasis patients,” Expert Rev Clin Immunol, vol. 7, pp. 9-13, Jan 2011.
[130] Kimball, AB; Gordon, KB; Fakharzadeh, S; Yeilding, N; Szapary, PO; Schenkel, B; et al., “Long-term efficacy of ustekinumab in patients with moderate-to-severe psoriasis: results from the PHOENIX 1 trial through up to 3 years,” Br J Dermatol, vol. 166, pp. 861-72, Apr 2012.
[131] Papp, K; Gottlieb, AB; Naldi, L; Pariser, D; Ho, V; Goyal, K; et al., “Safety Surveillance for Ustekinumab and Other Psoriasis Treatments From the Psoriasis Longitudinal Assessment and Registry (PSOLAR),” J Drugs Dermatol, vol. 14, pp. 706-14, Jul 2015.
[132] NICE, “Ustekinumab for the treatment of adults with moderate to severe psoriasis, NICE technology appraisal guidance TA180,” NICE, NICE Website09/2009 2009.
[133] NICE, “Ustekinumab for treating active psoriatic arthritis, NICE technology appraisal guidance (TA340),” NICE, NICE Website06/2015 2015.
[134] Langley, RG; Elewski, BE; Lebwohl, M; Reich, K; Griffiths, CEM; Papp, K; et al., “Secukinumab in Plaque Psoriasis — Results of Two Phase 3 Trials,” New England Journal of Medicine, vol. 371, pp. 326-338, 2014.
[135] Paul, C; Lacour, JP; Tedremets, L; Kreutzer, K; Jazayeri, S; Adams, S; et al., “Efficacy, safety and usability of secukinumab administration by autoinjector/pen in psoriasis: a randomised, controlled trial (JUNCTURE),” J Eur Acad Dermatol Venereol, Sep 22 2014.
[136] Blauvelt, A; Prinz, JC; Gottlieb, AB; Kingo, K; Sofen, H; Ruer-Mulard, M; et al., “Secukinumab administration by pre-filled syringe: efficacy, safety and usability results from a randomised controlled trial in psoriasis (FEATURE),” Br J Dermatol, vol. 172, pp. 484-93, Feb 2015.
[137] McInnes, IB; Sieper, J; Braun, J; Emery, P; van der Heijde, D; Isaacs, JD; et al., “Efficacy and safety of secukinumab, a fully human anti-interleukin-17A monoclonal antibody, in patients with moderate-to-severe psoriatic arthritis: a 24-week, randomised, double-blind, placebo-controlled, phase II proof-of-concept trial,” Ann Rheum Dis, vol. 73, pp. 349-56, Feb 2014.
[138] Mease, P; McInnes, I; Kirkham, B; Kavanaugh, A; Rahman, P; van der Heijde, D; et al., “Secukinumab, a Human Anti–Interleukin-17A Monoclonal Antibody, Improves Active Psoriatic Arthritis and Inhibits Radiographic Progression: Efficacy and Safety Data from a Phase 3 Randomised, Multicenter, Double-Blind, Placebo-Controlled Study.,” presented at the ACR 2014, Boston, 2014.
[139] McInnes, I; Mease, P; Kirkham, B; Kavanaugh, A; Ritchlin, C; Rahman, P; et al., “Secukinumab, a Human Anti-Interleukin-17A Monoclonal Antibody, Improves Active Psoriatic Arthritis: 24-Week Efficacy and Safety Data from a Phase 3 Randomised, Multicenter, Double-Blind, Placebo-Controlled Study Using Subcutaneous Dosing.,” presented at the ACR 2014, Boston, 2014.
[140] van der Heijde, D; Landewé, R; Mease, P; McInnes, I; Conaghan, P; Pricop, L; et al., “Secukinumab, a Monoclonal Antibody to Interleukin-17A, Provides Significant and Sustained Inhibition of Joint Structural Damage in Active Psoriatic Arthritis Regardless of Prior TNF Inhibitors or Concomitant Methotrexate: A Phase 3 Randomised, Double-Blind, Placebo-Controlled Study.,” presented at the ACR 2014, Boston, 2014.
[141] NICE, “Secukinumab for treating moderate to severe plaque psoriasis, NICE technology appraisal guidance TA350,” NICE, NICE Website07/2015 2015.
[142] Papp, KA; Leonardi, C; Menter, A; Ortonne, JP; Krueger, JG; Kricorian, G; et al., “Brodalumab, an Anti–Interleukin-17–Receptor Antibody for Psoriasis,” New England Journal of Medicine, vol. 366, pp. 1181-1189, 2012.
[143] Papp, K; Leonardi, C; Menter, A; Thompson, EH; Milmont, CE; Kricorian, G; et al., “Safety and efficacy of brodalumab for psoriasis after 120 weeks of treatment,” J Am Acad Dermatol, vol. 71, pp. 1183-1190.e3, Dec 2014.
[144] Mease, PJ; Genovese, MC; Greenwald, MW; Ritchlin, CT; Beaulieu, AD; Deodhar, A; et al., “Brodalumab, an Anti-IL17RA Monoclonal Antibody, in Psoriatic Arthritis,” New England Journal of Medicine, vol. 370, pp. 2295-2306, 2014.
[145] Leonardi, C; Matheson, R; Zachariae, C; Cameron, G; Li, L; Edson-Heredia, E; et al., “Anti–Interleukin-17 Monoclonal Antibody Ixekizumab in Chronic Plaque Psoriasis,” New England Journal of Medicine, vol. 366, pp. 1190-1199, 2012.
[146] Langley, RG; Rich, P; Menter, A; Krueger, G; Goldblum, O; Dutronc, Y; et al., “Improvement of scalp and nail lesions with ixekizumab in a phase 2 trial in patients with chronic plaque psoriasis,” J Eur Acad Dermatol Venereol, Feb 18 2015.
[147] Sieper, J; Porter-Brown, B; Thompson, L; Harari, O; Dougados, M. “Assessment of short-term symptomatic efficacy of tocilizumab in ankylosing spondylitis: results of randomised, placebo-controlled trials,” Ann Rheum Dis, vol. 73, pp. 95-100, Jan 2014.
[148] Mease, P; Genovese, MC; Gladstein, G; Kivitz, AJ; Ritchlin, C; Tak, PP; et al., “Abatacept in the treatment of patients with psoriatic arthritis: results of a six-month, multicenter, randomised, double-blind, placebo-controlled, phase II trial,” Arthritis Rheum, vol. 63, pp. 939-48, Apr 2011.
[149] Rodrigues, CE; Vieira, FJ; Callado, MR; Gomes, KW; de Andrade, JE; Vieira, WP. “Use of the abatacept in a patient with psoriatic arthritis,” Rev Bras Reumatol, vol. 50, pp. 340-5, May-Jun 2010.
[150] Altmeyer, MD; Kerisit, KG; Boh, EE. “Therapeutic hotline. Abatacept: our experience of use in two patients with refractory psoriasis and psoriatic arthritis,” Dermatol Ther, vol. 24, pp. 287-90, Mar-Apr 2011.
[151] Song, IH; Heldmann, F; Rudwaleit, M; Haibel, H; Weiss, A; Braun, J; et al., “Treatment of active ankylosing spondylitis with abatacept: an open-label, 24-week pilot study,” Ann Rheum Dis, vol. 70, pp. 1108-10, Jun 2011.
[152] Schett, G; Wollenhaupt, J; Papp, K; Joos, R; Rodrigues, JF; Vessey, AR; et al., “Oral apremilast in the treatment of active psoriatic arthritis: results of a multicenter, randomised, double-blind, placebo-controlled study,” Arthritis Rheum, vol. 64, pp. 3156-67, Oct 2012.
[153] Kavanaugh, A; Mease, PJ; Gomez-Reino, JJ; Adebajo, AO; Wollenhaupt, J; Gladman, DD; et al., “Treatment of psoriatic arthritis in a phase 3 randomised, placebo-controlled trial with apremilast, an oral phosphodiesterase 4 inhibitor,” Ann Rheum Dis, vol. 73, pp. 1020-6, Jun 2014.
[154] Strand, V; Fiorentino, D; Hu, C; Day, RM; Stevens, RM; Papp, KA. “Improvements in patient-reported outcomes with apremilast, an oral phosphodiesterase 4 inhibitor, in the treatment of moderate to severe psoriasis: results from a phase IIb randomised, controlled study,” Health Qual Life Outcomes, vol. 11, p. 82, 2013.
[155] Paul, C; Cather, J; Gooderham, M; Poulin, Y; Mrowietz, U; Ferrandiz, C; et al., “Efficacy and safety of apremilast, an oral phosphodiesterase 4 inhibitor, in patients with moderate-to-severe plaque psoriasis over 52 weeks: a phase III, randomised controlled trial (ESTEEM 2),” Br J Dermatol, vol. 173, pp. 1387-99, Dec 2015.
[156] Papp, K; Reich, K; Leonardi, CL; Kircik, L; Chimenti, S; Langley, RG; et al., “Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor, in patients with moderate to severe plaque psoriasis: Results of a phase III, randomised, controlled trial (Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis [ESTEEM] 1),” J Am Acad Dermatol, vol. 73, pp. 37-49, Jul 2015.
[157] Papp, K; Cather, JC; Rosoph, L; Sofen, H; Langley, RG; Matheson, RT; et al., “Efficacy of apremilast in the treatment of moderate to severe psoriasis: a randomised controlled trial,” Lancet, vol. 380, pp. 738-46, Aug 25 2012.
[158] Fala, L. “Otezla (Apremilast), an Oral PDE-4 Inhibitor, Receives FDA Approval for the Treatment of Patients with Active Psoriatic Arthritis and Plaque Psoriasis,” Am Health Drug Benefits, vol. 8, pp. 105-10, Mar 2015.
[159] Kavanaugh, A; Mease, PJ; Gomez-Reino, JJ; Adebajo, AO; Wollenhaupt, J; Gladman, DD; et al., “Longterm (52-week) results of a phase III randomised, controlled trial of apremilast in patients with psoriatic arthritis,” J Rheumatol, vol. 42, pp. 479-88, Mar 2015.
[160] Mughal, F; Cawston, H; Cure, S; Morris, J; Tencer, T; Zhang, F. “Cost-Effectiveness of Apremilast In Psoriatic Arthritis In Scotland,” Value Health, vol. 18, p. A644, Nov 2015.
[161] Gonzalez, CM; Almodovar, R; Caloto, T; Echave, M; Elias, I; Tencer, T. “Cost-Utility Analysis of Apremilast for The Treatment of Psoriatic Arthritis Patients In Spain,” Value Health, vol. 18, p. A645, Nov 2015.
[162] Capri, S; Barbieri, M; Oskar, B. “Cost-Utility Analysis of Apremilast for The Treatment of Psoriatic Arthritis In The Italian Setting,” Value Health, vol. 18, p. A646, Nov 2015.
[163] Krueger, GG; Papp, KA; Stough, DB; Loven, KH; Gulliver, WP; Ellis, CN; et al., “A randomised, double-blind, placebo-controlled phase III study evaluating efficacy and tolerability of 2 courses of alefacept in patients with chronic plaque psoriasis,” J Am Acad Dermatol, vol. 47, pp. 821-33, Dec 2002.
[164] Lebwohl, M; Christophers, E; Langley, R; Ortonne, JP; Roberts, J; Griffiths, CE; et al., “An international, randomised, double-blind, placebo-controlled phase 3 trial of intramuscular alefacept in patients with chronic plaque psoriasis,” Arch Dermatol, vol. 139, pp. 719-27, Jun 2003.
[165] Ortonne, JP. “Clinical response to alefacept: results of a phase 3 study of intramuscular administration of alefacept in patients with chronic plaque psoriasis,” J Eur Acad Dermatol Venereol, vol. 17 Suppl 2, pp. 12-6, Jul 2003.
[166] Feldman, SR; Menter, A; Koo, JY. “Improved health-related quality of life following a randomised controlled trial of alefacept treatment in patients with chronic plaque psoriasis,” Br J Dermatol, vol. 150, pp. 317-26, Feb 2004.
[167] Mease, PJ; Gladman, DD; Keystone, EC; G. Alefacept in Psoriatic Arthritis Study, “Alefacept in combination with methotrexate for the treatment of psoriatic arthritis: results of a randomised, double-blind, placebo-controlled study,” Arthritis Rheum, vol. 54, pp. 1638-45, May 2006.
[168] Papp, KA; Caro, I; Leung, HM; Garovoy, M; Mease, PJ. “Efalizumab for the treatment of psoriatic arthritis,” J Cutan Med Surg, vol. 11, pp. 57-66, Mar-Apr 2007.
[169] Gordon, KB; Papp, KA; Hamilton, TK; Walicke, PA; Dummer, W; Li, N; et al., “Efalizumab for patients with moderate to severe plaque psoriasis: a randomised controlled trial,” JAMA, vol. 290, pp. 3073-80, Dec 17 2003.
[170] Leonardi, CL. “Efalizumab in the treatment of psoriasis,” Dermatol Ther, vol. 17, pp. 393-400, 2004.
[171] Jordan, JK. “Efalizumab for the treatment of moderate to severe plaque psoriasis,” Ann Pharmacother, vol. 39, pp. 1476-82, Sep 2005.
[172] Fretzin, S; Crowley, J; Jones, L; Young, M; Sobell, J. “Successful treatment of hand and foot psoriasis with efalizumab therapy,” J Drugs Dermatol, vol. 5, pp. 838-46, Oct 2006.
[173] Papp, KA; Bressinck, R; Fretzin, S; Goffe, B; Kempers, S; Gordon, KB; et al., “Safety of efalizumab in adults with chronic moderate to severe plaque psoriasis: a phase IIIb, randomised, controlled trial,” Int J Dermatol, vol. 45, pp. 605-14, May 2006.
[174] Prater, EF; Day, A; Patel, M; Menter, A. “A retrospective analysis of 72 patients on prior efalizumab subsequent to the time of voluntary market withdrawal in 2009,” J Drugs Dermatol, vol. 13, pp. 712-8, Jun 2014.
[175] Kwan, JM; Reese, AM; Trafeli, JP. “Delayed autoimmune hemolytic anemia in efalizumab-treated psoriasis,” J Am Acad Dermatol, vol. 58, pp. 1053-5, Jun 2008.
[176] Balato, A; La Bella, S; Gaudiello, F; Balato, N. “Efalizumab-induced guttate psoriasis. Successful management and re-treatment,” J Dermatolog Treat, vol. 19, pp. 182-4, 2008.
[177] Stoppe, M; Thoma, E; Liebert, UG; Major, EO; Hoffmann, KT; Classen, J; et al., “Cerebellar manifestation of PML under fumarate and after efalizumab treatment of psoriasis,” J Neurol, vol. 261, pp. 1021-4, May 2014.
[178] Kothary, N; Diak, IL; Brinker, A; Bezabeh, S; Avigan, M; Dal Pan, G. “Progressive multifocal leukoencephalopathy associated with efalizumab use in psoriasis patients,” J Am Acad Dermatol, vol. 65, pp. 546-51, Sep 2011.
[179] Jimenez-Boj, E; Stamm, TA; Sadlonova, M; Rovensky, J; Raffayova, H; Leeb, B; et al., “Rituximab in psoriatic arthritis: an exploratory evaluation,” Ann Rheum Dis, vol. 71, pp. 1868-71, Nov 2012.
[180] Papp, KA; Menter, A; Strober, B; Langley, RG; Buonanno, M; Wolk, R; et al., “Efficacy and safety of tofacitinib, an oral Janus kinase inhibitor, in the treatment of psoriasis: a Phase 2b randomised placebo-controlled dose-ranging study,” Br J Dermatol, vol. 167, pp. 668-77, Sep 2012.
[181] Menter, A; Papp, KA; Tan, H; Tyring, S; Wolk, R; Buonanno, M. “Efficacy of tofacitinib, an oral janus kinase inhibitor, on clinical signs of moderate-to-severe plaque psoriasis in different body regions,” J Drugs Dermatol, vol. 13, pp. 252-6, Mar 2014.
[182] Gladman, DD; Mease, PJ; Ritchlin, CT; Choy, EH; Sharp, JT; Ory, PA; et al., “Adalimumab for long-term treatment of psoriatic arthritis: forty-eight week data from the adalimumab effectiveness in psoriatic arthritis trial,” Arthritis Rheum, vol. 56, pp. 476-88, Feb 2007.
[183] Menter, A; Kosinski, M; Bresnahan, BW; Papp, KA; Ware, Jr. JE. “Impact of efalizumab on psoriasis-specific patient-reported outcomes. Results from three randomised, placebo-controlled clinical trials of moderate to severe plaque psoriasis,” J Drugs Dermatol, vol. 3, pp. 27-38, Jan-Feb 2004.
[184] National Psoriasis, F. (2015). Biosimilar substitution. Available: https:// www.psoriasis.org/about-psoriasis/treatments/statement-on-biosimilars.
[185] Radtke, MA; Augustin, M. “Biosimilars in psoriasis: what can we expect?” J Dtsch Dermatol Ges, vol. 12, pp. 306-12, Apr 2014.
[186] Jani, RH; Gupta, R; Bhatia, G; Rathi, G; Ashok Kumar, P; Sharma, R; et al., “A prospective, randomised, double-blind, multicentre, parallel-group, active controlled study to compare efficacy and safety of biosimilar adalimumab (Exemptia; ZRC-3197) and adalimumab (Humira) in patients with rheumatoid arthritis,” Int J Rheum Dis, Jul 14 2015.
[187] Baji, P; Pentek, M; Szanto, S; Geher, P; Gulacsi, L; Balogh, O; et al., “Comparative efficacy and safety of biosimilar infliximab and other biological treatments in ankylosing spondylitis: systematic literature review and meta-analysis,” Eur J Health Econ, vol. 15 Suppl 1, pp. S45-52, May 2014.
[188] Budamakuntla, L; Madaiah, M; Sarvajnamurthy, S; Kapanigowda, S. “Itolizumab provides sustained remission in plaque psoriasis: a 5-year follow-up experience,” Clin Exp Dermatol, vol. 40, pp. 152-5, Mar 2015.
[189] Biggioggero, M; Favalli, EG. “Ten-year drug survival of anti-TNF agents in the treatment of inflammatory arthritides,” Drug Dev Res, vol. 75 Suppl 1, pp. S38-41, Nov 2014.

Chapter 14

[1] Ravelli, A; Martini, A. “Juvenile idiopathic arthritis,” Lancet, vol. 369, pp. 767-78, Mar 3 2007.
[2] Kulas, DT; Schanberg, L. “Juvenile idiopathic arthritis,” Curr Opin Rheumatol, vol. 13, pp. 392-8, Sep 2001.
[3] Foeldvari, I; Bidde, M. “Validation of the proposed ILAR classification criteria for juvenile idiopathic arthritis. International League of Associations for Rheumatology,” J Rheumatol, vol. 27, pp. 1069-72, Apr 2000.
[4] Prakken, B; Albani, S; Martini, A. “Juvenile idiopathic arthritis,” Lancet, vol. 377, pp. 2138-49, Jun 18 2011.
[5] Prahalad, S; Glass, DN. “Is juvenile rheumatoid arthritis/juvenile idiopathic arthritis different from rheumatoid arthritis?” Arthritis Res Ther, vol. 4(Suppl 3), pp. 303-310, 2002.
[6] Minden, K; Kiessling, U; Listing, J; Niewerth, M; Doring, E; Meincke, J; et al., “Prognosis of patients with juvenile chronic arthritis and juvenile spondyloarthropathy,” J Rheumatol, vol. 27, pp. 2256-63, Sep 2000.
[7] Zak, M; Pedersen, FK. “Juvenile chronic arthritis into adulthood: a long-term follow-up study,” Rheumatology (Oxford), vol. 39, pp. 198-204, Feb 2000.
[8] Petty, RE. “Growing pains: the ILAR classification of juvenile idiopathic arthritis,” J Rheumatol, vol. 28, pp. 927-8, May 2001.
[9] Petty, RE; Southwood, TR; Manners, P; Baum, J; Glass, DN; Goldenberg, J; et al., “International League of Associations for Rheumatology classification of juvenile idiopathic arthritis: second revision, Edmonton, 2001,” J Rheumatol, vol. 31, pp. 390-2, Feb 2004.
[10] Ringold, S; Bittner, R; Neogi, T; Wallace, CA; Singer, NG. “Performance of rheumatoid arthritis disease activity measures and juvenile arthritis disease activity scores in polyarticular-course juvenile idiopathic arthritis: Analysis of their ability to classify the American College of Rheumatology pediatric measures of response and the preliminary criteria for flare and inactive disease,” Arthritis Care Res (Hoboken), vol. 62, pp. 1095-102, Aug 2010.
[11] Wallace, CA; Giannini, EH; Huang, B; Itert, L; Ruperto, N. “American College of Rheumatology provisional criteria for defining clinical inactive disease in select categories of juvenile idiopathic arthritis,” Arthritis Care Res (Hoboken), vol. 63, pp. 929-36, Jul 2011.
[12] Consolaro, A; Bracciolini, G; Ruperto, N; Pistorio, A; Magni-Manzoni, S; Malattia, C; et al., “Remission, minimal disease activity, and acceptable symptom state in juvenile idiopathic arthritis: defining criteria based on the juvenile arthritis disease activity score,” Arthritis Rheum, vol. 64, pp. 2366-74, Jul 2012.
[13] McErlane, F; Beresford, MW; Baildam, EM; Chieng, SE; Davidson, JE; Foster, HE; et al., “Validity of a three-variable Juvenile Arthritis Disease Activity Score in children with new-onset juvenile idiopathic arthritis,” Ann Rheum Dis, vol. 72, pp. 1983-8, Dec 2013.
[14] Consolaro, A; Negro, G; Chiara Gallo, M; Bracciolini, G; Ferrari, C; Schiappapietra, B; et al., “Defining criteria for disease activity states in nonsystemic juvenile idiopathic arthritis based on a three-variable juvenile arthritis disease activity score,” Arthritis Care Res (Hoboken), vol. 66, pp. 1703-9, Nov 2014.
[15] Consolaro, A; Ruperto, N; Bracciolini, G; Frisina, A; Gallo, MC; Pistorio, A; et al., “Defining criteria for high disease activity in juvenile idiopathic arthritis based on the juvenile arthritis disease activity score,” Ann Rheum Dis, vol. 73, pp. 1380-3, Jul 2014.
[16] Wu, Q; Chaplin, H; Ambrose, N; Sen, D; Leandro, MJ; Wing, C; et al., “Juvenile arthritis disease activity score is a better reflector of active disease than the disease activity score 28 in adults with polyarticular juvenile idiopathic arthritis,” Ann Rheum Dis, Dec 29 2015.
[17] Hinze, C; Gohar, F; Foell, D. “Management of juvenile idiopathic arthritis: hitting the target,” Nat Rev Rheumatol, vol. 11, pp. 290-300, May 2015.
[18] Grigor, C; Capell, H; Stirling, A; McMahon, AD; Lock, P; Vallance, R; et al., “Effect of a treatment strategy of tight control for rheumatoid arthritis (the TICORA study): a single-blind randomised controlled trial,” Lancet, vol. 364, pp. 263-9, Jul 17-23 2004.
[19] Smolen, JS; Sokka, T; Pincus, T; Breedveld, FC. “A proposed treatment algorithm for rheumatoid arthritis: aggressive therapy, methotrexate, and quantitative measures,” Clin Exp Rheumatol, vol. 21, pp. S209-10, Sep-Oct 2003.
[20] Sokka, T; Pincus, T. “Rheumatoid arthritis: strategy more important than agent,” Lancet, vol. 374, pp. 430-2, Aug 8 2009.
[21] Anderson, JJ; Wells, G; Verhoeven, AC; Felson, DT. “Factors predicting response to treatment in rheumatoid arthritis: the importance of disease duration,” Arthritis Rheum, vol. 43, pp. 22-9, Jan 2000.
[22] Moreland, LW; Bridges, Jr., SL. “Early rheumatoid arthritis: a medical emergency?,” Am J Med, vol. 111, pp. 498-500, Oct 15 2001.
[23] Boers, M. “Understanding the window of opportunity concept in early rheumatoid arthritis,” Arthritis Rheum, vol. 48, pp. 1771-4, Jul 2003.
[24] Bartoli, M; Taro, M; Magni-Manzoni, S; Pistorio, A; Traverso, F; Viola, S; et al., “The magnitude of early response to methotrexate therapy predicts long-term outcome of patients with juvenile idiopathic arthritis,” Ann Rheum Dis, vol. 67, pp. 370-4, Mar 2008.
[25] Magnani, A; Pistorio, A; Magni-Manzoni, S; Falcone, A; Lombardini, G; Bandeira, M; et al., “Achievement of a state of inactive disease at least once in the first 5 years predicts better outcome of patients with polyarticular juvenile idiopathic arthritis,” J Rheumatol, vol. 36, pp. 628-34, Mar 2009.
[26] Tynjala, P; Vahasalo, P; Tarkiainen, M; Kroger, L; Aalto, K; Malin, M; et al., “Aggressive combination drug therapy in very early polyarticular juvenile idiopathic arthritis (ACUTE-JIA): a multicentre randomised open-label clinical trial,” Ann Rheum Dis, vol. 70, pp. 1605-12, Sep 2011.
[27] Webb, K; Wedderburn, LR. “Advances in the treatment of polyarticular juvenile idiopathic arthritis,” Curr Opin Rheumatol, vol. 27, pp. 505-10, Sep 2015.
[28] Wallace, CA; Giannini, EH; Spalding, SJ; Hashkes, PJ; O’Neil, KM; Zeft, AS; et al., “Trial of early aggressive therapy in polyarticular juvenile idiopathic arthritis,” Arthritis Rheum, vol. 64, pp. 2012-21, Jun 2012.
[29] Hashkes, PJ. “Pediatric rheumatology: Strengths and challenges of a new guide for treating JIA,” Nat Rev Rheumatol, vol. 7, pp. 377-8, Jul 2011.
[30] Hayward, K; Wallace, CA. “Recent developments in anti-rheumatic drugs in pediatrics: treatment of juvenile idiopathic arthritis,” Arthritis Res Ther, vol. 11, p. 216, 2009.
[31] Boros, C; Whitehead, B. “Juvenile idiopathic arthritis,” Aust Fam Physician, vol. 39, pp. 630-6, Sep 2010.
[32] Cavallo, S; April, KT; Grandpierre, V; Majnemer, A; Feldman, DE. “Leisure in children and adolescents with juvenile idiopathic arthritis: a systematic review,” PLoS One, vol. 9, p. e104642, 2014.
[33] Hashkes, PJ; Laxer, RM. “Medical treatment of juvenile idiopathic arthritis,” JAMA, vol. 294, pp. 1671-84, Oct 5 2005.
[34] Wallace, CA. “Current management of juvenile idiopathic arthritis,” Best Pract Res Clin Rheumatol, vol. 20, pp. 279-300, Apr 2006.
[35] Dent, PB; Walker, N. “Intra-articular corticosteroids in the treatment of juvenile rheumatoid arthritis,” Curr Opin Rheumatol, vol. 10, pp. 475-80, Sep 1998.
[36] Cleary, AG; Murphy, HD; Davidson, JE. “Intra-articular corticosteroid injections in juvenile idiopathic arthritis,” Arch Dis Child, vol. 88, pp. 192-6, Mar 2003.
[37] Bloom, BJ; Alario, AJ; Miller, LC. “Intra-articular corticosteroid therapy for juvenile idiopathic arthritis: report of an experiential cohort and literature review,” Rheumatol Int, vol. 31, pp. 749-56, Jun 2011.
[38] Sherry, DD; Stein, LD; Reed, AM; Schanberg, LE; Kredich, DW. “Prevention of leg length discrepancy in young children with pauciarticular juvenile rheumatoid arthritis by treatment with intraarticular steroids,” Arthritis Rheum, vol. 42, pp. 2330-4, Nov 1999.
[39] Padeh, S; Passwell, JH. “Intraarticular corticosteroid injection in the management of children with chronic arthritis,” Arthritis Rheum, vol. 41, pp. 1210-4, Jul 1998.
[40] Southwood, TR. “Report from a symposium on corticosteroid therapy in juvenile chronic arthritis,” Clin Exp Rheumatol, vol. 11, pp. 91-4, Jan-Feb 1993.
[41] Scott, C; Meiorin, S; Filocamo, G; Lanni, S; Valle, M; Martinoli, C; et al., “A reappraisal of intra-articular corticosteroid therapy in juvenile idiopathic arthritis,” Clin Exp Rheumatol, vol. 28, pp. 774-81, Sep-Oct 2010.
[42] Papadopoulou, C; Kostik, M; Gonzalez-Fernandez, MI; Bohm, M; Nieto-Gonzalez, JC; Pistorio, A; et al., “Delineating the role of multiple intraarticular corticosteroid injections in the management of juvenile idiopathic arthritis in the biologic era,” Arthritis Care Res (Hoboken), vol. 65, pp. 1112-20, Jul 2013.
[43] Giannini, EH; Brewer, EJ; Kuzmina, N; Shaikov, A; Maximov, A; Vorontsov, I; et al., “Methotrexate in resistant juvenile rheumatoid arthritis. Results of the U.S.A.-U.S.S.R. double-blind, placebo-controlled trial. The Pediatric Rheumatology Collaborative Study Group and The Cooperative Children’s Study Group,” N Engl J Med, vol. 326, pp. 1043-9, Apr 16 1992.
[44] Ruperto, N; Murray, KJ; Gerloni, V; Wulffraat, N; de Oliveira, SK; Falcini, F; et al., “A randomised trial of parenteral methotrexate comparing an intermediate dose with a higher dose in children with juvenile idiopathic arthritis who failed to respond to standard doses of methotrexate,” Arthritis Rheum, vol. 50, pp. 2191-201, Jul 2004.
[45] Chen, J; Liu, C; Lin, J. “Methotrexate for ankylosing spondylitis,” Cochrane Database Syst Rev, p. CD004524, 2006.
[46] Papadopoulou, C; Eleftheriou, D. “How do I ensure safe use of biological agents in children and adolescents with rheumatic diseases?,” Paediatrics and Child Health, vol. 24, pp. 264-268, 2014.
[47] Carswell, EA; Old, LJ; Kassel, RL; Green, S; Fiore, N; Williamson, B. “An endotoxin-induced serum factor that causes necrosis of tumors,” Proc Natl Acad Sci U S A, vol. 72, pp. 3666-70, Sep 1975.
[48] Bazzoni, F; Beutler, B. “The tumor necrosis factor ligand and receptor families,” N Engl J Med, vol. 334, pp. 1717-25, Jun 27 1996.
[49] Silva, LC; Ortigosa, LC; Benard, G. “Anti-TNF-alpha agents in the treatment of immune-mediated inflammatory diseases: mechanisms of action and pitfalls,” Immunotherapy, vol. 2, pp. 817-33, Nov 2010.
[50] Kollias, G; Kontoyiannis, D. “Role of TNF/TNFR in autoimmunity: specific TNF receptor blockade may be advantageous to anti-TNF treatments,” Cytokine Growth Factor Rev, vol. 13, pp. 315-21, Aug-Oct 2002.
[51] Pfeffer, K. “Biological functions of tumor necrosis factor cytokines and their receptors,” Cytokine Growth Factor Rev, vol. 14, pp. 185-91, Jun-Aug 2003.
[52] Beukelman, T; Patkar, NM; Saag, KG; Tolleson-Rinehart, S; Cron, RQ; DeWitt, EM; et al., “2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: initiation and safety monitoring of therapeutic agents for the treatment of arthritis and systemic features,” Arthritis Care Res (Hoboken), vol. 63, pp. 465-82, Apr 2011.
[53] Lovell, DJ; Giannini, EH; Reiff, A; Cawkwell, GD; Silverman, ED; Nocton, JJ; et al., “Etanercept in children with polyarticular juvenile rheumatoid arthritis. Pediatric Rheumatology Collaborative Study Group,” N Engl J Med, vol. 342, pp. 763-9, Mar 16 2000.
[54] Tzaribachev, N; Kuemmerle-Deschner, J; Eichner, M; Horneff, G. “Safety and efficacy of etanercept in children with juvenile idiopathic arthritis below the age of 4 years,” Rheumatol Int, vol. 28, pp. 1031-4, Aug 2008.
[55] Horneff, G; Schmeling, H; Biedermann, T; Foeldvari, I; Ganser, G; Girschick, HJ; et al., “The German etanercept registry for treatment of juvenile idiopathic arthritis,” Ann Rheum Dis, vol. 63, pp. 1638-44, Dec 2004.
[56] Kietz, DA; Pepmueller, PH; Moore, TL. “Therapeutic use of etanercept in polyarticular course juvenile idiopathic arthritis over a two year period,” Ann Rheum Dis, vol. 61, pp. 171-3, Feb 2002.
[57] Horneff, G; Burgos-Vargas, R; Constantin, T; Foeldvari, I; Vojinovic, J; Chasnyk, VG; et al., “Efficacy and safety of open-label etanercept on extended oligoarticular juvenile idiopathic arthritis, enthesitis-related arthritis and psoriatic arthritis: part 1 (week 12) of the CLIPPER study,” Ann Rheum Dis, vol. 73, pp. 1114-22, Jun 2014.
[58] Horneff, G; Foeldvari, I; Minden, K; Trauzeddel, R; Kummerle-Deschner, JB; Tenbrock, K; et al., “Efficacy and safety of etanercept in patients with the enthesitis-related arthritis category of juvenile idiopathic arthritis: results from a phase III randomised, double-blind study,” Arthritis Rheumatol, vol. 67, pp. 2240-9, May 2015.
[59] Horneff, G; Ebert, A; Fitter, S; Minden, K; Foeldvari, I; Kummerle-Deschner, J; et al., “Safety and efficacy of once weekly etanercept 0.8 mg/kg in a multicentre 12 week trial in active polyarticular course juvenile idiopathic arthritis,” Rheumatology (Oxford), vol. 48, pp. 916-9, Aug 2009.
[60] Wallace, CA; Ruperto, N; Giannini, E. “Preliminary criteria for clinical remission for select categories of juvenile idiopathic arthritis,” J Rheumatol, vol. 31, pp. 2290-4, Nov 2004.
[61] Prince, FH; Twilt, M; Simon, SC; van Rossum, MA; Armbrust, W; Hoppenreijs, EP. et al., “When and how to stop etanercept after successful treatment of patients with juvenile idiopathic arthritis,” Ann Rheum Dis, vol. 68, pp. 1228-9, Jul 2009.
[62] Lovell, DJ; Ruperto, N; Goodman, S; Reiff, A; Jung, L; Jarosova, K; et al., “Adalimumab with or without methotrexate in juvenile rheumatoid arthritis,” N Engl J Med, vol. 359, pp. 810-20, Aug 21 2008.
[63] Burgos-Vargas, R; Tse, SM; Horneff, G; Pangan, AL; Kalabic, J; Goss, S; et al., “A Randomised, Double-blind, Placebo-Controlled Multicenter Study of Adalimumab in Pediatric Patients With Enthesitis-Related Arthritis,” Arthritis Care Res (Hoboken), vol. 67, pp. 1503-12, Nov 2015.
[64] Heiligenhaus, A; Niewerth, M; Ganser, G; Heinz, C; Minden, K; “Prevalence and complications of uveitis in juvenile idiopathic arthritis in a population-based nation-wide study in Germany: suggested modification of the current screening guidelines,” Rheumatology (Oxford), vol. 46, pp. 1015-9, Jun 2007.
[65] Biester, S; Deuter, C; Michels, H; Haefner, R; Kuemmerle-Deschner, J; Doycheva, D; et al., “Adalimumab in the therapy of uveitis in childhood,” Br J Ophthalmol, vol. 91, pp. 319-24, Mar 2007.
[66] Tynjala, P; Kotaniemi, K; Lindahl, P; Latva, K; Aalto, K; Honkanen, V; et al., “Adalimumab in juvenile idiopathic arthritis-associated chronic anterior uveitis,” Rheumatology (Oxford), vol. 47, pp. 339-44, Mar 2008.
[67] Ramanan, AV; Dick, AD; Benton, D; Compeyrot-Lacassagne, S; Dawoud, D; Hardwick, B; et al., “A randomised controlled trial of the clinical effectiveness, safety and cost-effectiveness of adalimumab in combination with methotrexate for the treatment of juvenile idiopathic arthritis associated uveitis (SYCAMORE Trial),” Trials, vol. 15, p. 14, 2014.
[68] Steigerwald, KA; Ilowite, NT. “Novel treatment options for juvenile idiopathic arthritis,” Expert Rev Clin Pharmacol, vol. 8, pp. 559-73, Sep 2015.
[69] Maini, R; St Clair, EW; Breedveld, F; Furst, D; Kalden, J; Weisman, M; et al., “Infliximab (chimeric anti-tumour necrosis factor alpha monoclonal antibody) versus placebo in rheumatoid arthritis patients receiving concomitant methotrexate: a randomised phase III trial. ATTRACT Study Group,” Lancet, vol. 354, pp. 1932-9, Dec 4 1999.
[70] Lipsky, PE; van der Heijde, DM; St Clair, EW; Furst, DE; Breedveld, FC; Kalden, JR; et al., “Infliximab and methotrexate in the treatment of rheumatoid arthritis. Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group,” N Engl J Med, vol. 343, pp. 1594-602, Nov 30 2000.
[71] Ruperto, N; Lovell, DJ; Cuttica, R; Wilkinson, N; Woo, P; Espada, G; et al., “A randomised, placebo-controlled trial of infliximab plus methotrexate for the treatment of polyarticular-course juvenile rheumatoid arthritis,” Arthritis Rheum, vol. 56, pp. 3096-106, Sep 2007.
[72] Kahn, P. “Juvenile idiopathic arthritis - an update on pharmacotherapy,” Bull NYU Hosp Jt Dis, vol. 69, pp. 264-76, 2011.
[73] Simonini, G; Druce, K; Cimaz, R; Macfarlane, GJ; Jones, GT. “Current evidence of anti-tumor necrosis factor alpha treatment efficacy in childhood chronic uveitis: a systematic review and meta-analysis approach of individual drugs,” Arthritis Care Res (Hoboken), vol. 66, pp. 1073-84, Jul 2014.
[74] Tambralli, A; Beukelman, T; Weiser, P; Atkinson, TP; Cron, RQ; Stoll, ML. “High doses of infliximab in the management of juvenile idiopathic arthritis,” J Rheumatol, vol. 40, pp. 1749-55, Oct 2013.
[75] Maini, SR. “Infliximab treatment of rheumatoid arthritis,” Rheum Dis Clin North Am, vol. 30, pp. 329-47, vii, May 2004.
[76] Sandborn, WJ; Feagan, BG; Stoinov, S; Honiball, PJ; Rutgeerts, P; Mason, D; et al., “Certolizumab pegol for the treatment of Crohn’s disease,” N Engl J Med, vol. 357, pp. 228-38, Jul 19 2007.
[77] Kay, J; Matteson, EL; Dasgupta, B; Nash, P; Durez, P; Hall, S; et al., “Golimumab in patients with active rheumatoid arthritis despite treatment with methotrexate: a randomised, double-blind, placebo-controlled, dose-ranging study,” Arthritis Rheum, vol. 58, pp. 964-75, Apr 2008.
[78] Linsley, PS; Brady, W; Urnes, M; Grosmaire, LS; Damle, NK; Ledbetter, JA. “CTLA-4 is a second receptor for the B cell activation antigen B7,” J Exp Med, vol. 174, pp. 561-9, Sep 1 1991.
[79] Kremer, JM; Dougados, M; Emery, P; Durez, P; Sibilia, J; Shergy, W; et al., “Treatment of rheumatoid arthritis with the selective costimulation modulator abatacept: twelve-month results of a phase iib, double-blind, randomised, placebo-controlled trial,” Arthritis Rheum, vol. 52, pp. 2263-71, Aug 2005.
[80] Ruperto, N; Lovell, DJ; Quartier, P; Paz, E; Rubio-Perez, N; Silva, CA; et al., “Abatacept in children with juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled withdrawal trial,” Lancet, vol. 372, pp. 383-91, Aug 2 2008.
[81] Kuek, A; Hazleman, BL; Gaston, JH; Ostor, AJ. “Successful treatment of refractory polyarticular juvenile idiopathic arthritis with rituximab,” Rheumatology (Oxford), vol. 45, pp. 1448-9, Nov 2006.
[82] Alexeeva, EI; Valieva, SI; Bzarova, TM; Semikina, EL; Isaeva, KB; Lisitsyn, AO; et al., “Efficacy and safety of repeat courses of rituximab treatment in patients with severe refractory juvenile idiopathic arthritis,” Clin Rheumatol, vol. 30, pp. 1163-72, Sep 2011.
[83] “Interim Clinical Commissioning Policy Statement: Biologic Therapies for the treatment of Juvenile Idiopathic Arthritis (JIA),” 2015.
[84] De Benedetti, F; Martini, A. “Is systemic juvenile rheumatoid arthritis an interleukin 6 mediated disease?,” J Rheumatol, vol. 25, pp. 203-7, Feb 1998.
[85] Pascual, V; Allantaz, F; Arce, E; Punaro, M; Banchereau, J. “Role of interleukin-1 (IL1) in the pathogenesis of systemic onset juvenile idiopathic arthritis and clinical response to IL1 blockade,” J Exp Med, vol. 201, pp. 1479-86, May 2 2005.
[86] Irigoyen, PI; Olson, J; Hom, C. “Treatment of systemic onset juvenile rheumatoid arthritis with anakinra [abstract],” Arthritis Rheum, vol. 50(suppl), p. S437, 2004.
[87] Verbsky, JW; White, AJ. “Effective use of the recombinant interleukin 1 receptor antagonist anakinra in therapy resistant systemic onset juvenile rheumatoid arthritis,” J Rheumatol, vol. 31, pp. 2071-5, Oct 2004.
[88] Stoll, ML; Gotte, AC; “Biological therapies for the treatment of juvenile idiopathic arthritis: Lessons from the adult and pediatric experiences,” Biologics, vol. 2, pp. 229-52, Jun 2008.
[89] Quartier, P; Allantaz, F; Cimaz, R; Pillet, P; Messiaen, C; Bardin, C; et al., “A multicentre, randomised, double-blind, placebo-controlled trial with the interleukin-1 receptor antagonist anakinra in patients with systemic-onset juvenile idiopathic arthritis (ANAJIS trial),” Ann Rheum Dis, vol. 70, pp. 747-54, May 2011.
[90] Nigrovic, PA; Mannion, M; Prince, FH; Zeft, A; Rabinovich, CE; van Rossum, MA; et al., “Anakinra as first-line disease-modifying therapy in systemic juvenile idiopathic arthritis: report of forty-six patients from an international multicenter series,” Arthritis Rheum, vol. 63, pp. 545-55, Feb 2011.
[91] Vastert, SJ; de Jager, W; Noordman, BJ; Holzinger, D; Kuis, W; Prakken, BJ; et al., “Effectiveness of first-line treatment with recombinant interleukin-1 receptor antagonist in steroid-naive patients with new-onset systemic juvenile idiopathic arthritis: results of a prospective cohort study,” Arthritis Rheumatol, vol. 66, pp. 1034-43, Apr 2014.
[92] Kahn, PJ; Cron, RQ. “Higher-dose Anakinra is effective in a case of medically refractory macrophage activation syndrome,” J Rheumatol, vol. 40, pp. 743-4, May 2013.
[93] Miettunen, PM; Narendran, A; Jayanthan, A; Behrens, EM; Cron, RQ. “Successful treatment of severe paediatric rheumatic disease-associated macrophage activation syndrome with interleukin-1 inhibition following conventional immunosuppressive therapy: case series with 12 patients,” Rheumatology (Oxford), vol. 50, pp. 417-9, Feb 2011.
[94] Gattorno, M; Piccini, A; Lasiglie, D; Tassi, S; Brisca, G; Carta, S; et al., “The pattern of response to anti-interleukin-1 treatment distinguishes two subsets of patients with systemic-onset juvenile idiopathic arthritis,” Arthritis Rheum, vol. 58, pp. 1505-15, May 2008.
[95] Hoy, SM. “Canakinumab: a review of its use in the management of systemic juvenile idiopathic arthritis,” BioDrugs, vol. 29, pp. 133-42, Apr 2015.
[96] Ruperto, N; Brunner, HI; Quartier, P; Constantin, T; Wulffraat, N; Horneff, G; et al., “Two randomised trials of canakinumab in systemic juvenile idiopathic arthritis,” N Engl J Med, vol. 367, pp. 2396-406, Dec 20 2012.
[97] Grom, AA; Ilowite, NT; Pascual, V; Brunner, HI; Martini, A; Lovell, D; et al., “Canakinumab in Systemic Juvenile Idiopathic Arthritis: Impact on the Rate and Clinical Presentation of Macrophage Activation Syndrome,” Arthritis Rheumatol, Aug 28 2015.
[98] Economides, AN; Carpenter, LR; Rudge, JS; Wong, V; Koehler-Stec, EM; Hartnett, C; et al., “Cytokine traps: multi-component, high-affinity blockers of cytokine action,” Nat Med, vol. 9, pp. 47-52, Jan 2003.
[99] Lovell, DJ; Giannini, EH; Reiff, AO; Kimura, Y; Li, S; Hashkes, PJ; et al., “Long-term safety and efficacy of rilonacept in patients with systemic juvenile idiopathic arthritis,” Arthritis Rheum, vol. 65, pp. 2486-96, Sep 2013.
[100] Ilowite, NT; Prather, K; Lokhnygina, Y; Schanberg, LE; Elder, M; Milojevic, D; et al., “Randomised, double-blind, placebo-controlled trial of the efficacy and safety of rilonacept in the treatment of systemic juvenile idiopathic arthritis,” Arthritis Rheumatol, vol. 66, pp. 2570-9, Sep 2014.
[101] Yokota, S; Imagawa, T; Mori, M; Miyamae, T; Aihara, Y; Takei, S; et al., “Efficacy and safety of tocilizumab in patients with systemic-onset juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled, withdrawal phase III trial,” Lancet, vol. 371, pp. 998-1006, Mar 22 2008.
[102] De Benedetti, F; Brunner, HI; Ruperto, N; Kenwright, A; Wright, S; Calvo, I; et al., “Randomised trial of tocilizumab in systemic juvenile idiopathic arthritis,” N Engl J Med, vol. 367, pp. 2385-95, Dec 20 2012.
[103] Brunner, HI; Ruperto, N; Zuber, Z; Keane, C; Harari, O; Kenwright, A; et al., “Efficacy and safety of tocilizumab in patients with polyarticular-course juvenile idiopathic arthritis: results from a phase 3, randomised, double-blind withdrawal trial,” Ann Rheum Dis, vol. 74, pp. 1110-7, Jun 2015.
[104] Otten, MH; Prince, FH; Ten Cate, R; van Rossum, MA; Twilt, M; Hoppenreijs, EP; et al., “Tumour necrosis factor (TNF)-blocking agents in juvenile psoriatic arthritis: are they effective?,” Ann Rheum Dis, vol. 70, pp. 337-40, Feb 2011.
[105] Menter, A; Korman, NJ; Elmets, CA; Feldman, SR; Gelfand, JM; Gordon, KB; et al., “Guidelines of care for the management of psoriasis and psoriatic arthritis: section 6. Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions,” J Am Acad Dermatol, vol. 65, pp. 137-74, Jul 2011.
[106] Fotiadou, C; Lazaridou, E; Ioannides, D. “Management of psoriasis in adolescence,” Adolesc Health Med Ther, vol. 5, pp. 25-34, 2014.
[107] Leonardi, CL; Kimball, AB; Papp, KA; Yeilding, N; Guzzo, C; Wang, Y; et al., “Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 76-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 1),” Lancet, vol. 371, pp. 1665-74, May 17 2008.
[108] Papp, KA; Langley, RG; Lebwohl, M; Krueger, GG; Szapary, P; Yeilding, N; et al., “Efficacy and safety of ustekinumab, a human interleukin-12/23 monoclonal antibody, in patients with psoriasis: 52-week results from a randomised, double-blind, placebo-controlled trial (PHOENIX 2),” Lancet, vol. 371, pp. 1675-84, May 17 2008.
[109] Landells, I; Marano, C; Hsu, MC; Li, S; Zhu, Y; Eichenfield, LF; et al., “Ustekinumab in adolescent patients age 12 to 17 years with moderate-to-severe plaque psoriasis: Results of the randomised phase 3 CADMUS study,” J Am Acad Dermatol, vol. 73, pp. 594-603, Oct 2015.
[110] Ritchlin, C; Rahman, P; Kavanaugh, A; McInnes, IB; Puig, L; Li, S; et al., “Efficacy and safety of the anti-IL12/23 p40 monoclonal antibody, ustekinumab, in patients with active psoriatic arthritis despite conventional non-biological and biological anti-tumour necrosis factor therapy: 6-month and 1-year results of the phase 3, multicentre, double-blind, placebo-controlled, randomised PSUMMIT 2 trial,” Ann Rheum Dis, vol. 73, pp. 990-9, Jun 2014.
[111] Felquer, ML; Soriano, ER. “New treatment paradigms in psoriatic arthritis: an update on new therapeutics approved by the U.S. Food and Drug Administration,” Curr Opin Rheumatol, vol. 27, pp. 99-106, Mar 2015.
[112] Tse, SM; Burgos-Vargas, R; Laxer, RM. “Anti-tumor necrosis factor alpha blockade in the treatment of juvenile spondylarthropathy,” Arthritis Rheum, vol. 52, pp. 2103-8, Jul 2005.
[113] Otten, MH; Prince, FH; Twilt, M; Ten Cate, R; Armbrust, W; Hoppenreijs, EP; et al., “Tumor necrosis factor-blocking agents for children with enthesitis-related arthritis--data from the dutch arthritis and biologicals in children register, 1999-2010,” J Rheumatol, vol. 38, pp. 2258-63, Oct 2011.
[114] Horneff, G; Fitter, S; Foeldvari, I; Minden, K; Kuemmerle-Deschner, J; Tzaribacev, N; et al., “Double-blind, placebo-controlled randomised trial with adalimumab for treatment of juvenile onset ankylosing spondylitis (JoAS): significant short term improvement,” Arthritis Res Ther, vol. 14, p. R230, 2012.
[115] Haroon, N; Inman, RD; Learch, TJ; Weisman, MH; Lee, M; Rahbar, MH; et al., “The impact of tumor necrosis factor alpha inhibitors on radiographic progression in ankylosing spondylitis,” Arthritis Rheum, vol. 65, pp. 2645-54, Oct 2013.
[116] Aggarwal, A; Misra, DP. “Enthesitis-related arthritis,” Clin Rheumatol, Aug 2 2015.


Chapter 15

[1] Symmons, DPM; Barrett, EM; Bankhead, CR; Scott, DGI; Silman, AJ. “The Incidence of Rheumatoid-Arthritis in the United-Kingdom - Results from the Norfolk Arthritis Register,” British Journal of Rheumatology, vol. 33, pp. 735-739, Aug 1994.
[2] Gladman, DD; Antoni, C; Mease, P; Clegg, DO; Nash, P. “Psoriatic arthritis: epidemiology, clinical features, course, and outcome,” Annals of the Rheumatic Diseases, vol. 64, pp. 14-17, Mar 2005.
[3] Chakravarty, EF; Nelson, L; Krishnan, E. “Obstetric hospitalizations in the United States for women with systemic lupus erythematosus and rheumatoid arthritis,” Arthritis and Rheumatism, vol. 54, pp. 899-907, Mar 2006.
[4] Clowse, ME; Jamison, M; Myers, E; James, AH. “A national study of the complications of lupus in pregnancy,” Am J Obstet Gynecol, vol. 199, pp. 127 e1-6, Aug 2008.
[5] Andreoli, L; Chighizola, CB; Banzato, A; Pons-Estel, GJ; de Jesus, GR; Erkan, D; et al., “Estimated Frequency of Antiphospholipid Antibodies in Patients With Pregnancy Morbidity, Stroke, Myocardial Infarction, and Deep Vein Thrombosis: A Critical Review of the Literature,” Arthritis Care and Research, vol. 65, pp. 1869-1873, Nov 2013.
[6] Borella, E; Lojacono, A; Gatto, M; Andreoli, L; Taglietti, M; Iaccarino, L; et al., “Predictors of maternal and fetal complications in SLE patients: a prospective study,” Immunologic Research, vol. 60, pp. 170-176, Dec 2014.
[7] De Man, YA; Hazes, JMW; van der Heide, H; Willemsen, SP; de Groot, CJM; Steegers, EAP; et al., “Association of Higher Rheumatoid Arthritis Disease Activity During Pregnancy With Lower Birth Weight Results of a National Prospective Study,” Arthritis and Rheumatism, vol. 60, pp. 3196-3206, Nov 2009.
[8] Clowse, MEB. “Lupus activity in pregnancy,” Rheumatic Disease Clinics of North America, vol. 33, pp. 237-+, May 2007.
[9] Yang, MJ; Chen, CY; Chang, WH; Tseng, JY; Yeh, CC. “Pregnancy outcome of systemic lupus erythematosus in relation to lupus activity before and during pregnancy,” Journal of the Chinese Medical Association, vol. 78, pp. 235-240, Apr 2015.
[10] Clowse, MEB. “Managing contraception and pregnancy in the rheumatologic diseases,” Best Practice and Research in Clinical Rheumatology, vol. 24, pp. 373-385, Jun 2010.
[11] Hazes, JMW; Coulie, PG; Geenen, V; Vermeire, S; Carbonnel, F; Louis, E; et al., “Rheumatoid arthritis and pregnancy: evolution of disease activity and pathophysiological considerations for drug use,” Rheumatology, vol. 50, pp. 1955-1968, Nov 2011.
[12] De Man, YA; Dolhain, RJEM; Van De Geijn, FE; Willemsen, SP; Hazes, JNW. “Disease activity of rheumatoid arthritis during pregnancy: Results from a nationwide prospective study,” Arthritis and Rheumatism-Arthritis Care and Research, vol. 59, pp. 1241-1248, Sep 15 2008.
[13] Clowse, MEB; Magder, LS; Witter, F; Petri, M. “The impact of increased lupus activity on obstetric outcomes,” Arthritis and Rheumatism, vol. 52, pp. 514-521, Feb 2005.
[14] Ko, HS; Ahn, HY; Jang, DG; Choi, SK; Park, YG; Park, IY; et al., “Pregnancy Outcomes and Appropriate Timing of Pregnancy in 183 pregnancies in Korean Patients with SLE,” International Journal of Medical Sciences, vol. 8, pp. 577-583, 2011.
[15] Urowitz, MB; Gladman, DD; Farewell, VT; Stewart, J; Mcdonald, J. “Lupus and Pregnancy Studies,” Arthritis and Rheumatism, vol. 36, pp. 1392-1397, Oct 1993.
[16] Chakravarty, EF; Colon, I; Langen, ES; Nix, DA; El-Sayed, YY; Genovese, MC; et al., “Factors that predict prematurity and preeclampsia in pregnancies that are complicated by systemic lupus erythematosus,” American Journal of Obstetrics and Gynecology, vol. 192, pp. 1897-1904, Jun 2005.
[17] Cortes-Hernandez, J; Ordi-Ros, J; Paredes, F; Casellas, M; Castillo, F; Vilardell-Tarres, M. “Clinical predictors of fetal and maternal outcome in systemic lupus erythematosus: a prospective study of 103 pregnancies,” Rheumatology, vol. 41, pp. 643-650, Jun 2002.
[18] Clowse, MEB; Magder, L; Witter, F; Petri, M. “Hydroxychloroquine in lupus pregnancy,” Arthritis and Rheumatism, vol. 54, pp. 3640-3647, Nov 2006.
[19] Ostensen, M; Khamashta, M; Lockshin, M; Parke, A; Brucato, A; Carp, H; et al., “Anti-inflammatory and immunosuppressive drugs and reproduction,” Arthritis Research and Therapy, vol. 8, 2006.
[20] Ostensen, M; Lockshin, M; Doria, A; Valesini, G; Meroni, P; Gordon, C; et al., “Update on safety during pregnancy of biological agents and some immunosuppressive anti-rheumatic drugs,” Rheumatology, vol. 47, pp. 28-31, Jun 2008.
[21] Mahadevan, U; Cucchiara, S; Hyams, JS; Steinwurz, F; Nuti, F; Travis, SPL; et al., “The London Position Statement of the World Congress of Gastroenterology on Biological Therapy for IBD With the European Crohn's and Colitis Organization: Pregnancy and Pediatrics,” American Journal of Gastroenterology, vol. 106, pp. 214-223, Feb 2011.
[22] Flint, J; Panchal, S; Hurrell, A; van de Venne, M; Gayed, M; Schreiber, K; et al., “BSR and BHPR guideline on prescribing drugs in pregnancy and breastfeeding-Part I: standard and biologic disease modifying anti-rheumatic drugs and corticosteroids,” Rheumatology (Oxford), Jan 10 2016.
[23] Nesbitt, A; Kevorkian, L; Baker, T. “Lack of FcRn binding in vitro and no measurable levels of ex vivo placental transfer of certolizumab pegol,” Human Reproduction, vol. 29, pp. 127-127, Jul 2014.
[24] Herrera-Esparza, R; Bollain-y-Goytia, JJ; Avalos-Díaz, E. “Pathogenic effects of maternal antinuclear antibodies during pregnancy in women with lupus,” Rheumatology Reports, vol. 6, 2014.
[25] Hyrich, KL; Verstappen, SMM. “Biologic therapies and pregnancy: the story so far,” Rheumatology, vol. 53, pp. 1377-1385, Aug 2014.
[26] Zaretsky, MV; Alexander, JM; Byrd, W; Bawdon, RE. “Transfer of inflammatory cytokines across the placenta,” Obstetrics and Gynecology, vol. 103, pp. 546-550, Mar 2004.
[27] Atzeni, F; Benucci, M; Sallì, S; Bongiovanni, S; Boccassini, L; Sarzi-Puttini, P. “Different effects of biological drugs in rheumatoid arthritis,” Autoimmunity Reviews, vol. 12, pp. 575-579, 2013.
[28] Sammaritano, LR; Bermas, BL. “Rheumatoid arthritis medications and lactation,” Current Opinion in Rheumatology, vol. 26, pp. 354-360, May 2014.
[29] Clowse, ME; Wolf, DC; Forger, F; Cush, JJ; Golembesky, A; Shaughnessy, L; et al., “Pregnancy Outcomes in Subjects Exposed to Certolizumab Pegol,” J Rheumatol, vol. 42, pp. 2270-8, Dec 2015.
[30] Matro, R; Martin, CF; Wolf, DC; Shah, SA; Mahadevan, U. “747 Detection of Biologic Agents in Breast Milk and Implication for Infection, Growth and Development in Infants Born to Women With Inflammatory Bowel Disease: Results From the PIANO Registry,” Gastroenterology, vol. 148, pp. S-141, 2015.
[31] Mahadevan, U; Wolf, DC; Dubinsky, M; Cortot, A; Lee, SD; Siegel, CA; et al., “Placental transfer of anti-tumor necrosis factor agents in pregnant patients with inflammatory bowel disease,” Clin Gastroenterol Hepatol, vol. 11, pp. 286-92; quiz e24, Mar 2013.
[32] Kane, S; "Anti-tumor necrosis factor agents and placental transfer: relevant clinical data for rational decision-making," Clin Gastroenterol Hepatol, vol. 11, pp. 293-4, Mar 2013.
[33] Murashima, A; Watanabe, N; Ozawa, N; Saito, H; Yamaguchi, K. “Etanercept during pregnancy and lactation in a patient with rheumatoid arthritis: drug levels in maternal serum, cord blood, breast milk and the infant's serum,” Annals of the Rheumatic Diseases, vol. 68, pp. 1793-1794, Nov 2009.
[34] Berthelsen, BG; Fjeldsoe-Nielsen, H; Nielsen, CT; Hellmuth, E. “Etanercept concentrations in maternal serum, umbilical cord serum, breast milk and child serum during breastfeeding,” Rheumatology, vol. 49, pp. 2225-2227, Nov 2010.
[35] Cheent, K; Nolan, J; Shariq, S; Kiho, L; Pal, A; Arnold, J. “Case Report: Fatal case of disseminated BCG infection in an infant born to a mother taking infliximab for Crohn's Disease,” Journal of Crohns and Colitis, vol. 4, pp. 603-605, Nov 2010.
[36] Ostensen, M; Khamashta, M; Lockshin, M; Parke, A; Brucato, A; Carp, H; et al., “Anti-inflammatory and immunosuppressive drugs and reproduction,” Arthritis Res Ther, vol. 8, p. 209, 2006.
[37] Carter, JD; Ladhani, A; Ricca, LR; Valeriano, J; Vasey, FB. “A safety assessment of tumor necrosis factor antagonists during pregnancy: a review of the Food and Drug Administration database,” J Rheumatol, vol. 36, pp. 635-41, Mar 2009.
[38] Kuriya, B; Hernandez-Diaz, S; Liu, J; Bermas, BL; Daniel, G; Solomon, DH. “Patterns of Medication Use During Pregnancy in Rheumatoid Arthritis,” Arthritis Care and Research, vol. 63, pp. 721-728, May 2011.
[39] Schnitzler, F; Fidder, H; Ferrante, M; Ballet, V; Noman, M; Van Assche, G; et al., “Outcome of pregnancy in women with inflammatory bowel disease treated with antitumor necrosis factor therapy,” Inflammatory bowel diseases, vol. 17, pp. 1846-1854, 2011.
[40] Argüelles-Arias, F; Castro-Laria, L; Barreiro-de Acosta, M; García-Sánchez, MV; Guerrero-Jiménez, P; Gómez-García, MR. et al., “Is safety infliximb during pregnancy in patients with inflammatory bowel disease?,” Revista Espanola de Enfermedades Digestivas, vol. 104, p. 59, 2012.
[41] Lichtenstein, GR; Feagan, BG; Cohen, RD; Salzberg, BA; Diamond, RH; Price, S; et al., “Serious Infection and Mortality in Patients With Crohn's Disease: More Than 5 Years of Follow-Up in the TREAT (TM) Registry,” American Journal of Gastroenterology, vol. 107, pp. 1409-1422, Sep 2012.
[42] Paschou, S; Voulgari, PV; Vrabie, IG; Saougou, IG; Drosos, AA. “Fertility and Reproduction in Male Patients with Ankylosing Spondylitis Treated with Infliximab,” Journal of Rheumatology, vol. 36, pp. 351-354, Feb 2009.
[43] Kane, S; Ford, J; Cohen, R; Wagner, C. “Absence of Infliximab in Infants and Breast Milk From Nursing Mothers Receiving Therapy for Crohn’s Disease Before and After Delivery,” Journal of Clinical Gastroenterology, vol. 43, pp. 613-616, Aug 2009.
[44] Berthelot, JM; De Bandt, M; Goupille, P; Solau-Gervais, E; Liote, F; Goeb, V; et al., “Exposition to anti-TNF drugs during pregnancy: outcome of 15 cases and review of the literature,” Joint Bone Spine, vol. 76, pp. 28-34, Jan 2009.
[45] Ben-Horin, S; Yavzori, M; Kopylov, U; Picard, O; Fudim, E; Eliakim, R; et al., “Detection of infliximab in breast milk of nursing mothers with inflammatory bowel disease,” J Crohns Colitis, vol. 5, pp. 555-8, Dec 2011.
[46] Zelinkova, Z; de Haar, C; de Ridder, L; Pierik, MJ; Kuipers, EJ; Peppelenbosch, MP; et al., “High intra-uterine exposure to infliximab following maternal anti-TNF treatment during pregnancy,” Aliment Pharmacol Ther, vol. 33, pp. 1053-8, May 2011.
[47] Zelinkova, Z; van der Ent, C; Bruin, KF; van Baalen, O; Vermeulen, HG; Smalbraak, HJ. et al., “Effects of discontinuing anti-tumor necrosis factor therapy during pregnancy on the course of inflammatory bowel disease and neonatal exposure,” Clin Gastroenterol Hepatol, vol. 11, pp. 318-21, Mar 2013.
[48] Fritzsche, J; Pilch, A; Mury, D; Schaefer, C; Weber-Schoendorfer, C. “Infliximab and adalimumab use during breastfeeding,” Journal of Clinical Gastroenterology, vol. 46, pp. 718-719, 2012.
[49] Wibaux, C; Andrei, I; Paccou, J; Philippe, P; Biver, E; Duquesnoy, B. et al., “Pregnancy during TNFalpha antagonist therapy: beware the rifampin-oral contraceptive interaction. Report of two cases,” Joint Bone Spine, vol. 77, pp. 268-70, May 2010.
[50] Viktil, KK; Engeland, A; Furu, K. “Outcomes after anti-rheumatic drug use before and during pregnancy: a cohort study among 150 000 pregnant women and expectant fathers,” Scandinavian Journal of Rheumatology, vol. 41, pp. 196-201, 2012.
[51] Natsumi, I; Matsukawa, Y; Miyagawa, K; Kodaira, H; Tanaka, T; Horikoshi, A. et al., “Successful childbearing in two women with rheumatoid arthritis and a history of miscarriage after etanercept treatment,” Rheumatology International, vol. 33, pp. 2433-2435, Sep 2013.
[52] Scioscia, C; Scioscia, M; Anelli, MG; Praino, E; Bettocchi, S; Lapadula, G. “Intentional etanercept use during pregnancy for maintenance of remission in rheumatoid arthritis,” Clinical and Experimental Rheumatology, vol. 29, pp. 93-95, Jan-Feb 2011.
[53] Hemmati, I; Ensworth, S; Shojania, K. “Coarctation of the Aorta in an Infant Exposed to Etanercept in Utero,” Journal of Rheumatology, vol. 36, pp. 2848-2849, Dec 2009.
[54] Keeling, S; Wolbink, GJ. “Measuring Multiple Etanercept Levels in the Breast Milk of a Nursing Mother with Rheumatoid Arthritis,” Journal of Rheumatology, vol. 37, pp. 1551-1551, Jul 2010.
[55] Winger, EE; Reed, JL. “Treatment with tumor necrosis factor inhibitors and intravenous immunoglobulin improves live birth rates in women with recurrent spontaneous abortion,” American Journal of Reproductive Immunology, vol. 60, pp. 8-16, Jul 2008.
[56] Merlob, P; Stahl, B; Klinger, G. “Tetrada of the possible mycophenolate mofetil embryopathy: A review,” Reproductive Toxicology, vol. 28, pp. 105-108, Jul 2009.
[57] Dessinioti, C; Stefanaki, I; Stratigos, AJ; Kostaki, M; Katsambas, A; Antoniou, C. “Pregnancy during adalimumab use for psoriasis,” Journal of the European Academy of Dermatology and Venereology, vol. 25, pp. 738-9, Jun 2011.
[58] Jurgens, M; Brand, S; Filik, L; Huebener, C; Hasbargen, U; Beigel, F; et al., “Safety of Adalimumab in Crohn’s Disease During Pregnancy: Case Report and Review of the Literature,” Inflammatory bowel diseases, vol. 16, pp. 1634-1636, Oct 2010.
[59] Verstappen, SM; King, Y; Watson, KD; Symmons, DP; Hyrich, KL. “Anti-TNF therapies and pregnancy: outcome of 130 pregnancies in the British Society for Rheumatology Biologics Register,” Annals of the rheumatic diseases, p. annrheumdis140822, 2011.
[60] Bortlik, M; Machkova, N; Duricova, D; Malickova, K; Hrdlicka, L; Lukas, M; et al., “Pregnancy and newborn outcome of mothers with inflammatory bowel diseases exposed to anti-TNF-alpha therapy during pregnancy: three-center study,” Scand J Gastroenterol, vol. 48, pp. 951-8, Aug 2013.
[61] Casanova, M; Chaparro, M; Domenech, E; Barreiro-de Acosta, M; Bermejo, F; Iglesias, E; et al., “Safety of thiopurines and anti-TNF-α drugs during pregnancy in patients with inflammatory bowel disease,” The American journal of gastroenterology, vol. 108, pp. 433-440, 2013.
[62] Cooper, WO; Cheetham, TC; Li, DK; Stein, CM; Callahan, ST; Morgan, TM; et al., “Brief report: Risk of adverse fetal outcomes associated with immunosuppressive medications for chronic immune-mediated diseases in pregnancy,” Arthritis Rheumatol, vol. 66, pp. 444-50, Feb 2014.
[63] Nielsen, OH; Loftus, EV. Jr, Jess, T. “Safety of TNF-α inhibitors during IBD pregnancy: a systematic review,” BMC medicine, vol. 11, p. 174, 2013.
[64] Diav-Citrin, O; Otcheretianski-Volodarsky, A; Shechtman, S; Ornoy, A. “Pregnancy outcome following gestational exposure to TNF-alpha-inhibitors: a prospective, comparative, observational study,” Reproductive Toxicology, vol. 43, pp. 78-84, 2014.
[65] Lau, A; Clark, M; Harrison, D; Geldhof, A; Nissinen, R; Sanders, M. “THU0153 Pregnancy Outcomes in Women Exposed to the Tumor Necrosis Factor Inhibitor, Golimumab,” Annals of the rheumatic diseases, vol. 73, pp. 232-233, 2014.
[66] Strangfeld, A; Pattloch, D; Spilka, M; Manger, B; Krummel-Lorenz, B; Gräßler, A. et al., “OP0017 Pregnancies in Patients with Rheumatoid Arthritis: Treatment Decisions, Course of the Disease, and Pregnancy Outcomes,” Annals of the Rheumatic Diseases, vol. 74, pp. 70-71, 2015.
[67] Vasiliauskas, EA; Church, JA; Silverman, N; Barry, M; Targan, SR; Dubinsky, MC. “Case report: Evidence for transplacental transfer of maternally administered infliximab to the newborn,” Clinical Gastroenterology and Hepatology, vol. 4, pp. 1255-1258, Oct 2006.
[68] Förger, F; Zbinden, A; Villiger, PM. “Certolizumab treatment during late pregnancy in patients with rheumatic diseases: Low drug levels in cord blood but possible risk for maternal infections. A case series of 13 patients,” Joint Bone Spine, 2015.
[69] Mahadevan, U; Vermeire, S; Wolf, D; Forger, F; Cush, J; Golembesky, A. et al., “DOP024 Pregnancy outcomes after exposure to certolizumab pegol: Results from safety surveillance,” Journal of Crohn’s and Colitis, p. S26, 2014.
[70] Weber-Schoendorfer, C; Oppermann, M; Wacker, E; Bernard, N; Beghin, D; Cuppers-Maarschalkerweerd, B. et al., “Pregnancy outcome after TNF-alpha inhibitor therapy during the first trimester: a prospective multicentre cohort study,” Br J Clin Pharmacol, vol. 80, pp. 727-39, Oct 2015.
[71] Bazzani, C. “Respiratory distress syndrome and pneumothorax following in utero exposure: 2 case reports,” Reactions, vol. 1578, pp. 139-21, 2015.
[72] Stengel, JZ; Arnold, HL. “Is infliximab safe to use while breastfeeding?” World journal of gastroenterology: WJG, vol. 14, p. 3085, 2008.
[73] Steenholdt, C; Al-Khalaf, M; Ainsworth, MA; Brynskov, J. “Therapeutic infliximab drug level in a child born to a woman with ulcerative colitis treated until gestation week 31,” Journal of Crohn's and Colitis, vol. 6, pp. 358-361, 2012.
[74] Ostensen, M; Eigenmann, GO. “Etanercept in breast milk,” Journal of Rheumatology, vol. 31, pp. 1017-1018, May 2004.
[75] Cambridge, G; Perry, HC; Nogueira, L; Serre, G; Parsons, HM; De La Torre, I. et al., “The effect of B cell depletion therapy on serological evidence of B cell and plasmablast activation in patients with rheumatoid arthritis over multiple cycles of rituximab treatment,” J Autoimmun, vol. 50, pp. 67-76, May 2014.
[76] Curtis, JR; Singh, JA. “Use of biologics in rheumatoid arthritis: current and emerging paradigms of care,” Clin Ther, vol. 33, pp. 679-707, Jun 2011.
[77] Lopez-Olivo, MA; Amezaga Urruela, M; McGahan, L; Pollono, EN; Suarez-Almazor, ME. “Rituximab for rheumatoid arthritis,” Cochrane Database Syst Rev, vol. 1, p. CD007356, 2015.
[78] Krause, ML; Amin, S; Makol, A. “Use of DMARDs and biologics during pregnancy and lactation in rheumatoid arthritis: what the rheumatologist needs to know,” Ther Adv Musculoskelet Dis, vol. 6, pp. 169-84, Oct 2014.
[79] Soh, MC; Nelson-Piercy, C. “High-risk pregnancy and the rheumatologist,” Rheumatology (Oxford), vol. 54, pp. 572-87, Apr 2015.
[80] Chakravarty, EF; Murray, ER; Kelman, A; Farmer, P. “Pregnancy outcomes after maternal exposure to rituximab,” Blood, vol. 117, pp. 1499-506, Feb 3 2011.
[81] Pendergraft, WF; 3rd, McGrath, MM; Murphy, AP; Murphy, P; Laliberte, KA; Greene, MF. et al., “Fetal outcomes after rituximab exposure in women with autoimmune vasculitis,” Ann Rheum Dis, vol. 72, pp. 2051-3, Dec 2013.
[82] Sangle, SR; Lutalo, PMK; Davies, RJ; Khamashta, MA; D’Cruz, DP. “B cell depletion therapy and pregnancy outcome in severe, refractory systemic autoimmune diseases,” Journal of Autoimmunity, vol. 43, pp. 55-59, Jun 2013.
[83] Alkaabi, JK; Alkindi, S; Riyami, NA; Zia, F; Balla, LM; Balla, SM. “Successful treatment of severe thrombocytopenia with romiplostim in a pregnant patient with systemic lupus erythematosus,” Lupus, vol. 21, pp. 1571-4, Dec 2012.
[84] Gualtierotti, R; Ingegnoli, F; Meroni, PL. “Pre-conceptional exposure to rituximab: comment on the article by Ojeda-Uribe et al.,” Clin Rheumatol, vol. 32, pp. 727-8, May 2013.
[85] Ojeda-Uribe, M; Afif, N; Dahan, E; Sparsa, L; Haby, C; Sibilia, J; et al., “Exposure to abatacept or rituximab in the first trimester of pregnancy in three women with autoimmune diseases,” Clin Rheumatol, vol. 32, pp. 695-700, May 2013.
[86] Ton, E; Tekstra, J; Hellmann, PM; Nuver-Zwart, IH; Bijlsma, JW. “Safety of rituximab therapy during twins' pregnancy,” Rheumatology (Oxford), vol. 50, pp. 806-8, Apr 2011.
[87] Chakravarty, EF; Murray, ER; Kelman, A; Farmer, P. “Pregnancy outcomes after maternal exposure to rituximab,” Blood, vol. 117, pp. 1499-1506, Feb 3 2011.
[88] Klink, DT; van Elburg, RM; Schreurs, MW; van Well, GT. “Rituximab administration in third trimester of pregnancy suppresses neonatal B cell development,” Clin Dev Immunol, vol. 2008, p. 271363, 2008.
[89] Ostensen, M. “Safety issues of biologics in pregnant patients with rheumatic diseases,” Steroids in Neuroendocrine Immunology and Therapy of Rheumatic Diseases I, vol. 1317, pp. 32-38, 2014.
[90] Gall, B; Yee, A; Berry, B; Birchman, D; Hayashi, A; Dansereau, J. et al., “Rituximab for management of refractory pregnancy-associated immune thrombocytopenic purpura,” J Obstet Gynaecol Can, vol. 32, pp. 1167-71, Dec 2010.
[91] Martinez-Martinez, MU; Baranda-Candido, L; Gonzalez-Amaro, R; Perez-Ramirez, O; Abud-Mendoza, C. “Modified neonatal B cell repertoire as a consequence of rituximab administration to a pregnant woman,” Rheumatology (Oxford), vol. 52, pp. 405-6, Feb 2013.
[92] Pellkofer, HL; Suessmair, C; Schulze, A; Hohlfeld, R; Kuempfel, T. “Course of neuromyelitis optica during inadvertent pregnancy in a patient treated with rituximab,” Mult Scler, vol. 15, pp. 1006-8, Aug 2009.
[93] Ng, CT; O'Neil, M; Walsh, D; Walsh, T; Veale, DJ. “Successful pregnancy after rituximab in a women with recurrent in vitro fertilisation failures and anti-phospholipid antibody positive,” Ir J Med Sci, vol. 178, pp. 531-3, Dec 2009.
[94] Ponte, P; Lopes, MJP. “Apparent safe use of single dose rituximab for recalcitrant atopic dermatitis in the first trimester of a twin pregnancy,” Journal of the American Academy of Dermatology, vol. 63, pp. 355-356, 2010.
[95] Daver, N; Nazha, A; Kantarjian, HM; Haltom, R; Ravandi, F. “Treatment of Hairy Cell Leukemia During Pregnancy: Are Purine Analogues and Rituximab Viable Therapeutic Options,” Clinical Lymphoma Myeloma and Leukemia, vol. 13, pp. 86-89, Feb 2013.
[96] Kimby, E; Sverrisdottir, A; Elinder, G. “Safety of rituximab therapy during the first trimester of pregnancy: a case history,” European journal of haematology, vol. 72, pp. 292-295, 2004.
[97] Rey, J; Coso, D; Roger, V; Bouayed, N; Belmecheri, N; Ivanov, V. et al., “Rituximab combined with chemotherapy for lymphoma during pregnancy,” Leuk Res, vol. 33, pp. e8-9, Mar 2009.
[98] Herold, M; Schnohr, S; Bittrich, H. “Efficacy and safety of a combined rituximab chemotherapy during pregnancy,” J Clin Oncol, vol. 19, p. 3439, Jul 15 2001.
[99] Friedrichs, B; Tiemann, M; Salwender, H; Verpoort, K; Wenger, MK; Schmitz, N. “The effects of rituximab treatment during pregnancy on a neonate,” Haematologica, vol. 91, pp. 1426-7, Oct 2006.
[100] Decker, M; Rothermundt, C; Hollander, G; Tichelli, A; Rochlitz, C. “Rituximab plus CHOP for treatment of diffuse large B cell lymphoma during second trimester of pregnancy,” Lancet Oncol, vol. 7, pp. 693-4, Aug 2006.
[101] Perez, CA; Amin, J; Aguina, LM; Cioffi-Lavina, M; Santos, ES. “Primary Mediastinal Large B cell Lymphoma during Pregnancy,” Case Rep Hematol, vol. 2012, p. 197347, 2012.
[102] Rubbert-Roth, A; Goupille, P; Moosavi, S. “First experiences with pregnancies in RA patients (pts) receiving tocilizumab therapy (abstract). ACR,” Atlanta, USA, 2010.
[103] Ishikawa, H; Kaneko, A; Hattori, Y; Takahashi, N; Kida, D; Sato, T; et al., “FRI0320 Pregnancy Outcomes in Rheumatoid Arthritis Patients Treated with Tocilizumab,” Annals of the rheumatic diseases, vol. 73, pp. 501-502, 2014.
[104] Fischer-Betz, R; Specker, C; Schneider, M. “Successful outcome of two pregnancies in patients with adult-onset Still’s disease treated with IL-1 receptor antagonist (anakinra),” Clinical and Experimental Rheumatology, vol. 29, pp. 1021-1023, Nov-Dec 2011.
[105] Berger, CT; Recher, M; Steiner, U; Hauser, TM. “A patient’s wish: anakinra in pregnancy,” Annals of the rheumatic diseases, vol. 68, pp. 1794-1795, Nov 2009.
[106] Westhovens, R; Robles, M; Ximenes, AC; Nayiager, S; Wollenhaupt, J; Durez, P; et al., “Clinical efficacy and safety of abatacept in methotrexate-naive patients with early rheumatoid arthritis and poor prognostic factors,” Ann Rheum Dis, vol. 68, pp. 1870-7, Dec 2009.
[107] Pham, T; Bachelez, H; Berthelot, JM; Blacher, J; Claudepierre, P; Constantin, A. et al., “Abatacept therapy and safety management,” Joint Bone Spine, vol. 79 Suppl 1, pp. 3-84, Mar 2012.
[108] Hui-Yuen, JS; Reddy, A; Taylor, J; Li, XQ; Eichenfield, AH; Bermudez, LM; et al., “Safety and Efficacy of Belimumab to Treat Systemic Lupus Erythematosus in Academic Clinical Practices,” Journal of Rheumatology, vol. 42, pp. 2288-2295, Dec 2015.
[109] Vilas-Boas, A; Morais, SA; Isenberg, DA. “Belimumab in systemic lupus erythematosus,” RMD Open, vol. 1, p. e000011, 2015.
[110] Landy, H; Powell, M; Hill, D; Eudy, A; Petri, M. “Belimumab Pregnancy Registry Prospective Cohort Study of Pregnancy Outcomes,” Obstetrics and Gynecology, vol. 123, pp. 62s-62s, May 2014.
[111] “Title,” unpublished|.
[112] Powell, M; Hill, D; Eudy, A; Landy, H; Petri, M. “OP0041 Pregnancy Outcomes for Systemic Lupus Erythematosus (SLE) Subjects with Conception during Belimumab Intravenous (IV) and Subcutaneous (SC) Placebo-Controlled Clinical Trials and Long Term Extension Trials,” Annals of the rheumatic diseases, vol. 73, pp. 75-76, 2014.

Chapter 16

[1] “Osteoporosis Prevention, Diagnosis, and Therapy. NIH Consens Statement Online, 2000 March 27-29, 17(1), 1-36.” [Online]. Available: https://consensus.nih.gov/ 2000/2000osteoporosis111html.htm.
[2] Willson, T; Nelson, SD; Newbold, J; Nelson, RE; LaFleur, J. “The clinical epidemiology of male osteoporosis: a review of the recent literature.,” Clin. Epidemiol., vol. 7, pp. 65–76, Jan. 2015.
[3] Johnell, O; Kanis, JA. “An estimate of the worldwide prevalence and disability associated with osteoporotic fractures.,” Osteoporos. Int., vol. 17, no. 12, pp. 1726–33, Dec. 2006.
[4] Pacifici, R. “Estrogen, cytokines, and pathogenesis of postmenopausal osteoporosis.,” J. Bone Miner. Res., vol. 11, no. 8, pp. 1043–51, Aug. 1996.
[5] Tella, SH; Gallagher, JC. “Biological agents in management of osteoporosis.,” Eur. J. Clin. Pharmacol., vol. 70, no. 11, pp. 1291–301, Nov. 2014.
[6] El Azreq, MA; Boisvert, M; Cesaro, A; Pagé, N; Loubaki, L; Allaeys, I; Chakir, J; Poubelle, PE; Tessier, PA; Aoudjit, F. “α2β1 integrin regulates Th17 cell activity and its neutralization decreases the severity of collagen-induced arthritis.,” J. Immunol., vol. 191, no. 12, pp. 5941–50, Dec. 2013.
[7] Syrbe, U; Siegmund, B. “Bone marrow Th17 TNFα cells induce osteoclast differentiation and link bone destruction to IBD.,” Gut, vol. 64, no. 7, pp. 1011–2, Jul. 2015.
[8] McLean, RR. “Proinflammatory cytokines and osteoporosis.,” Curr. Osteoporos. Rep., vol. 7, no. 4, pp. 134–9, Dec. 2009.
[9] Hodsman, AB; Bauer, DC; Dempster, DW; Dian, L; Hanley, DA; Harris, ST; Kendler, DL; McClung, MR; Miller, PD; Olszynski, WP; Orwoll, E; Yuen, CK. “Parathyroid hormone and teriparatide for the treatment of osteoporosis: a review of the evidence and suggested guidelines for its use.,” Endocr. Rev., vol. 26, no. 5, pp. 688–703, Aug. 2005.
[10] Cheloha, RW; Gellman, SH; Vilardaga, JP; Gardella, TJ. “PTH receptor-1 signalling-mechanistic insights and therapeutic prospects.,” Nat. Rev. Endocrinol., vol. 11, no. 12, pp. 712–24, Dec. 2015.
[11] Vilardaga, JP; Romero, G; Friedman, PA; Gardella, TJ. “Molecular basis of parathyroid hormone receptor signaling and trafficking: a family B GPCR paradigm.,” Cell. Mol. Life Sci., vol. 68, no. 1, pp. 1–13, Jan. 2011.
[12] Rosen, CJ. “The cellular and clinical parameters of anabolic therapy for osteoporosis.,” Crit. Rev. Eukaryot. Gene Expr., vol. 13, no. 1, pp. 25–38, Jan. 2003.
[13] Dobnig, H; Sipos, A; Jiang, Y; Fahrleitner-Pammer, A; Ste-Marie, LG; Gallagher, JC; Pavo, I; Wang, J; Eriksen, EF. “Early changes in biochemical markers of bone formation correlate with improvements in bone structure during teriparatide therapy.,” J. Clin. Endocrinol. Metab., vol. 90, no. 7, pp. 3970–7, Jul. 2005.
[14] Misof, BM; Roschger, P; Cosman, F; Kurland, ES; Tesch, W; Messmer, P; Dempster, DW; Nieves, J; Shane, E; Fratzl, P; Klaushofer, K; Bilezikian, J; Lindsay, R. “Effects of intermittent parathyroid hormone administration on bone mineralization density in iliac crest biopsies from patients with osteoporosis: a paired study before and after treatment.,” J. Clin. Endocrinol. Metab., vol. 88, no. 3, pp. 1150–6, Mar. 2003.
[15] Jerome, CP; Burr, DB; Van Bibber, T; Hock, JM; Brommage, R. “Treatment with human parathyroid hormone (1-34) for 18 months increases cancellous bone volume and improves trabecular architecture in ovariectomized cynomolgus monkeys (Macaca fascicularis).,” Bone, vol. 28, no. 2, pp. 150–9, Mar. 2001.
[16] Neer, RM; Arnaud, CD; Zanchetta, JR; Prince, R; Gaich, GA; Reginster, JY; Hodsman, AB; Eriksen, EF; Ish-Shalom, S; Genant, HK; Wang, O; Mitlak, BH. “Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis.,” N. Engl. J. Med., vol. 344, no. 19, pp. 1434–41, May 2001.
[17] Eastell, R; Nickelsen, T; Marin, F; Barker, C; Hadji, P; Farrerons, J; Audran, M; Boonen, S; Brixen, K; Gomes, JM; Obermayer-Pietsch, B; Avramidis, A; Sigurdsson, G; Glüer, CC. “Sequential treatment of severe postmenopausal osteoporosis after teriparatide: final results of the randomised, controlled European Study of Forsteo (EUROFORS).,” J. Bone Miner. Res., vol. 24, no. 4, pp. 726–36, Apr. 2009.
[18] Black, DM; Greenspan, SL; Ensrud, KE; Palermo, L; McGowan, JA; Lang, TF; Garnero, P; Bouxsein, ML; Bilezikian, JP; Rosen, CJ. “The effects of parathyroid hormone and alendronate alone or in combination in postmenopausal osteoporosis.,” N. Engl. J. Med., vol. 349, no. 13, pp. 1207–15, Sep. 2003.
[19] Andrews, EB; Gilsenan, AW; Midkiff, K; Sherrill, B; Wu, Y; Mann, BH; Masica, D. “The US postmarketing surveillance study of adult osteosarcoma and teriparatide: study design and findings from the first 7 years.,” J. Bone Miner. Res., vol. 27, no. 12, pp. 2429–37, Dec. 2012.
[20] Vahle, JL; Sato, M; Long, GG; Young, JK; Francis, PC; Engelhardt, JA; Westmore, MS; Linda, Y; Nold, JB. “Skeletal changes in rats given daily subcutaneous injections of recombinant human parathyroid hormone (1-34) for 2 years and relevance to human safety.,” Toxicol. Pathol., vol. 30, no. 3, pp. 312–21, Jan.
[21] Leder, BZ; O’Dea, LSL; Zanchetta, JR; Kumar, P; Banks, K; McKay, K; Lyttle, CR; Hattersley, G. “Effects of abaloparatide, a human parathyroid hormone-related peptide analog, on bone mineral density in postmenopausal women with osteoporosis.,” J. Clin. Endocrinol. Metab., vol. 100, no. 2, pp. 697–706, Feb. 2015.
[22] MS; et al. Miller, PD; Leder, BZ; Hattersley, G; Lau, E; Alexandersen, P; Hala, T. “Effects of Abaloparatide on Vertebral and Non-Vertebral Fracture Incidence in Postmenopausal Women with Osteoporosis - Results of the Phase III Active Trial,” Endocr. Rev., vol. 36, 2015.
[23] McClung, H; Grauer, MR; Boonen, A; Brown, S; Diez-Perez, JP; Langdahl, A; Reginster, B; Zanchetta, JY; Katz, JR; Maddox, L; Yang, J; Bone, YC. “Inhibition of Sclerostin With AMG 785 in Postmenopausal Women With Low Bone Mineral Density: Phase II Trial Results,” ACR Late-breaking Abstracts Session, 2012. [Online]. Available: http://www.asbmr.org/education/2012-abstracts. [Accessed: 07-Feb-2016].
[24] Li, X; Ominsky, MS; Warmington, KS; Morony, S; Gong, J; Cao, J; Gao, Y; Shalhoub, V; Tipton, B; Haldankar, R; Chen, Q; Winters, A; Boone, T; Geng, Z; Niu, QT; Ke, HZ; Kostenuik, PJ; Simonet, WS; Lacey, DL; Paszty, C. “Sclerostin antibody treatment increases bone formation, bone mass, and bone strength in a rat model of postmenopausal osteoporosis.,” J. Bone Miner. Res., vol. 24, no. 4, pp. 578–88, Apr. 2009.
[25] Padhi, D; Jang, G; Stouch, B; Fang, L; Posvar, E. “Single-dose, placebo-controlled, randomised study of AMG 785, a sclerostin monoclonal antibody.,” J. Bone Miner. Res., vol. 26, no. 1, pp. 19–26, Jan. 2011.
[26] McClung, MR; Grauer, A; Boonen, S; Bolognese, MA; Brown, JP; Diez-Perez, A; Langdahl, BL; Reginster, JY; Zanchetta, JR; Wasserman, SM; Katz, L; Maddox, J; Yang, YC; Libanati, C; Bone, HG. “Romosozumab in postmenopausal women with low bone mineral density.,” N. Engl. J. Med., vol. 370, no. 5, pp. 412–20, Jan. 2014.
[27] Kendler, DL; Roux, C; Benhamou, CL; Brown, JP; Lillestol, M; Siddhanti, S; Man, HS; San Martin, J; Bone, HG. “Effects of denosumab on bone mineral density and bone turnover in postmenopausal women transitioning from alendronate therapy.,” J. Bone Miner. Res., vol. 25, no. 1, pp. 72–81, Jan. 2010.
[28] “Amgen, UCB announce phase III study of romosozumab in postmenopausal women with osteoporosis meets co-primary endpoints.” [Online]. Available: http://www. pharmabiz.com/NewsDetails.aspx?aid =93650&sid=2. [Accessed: 26-Feb-2016].
[29] Recker, RR; Benson, CT; Matsumoto, T; Bolognese, MA; Robins, DA; Alam, J; Chiang, AY; Hu, L; Krege, JH; Sowa, H; Mitlak, BH; Myers, SL. “A randomised, double-blind phase II clinical trial of blosozumab, a sclerostin antibody, in postmenopausal women with low bone mineral density.,” J. Bone Miner. Res., vol. 30, no. 2, pp. 216–24, Mar. 2015.
[30] Papapoulos, S; Lippuner, K; Roux, C; Lin, CJF; Kendler, DL; Lewiecki, EM; Brandi, ML; Czerwiński, E; Franek, E; Lakatos, P; Mautalen, C; Minisola, S; Reginster, JY; Jensen, S; Daizadeh, NS; Wang, A; Gavin, M; Libanati, C; Wagman, RB; Bone, HG. “The effect of 8 or 5 years of denosumab treatment in postmenopausal women with osteoporosis: results from the FREEDOM Extension study.,” Osteoporos. Int., vol. 26, no. 12, pp. 2773–83, Dec. 2015.
[31] Cummings, SR; San Martin, J; McClung, MR; Siris, ES; Eastell, R; Reid, IR; Delmas, P; Zoog, HB; Austin, M; Wang, A; Kutilek, S; Adami, S; Zanchetta, J; Libanati, C; Siddhanti, S; Christiansen, C. “Denosumab for prevention of fractures in postmenopausal women with osteoporosis.,” N. Engl. J. Med., vol. 361, no. 8, pp. 756–65, Aug. 2009.
[32] Boonen, S; Adachi, JD; Man, Z; Cummings, SR; Lippuner, K; Törring, O; Gallagher, JC; Farrerons, J; Wang, A; Franchimont, N; San Martin, J; Grauer, A; McClung, M. “Treatment with denosumab reduces the incidence of new vertebral and hip fractures in postmenopausal women at high risk.,” J. Clin. Endocrinol. Metab., vol. 96, no. 6, pp. 1727–36, Jun. 2011.
[33] Bone, HG; Bolognese, MA; Yuen, CK; Kendler, DL; Miller, PD; Yang, YC; Grazette, L; San Martin, J; Gallagher, JC. “Effects of denosumab treatment and discontinuation on bone mineral density and bone turnover markers in postmenopausal women with low bone mass.,” J. Clin. Endocrinol. Metab., vol. 96, no. 4, pp. 972–80, Apr. 2011.
[34] Lewiecki, EM; Miller, PD; McClung, MR; Cohen, SB; Bolognese, MA; Liu, Y; Wang, A; Siddhanti, S; Fitzpatrick, LA. “Two-year treatment with denosumab (AMG 162) in a randomised phase II study of postmenopausal women with low BMD.,” J. Bone Miner. Res., vol. 22, no. 12, pp. 1832–41, Dec. 2007.
[35] Ruggiero, SL; Dodson, TB; Fantasia, J; Goodday, R; Aghaloo, T; Mehrotra, B; O’Ryan, F. “American Association of Oral and Maxillofacial Surgeons position paper on medication-related osteonecrosis of the jaw--2014 update.,” J. Oral Maxillofac. Surg., vol. 72, no. 10, pp. 1938–56, Oct. 2014.
[36] Geller, M; Wagman, R; Ho, P; Siddhanti, S; Stehman-Breen, C; Watts, N; Papapoulos, S. “SAT0479 Early Findings from Prolia(R) Post-Marketing Safety Surveillance for Atypical Femoral Fracture, Osteonecrosis of the Jaw, Severe Symptomatic Hypocalcemia, and Anaphylaxis,” Ann. Rheum. Dis., vol. 73, no. Suppl 2, pp. 766–767, Jun. 2014.
[37] Jamal, SA; Ljunggren, O; Stehman-Breen, C; Cummings, SR; McClung, MR; Goemaere, S; Ebeling, PR; Franek, E; Yang, YC; Egbuna, OI; Boonen, S; Miller, PD. “Effects of denosumab on fracture and bone mineral density by level of kidney function.,” J. Bone Miner. Res., vol. 26, no. 8, pp. 1829–35, Aug. 2011.
[38] Anastasilakis, AD; Toulis, KA; Goulis, DG; Polyzos, SA; Delaroudis, S; Giomisi, A; Terpos, E. “Efficacy and safety of denosumab in postmenopausal women with osteopenia or osteoporosis: a systematic review and a meta-analysis.,” Horm. Metab. Res. = Horm. und Stoffwechselforsch. = Horm. meìtabolisme, vol. 41, no. 10, pp. 721–9, Oct. 2009.
[39] Zhou, Z; Chen, C; Zhang, J; Ji, X; Liu, L; Zhang, G; Cao, X; Wang, P. “Safety of denosumab in postmenopausal women with osteoporosis or low bone mineral density: a meta-analysis.,” Int. J. Clin. Exp. Pathol., vol. 7, no. 5, pp. 2113–22, Jan. 2014.
[40] “The Long and the Short of Bone Therapy — NEJM.” [Online]. Available:http://www. nejm.org/doi/full/10.1056/NEJMe068003. [Accessed: 30-Jan-2016].
[41] Bone, HG; McClung, MR; Roux, C; Recker, RR; Eisman, JA; Verbruggen, N; Hustad, CM; DaSilva, C; Santora, AC; Ince, BA. “Odanacatib, a cathepsin-K inhibitor for osteoporosis: a two-year study in postmenopausal women with low bone density.,” J. Bone Miner. Res., vol. 25, no. 5, pp. 937–47, May 2010.
[42] Brixen, K; Chapurlat, R; Cheung, AM; Keaveny, TM; Fuerst, T; Engelke, K; Recker, R; Dardzinski, B; Verbruggen, N; Ather, S; Rosenberg, E; de Papp, AE. “Bone density, turnover, and estimated strength in postmenopausal women treated with odanacatib: a randomised trial.,” J. Clin. Endocrinol. Metab., vol. 98, no. 2, pp. 571–80, Mar. 2013.
[43] Bone, HG; Dempster, DW; Eisman, JA; Greenspan, SL; McClung, MR; Nakamura, T; Papapoulos, S; Shih, WJ; Rybak-Feiglin, A; Santora, AC; Verbruggen, N; Leung, AT; Lombardi, A. “Odanacatib for the treatment of postmenopausal osteoporosis: development history and design and participant characteristics of LOFT, the Long-Term Odanacatib Fracture Trial.,” Osteoporos. Int., vol. 26, no. 2, pp. 699–712, Mar. 2015.
[44] Stoch, SA; Zajic, S; Stone, J; Miller, DL; Van Dyck, K; Gutierrez, MJ; De Decker, M; Liu, L; Liu, Q; Scott, BB; Panebianco, D; Jin, B; Duong, LT; Gottesdiener, K; Wagner, JA. “Effect of the cathepsin K inhibitor odanacatib on bone resorption biomarkers in healthy postmenopausal women: two double-blind, randomised, placebo-controlled phase I studies.,” Clin. Pharmacol. Ther., vol. 86, no. 2, pp. 175–82, Aug. 2009.
[45] Langdahl, B; Binkley, N; Bone, H; Gilchrist, N; Resch, H; Rodriguez Portales, J; Denker, A; Lombardi, A; Le Bailly De Tilleghem, C; Dasilva, C; Rosenberg, E; Leung, A. “Odanacatib in the treatment of postmenopausal women with low bone mineral density: five years of continued therapy in a phase II study.,” J. Bone Miner. Res., vol. 27, no. 11, pp. 2251–8, Nov. 2012.
[46] McClung, M; Langdahl, B; Papapoulos, S; Saag, K; Bone, H; Rybak-Feiglin, A; Cohn, D; Da Silva, C; Massad, R; Santora, A; Scott, B; Verbruggen, KKDN; Leung, A; Lombardi, A. “Odanacatib anti-fracture efficacy and safety in postmenopausal women with osteoporosis: results from the phase III long-term odanacatib fracture trial (LOFT),” BoneKEy, vol. 13, no. 677, p. Abstract, 2015.
[47] “Merck Announces Data from Pivotal Phase III Fracture Outcomes Study for Odanacatib, an Investigational Oral, Once-Weekly Treatment for Osteoporosis|Merck Newsroom Home.” [Online]. Available: http:// www.mercknewsroom.com/news-release/research-and-development-news/merck-announces-data-pivotal-phase-3-fracture-outcomes-st. [Accessed: 20-Feb-2016].
[48] “Merck Announces Data from Pivotal Phase III Fracture Outcomes Study for Odanacatib, an Investigational Oral, Once-Weekly Treatment for Osteoporosis|Reuters.” [Online]. Available: http:// www. reuters.com/article/ nj-merck-idUSnBw156286a+100+BSW20140915. [Accessed: 19-Feb-2016].
[49] Murphy, MG; Cerchio, K; Stoch, SA; Gottesdiener, K; Wu, M; Recker, R. “Effect of L-000845704, an alphaVbeta3 integrin antagonist, on markers of bone turnover and bone mineral density in postmenopausal osteoporotic women.,” J. Clin. Endocrinol. Metab., vol. 90, no. 4, pp. 2022–8, Apr. 2005.
[50] Hernlund, E; Svedbom, A; Ivergård, M; Compston, J; Cooper, C; Stenmark, J; McCloskey, EV; Jönsson, B; Kanis, JA. “Osteoporosis in the European Union: medical management, epidemiology and economic burden. A report prepared in collaboration with the International Osteoporosis Foundation (IOF) and the European Federation of Pharmaceutical Industry Associations (EFPIA).,” Arch. Osteoporos., vol. 8, p. 136, Jan. 2013.
[51] MM; Becker, DJ; Kilgore, ML. “Bone Health and Osteoporosis.” Office of the Surgeon General (US), 2004.
[52] NO. Society, “Falling short: Delivering Integrated Falls and Osteoporosis Services in England,” 2004. [Online]. Available: https:// www.nos.org.uk/document.doc?id=752. [Accessed: 30-Jan-2016].
[53] Murphy, DR; Smolen, LJ; Klein, TM; Klein, RW. “The cost effectiveness of teriparatide as a first-line treatment for glucocorticoid-induced and postmenopausal osteoporosis patients in Sweden.,” BMC Musculoskelet. Disord., vol. 13, p. 213, Jan. 2012.
[54] Parthan, A; Kruse, M; Yurgin, N; Huang, J; Viswanathan, HN; Taylor, D. “Cost effectiveness of denosumab versus oral bisphosphonates for postmenopausal osteoporosis in the US.,” Appl. Health Econ. Health Policy, vol. 11, no. 5, pp. 485–97, Oct. 2013.
[55] Cotté, FE; Fardellone, P; Mercier, F; Gaudin, AF; Roux, C. “Adherence to monthly and weekly oral bisphosphonates in women with osteoporosis.,” Osteoporos. Int., vol. 21, no. 1, pp. 145–55, Jan. 2010.
[56] Jönsson, B; Ström, O; Eisman, JA; Papaioannou, A; Siris, ES; Tosteson, A; Kanis, JA. “Cost-effectiveness of Denosumab for the treatment of postmenopausal osteoporosis.,” Osteoporos. Int., vol. 22, no. 3, pp. 967–82, Mar. 2011.

Chapter 17

[1] Fischer, A; Antoniou, KM; Brown, KK; Cadranel, J; Corte, TJ; du Bois, RM; Lee, JS; Leslie, KO; Lynch, DA; Matteson, EL; Mosca, M; Noth, I; Richeldi, L; Strek, ME; Swigris, JJ; Wells, AU; West, SG; Collard, HR; Cottin, V. ‘An official European Respiratory Society/American Thoracic Society research statement: interstitial pneumonia with autoimmune features.’, Eur. Respir. J., vol. 46, no. 4, pp. 976–87, Oct. 2015.
[2] Walker, UA; Tyndall, A; Czirják, L; Denton, C; Farge-Bancel, D; Kowal-Bielecka, O; Müller-Ladner, U; Bocelli-Tyndall, C; Matucci-Cerinic, M. ‘Clinical risk assessment of organ manifestations in systemic sclerosis: a report from the EULAR Scleroderma Trials And Research group database.’, Ann. Rheum. Dis., vol. 66, no. 6, pp. 754–63, Jun. 2007.
[3] Fathi, M; Vikgren, J; Boijsen, M; Tylen, U; Jorfeldt, L; Tornling, G; Lundberg, IE. ‘Interstitial lung disease in polymyositis and dermatomyositis: longitudinal evaluation by pulmonary function and radiology.’, Arthritis Rheum., vol. 59, no. 5, pp. 677–85, May 2008.
[4] Fathi, M; Dastmalchi, M; Rasmussen, E; Lundberg, IE; Tornling, G. ‘Interstitial lung disease, a common manifestation of newly diagnosed polymyositis and dermatomyositis.’, Ann. Rheum. Dis., vol. 63, no. 3, pp. 297–301, Mar. 2004.
[5] Solomon, J; Swigris, JJ; Brown, KK. ‘Myositis-related interstitial lung disease and antisynthetase syndrome.’, J. Bras. Pneumol. publicaço Of. da Soc. Bras. Pneumol. e Tisilogia, vol. 37, no. 1, pp. 100–9, Jan.
[6] Dawson, JK; Fewins, HE; Desmond, J; Lynch, MP; Graham, DR. ‘Fibrosing alveolitis in patients with rheumatoid arthritis as assessed by high resolution computed tomography, chest radiography, and pulmonary function tests.’, Thorax, vol. 56, no. 8, pp. 622–7, Aug. 2001.
[7] Anaya, JM; Diethelm, L; Ortiz, LA; Gutierrez, M; Citera, G; Welsh, RA; Espinoza, LR. ‘Pulmonary involvement in rheumatoid arthritis’, Semin. Arthritis Rheum., vol. 24, no. 4, pp. 242–254, Feb. 1995.
[8] Ito, I; Nagai, S; Kitaichi, M; Nicholson, AG; Johkoh, T; Noma, S; Kim, DS; Handa, T; Izumi, T; Mishima, M. ‘Pulmonary manifestations of primary Sjogren’s syndrome: a clinical, radiologic, and pathologic study.’, Am. J. Respir. Crit. Care Med., vol. 171, no. 6, pp. 632–8, Mar. 2005.
[9] Jacobsen, S; Petersen, J; Ullman, S; Junker, P; Voss, A; Rasmussen, JM; Tarp, U; Poulsen, LH; van Overeem Hansen, G; Skaarup, B; Hansen, TM; Pødenphant, J; Halberg, P. ‘A multicentre study of 513 Danish patients with systemic lupus erythematosus. I. Disease manifestations and analyses of clinical subsets’, Clin. Rheumatol., vol. 17, no. 6, pp. 468–477, Nov. 1998.
[10] Jacobsen, S; Petersen, J; Ullman, S; Junker, P; Voss, A; Rasmussen, JM; Tarp, U; Poulsen, LH; van Overeem Hansen, G; Skaarup, B; Hansen, TM; Pødenphant, J; Halberg, P. ‘A multicentre study of 513 Danish patients with systemic lupus erythematosus. II. Disease mortality and clinical factors of prognostic value’, Clin. Rheumatol., vol. 17, no. 6, pp. 478–484, Nov. 1998.
[11] Tyndall, AJ; Bannert, B; Vonk, M; Airò, P; Cozzi, F; Carreira, PE; Bancel, DF; Allanore, Y; Müller-Ladner, U; Distler, O; Iannone, F; Pellerito, R; Pileckyte, M; Miniati, I; Ananieva, L; Gurman, AB; Damjanov, N; Mueller, A; Valentini, G; Riemekasten, G; Tikly, M; Hummers, L; Henriques, MJS; Caramaschi, P; Scheja, A; Rozman, B; Ton, E; Kumánovics, G; Coleiro, B; Feierl, E; Szucs, G; Von Mühlen, CA; Riccieri, V; Novak, S; Chizzolini, C; Kotulska, A; Denton, C; Coelho, PC; Kötter, I; Simsek, I; de la Pena Lefebvre, PG; Hachulla, E; Seibold, JR; Rednic, S; Stork, J; Morovic-Vergles, J; Walker, UA. ‘Causes and risk factors for death in systemic sclerosis: a study from the EULAR Scleroderma Trials and Research (EUSTAR) database.’, Ann. Rheum. Dis., vol. 69, no. 10, pp. 1809–15, Oct. 2010.
[12] Atkins, SR; Turesson, C; Myers, JL; Tazelaar, HD; Ryu, JH; Matteson, EL; Bongartz, T. ‘Morphologic and quantitative assessment of CD20+ B cell infiltrates in rheumatoid arthritis-associated nonspecific interstitial pneumonia and usual interstitial pneumonia.’, Arthritis Rheum., vol. 54, no. 2, pp. 635–41, Feb. 2006.
[13] Asano, N; Fujimoto, M; Yazawa, N; Shirasawa, S; Hasegawa, M; Okochi, H; Tamaki, K; Tedder, TF; Sato, S. ‘B Lymphocyte signaling established by the CD19/CD22 loop regulates autoimmunity in the tight-skin mouse.’, Am. J. Pathol., vol. 165, no. 2, pp. 641–50, Aug. 2004.
[14] Sato, S; Fujimoto, M; Hasegawa, M; Takehara, K. ‘Altered blood B lymphocyte homeostasis in systemic sclerosis: expanded naive B cells and diminished but activated memory B cells.’, Arthritis Rheum., vol. 50, no. 6, pp. 1918–27, Jun. 2004.
[15] Lafyatis, R; O’Hara, C; Feghali-Bostwick, CA; Matteson, E. ‘B cell infiltration in systemic sclerosis-associated interstitial lung disease.’, Arthritis Rheum., vol. 56, no. 9, pp. 3167–8, Sep. 2007.
[16] Berman, B. ‘Rituximab in diffuse cutaneous systemic sclerosis: an open-label clinical and histopathological study’, Yearb. Dermatology Dermatologic Surg., vol. 2011, pp. 221–222, Jan. 2011.
[17] Lafyatis, R; Kissin, E; York, M; Farina, G; Viger, K; Fritzler, MJ; Merkel, PA; Simms, RW. ‘B cell depletion with rituximab in patients with diffuse cutaneous systemic sclerosis.’, Arthritis Rheum., vol. 60, no. 2, pp. 578–83, Mar. 2009.
[18] McGonagle, D; Tan, AL; Madden, J; Rawstron, AC; Rehman, A; Emery, P; Thomas, S. ‘Successful treatment of resistant scleroderma-associated interstitial lung disease with rituximab.’, Rheumatology (Oxford)., vol. 47, no. 4, pp. 552–3, Apr. 2008.
[19] Haroon, M; McLaughlin, P; Henry, M; Harney, S. ‘Cyclophosphamide-refractory scleroderma-associated interstitial lung disease: remarkable clinical and radiological response to a single course of rituximab combined with high-dose corticosteroids.’, Ther. Adv. Respir. Dis., vol. 5, no. 5, pp. 299–304, Oct. 2011.
[20] Daoussis, D; Liossis, SNC; Tsamandas, AC; Kalogeropoulou, C; Kazantzi, A; Sirinian, C; Karampetsou, M; Yiannopoulos, G; Andonopoulos, AP. ‘Experience with rituximab in scleroderma: results from a 1-year, proof-of-principle study.’, Rheumatology (Oxford)., vol. 49, no. 2, pp. 271–80, Mar. 2010.
[21] Daoussis, D; Liossis, SNC; Tsamandas, AC; Kalogeropoulou, C; Paliogianni, F; Sirinian, C; Yiannopoulos, G; Andonopoulos, AP. ‘Effect of long-term treatment with rituximab on pulmonary function and skin fibrosis in patients with diffuse systemic sclerosis.’, Clin. Exp. Rheumatol., vol. 30, no. 2 Suppl 71, pp. S17–22, Jan.
[22] Sem, M; Molberg, O; Lund, MB; Gran, JT. ‘Rituximab treatment of the anti-synthetase syndrome: a retrospective case series.’, Rheumatology (Oxford)., vol. 48, no. 8, pp. 968–71, Aug. 2009.
[23] Andersson, H; Sem, M; Lund, MB; Aaløkken, TM; Günther, A; Walle-Hansen, R; Garen, T; Molberg, Ø. ‘Long-term experience with rituximab in anti-synthetase syndrome-related interstitial lung disease.’, Rheumatology (Oxford)., vol. 54, no. 8, pp. 1420–8, Aug. 2015.
[24] Marie, I; Dominique, S; Janvresse, A; Levesque, H; Menard, JF. ‘Rituximab therapy for refractory interstitial lung disease related to antisynthetase syndrome’, Respir. Med., vol. 106, no. 4, pp. 581–587, Apr. 2012.
[25] Keir, GJ; Maher, TM; Ming, D; Abdullah, R; de Lauretis, A; Wickremasinghe, M; Nicholson, AG; Hansell, DM; Wells, AU; Renzoni, EA. ‘Rituximab in severe, treatment-refractory interstitial lung disease.’, Respirology, vol. 19, no. 3, pp. 353–9, Apr. 2014.
[26] Salazar-Fontana, LI; Sanz, E; Mérida, I; Zea, A; Sanchez-Atrio, A; Villa, L; Martínez-A, C; de la Hera, A; Alvarez-Mon, M. ‘Cell surface CD28 levels define four CD4+ T cell subsets: abnormal expression in rheumatoid arthritis.’, Clin. Immunol., vol. 99, no. 2, pp. 253–65, May 2001.
[27] White, B. ‘Immunopathogenesis of systemic sclerosis.’, Rheum. Dis. Clin. North Am., vol. 22, no. 4, pp. 695–708, Nov. 1996.
[28] Sato, S; Fujimoto, M; Hasegawa, M; Komura, K; Yanaba, K; Hayakawa, I; Matsushita, T; Takehara, K. ‘Serum soluble CTLA-4 levels are increased in diffuse cutaneous systemic sclerosis.’, Rheumatology (Oxford)., vol. 43, no. 10, pp. 1261–6, Oct. 2004.
[29] Okazaki, T; Nakao, A; Nakano, H; Takahashi, F; Takahashi, K; Shimozato, O; Takeda, K; Yagita, H; Okumura, K. ‘Impairment of Bleomycin-Induced Lung Fibrosis in CD28-Deficient Mice’, J. Immunol., vol. 167, no. 4, pp. 1977–1981, Aug. 2001.
[30] Israël-Assayag, E; Fournier, M; Cormier, Y. ‘Blockade of T cell costimulation by CTLA4-Ig inhibits lung inflammation in murine hypersensitivity pneumonitis.’, J. Immunol., vol. 163, no. 12, pp. 6794–9, Dec. 1999.
[31] Jiménez-Alvarez, L; Arreola, JL; Ramírez-Martínez, G; Ortiz-Quintero, B; Gaxiola, M; Reynoso-Robles, R; Avila-Moreno, F; Urrea, F; Pardo, A; Selman, M; Zuñiga, J. ‘The effect of CTLA-4Ig, a CD28/B7 antagonist, on the lung inflammation and T cell subset profile during murine hypersensitivity pneumonitis.’, Exp. Mol. Pathol., vol. 91, no. 3, pp. 718–22, Dec. 2011.
[32] Mera-Varela, A; Pérez-Pampín, E. ‘Abatacept therapy in rheumatoid arthritis with interstitial lung disease.’, J. Clin. Rheumatol., vol. 20, no. 8, pp. 445–6, Dec. 2014.
[33] Hayes, F; Ostor, A. ‘26. Refractory Rheumatoid Arthritis with Interstitial Lung Disease: Could Abatacept Be the Answer?’, Rheumatology, vol. 53, no. suppl_1, p. i65–b–, Apr. 2014.
[34] Ortiz, LA; Lasky, J; Hamilton, RF; Holian, A; Hoyle, GW; Banks, W; Peschon, JJ; Brody, AR; Lungarella, G; Friedman, M. ‘Expression of TNF and the necessity of TNF receptors in bleomycin-induced lung injury in mice.’, Exp. Lung Res., vol. 24, no. 6, pp. 721–43, Jan.
[35] Piguet, PF; Vesin, C. ‘Treatment by human recombinant soluble TNF receptor of pulmonary fibrosis induced by bleomycin or silica in mice.’, Eur. Respir. J., vol. 7, no. 3, pp. 515–8, Mar. 1994.
[36] Liu, JY; Brass, DM; Hoyle, GW; Brody, AR. ‘TNF-alpha receptor knockout mice are protected from the fibroproliferative effects of inhaled asbestos fibers.’, Am. J. Pathol., vol. 153, no. 6, pp. 1839–47, Dec. 1998.
[37] Distler, JHW; Schett, G; Gay, S; Distler, O. ‘The controversial role of tumor necrosis factor alpha in fibrotic diseases.’, Arthritis Rheum., vol. 58, no. 8, pp. 2228–35, Aug. 2008.
[38] Vassallo, R; Matteson, E; Thomas, CF. ‘Clinical response of rheumatoid arthritis-associated pulmonary fibrosis to tumor necrosis factor-alpha inhibition.’, Chest, vol. 122, no. 3, pp. 1093–6, Sep. 2002.
[39] Antoniou, KM; Mamoulaki, M; Malagari, K; Kritikos, HD; Bouros, D; Siafakas, NM; Boumpas, DT. ‘Infliximab therapy in pulmonary fibrosis associated with collagen vascular disease.’, Clin. Exp. Rheumatol., vol. 25, no. 1, pp. 23–8, Jan.
[40] Bargagli, E; Galeazzi, M; Rottoli, P. ‘Infliximab treatment in a patient with rheumatoid arthritis and pulmonary fibrosis.’, Eur. Respir. J., vol. 24, no. 4, p. 708, Oct. 2004.
[41] Park, JK; Yoo, HG; Ahn, DS; Jeon, HS; Yoo, WH. ‘Successful treatment for conventional treatment-resistant dermatomyositis-associated interstitial lung disease with adalimumab.’, Rheumatol. Int., vol. 32, no. 11, pp. 3587–90, Nov. 2012.
[42] Chen, D; Wang, X; Zhou, Y; Zhu, X. ‘Efficacy of infliximab in the treatment for dermatomyositis with acute interstitial pneumonia: a study of fourteen cases and literature review.’, Rheumatol. Int., vol. 33, no. 10, pp. 2455–8, Oct. 2013.
[43] Kishimoto, T. ‘The biology of interleukin-6.’, Blood, vol. 74, no. 1, pp. 1–10, Jul. 1989.
[44] Hirano, T; Akira, S; Taga, T; Kishimoto, T. ‘Biologic and clinical aspects of interleukin 6’, Immunol. Today, vol. 11, pp. 443–449, Jan. 1990.
[45] Mortensen, RF. ‘C-reactive protein, inflammation, and innate immunity.’, Immunol. Res., vol. 24, no. 2, pp. 163–76, Jan. 2001.
[46] Duncan, MR; Berman, B. ‘Stimulation of Collagen and Glycosaminoglycan Production in Cultured Human Adult Dermal Fibroblasts by Recombinant Human Interleukin 6.’, J. Invest. Dermatol., vol. 97, no. 4, pp. 689–692, Oct. 1991.
[47] Hasegawa, M; Sato, S; Fujimoto, M; Ihn, H; Kikuchi, K; Takehara, K. ‘Serum levels of interleukin 6 (IL-6), oncostatin M, soluble IL-6 receptor, and soluble gp130 in patients with systemic sclerosis.’, J. Rheumatol., vol. 25, no. 2, pp. 308–13, Feb. 1998.
[48] Sato, S; Hasegawa, M; Takehara, K. ‘Serum levels of interleukin-6 and interleukin-10 correlate with total skin thickness score in patients with systemic sclerosis.’, J. Dermatol. Sci., vol. 27, no. 2, pp. 140–6, Oct. 2001.
[49] Kitaba, S; Murota, H; Terao, M; Azukizawa, H; Terabe, F; Shima, Y; Fujimoto, M; Tanaka, T; Naka, T; Kishimoto, T; Katayama, I. ‘Blockade of interleukin-6 receptor alleviates disease in mouse model of scleroderma.’, Am. J. Pathol., vol. 180, no. 1, pp. 165–76, Jan. 2012.
[50] Yousif, M; Habib, R; Esaely, H; Yasin, R; Sonbol, A. ‘Interleukin-6 in systemic sclerosis and potential correlation with pulmonary involvement’, Egypt. J. Chest Dis. Tuberc., vol. 64, no. 1, pp. 237–241, Jan. 2015.
[51] De Santis, M; Bosello, S; La Torre, G; Capuano, A; Tolusso, B; Pagliari, G; Pistelli, R; Danza, FM; Zoli, A; Ferraccioli, G. ‘Functional, radiological and biologic markers of alveolitis and infections of the lower respiratory tract in patients with systemic sclerosis.’, Respir. Res., vol. 6, no. 1, p. 96, Jan. 2005.
[52] Keidel, SM; Hoyles, RK; Wilkinson, NMR. ‘Efficacy of tocilizumab for interstitial lung disease in an undifferentiated autoinflammatory disorder partially responsive to anakinra.’, Rheumatology (Oxford)., vol. 53, no. 3, pp. 573–4, Mar. 2014.
[53] Justet, A; Ottaviani, S; Dieudé, P; Taillé, C. ‘Tocilizumab for refractory organising pneumonia associated with Sjögren’s disease.’, BMJ Case Rep., vol. 2015, no. may14_1, p. bcr2014209076–, Jan. 2015.
[54] Khanna, D. ‘Safety and Efficacy of Subcutaneous Tocilizumab in Adults with Systemic Sclerosis: Week 24 Data from a Phase 2/3 Trial.’ [Online]. Available: http://acrabstracts.org/abstract/safety-and-efficacy-of-subcutaneous-tocilizumab-in-adults-with-systemic-sclerosis-week-24-data-from-a-phase-23-trial/.
[55] Jiang, Y; Genant, HK; Watt, I; Cobby, M; Bresnihan, B; Aitchison, R; McCabe, D. ‘A multicenter, double-blind, dose-ranging, randomised, placebo-controlled study of recombinant human interleukin-1 receptor antagonist in patients with rheumatoid arthritis: radiologic progression and correlation of Genant and Larsen scores.’, Arthritis Rheum., vol. 43, no. 5, pp. 1001–9, May 2000.
[56] Cohen, SB; Moreland, LW; Cush, JJ; Greenwald, MW; Block, S; Shergy, WJ; Hanrahan, PS; Kraishi, MM; Patel, A; Sun, G; Bear, MB. ‘A multicentre, double blind, randomised, placebo controlled trial of anakinra (Kineret), a recombinant interleukin 1 receptor antagonist, in patients with rheumatoid arthritis treated with background methotrexate.’, Ann. Rheum. Dis., vol. 63, no. 9, pp. 1062–8, Sep. 2004.
[57] Cohen, S; Hurd, E; Cush, J; Schiff, M; Weinblatt, ME; Moreland, LW; Kremer, J; Bear, MB; Rich, WJ; McCabe, D. ‘Treatment of rheumatoid arthritis with anakinra, a recombinant human interleukin-1 receptor antagonist, in combination with methotrexate: results of a twenty-four-week, multicenter, randomised, double-blind, placebo-controlled trial.’, Arthritis Rheum., vol. 46, no. 3, pp. 614–24, Mar. 2002.
[58] Piguet, PF; Vesin, C; Grau, GE; Thompson, RC. ‘Interleukin 1 receptor antagonist (IL-1ra) prevents or cures pulmonary fibrosis elicited in mice by bleomycin or silica’, Cytokine, vol. 5, no. 1, pp. 57–61, Jan. 1993.
[59] Mikuniya, T; Nagai, S; Shimoji, T; Takeuchi, M; Morita, K; Mio, T; Satake, N; Izumi, T. ‘Quantitative evaluation of the IL-1 beta and IL-1 receptor antagonist obtained from BALF macrophages in patients with interstitial lung diseases.’, Sarcoidosis Vasc. Diffuse Lung Dis., vol. 14, no. 1, pp. 39–45, Mar. 1997.
[60] Dostert, C; Pétrilli, V; Van Bruggen, R; Steele, C; Mossman, BT; Tschopp, J. ‘Innate immune activation through Nalp3 inflammasome sensing of asbestos and silica.’, Science, vol. 320, no. 5876, pp. 674–7, May 2008.
[61] Peno-Green, L; Lluberas, G; Kingsley, T; Brantley, S. ‘Lung injury linked to etanercept therapy.’, Chest, vol. 122, no. 5, pp. 1858–60, Nov. 2002.
[62] Hagiwara, K; Sato, T; Takagi-Kobayashi, S; Hasegawa, S; Shigihara, N; Akiyama, O. ‘Acute exacerbation of preexisting interstitial lung disease after administration of etanercept for rheumatoid arthritis.’, J. Rheumatol., vol. 34, no. 5, pp. 1151–4, May 2007.
[63] Dias, OM; Pereira, DAS; Baldi, BG; Costa, AN; Athanazio, RA; Kairalla, RA; Carvalho, CRR. ‘Adalimumab-induced acute interstitial lung disease in a patient with rheumatoid arthritis.’, J. Bras. Pneumol. publicaça̋o Of. da Soc. Bras. Pneumol. e Tisilogia, vol. 40, no. 1, pp. 77–81, Jan.
[64] Takeuchi, T; Tatsuki, Y; Nogami, Y; Ishiguro, N; Tanaka, Y; Yamanaka, H; Kamatani, N; Harigai, M; Ryu, J; Inoue, K; Kondo, H; Inokuma, S; Ochi, T; Koike, T. ‘Postmarketing surveillance of the safety profile of infliximab in 5000 Japanese patients with rheumatoid arthritis.’, Ann. Rheum. Dis., vol. 67, no. 2, pp. 189–94, Feb. 2008.
[65] Koike, T; Harigai, M; Inokuma, S; Inoue, K; Ishiguro, N; Ryu, J; Takeuchi, T; Tanaka, Y; Yamanaka, H; Fujii, K; Freundlich, B; Suzukawa, M. ‘Postmarketing surveillance of the safety and effectiveness of etanercept in Japan.’, J. Rheumatol., vol. 36, no. 5, pp. 898–906, May 2009.
[66] Koike, T; Harigai, M; Ishiguro, N; Inokuma, S; Takei, S; Takeuchi, T; Yamanaka, H; Tanaka, Y. ‘Safety and effectiveness of adalimumab in Japanese rheumatoid arthritis patients: postmarketing surveillance report of the first 3,000 patients.’, Mod. Rheumatol., vol. 22, no. 4, pp. 498–508, Aug. 2012.
[67] Kawashiri, SY; Kawakami, A; Sakamoto, N; Ishimatsu, Y; Eguchi, K. ‘A fatal case of acute exacerbation of interstitial lung disease in a patient with rheumatoid arthritis during treatment with tocilizumab.’, Rheumatol. Int., vol. 32, no. 12, pp. 4023–6, Dec. 2012.
[68] Soubrier, M; Jeannin, G; Kemeny, JL; Tournadre, A; Caillot, N; Caillaud, D; Dubost, JJ. ‘Organizing pneumonia after rituximab therapy: Two cases.’, Joint. Bone. Spine, vol. 75, no. 3, pp. 362–5, May 2008.
[69] Leon, RJ; Gonsalvo, A; Salas, R; Hidalgo, NC. ‘Rituximab-induced acute pulmonary fibrosis.’, Mayo Clin. Proc., vol. 79, no. 7, pp. 949, 953, Jul. 2004.
[70] Kishi, J; Nanki, T; Watanabe, K; Takamura, A; Miyasaka, N. ‘A case of rituximab-induced interstitial pneumonitis observed in systemic lupus erythematosus.’, Rheumatology (Oxford)., vol. 48, no. 4, pp. 447–8, Apr. 2009.
[71] Wada, T; Akiyama, Y; Yokota, K; Sato, K; Funakubo, Y; Mimura, T. ‘[A case of rheumatoid arthritis complicated with deteriorated interstitial pneumonia after the administration of abatacept].’, Nihon Rinsh Men’eki Gakkai kaishi = Japanese J. Clin. Immunol., vol. 35, no. 5, pp. 433–8, Jan. 2012.
[72] Ikegawa, K; Hanaoka, M; Ushiki, A; Yamamoto, H; Kubo, K. ‘A case of organizing pneumonia induced by tocilizumab.’, Intern. Med., vol. 50, no. 19, pp. 2191–3, Jan. 2011.
[73] Wendling, D; Vidon, C; Godfrin-Valnet, M; Rival, G; Guillot, X; Prati, C. ‘Exacerbation of combined pulmonary fibrosis and emphysema syndrome during tocilizumab therapy for rheumatoid arthritis.’, Joint. Bone. Spine, vol. 80, no. 6, pp. 670–1, Dec. 2013.
[74] Ostor, AJK; Crisp, AJ; Somerville, MF; Scott, DGI. ‘Fatal exacerbation of rheumatoid arthritis associated fibrosing alveolitis in patients given infliximab.’, BMJ, vol. 329, no. 7477, p. 1266, Nov. 2004.
[75] Ramos-Casals, M; Roberto-Perez-Alvarez, Diaz-Lagares, C; Cuadrado, MJ; Khamashta, MA. ‘Autoimmune diseases induced by biologic agents: a double-edged sword?’, Autoimmun. Rev., vol. 9, no. 3, pp. 188–93, Jan. 2010.
[76] Wolfe, F; Caplan, L; Michaud, K. ‘Rheumatoid arthritis treatment and the risk of severe interstitial lung disease.’, Scand. J. Rheumatol., vol. 36, no. 3, pp. 172–8, Jan.
[77] Dixon, WG; Hyrich, KL; Watson, KD; Lunt, M; Symmons, DPM. ‘Influence of anti-TNF therapy on mortality in patients with rheumatoid arthritis-associated interstitial lung disease: results from the British Society for Rheumatology Biologics Register.’, Ann. Rheum. Dis., vol. 69, no. 6, pp. 1086–91, Jun. 2010.
[78] Curtis, JR; Sarsour, K; Napalkov, P; Costa, LA; Schulman, KL. ‘Incidence and complications of interstitial lung disease in users of tocilizumab, rituximab, abatacept and anti-tumor necrosis factor α agents, a retrospective cohort study.’, Arthritis Res. Ther., vol. 17, p. 319, Jan. 2015.
[79] Herrinton, LJ; Harrold, LR; Liu, L; Raebel, MA; Taharka, A; Winthrop, KL; Solomon, DH; Curtis, JR; Lewis, JD; Saag, KG. ‘Association between anti-TNF-α therapy and interstitial lung disease.’, Pharmacoepidemiol. Drug Saf., vol. 22, no. 4, pp. 394–402, Apr. 2013.

Chapter 18

[1] S. Hewlett, M. Carr, S. Ryan, J. Kirwan, P. Richards, A. Carr, et al., “Outcomes generated by patients with rheumatoid arthritis: how important are they?,” Musculoskeletal Care, vol. 3, pp. 131-42, 2005.
[2] J. R. Kirwan, P. Minnock, A. Adebajo, B. Bresnihan, E. Choy, M. de Wit, et al., “Patient perspective: fatigue as a recommended patient centered outcome measure in rheumatoid arthritis,” J Rheumatol, vol. 34, pp. 1174-7, May 2007.
[3] B. L. Hart, “Biological basis of the behavior of sick animals,” Neurosci Biobehav Rev, vol. 12, pp. 123-37, Summer 1988.
[4] K. L. Druce, G. T. Jones, G. J. Macfarlane, and N. Basu, “Patients receiving anti-TNF therapies experience clinically important improvements in RA-related fatigue: results from the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis,” Rheumatology (Oxford), vol. 54, pp. 964-71, Jun 2015.
[5] J. L. Hoving, G. M. Bartelds, J. K. Sluiter, K. Sadiraj, I. Groot, W. F. Lems, et al., “Perceived work ability, quality of life, and fatigue in patients with rheumatoid arthritis after a 6-month course of TNF inhibitors: prospective intervention study and partial economic evaluation,” Scand J Rheumatol, vol. 38, pp. 246-50, 2009.
[6] M. M. Herenius, J. L. Hoving, J. K. Sluiter, H. G. Raterman, W. F. Lems, B. A. Dijkmans, et al., “Improvement of work ability, quality of life, and fatigue in patients with rheumatoid arthritis treated with adalimumab,” J Occup Environ Med, vol. 52, pp. 618-21, Jun 2010.
[7] S. Yount, M. V. Sorensen, D. Cella, N. Sengupta, J. Grober, and E. K. Chartash, “Adalimumab plus methotrexate or standard therapy is more effective than methotrexate or standard therapies alone in the treatment of fatigue in patients with active, inadequately treated rheumatoid arthritis,” Clin Exp Rheumatol, vol. 25, pp. 838-46, Nov-Dec 2007.
[8] M. E. Weinblatt, E. C. Keystone, D. E. Furst, L. W. Moreland, M. H. Weisman, C. A. Birbara, et al., “Adalimumab, a fully human anti-tumor necrosis factor alpha monoclonal antibody, for the treatment of rheumatoid arthritis in patients taking concomitant methotrexate: the ARMADA trial,” Arthritis Rheum, vol. 48, pp. 35-45, Jan 2003.
[9] E. C. Keystone, A. F. Kavanaugh, J. T. Sharp, H. Tannenbaum, Y. Hua, L. S. Teoh, et al., “Radiographic, clinical, and functional outcomes of treatment with adalimumab (a human anti-tumor necrosis factor monoclonal antibody) in patients with active rheumatoid arthritis receiving concomitant methotrexate therapy: a randomised, placebo-controlled, 52-week trial,” Arthritis Rheum, vol. 50, pp. 1400-11, May 2004.
[10] K. L. Druce, G. T. Jones, G. J. Macfarlane, and N. Basu, “Determining Pathways to Improvements in Fatigue in Rheumatoid Arthritis: Results From the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis,” Arthritis Rheumatol, vol. 67, pp. 2303-10, Sep 2015.
[11] D. A. Revicki, M. P. Luo, P. Wordsworth, R. L. Wong, N. Chen, J. C. Davis, Jr., et al., “Adalimumab reduces pain, fatigue, and stiffness in patients with ankylosing spondylitis: results from the adalimumab trial evaluating long-term safety and efficacy for ankylosing spondylitis (ATLAS),” J Rheumatol, vol. 35, pp. 1346-53, Jul 2008.
[12] P. Minnock, J. Kirwan, D. Veale, O. Fitzgerald, and B. Bresnihan, “Fatigue is an independent outcome measure and is sensitive to change in patients with psoriatic arthritis,” Clin Exp Rheumatol, vol. 28, pp. 401-4, May-Jun 2010.
[13] S. Brophy, H. Davies, M. S. Dennis, R. Cooksey, M. J. Husain, E. Irvine, et al., “Fatigue in ankylosing spondylitis: treatment should focus on pain management,” Semin Arthritis Rheum, vol. 42, pp. 361-7, Feb 2013.
[14] A. J. Zautra, B. P. Parrish, C. M. Van Puymbroeck, H. Tennen, M. C. Davis, J. W. Reich, et al., “Depression history, stress, and pain in rheumatoid arthritis patients,” J Behav Med, vol. 30, pp. 187-97, Jun 2007.
[15] F. Uguz, C. Akman, S. Kucuksarac, and O. Tufekci, “Anti-tumor necrosis factor-alpha therapy is associated with less frequent mood and anxiety disorders in patients with rheumatoid arthritis,” Psychiatry Clin Neurosci, vol. 63, pp. 50-5, Feb 2009.
[16] T. Tokunaga, Y. Miwa, A. Nishimi, S. Nishimi, M. Saito, N. Oguro, et al., “Sex Differences in the Effects of a Biological Drug for Rheumatoid Arthritis on Depressive State,” Open Rheumatol J, vol. 9, pp. 51-6, 2015.
[17] H. Himmerich, S. Fulda, J. Linseisen, H. Seiler, G. Wolfram, S. Himmerich, et al., “Depression, comorbidities and the TNF-alpha system,” Eur Psychiatry, vol. 23, pp. 421-9, Sep 2008.
[18] C. B. Zhu, R. D. Blakely, and W. A. Hewlett, “The proinflammatory cytokines interleukin-1beta and tumor necrosis factor-alpha activate serotonin transporters,” Neuropsychopharmacology, vol. 31, pp. 2121-31, Oct 2006.
[19] M. Maes, H. Y. Meltzer, S. Scharpe, E. Bosmans, E. Suy, I. De Meester, et al., “Relationships between lower plasma L-tryptophan levels and immune-inflammatory variables in depression,” Psychiatry Res, vol. 49, pp. 151-65, Nov 1993.
[20] S. M. Dursun, J. R. Blackburn, and S. P. Kutcher, “An exploratory approach to the serotonergic hypothesis of depression: bridging the synaptic gap,” Med Hypotheses, vol. 56, pp. 235-43, Feb 2001.
[21] M. P. Heyes, K. Saito, J. S. Crowley, L. E. Davis, M. A. Demitrack, M. Der, et al., “Quinolinic acid and kynurenine pathway metabolism in inflammatory and non-inflammatory neurological disease,” Brain, vol. 115 (Pt 5), pp. 1249-73, Oct 1992.
[22] R. Krishnadas, A. Nicol, J. Sassarini, N. Puri, A. D. Burden, J. Leman, et al., “Circulating tumour necrosis factor is highly correlated with brainstem serotonin transporter availability in humans,” Brain Behav Immun, Aug 6 2015.
[23] M. P. Kaster, V. M. Gadotti, J. B. Calixto, A. R. Santos, and A. L. Rodrigues, “Depressive-like behavior induced by tumor necrosis factor-alpha in mice,” Neuropharmacology, vol. 62, pp. 419-26, Jan 2012.
[24] U. Krugel, J. Fischer, S. Radicke, U. Sack, and H. Himmerich, “Antidepressant effects of TNF-alpha blockade in an animal model of depression,” J Psychiatr Res, vol. 47, pp. 611-6, May 2013.
[25] C. L. Raison, R. E. Rutherford, B. J. Woolwine, C. Shuo, P. Schettler, D. F. Drake, et al., “A randomised controlled trial of the tumor necrosis factor antagonist infliximab for treatment-resistant depression: the role of baseline inflammatory biomarkers,” JAMA Psychiatry, vol. 70, pp. 31-41, Jan 2013.
[26] J. Kekow, R. Moots, R. Khandker, J. Melin, B. Freundlich, and A. Singh, “Improvements in patient-reported outcomes, symptoms of depression and anxiety, and their association with clinical remission among patients with moderate-to-severe active early rheumatoid arthritis,” Rheumatology (Oxford), vol. 50, pp. 401-9, Feb 2011.
[27] D. A. Machado, R. M. Guzman, R. M. Xavier, J. A. Simon, L. Mele, R. Pedersen, et al., “Open-label observation of addition of etanercept versus a conventional disease-modifying antirheumatic drug in subjects with active rheumatoid arthritis despite methotrexate therapy in the Latin American region,” J Clin Rheumatol, vol. 20, pp. 25-33, Jan 2014.
[28] I. Ertenli, S. Ozer, S. Kiraz, S. B. Apras, A. Akdogan, O. Karadag, et al., “Infliximab, a TNF-alpha antagonist treatment in patients with ankylosing spondylitis: the impact on depression, anxiety and quality of life level,” Rheumatol Int, vol. 32, pp. 323-30, Feb 2012.
[29] P. Fleming, C. Roubille, V. Richer, T. Starnino, C. McCourt, A. McFarlane, et al., “Effect of biologics on depressive symptoms in patients with psoriasis: a systematic review,” J Eur Acad Dermatol Venereol, vol. 29, pp. 1063-70, Jun 2015.
[30] E. M. Barrett, D. G. Scott, N. J. Wiles, and D. P. Symmons, “The impact of rheumatoid arthritis on employment status in the early years of disease: a UK community-based study,” Rheumatology (Oxford), vol. 39, pp. 1403-9, Dec 2000.
[31] S. Allaire, F. Wolfe, J. Niu, M. P. LaValley, B. Zhang, and S. Reisine, “Current risk factors for work disability associated with rheumatoid arthritis: recent data from a US national cohort,” Arthritis Rheum, vol. 61, pp. 321-8, Mar 15 2009.
[32] A. Young, J. Dixey, E. Kulinskaya, N. Cox, P. Davies, J. Devlin, et al., “Which patients stop working because of rheumatoid arthritis? Results of five years' follow up in 732 patients from the Early RA Study (ERAS),” Ann Rheum Dis, vol. 61, pp. 335-40, Apr 2002.
[33] S. M. Verstappen, A. Boonen, J. W. Bijlsma, E. Buskens, H. Verkleij, Y. Schenk, et al., “Working status among Dutch patients with rheumatoid arthritis: work disability and working conditions,” Rheumatology (Oxford), vol. 44, pp. 202-6, Feb 2005.
[34] S. M. Verstappen, J. W. Bijlsma, H. Verkleij, E. Buskens, A. A. Blaauw, E. J. ter Borg, et al., “Overview of work disability in rheumatoid arthritis patients as observed in cross-sectional and longitudinal surveys,” Arthritis Rheum, vol. 51, pp. 488-97, Jun 15 2004.
[35] F. Wolfe and S. H. Zwillich, “The long-term outcomes of rheumatoid arthritis: a 23-year prospective, longitudinal study of total joint replacement and its predictors in 1,600 patients with rheumatoid arthritis,” Arthritis Rheum, vol. 41, pp. 1072-82, Jun 1998.
[36] D. F. McWilliams, S. Varughese, A. Young, P. D. Kiely, and D. A. Walsh, “Work disability and state benefit claims in early rheumatoid arthritis: the ERAN cohort,” Rheumatology (Oxford), vol. 53, pp. 473-81, Mar 2014.
[37] J. Augustsson, M. Neovius, C. Cullinane-Carli, S. Eksborg, and R. F. van Vollenhoven, “Patients with rheumatoid arthritis treated with tumour necrosis factor antagonists increase their participation in the workforce: potential for significant long-term indirect cost gains (data from a population-based registry),” Ann Rheum Dis, vol. 69, pp. 126-31, Jan 2010.
[38] S. Allaire, F. Wolfe, J. Niu, Y. Zhang, B. Zhang, and M. LaValley, “Evaluation of the effect of anti-tumor necrosis factor agent use on rheumatoid arthritis work disability: the jury is still out,” Arthritis Rheum, vol. 59, pp. 1082-9, Aug 15 2008.
[39] M. Ryden, A. Dicker, V. van Harmelen, H. Hauner, M. Brunnberg, L. Perbeck, et al., “Mapping of early signaling events in tumor necrosis factor-alpha -mediated lipolysis in human fat cells,” J Biol Chem, vol. 277, pp. 1085-91, Jan 11 2002.
[40] E. Toussirot, L. Mourot, B. Dehecq, D. Wendling, E. Grandclement, G. Dumoulin, et al., “TNFalpha blockade for inflammatory rheumatic diseases is associated with a significant gain in android fat mass and has varying effects on adipokines: a 2-year prospective study,” Eur J Nutr, vol. 53, pp. 951-61, Apr 2014.
[41] N. Alcorn, A. Tierney, O. Wu, H. Gilmour, and R. Madhok, “Impact of anti-tumour necrosis factor therapy on the weight of patients with rheumatoid arthritis,” Ann Rheum Dis, vol. 69, p. 1571, Aug 2010.
[42] C. Y. Chen, C. Y. Tsai, P. C. Lee, and S. D. Lee, “Long-term etanercept therapy favors weight gain and ameliorates cachexia in rheumatoid arthritis patients: roles of gut hormones and leptin,” Curr Pharm Des, vol. 19, pp. 1956-64, 2013.
[43] I. L. Engvall, B. Tengstrand, K. Brismar, and I. Hafstrom, “Infliximab therapy increases body fat mass in early rheumatoid arthritis independently of changes in disease activity and levels of leptin and adiponectin: a randomised study over 21 months,” Arthritis Res Ther, vol. 12, p. R197, 2010.
[44] L. D. Renzo, R. Saraceno, C. Schipani, M. Rizzo, A. Bianchi, A. Noce, et al., “Prospective assessment of body weight and body composition changes in patients with psoriasis receiving anti-TNF-alpha treatment,” Dermatol Ther, vol. 24, pp. 446-51, Jul-Aug 2011.
[45] I. Hmamouchi, C. Roux, S. Paternotte, S. Kolta, M. Dougados, and K. Briot, “Early increase of abdominal adiposity in patients with spondyloarthritis receiving anti-tumor necrosis factor-alpha treatment,” J Rheumatol, vol. 41, pp. 1112-7, Jun 2014.
[46] K. Briot, L. Gossec, S. Kolta, M. Dougados, and C. Roux, “Prospective assessment of body weight, body composition, and bone density changes in patients with spondyloarthropathy receiving anti-tumor necrosis factor-alpha treatment,” J Rheumatol, vol. 35, pp. 855-61, May 2008.
[47] S. Younis, I. Rosner, D. Rimar, N. Boulman, M. Rozenbaum, M. Odeh, et al., “Weight change during pharmacological blockade of interleukin-6 or tumor necrosis factor-alpha in patients with inflammatory rheumatic disorders: a 16-week comparative study,” Cytokine, vol. 61, pp. 353-5, Feb 2013.
[48] E. Tan, C. Baker, and P. Foley, “Weight gain and tumour necrosis factor-alpha inhibitors in patients with psoriasis,” Australas J Dermatol, vol. 54, pp. 259-63, Nov 2013.
[49] P. Gisondi, A. Conti, G. Galdo, S. Piaserico, C. De Simone, and G. Girolomoni, “Ustekinumab does not increase body mass index in patients with chronic plaque psoriasis: a prospective cohort study,” Br J Dermatol, vol. 168, pp. 1124-7, May 2013.
[50] K. Kobayashi, N. Takahashi, E. Jimi, N. Udagawa, M. Takami, S. Kotake, et al., “Tumor necrosis factor alpha stimulates osteoclast differentiation by a mechanism independent of the ODF/RANKL-RANK interaction,” J Exp Med, vol. 191, pp. 275-86, Jan 17 2000.
[51] J. Lam, S. Takeshita, J. E. Barker, O. Kanagawa, F. P. Ross, and S. L. Teitelbaum, “TNF-alpha induces osteoclastogenesis by direct stimulation of macrophages exposed to permissive levels of RANK ligand,” J Clin Invest, vol. 106, pp. 1481-8, Dec 2000.
[52] R. Yoshihara, S. Shiozawa, Y. Imai, and T. Fujita, “Tumor necrosis factor alpha and interferon gamma inhibit proliferation and alkaline phosphatase activity of human osteoblastic SaOS-2 cell line,” Lymphokine Res, vol. 9, pp. 59-66, Spring 1990.
[53] L. Gilbert, X. He, P. Farmer, S. Boden, M. Kozlowski, J. Rubin, et al., “Inhibition of osteoblast differentiation by tumor necrosis factor-alpha,” Endocrinology, vol. 141, pp. 3956-64, Nov 2000.
[54] E. Pascher, A. Perniok, A. Becker, and J. Feldkamp, “Effect of 1alpha,25(OH)2-vitamin D3 on TNF alpha-mediated apoptosis of human primary osteoblast-like cells in vitro,” Horm Metab Res, vol. 31, pp. 653-6, Dec 1999.
[55] M. Guler-Yuksel, C. F. Allaart, Y. P. Goekoop-Ruiterman, J. K. de Vries-Bouwstra, J. H. van Groenendael, C. Mallee, et al., “Changes in hand and generalised bone mineral density in patients with recent-onset rheumatoid arthritis,” Ann Rheum Dis, vol. 68, pp. 330-6, Mar 2009.
[56] L. Dirven, M. Guler-Yuksel, W. M. de Beus, H. K. Ronday, I. Speyer, T. W. Huizinga, et al., “Changes in hand bone mineral density and the association with the level of disease activity in patients with rheumatoid arthritis: bone mineral density measurements in a multicenter randomised clinical trial,” Arthritis Care Res (Hoboken), vol. 63, pp. 1691-9, Dec 2011.
[57] M. Hoff, T. K. Kvien, J. Kalvesten, A. Elden, and G. Haugeberg, “Adalimumab therapy reduces hand bone loss in early rheumatoid arthritis: explorative analyses from the PREMIER study,” Ann Rheum Dis, vol. 68, pp. 1171-6, Jul 2009.
[58] U. Lange, J. Teichmann, U. Muller-Ladner, and J. Strunk, “Increase in bone mineral density of patients with rheumatoid arthritis treated with anti-TNF-alpha antibody: a prospective open-label pilot study,” Rheumatology (Oxford), vol. 44, pp. 1546-8, Dec 2005.
[59] F. Chopin, P. Garnero, A. le Henanff, F. Debiais, A. Daragon, C. Roux, et al., “Long-term effects of infliximab on bone and cartilage turnover markers in patients with rheumatoid arthritis,” Ann Rheum Dis, vol. 67, pp. 353-7, Mar 2008.
[60] C. A. Wijbrandts, R. Klaasen, M. G. Dijkgraaf, D. M. Gerlag, B. L. van Eck-Smit, and P. P. Tak, “Bone mineral density in rheumatoid arthritis patients 1 year after adalimumab therapy: arrest of bone loss,” Ann Rheum Dis, vol. 68, pp. 373-6, Mar 2009.
[61] M. Vis, E. A. Havaardsholm, G. Haugeberg, T. Uhlig, A. E. Voskuyl, R. J. van de Stadt, et al., “Evaluation of bone mineral density, bone metabolism, osteoprotegerin and receptor activator of the NFkappaB ligand serum levels during treatment with infliximab in patients with rheumatoid arthritis,” Ann Rheum Dis, vol. 65, pp. 1495-9, Nov 2006.
[62] G. Haugeberg, P. G. Conaghan, M. Quinn, and P. Emery, “Bone loss in patients with active early rheumatoid arthritis: infliximab and methotrexate compared with methotrexate treatment alone. Explorative analysis from a 12-month randomised, double-blind, placebo-controlled study,” Ann Rheum Dis, vol. 68, pp. 1898-901, Dec 2009.
[63] H. Marotte, B. Pallot-Prades, L. Grange, P. Gaudin, C. Alexandre, and P. Miossec, “A 1-year case-control study in patients with rheumatoid arthritis indicates prevention of loss of bone mineral density in both responders and nonresponders to infliximab,” Arthritis Res Ther, vol. 9, p. R61, 2007.
[64] S. Y. Kim, S. Schneeweiss, J. Liu, and D. H. Solomon, “Effects of disease-modifying antirheumatic drugs on nonvertebral fracture risk in rheumatoid arthritis: a population-based cohort study,” J Bone Miner Res, vol. 27, pp. 789-96, Apr 2012.
[65] M. Pazianas, A. D. Rhim, A. M. Weinberg, C. Su, and G. R. Lichtenstein, “The effect of anti-TNF-alpha therapy on spinal bone mineral density in patients with Crohn's disease,” Ann N Y Acad Sci, vol. 1068, pp. 543-56, Apr 2006.
[66] K. Y. Kang, K. Y. Lee, S. K. Kwok, J. H. Ju, K. S. Park, Y. S. Hong, et al., “The change of bone mineral density according to treatment agents in patients with ankylosing spondylitis,” Joint Bone Spine, vol. 78, pp. 188-93, Mar 2011.
[67] M. Mauro, V. Radovic, and D. Armstrong, “Improvement of lumbar bone mass after infliximab therapy in Crohn's disease patients,” Can J Gastroenterol, vol. 21, pp. 637-42, Oct 2007.
[68] S. Visvanathan, D. van der Heijde, A. Deodhar, C. Wagner, D. G. Baker, J. Han, et al., “Effects of infliximab on markers of inflammation and bone turnover and associations with bone mineral density in patients with ankylosing spondylitis,” Ann Rheum Dis, vol. 68, pp. 175-82, Feb 2009.
[69] H. Marzo-Ortega, D. McGonagle, G. Haugeberg, M. J. Green, S. P. Stewart, and P. Emery, “Bone mineral density improvement in spondyloarthropathy after treatment with etanercept,” Ann Rheum Dis, vol. 62, pp. 1020-1, Oct 2003.
[70] S. I. van Leuven, R. Franssen, J. J. Kastelein, M. Levi, E. S. Stroes, and P. P. Tak, “Systemic inflammation as a risk factor for atherothrombosis,” Rheumatology (Oxford), vol. 47, pp. 3-7, Jan 2008.
[71] M. A. Gonzalez-Gay, C. Gonzalez-Juanatey, T. R. Vazquez-Rodriguez, J. A. Miranda-Filloy, and J. Llorca, “Insulin resistance in rheumatoid arthritis: the impact of the anti-TNF-alpha therapy,” Ann N Y Acad Sci, vol. 1193, pp. 153-9, Apr 2010.
[72] L. S. Tam, B. Tomlinson, T. T. Chu, T. K. Li, and E. K. Li, “Impact of TNF inhibition on insulin resistance and lipids levels in patients with rheumatoid arthritis,” Clin Rheumatol, vol. 26, pp. 1495-8, Sep 2007.
[73] S. L. Westlake, A. N. Colebatch, J. Baird, P. Kiely, M. Quinn, E. Choy, et al., “The effect of methotrexate on cardiovascular disease in patients with rheumatoid arthritis: a systematic literature review,” Rheumatology (Oxford), vol. 49, pp. 295-307, Feb 2010.
[74] S. L. Westlake, A. N. Colebatch, J. Baird, N. Curzen, P. Kiely, M. Quinn, et al., “Tumour necrosis factor antagonists and the risk of cardiovascular disease in patients with rheumatoid arthritis: a systematic literature review,” Rheumatology (Oxford), vol. 50, pp. 518-31, Mar 2011.
[75] M. Nurmohamed, Y. Bao, J. Signorovitch, A. Trahey, P. Mulani, and D. E. Furst, “Longer durations of antitumour necrosis factor treatment are associated with reduced risk of cardiovascular events in patients with rheumatoid arthritis,” RMD Open, vol. 1, p. e000080, 2015.
[76] F. Abbasi, B. W. Brown, Jr., C. Lamendola, T. McLaughlin, and G. M. Reaven, “Relationship between obesity, insulin resistance, and coronary heart disease risk,” J Am Coll Cardiol, vol. 40, pp. 937-43, Sep 4 2002.
[77] D. N. Kiortsis, A. K. Mavridis, T. D. Filippatos, S. Vasakos, S. N. Nikas, and A. A. Drosos, “Effects of infliximab treatment on lipoprotein profile in patients with rheumatoid arthritis and ankylosing spondylitis,” J Rheumatol, vol. 33, pp. 921-3, May 2006.
[78] I. Stagakis, G. Bertsias, S. Karvounaris, M. Kavousanaki, D. Virla, A. Raptopoulou, et al., “Anti-tumor necrosis factor therapy improves insulin resistance, beta cell function and insulin signaling in active rheumatoid arthritis patients with high insulin resistance,” Arthritis Res Ther, vol. 14, p. R141, 2012.
[79] T. Pina, S. Armesto, R. Lopez-Mejias, F. Genre, B. Ubilla, M. A. Gonzalez-Lopez, et al., “Anti-TNF-alpha therapy improves insulin sensitivity in non-diabetic patients with psoriasis: a 6-month prospective study,” J Eur Acad Dermatol Venereol, vol. 29, pp. 1325-30, Jul 2015.
[80] U. Bergstrom, C. Grundtman, I. E. Lundberg, L. T. Jacobsson, K. Nilsson, and C. Turesson, “Effects of adalimumab treatment on endothelial cell activation markers in the skeletal muscle of patients with rheumatoid arthritis,” Clin Exp Rheumatol, vol. 32, pp. 883-90, Nov-Dec 2014.
[81] F. Genre, R. Lopez-Mejias, J. A. Miranda-Filloy, B. Ubilla, V. Mijares, B. Carnero-Lopez, et al., “Anti-TNF-alpha therapy reduces endothelial cell activation in non-diabetic ankylosing spondylitis patients,” Rheumatol Int, Jul 5 2015.
[82] A. Algaba, P. M. Linares, M. Encarnacion Fernandez-Contreras, A. Figuerola, X. Calvet, I. Guerra, et al., “The effects of infliximab or adalimumab on vascular endothelial growth factor and angiopoietin 1 angiogenic factor levels in inflammatory bowel disease: serial observations in 37 patients,” Inflamm Bowel Dis, vol. 20, pp. 695-702, Apr 2014.
[83] F. Wolfe and K. Michaud, “Anemia and renal function in patients with rheumatoid arthritis,” J Rheumatol, vol. 33, pp. 1516-22, Aug 2006.
[84] L. S. Rusten and S. E. Jacobsen, “Tumor necrosis factor (TNF)-alpha directly inhibits human erythropoiesis in vitro: role of p55 and p75 TNF receptors,” Blood, vol. 85, pp. 989-96, Feb 15 1995.
[85] H. A. Papadaki, H. D. Kritikos, V. Valatas, D. T. Boumpas, and G. D. Eliopoulos, “Anemia of chronic disease in rheumatoid arthritis is associated with increased apoptosis of bone marrow erythroid cells: improvement following anti-tumor necrosis factor-alpha antibody therapy,” Blood, vol. 100, pp. 474-82, Jul 15 2002.
[86] X. Alvarez-Hernandez, J. Liceaga, I. C. McKay, and J. H. Brock, “Induction of hypoferremia and modulation of macrophage iron metabolism by tumor necrosis factor,” Lab Invest, vol. 61, pp. 319-22, Sep 1989.
[87] G. Vreugdenhil, B. Lowenberg, H. G. Van Eijk, and A. J. Swaak, “Tumor necrosis factor alpha is associated with disease activity and the degree of anemia in patients with rheumatoid arthritis,” Eur J Clin Invest, vol. 22, pp. 488-93, Jul 1992.
[88] D. Davis, P. J. Charles, A. Potter, M. Feldmann, R. N. Maini, and M. J. Elliott, “Anaemia of chronic disease in rheumatoid arthritis: in vivo effects of tumour necrosis factor alpha blockade,” Br J Rheumatol, vol. 36, pp. 950-6, Sep 1997.
[89] C. Bes, A. Yazici, and M. Soy, “Monoclonal anti-TNF antibodies can elevate hemoglobin level in patients with ankylosing spondylitis,” Rheumatol Int, vol. 33, pp. 1415-8, Jun 2013.
[90] L. Niccoli, C. Nannini, E. Cassara, O. Kaloudi, and F. Cantini, “Frequency of anemia of inflammation in patients with ankylosing spondylitis requiring anti-TNFalpha drugs and therapy-induced changes,” Int J Rheum Dis, vol. 15, pp. 56-61, Feb 2012.
[91] D. E. Furst, J. Kay, M. C. Wasko, E. Keystone, A. Kavanaugh, A. Deodhar, et al., “The effect of golimumab on haemoglobin levels in patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis,” Rheumatology (Oxford), vol. 52, pp. 1845-55, Oct 2013.
[92] I. Natsumi, Y. Matsukawa, K. Miyagawa, H. Kodaira, T. Tanaka, A. Horikoshi, et al., “Successful childbearing in two women with rheumatoid arthritis and a history of miscarriage after etanercept treatment,” Rheumatol Int, vol. 33, pp. 2433-5, Sep 2013.
[93] A. Murashima, “[Treatment of patients with rheumatoid arthritis who desire to become pregnant--successful pregnancy in three cases treated with etanercept],” Nihon Rinsho, vol. 66, pp. 2215-20, Nov 2008.
[94] E. E. Winger and J. L. Reed, “Treatment with tumor necrosis factor inhibitors and intravenous immunoglobulin improves live birth rates in women with recurrent spontaneous abortion,” Am J Reprod Immunol, vol. 60, pp. 8-16, Jul 2008.
[95] J. S. Suominen, Y. Wang, A. Kaipia, and J. Toppari, “Tumor necrosis factor-alpha (TNF-alpha) promotes cell survival during spermatogenesis, and this effect can be blocked by infliximab, a TNF-alpha antagonist,” Eur J Endocrinol, vol. 151, pp. 629-40, Nov 2004.
[96] T. M. Said, A. Agarwal, T. Falcone, R. K. Sharma, M. A. Bedaiwy, and L. Li, “Infliximab may reverse the toxic effects induced by tumor necrosis factor alpha in human spermatozoa: an in vitro model,” Fertil Steril, vol. 83, pp. 1665-73, Jun 2005.
[97] P. M. Villiger, G. Caliezi, V. Cottin, F. Forger, A. Senn, and M. Ostensen, “Effects of TNF antagonists on sperm characteristics in patients with spondyloarthritis,” Ann Rheum Dis, vol. 69, pp. 1842-4, Oct 2010.
[98] M. C. Micu, R. Micu, S. Surd, M. Girlovanu, S. D. Bolboaca, and M. Ostensen, “TNF-alpha inhibitors do not impair sperm quality in males with ankylosing spondylitis after short-term or long-term treatment,” Rheumatology (Oxford), vol. 53, pp. 1250-5, Jul 2014.
[99] R. Puchner, K. Danninger, A. Puchner, and H. Pieringer, “Impact of TNF-blocking agents on male sperm characteristics and pregnancy outcomes in fathers exposed to TNF-blocking agents at time of conception,” Clin Exp Rheumatol, vol. 30, pp. 765-7, Sep-Oct 2012.

Chapter 19

[1] A. Strangfeld, M. Eveslage, M. Schneider, H. J. Bergerhausen, T. Klopsch, A. Zink, et al., “Treatment benefit or survival of the fittest: what drives the time-dependant decrease in serious infection rates under TNF inhibition and does that imply for the individual patient?,” Ann Rheum Dis, vol. 70, pp. 1914-20, 2011.
[2] W. G. Dixon, S. Suissa, and M. Hudson, “The association between systemic glucocorticoid therapy and the risk of infection in patients with rheumatoid arthritis: systematic review and meta-analyses,” Arthritis Res Ther, vol. 13, p. R139, 2011.
[3] S. A. Novosad and K. L. Winthrop, “Beyond tumor necrosis factor inhibition: the expanding pipeline of biologic therapies for inflammatory diseases and their associated infectious sequelae,” Clin Infect Dis, vol. 58, pp. 1587-98, Jun 2014.
[4] C. G. Grijalva, L. Chen, E. Delzell, J. W. Baddley, T. Beukelman, K. L. Winthrop, et al., “Initiation of tumor necrosis factor-α antagonists and the risk of hospitalization for infection in patients with autoimmune diseases,” JAMA, vol. 306, pp. 2331-9, 2011.
[5] W. G. Dixon, K. Watson, M. Lunt, K. L. Hyrich, A. J. Silman, D. P. Symmons, et al., “Rates of serious infection, including site-specific and bacterial intracellular infection, in rheumatoid arthritis patients receiving anti-tumor necrosis factor therapy: results from the British Society for Rheumatology Biologics Register,” Arthritis Rheum, vol. 54, pp. 2368-76, 2006.
[6] K. L. Winthrop, S. Yamashita, S. E. Beekman, P. M. Polgreen, and Infectious Diseases Society of America Emerging Infections Network, “Mycobacterial and other serious infections in patients receiving anti-tumor necrosis factor and other newly approved biologic therapies: case finding through the Emerging Infections Network,” Clin Infect Dis, vol. 1;46, pp. 1738-40, 2008.
[7] J. B. Galloway, K. L. Hyrich, L. K. Mercer, W. G. Dixon, A. P. Ustianowski, M. Helbert, et al., “Risk of septic arthritis in patients with rheumatoid arthritis and the effect of anti-TNF therapy: results from the British Society for Rheumatology Biologics Register,” Ann Rheum Dis, vol. 70, pp. 1810-4, 2011.
[8] M. Bodro and D. L. Paterson, “Listeriosis in patients receiving biologic therapies,” Eur J Clin Microbiol Infect Dis, vol. 32, pp. 1225-30, 2013.
[9] N. R. Slifman, S. K. Gershon, J. H. Lee, E. T. Edwards, and M. M. Braun, “Listeria Monocytogenes infection as a complication of treatement with tumour necrosis factor alpha-neutralizing agents,” Arthritis Rheum, vol. 48, pp. 319-24, 2003.
[10] F. Tubach, P. Ravaud, D. Salmon-Ceron, and e. al, “Emergence of Legionella pneumophila pneumonia in patients receiving tumor necrosis factor-alpha antagonists,” Clin Infect Dis, vol. 43, pp. e95-100, 2006.
[11] R. Lorenzetti, A. Zullo, L. Ridola, A. P. Diamanti, B. Laganà, L. Gatta, et al., “Higher risk of tuberculosis reactivation when anti-TNF is combined with immunosuppressive agents: a systematic review of randomised controlled trials,” Ann Med, vol. 46, pp. 547-54, 2014.
[12] I. Solovic, M. Sester, J. J. Gomez-Reino, H. L. Rieder, S. Ehlers, H. J. Milburn, et al., “The risk of tuberculosis related to tumour necrosis factor antagonist therapies: a TBNET consensus statement,” Eur Respir J, vol. 36, pp. 1185-206, 2010.
[13] S. Mankia, J. E. Peters, S. Kang, S. Moore, and M. R. Ehrenstein, “Tuberculosis and anti-TNF treatment: experience of a central London hospital,” Clin Rheumatol, vol. 30, pp. 399-401, Mar 2011.
[14] W. G. Dixon, K. L. Hyrich, K. D. Watson, M. Lunt, J. Galloway, A. Ustianowski, et al., “Drug-specific risk of tuberculosis in patients with rheumatoid arthritis treated with anti-TNF therapy: results from the British Society for Rheumatology Biologics Register (BSRBR),” Ann Rheum Dis, vol. 69, pp. 522-528, 2010.
[15] F. Tubach, D. Salmon, P. Ravaud, Y. Allanore, P. Goupille, M. Bréban, et al., “Risk of tuberculosis is higher with anti-tumor necrosis factor monoclonal antibody therapy than with soluble tumor necrosis factor receptor therapy: The three-year prospective French Research Axed on Tolerance of Biotherapies registry,” Arthritis Rheum, vol. 60, pp. 1884-94, 2009.
[16] J. J. Gomez-Reino, L. Carmona, M. Angel Descalzo, and Biobadaser Group, “Risk of tuberculosis in patients treated with tumor necrosis factor antagonists due to incomplete prevention of reactivation of latent infection,” Arthritis Rheum, vol. 57, pp. 56-61, 2007.
[17] S. Ehlers, “Tumor necrosis factor and its blockade in granulomatous infections: differential modes of action of infliximab and etanercept?,” Clin Infect Dis, vol. 41 Suppl 3, pp. S199-203, Aug 1 2005.
[18] T. Tanaka, A. Sekine, Y. Tsunoda, H. Takoi, S. Y. Lin, Y. Yatagai, et al., “Central nervous system manifestations of tuberculosis-associated immune reconstitution inflammatory syndrome during adalimumab therapy: a case report and review of the literature,” Intern Med, vol. 54, pp. 847-51, 2015.
[19] J. A. Smith and C. A. Kauffman, “Endemic fungal infections in patients receiving tumour necrosis factor-alpha inhibitor therapy,” Drugs, vol. 69, pp. 1403-15, 2009.
[20] E. Salt, A. T. Wiggins, M. K. Rayens, M. A. Huaman, D. Mannino, P. Schwieterman, et al., “Risk Factors for Targeted Fungal and Mycobacterial Infections in Patients Taking TNF-alpha Inhibitors,” Arthritis Rheumatol, 2015.
[21] S. Tsiodras, G. Samonis, D. T. Boumpas, and D. P. Kontoyiannis, “Fungal infections complicationg tumour necrosis factor-a blockade therapy,” Mayo Clin Proc, vol. 83, pp. 181-94, 2008.
[22] C. A. Hage, S. Bowyer, S. E. Tarvin, D. Helper, M. B. Kleiman, and L. J. Wheat, “Recognition, diagnosis, and treatment of histoplasmosis complicating tumor necrosis factor blocker therapy,” Clin Infect Dis, vol. 50, pp. 85-92, 2010.
[23] G. A. Zattar, F. Cardoso, S. Nakandakari, and C. T. Soares, “Cutaneous histoplasmosis as a complication after anti-TNF use - Case report,” An Bras Dermatol, vol. 90, pp. 104-107, 2015.
[24] US Food and drug administration. (22 Oct). FDA requires stronger fungal infection warning for TNF blockers. Available: http://www.fda.gov/ForConsumers/Consumer Updates/ucm107878.htm.
[25] C. Abreu, N. Rocha-Pereira, A. Sarmento, and F. Magro, “Nocardia infections among immunomodulated inflammatory bowel disease patients: A review,” World J Gastroenterol, vol. 21, pp. 6491-8, 2015.
[26] I. D. Xynos, M. G. Tektonidou, D. Pikazis, and N. V. Sipsas, “Leishmaniasis, autoimmune rheumatic disease, and anti-tumor necrosis factor therapy, Europe,” Emerg Infect Dis, vol. 15, pp. 956-9, 2009.
[27] A. L. Smitten, H. K. Choi, M. C. Hochberg, S. Suissa, T. A. Simon, M. A. Testa, et al., “The risk of herpes zoster in patients with rheumatoid arthritis in the United States and the United Kingdom,” Arthritis Rheum, vol. 57, pp. 1431-8, 2007.
[28] A. Strangfeld, J. Listing, P. Herzer, A. Liebhaber, K. Rockwitz, C. Richter, et al., “Risk of herpes zoster in patients with rheumatoid arthritis treated with anti-TNF-alpha agents,” JAMA, vol. 301, pp. 737-44, 2009.
[29] J. R. McDonald, A. L. Zeringue, L. Caplan, P. Ranganathan, H. Xian, T. E. Burroughs, et al., “Herpes zoster risk factors in a national cohort of veterans with rheumatoid arthritis,” Clin Infect Dis, vol. 48, pp. 1364-71, 2009.
[30] K. L. Winthrop, J. W. Baddley, L. Chen, L. Liu, C. G. Grijalva, E. Delzell, et al., “Association between the initiation of anti-tumor necrosis factor therapy and the risk of herpes zoster,” JAMA, vol. 309, pp. 887-95, 2013.
[31] J. Zhang, E. Delzell, F. Xie, J. W. Baddley, C. Spettell, R. M. McMahan, et al., “The use, safety, and effectiveness of herpes zoster vaccination in individuals with inflammatory and autoimmune diseases: a longitudinal observational study,” Arthritis Res Ther, vol. 13, p. R174, 2011.
[32] M. J. Shale, C. H. Seow, C. S. Coffin, G. G. Kaplan, R. Panaccione, and S. Ghosh, “Review article: chronic viral infection in the anti-tumour necrosis fac- tor therapy era in inflammatory bowel disease,” Aliment Pharmacol Ther, vol. 31, pp. 20-34, 2010.
[33] K. Subramaniam, J. D'Rozario, and P. Pavli, “Lymphoma and other lymphoproliferative disorders in inflammatory bowel disease: a review,” J Gastroenterol Hepatol, vol. 28, pp. 24-30, 2013.
[34] N. Balandraud, S. Guis, J. B. Meynard, I. Auger, J. Roudier, and C. Roudier, “Long-term treatment with methotrexate or tumor necrosis factor alpha inhibitors does not increase epstein-barr virus load in patients with rheumatoid arthritis,” Arthritis Rheum, vol. 57, pp. 762-7, 2007.
[35] L. Beaugerie, “Immunosuppression-related lymphomas and cancers in IBD: how can they be prevented?,” Dig Dis, vol. 30, pp. 415-9, 2012.
[36] L. Bojito-Marrero and N. Pyrsopoulos, “Hepatitis B and Hepatitis C Reactivation in the Biologic Era,” J Clin Transl Hepatol, vol. 2, pp. 240-46, 2014.
[37] R. Pérez-Alvarez, C. Díaz-Lagares, F. García-Hernández, L. Lopez-Roses, P. Brito-Zerón, M. Pérez-de-Lis, et al., “Hepatitis B virus (HBV) reactivation in patients receiving tumor necrosis factor (TNF)-targeted therapy: analysis of 257 cases,” Medicine (Baltimore), vol. 90, pp. 359-71, 2011.

Chapter 20

[1] Department of Health, “Best Research for Best Health,” A New Natl. Heal. Res. Strateg. NHS Contrib. to Heal. Res. England., vol. 17, no. Suppl.1, pp. 11-315, 2006.
[2] Thoma A., Farrokhyar F., Mcknight L., and Bhandari M., “How to optimize patient recruitment,” Can. J. Surg., vol. 53, no. 3, pp. 205-210, 2010.
[3] Joffe S., Cook E. F., Cleary P. D., Clark J. W., and Weeks J. C., “Quality of informed consent in cancer clinical trials: a cross-sectional survey.,” Lancet, vol. 358, no. 9295, pp. 1772-1777, 2001.
[4] Shankar J., “Patients’ memory for medical information.,” J. R. Soc. Med., vol. 96, no. 10, p. 520, 2003.
[5] Turner P. and Williams C., “Informed consent: Patients listen and read, but what information do they retain?,” N. Z. Med. J., vol. 115, no. 1164, 2002.
[6] Antoniou E. E., Draper H., Reed K., Burls A., Southwood T. R., and Zeegers M. P., “An empirical study on the preferred size of the participant information sheet in research,” J. Med. Ethics, vol. 37, no. 9, pp. 557-562, 2011.

Chapter 21

[1] J. Guzman, K. Oen, L. B. Tucker, A. M. Huber, N. Shiff, G. Boire, et al., “The outcomes of juvenile idiopathic arthritis in children managed with contemporary treatments: results from the ReACCh-Out cohort,” Ann Rheum Dis, vol. 74, pp. 1854-60, Oct 2015.
[2] E. J. Coulson, H. J. Hanson, and H. E. Foster, “What does an adult rheumatologist need to know about juvenile idiopathic arthritis?,” Rheumatology (Oxford), vol. 53, pp. 2155-66, Dec 2014.
[3] R. I. Hart, H. E. Foster, J. E. McDonagh, B. Thompson, L. Kay, A. Myers, et al., “Young people's decisions about biologic therapies: who influences them and how?,” Rheumatology (Oxford), vol. 54, pp. 1294-301, Jul 2015.
[4] D. Hilderson, P. Moons, K. Van der Elst, K. Luyckx, C. Wouters, and R. Westhovens, “The clinical impact of a brief transition programme for young people with juvenile idiopathic arthritis: results of the DON'T RETARD project,” Rheumatology (Oxford), vol. 55, pp. 133-42, Jan 2016.
[5] P. A. van Pelt, C. H. Drossaert, A. A. Kruize, J. Huisman, R. J. Dolhain, and N. M. Wulffraat, “Use and perceived relevance of health-related Internet sites and online contact with peers among young people with juvenile idiopathic arthritis,” Rheumatology (Oxford), vol. 54, pp. 1833-41, Oct 2015.
[6] K. L. Vidqvist, M. Malin, T. Varjolahti-Lehtinen, and M. M. Korpela, “Disease activity of idiopathic juvenile arthritis continues through adolescence despite the use of biologic therapies," Rheumatology (Oxford), vol. 52, pp. 1999-2003, Nov 2013.

Chapter 22

[1] J. H. Barlow, L. A. Cullen, and I. F. Rowe, “Educational preferences, psychological well-being and self-efficacy among people with rheumatoid arthritis,” Patient Educ Couns, vol. 46, pp. 11-9, Jan 2002.
[2] C. E. Zimmern, “Medical-Surgical Nursing - Concepts and Clinical-Practice - Phipps,Wj, Long,Bc, Woods,Nf,” American Journal of Nursing, vol. 80, pp. 1367-1367, 1980.
[3] A. Leary, J. White, and L. Yarnell, “The work left undone. Understanding the challenge of providing holistic lung cancer nursing care in the UK,” European Journal of Oncology Nursing, vol. 18, pp. 23-28, Feb 2014.
[4] J. A. Singh, R. Christensen, and G. A. Wells, “A network meta-analysis of randomised controlled trials of biologics for rheumatoid arthritis: a Cochrane overview (vol 181, pg 787, 2009),” Canadian Medical Association Journal, vol. 182, pp. 806-806, May 18 2010.
[5] J. Ledingham, C. Deighton, and Sgawg, “Update on the British Society for Rheumatology guidelines for prescribing TNF alpha blockers in adults with rheumatoid arthritis (update of previous guidelines of April 2001),” Rheumatology, vol. 44, pp. 157-163, Feb 2005.
[6] T. Ding, J. Ledingham, R. Luqmani, S. Westlake, K. Hyrich, M. Lunt, et al., “BSR and BHPR rheumatoid arthritis guidelines on safety of anti-TNF therapies,” Rheumatology, vol. 49, pp. 2217-2219, Nov 2010.
[7] N. J. Marshall, G. Wilson, K. Lapworth, and L. J. Kay, “Patients' perceptions of treatment with anti-TNF therapy for rheumatoid arthritis: a qualitative study,” Rheumatology, vol. 43, pp. 1034-1038, Aug 2004.
[8] M. Ostensen, A. Brucato, H. Carp, C. Chambers, R. J. Dolhain, A. Doria, et al., “Pregnancy and reproduction in autoimmune rheumatic diseases,” Rheumatology (Oxford), vol. 50, pp. 657-64, Apr 2011.
[9] P. P. Katz, “Childbearing decisions and family size among women with rheumatoid arthritis,” Arthritis Rheum, vol. 55, pp. 217-23, Apr 15 2006.
[10] A. Rezvani and N. Ozaras, “Infertility improved by etanercept in ankylosing spondylitis,” Indian J Pharmacol, vol. 40, pp. 276-7, Nov 2008.
[11] T. Ding, J. Ledingham, R. Luqmani, S. Westlake, K. Hyrich, M. Lunt, et al., “BSR and BHPR rheumatoid arthritis guidelines on safety of anti-TNF therapies,” Rheumatology (Oxford), vol. 49, pp. 2217-9, Nov 2010.
[12] J. A. Singh, R. Christensen, G. A. Wells, M. E. Suarez-Almazor, R. Buchbinder, M. A. Lopez-Olivo, et al., “Biologics for rheumatoid arthritis: an overview of Cochrane reviews,” Sao Paulo Med J, vol. 128, pp. 309-10, 2010.
[13] T. T. Hansel, H. Kropshofer, T. Singer, J. A. Mitchell, and A. J. George, “The safety and side effects of monoclonal antibodies,” Nat Rev Drug Discov, vol. 9, pp. 325-38, Apr 2010.
[14] L. Liu and Y. Li, “The unexpected side effects and safety of therapeutic monoclonal antibodies,” Drugs Today (Barc), vol. 50, pp. 33-50, Jan 2014.
[15] T. R. Radstake, M. Svenson, A. M. Eijsbouts, F. H. van den Hoogen, C. Enevold, P. L. van Riel, et al., “Formation of antibodies against infliximab and adalimumab strongly correlates with functional drug levels and clinical responses in rheumatoid arthritis,” Ann Rheum Dis, vol. 68, pp. 1739-45, Nov 2009.
[16] C. Casulo, J. Maragulia, and A. D. Zelenetz, “Incidence of hypogammaglobulinemia in patients receiving rituximab and the use of intravenous immunoglobulin for recurrent infections,” Clin Lymphoma Myeloma Leuk, vol. 13, pp. 106-11, Apr 2013.
[17] J. Lyneham, “A conceptual model for medical-surgical nursing: moving toward an international clinical specialty,” Medsurg Nurs, vol. 22, pp. 215-20, 263, Jul-Aug 2013.
[18] D. Lacaille, M. A. White, C. L. Backman, and M. A. Gignac, “Problems faced at work due to inflammatory arthritis: new insights gained from understanding patients' perspective,” Arthritis Rheum, vol. 57, pp. 1269-79, Oct 15 2007.
[19] L. Valizadeh, V. Zamanzadeh, M. Jasemi, F. Taleghani, B. Keoch, and C. M. Spade, “Going beyond-the-routines view in nursing: a qualitative study,” J Caring Sci, vol. 4, pp. 25-34, Mar 2015.

The book is aimed at specialist doctors, trainees, nurses and health professionals working in the field of rheumatology.

You have not viewed any product yet.