A Randomized, Double-Blind, Placebo-Controlled, Sixteen-Week Study of Subcutaneous Golimumab in Patients With Active Nonradiographic Axial Spondyloarthritis

Arthritis and Rheumatology

Volumn 67, Issue 10, 2015, Pages 2702-2712

  Sieper, J ^a   Van Der Heijde, D ^b,f,g   Dougados, M ^c   Maksymowych, W P ^d   Scott, B B ^e   Boice, J A ^e   Berd, Y ^e   Bergman, G ^e   Curtis, S ^e   Tzontcheva, A ^e   Huyck, S ^e   Weng, H H ^e  

^a CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^b LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^c PRES Sorbonne Paris Cite ^*  (France)

^d UNIVERSITY OF ALBERTA   (Canada)

^e MERCK RESEARCH LABORATORIES   (United States)

^f MAASTRICHT UNIVERSITY MEDICAL CENTER   (Netherlands)

^g DIAKONHJEMMET HOSPITAL   (Norway)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIRHEUMATIC AGENT; GOLIMUMAB; MONOCLONAL ANTIBODY; TUMOR NECROSIS FACTOR ALPHA;

ADULT; BIOASSAY; CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; FEMALE; HUMAN; IMMUNOLOGY; INTERNATIONAL COOPERATION; LONGITUDINAL STUDY; MALE; MULTICENTER STUDY; PHASE 3 CLINICAL TRIAL; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; SECOND CERVICAL VERTEBRA; SEVERITY OF ILLNESS INDEX; SPONDYLARTHRITIS; SUBCUTANEOUS DRUG ADMINISTRATION; TREATMENT OUTCOME;

ADULT; ANTIBODIES, MONOCLONAL; ANTIRHEUMATIC AGENTS; AXIS, CERVICAL VERTEBRA; DOUBLE-BLIND METHOD; ENDPOINT DETERMINATION; FEMALE; HUMANS; INJECTIONS, SUBCUTANEOUS; INTERNATIONAL COOPERATION; LONGITUDINAL STUDIES; MALE; RISK ASSESSMENT; SEVERITY OF ILLNESS INDEX; SPONDYLARTHRITIS; TREATMENT OUTCOME; TUMOR NECROSIS FACTOR-ALPHA;

EID: 84948769543     PISSN: 23265191     EISSN: 23265205     Source Type: Journal    
DOI: 10.1002/ART.39257     Document Type: Article

References (38)

1. Braun J, Sieper J. Ankylosing spondylitis. Lancet 2007;369:1379-90.
2. 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 2009;68:777-83.
3. Sieper J, Rudwaleit M, Baraliakos X. The Assessement of Spondyloarthritis international Society (ASAS) handbook: A guide to assess spondylarthritis. Ann Rheum Dis 2009; 68 Suppl 2: Ii1-44.
4. 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 1984;27:361-8.
5. Freeston J, Barkham N, Hensor E, Emery P, Fraser A. Ankylosing spondylitis, HLA-B27 positivity and the need for biologic therapies. Joint Bone Spine 2007;74:140-3.
6. Rudwaleit M, van der Heijde D, Khan MA, Braun J, Sieper J. How to diagnose axial spondyloarthritis early. Ann Rheum Dis 2004;63:535-43.
7. Rudwaleit M, Landewe R, van der Heijde D, Listing J, Brandt J, Braun J, et al. The development of Assessment of Spondy-loArthritis international Society classification criteria for axial spondyloarthritis (part I): Classification of paper patients by expert opinion including uncertainty appraisal. Ann Rheum Dis 2009;68: 770-6.
8. Feldtkeller E, Khan MA, van der Heijde D, van der Linden S, Braun J. Age at disease onset and diagnosis delay in HLA-B27 negative vs. positive patients with ankylosing spondylitis. Rheumatol Int 2003;23:61-6.
9. Barkhuizen A, Steinfeld S, Robbins J, West C, Coombs J, Zwillich S. Celecoxib is efficacious and well tolerated in treating signs and symptoms of ankylosing spondylitis. J Rheumatol 2006;33:1805-12.
10. 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 2012;71:1616-22.
11. Sieper J, Klopsch T, Richter M, Kapelle A, Rudwaleit M, Schwank S, et al. Comparison of two different dosages of celecoxib with diclofenac for the treatment of active ankylosing spondylitis: Results of a 12-week randomised, double-blind, controlled study. Ann Rheum Dis 2008;67:323-9.
12. Van der Heijde D, Baraf HS, Ramos-Remus C, Calin A, Weaver AL, Schiff M, et al. Evaluation of the efficacy of etoricoxib in ankylosing spondylitis: Results of a fifty-two-week, randomized, controlled study. Arthritis Rheum 2005;52:1205-15.
13. Wanders A, van der Heijde D, Landewe R, Behier JM, Calin A, Olivieri I, et al. Nonsteroidal antiinflammatory drugs reduce radiographic progression in patients with ankylosing spondylitis: A randomized clinical trial. Arthritis Rheum 2005;52:1756-65.
14. Haibel H, Rudwaleit M, Listing J, Heldmann F, Wong RL, Kupper H, et al. Efficacy of adalimumab in the treatment of axial spondylarthritis without radiographically defined sacroiliitis: Results of a twelveweek randomized, double-blind, placebo-controlled trial followed by an open-label extension up to week fifty-two. Arthritis Rheum 2008; 58:1981-91.
15. 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 placebocontrolled phase 3 study. Ann Rheum Dis 2014;73:39-47.
16. 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 2013;72:815-22.
17. Sieper J, Landewe R, Rudwaleit M, van der Heijde D, Douga-dos M, Mease PJ, et al. Effect of certolizumab pegol over ninety-six weeks in patients with axial spondyloarthritis: Results from a phase III randomized trial. Arthritis Rheumatol 2015;67: 668-77.
18. Sieper J, Lenaerts J, Wollenhaupt J, Rudwaleit M, Mazurov VI, Myasoutova L, et al. on behalf of all INFAST Investigators. Efficacy and safety of infliximab plus naproxen versus naproxen alone in patients with early, active axial spondyloarthritis: Results from the double-blind, placebo-controlled INFAST study, part 1. Ann Rheum Dis 2014;73:101-7.
19. Song IH, Hermann K, Haibel H, Althoff CE, Listing J, Burmester G, et al. Effects of etanercept versus 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 2011;70:590-6.
20. Anderson JJ, Baron G, van der Heijde D, Felson DT, Dougados M. Ankylosing Spondylitis Assessment Group preliminary definition of short-term improvement in ankylosing spondylitis. Arthritis Rheum 2001;44:1876-86.
21. 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 1994;21:2286-91.
22. Maksymowych WP, Inman RD, Salonen D, Dhillon SS, Williams M, Stone M, et al. Spondyloarthritis Research Consortium of Canada Magnetic Resonance Imaging Index for assessment of sacroiliac joint inflammation in ankylosing spondylitis. Arthritis Rheum 2005;53:703-9.
23. Van der Heijde D, Lie E, Kvien TK, Sieper J, van den Bosch F, Listing J, et al., for the Assessment of SpondyloArthritis international Society (ASAS). ASDAS, a highly discriminatory ASASendorsed disease activity score in patients with ankylosing spondylitis. Ann Rheum Dis 2009;68:1811-8.
24. Calin A, Garrett S, Whitelock H, Kennedy LG, O’Hea J, Mallorie P, et al. A new approach to defining functional ability in ankylosing spondylitis: The development of the Bath Ankylosing Spondylitis Functional Index. J Rheumatol 1994;21:2281-5.
25. Jenkinson TR, Mallorie PA, Whitelock HC, Kennedy LG, Garrett SL, Calin A. Defining spinal mobility in ankylosing spondylitis (AS): The Bath AS Metrology Index. J Rheumatol 1994;21:1694-8.
26. Heuft-Dorenbosch L, Spoorenberg A, van Tubergen A, Landewe R, van ver Tempel H, Mielants H, et al. Assessment of enthesitis in ankylosing spondylitis. Ann Rheum Dis 2003;62:127-32.
27. Ware JE Jr., Snow KK, Kosinski M, Gandek B. SF-36 health sur-vey: Manual and interpretation guide. Boston: The Health Institute, New England Medical Center; 1993.
28. Helliwell PS, Doward L, Whalley D, Tennant A, McKenna S, Reynolds S, et al. Psychometric and scaline properties of a new quality of life instrument specific to ankylosing spondylitis [abstract]. Arthritis Rheum 1999;42 Suppl:S72.
29. Hurst NP, Kind P, Ruta D, Hunter M, Stubbings A. Measuring health-related quality of life in rheumatoid arthritis: Validity, responsiveness and reliability of EuroQol (EQ-5D). Br J Rheumatol 1997;36:551-9.
30. Miettinen O, Nurminen M. Comparative analysis of two rates. Stat Med 1985;4:213-26.
31. Liang KY, Zeger SL. Longitudinal data analysis of continuous and discrete responses for pre-post designs. Indian J Stat 2000; 62:134-48.
32. Rudwaleit M, Listing J, Brandt J, Braun J, Sieper J. Prediction of a major clinical response (BASDAI 50) to tumour necrosis factor a blockers in ankylosing spondylitis. Ann Rheum Dis 2004;63:665-70.
33. 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 2009;36:801-8.
34. Inman RD, Davis JC Jr., van der Heijde D, Diekman L, Sieper J, Kim SI, et al. Efficacy and safety of golimumab in patients with ankylosing spondylitis: Results of a randomized, doubleblind, placebo-controlled, phase III trial. Arthritis Rheum 2008; 58:3402-12.
35. Dougados M, van der Heijde D, Sieper J, Braun J, Maksymo-wych WP, Citera G, et al. Symptomatic efficacy of etanercept and its effects on objective signs of inflammation in early nonradiographic axial spondyloarthritis: A multicenter, randomized, double-blind, placebo-controlled trial. Arthritis Rheumatol 2014; 66:2091-102.
36. Kavanaugh A, McInnes I, Mease P, Krueger GG, Gladman D, Gomez-Reino J, et al. Golimumab, a new human tumor necrosis factor a antibody, administered every four weeks as a subcutaneous injection in psoriatic arthritis: Twenty-four-week efficacy and safety results of a randomized, placebo-controlled study [published erratum appears in Arthritis Rheum 2010;62:2555]. Arthritis Rheum 2009;60:976-86.
37. Smolen JS, Kay J, Doyle MK, Landewe R, Matteson EL, Wollenhaupt J, et al. Golimumab in patients with active rheumatoid arthritis after treatment with tumour necrosis factor a inhibitors (GO-AFTER study): A multicentre, randomised, double-blind, placebo-controlled, phase III trial. Lancet 2009;374:210-21.
38. Selmi C, Ceribelli A, Naguwa SM, Cantarini L, Shoenfeld Y. Safety issues and concerns of new immunomodulators in rheumatology. Expert Opin Drug Saf 2015;14:389-99.