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

The Lancet

Volumn 381, Issue 9865, 2013, Pages 451-460

  Burmester, Gerd R ^a   Blanco, Ricardo ^b   Charles Schoeman, Christina ^c   Wollenhaupt, Jürgen ^d   Zerbini, Cristiano ^e,f   Benda, Birgitta ^g   Gruben, David ^g   Wallenstein, Gene ^g   Krishnaswami, Sriram ^g   Zwillich, Samuel H ^g   Koncz, Tamas ^g   Soma, Koshika ^g   Bradley, John ^g   Mebus, Charles ^g  

^a CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^b HOSPITAL UNIVERSITARIO MARQUÉS DE VALDECILLA   (Spain)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d UNIVERSITY OF HAMBURG   (Germany)

^e Centro Paulista de Investigacao Clinica   (Brazil)

^f HOSPITAL HELIÓPOLIS   (Brazil)

^g PFIZER INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

METHOTREXATE; PLACEBO; TOFACITINIB; TUMOR NECROSIS FACTOR INHIBITOR;

ADULT; ARTICLE; CONTROLLED STUDY; DIARRHEA; DISEASE ACTIVITY SCORE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; EUROPE; FEMALE; HEADACHE; HEALTH ASSESSMENT QUESTIONNAIRE DISABILITY INDEX; HUMAN; INTERNET; MAJOR CLINICAL STUDY; MALE; NAUSEA; NORTH AMERICA; PRIORITY JOURNAL; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; RHEUMATOID ARTHRITIS; RHINOPHARYNGITIS; TELEPHONE; TREATMENT DURATION; TREATMENT RESPONSE; URINARY TRACT INFECTION;

EID: 84873707288     PISSN: 01406736     EISSN: 1474547X     Source Type: Journal    
DOI: 10.1016/S0140-6736(12)61424-X     Document Type: Article

References (27)

1. DL Scott, F Wolfe, TW Huizinga Rheumatoid arthritis Lancet 376 2010 1094 1108
2. JS Smolen, D Aletaha, JW Bijlsma et al. Treating rheumatoid arthritis to target: recommendations of an international task force Ann Rheum Dis 69 2010 631 637
3. KG Saag, GG Teng, NM Patkar et al. American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis Arthritis Rheum 59 2008 762 784
4. V Strand, JA Singh Improved health-related quality of life with effective disease-modifying antirheumatic drugs: evidence from randomized controlled trials Am J Manag Care 13 suppl 9 2007 S237 S251
5. L Klareskog, D van der Heijde, JP de Jager et al. 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 363 2004 675 681
6. EC Keystone, AF Kavanaugh, JT Sharp 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 randomized, placebo-controlled, 52-week trial Arthritis Rheum 50 2004 1400 1411
7. PE Lipsky, DM van der Heijde, EW St Clair 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 343 2000 1594 1602
8. A Finckh, JF Simard, C Gabay, PA Guerne Evidence for differential acquired drug resistance to anti-tumour necrosis factor agents in rheumatoid arthritis Ann Rheum Dis 65 2006 746 752
9. DT Felson, JJ Anderson, M Boers et al. American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis Arthritis Rheum 38 1995 727 735
10. JF Fries, PW Spitz, DY Young The dimensions of health outcomes: the health assessment questionnaire, disability and pain scales J Rheumatol 9 1982 789 793
11. MC Hochberg, RW Chang, I Dwosh, S Lindsey, T Pincus, F Wolfe The American College of Rheumatology 1991 revised criteria for the classification of global functional status in rheumatoid arthritis Arthritis Rheum 35 1992 498 502
12. ML Prevoo, MA van 't Hof, HH Kuper, MA van Leeuwen, LB van de Putte, PL van Riel 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 38 1995 44 48
13. Radboud University Nijmegen Medical Centre DAS-score.nl: disease activity score in rheumatoid arthritis http://www.das-score.nl/ (accessed Nov 3, 2011).
14. D Cella, JS Lai, CH Chang, A Peterman, M Slavin Fatigue in cancer patients compared with fatigue in the general United States population Cancer 94 2002 528 538
15. DT Felson, JS Smolen, G Wells et al. American College of Rheumatology/European League Against Rheumatism provisional definition of remission in rheumatoid arthritis for clinical trials Arthritis Rheum 63 2011 573 586
16. JM Kremer, BJ Bloom, FC Breedveld et al. The safety and efficacy of a JAK inhibitor in patients with active rheumatoid arthritis: results of a double-blind, placebo-controlled phase IIa trial of three dose levels of CP-690,550 versus placebo Arthritis Rheum 60 2009 1895 1905
17. JM Kremer, S Cohen, B Wilkinson et al. The oral JAK inhibitor CP-690,550 (CP) in combination with methotrexate (MTX) is efficacious, safe and well tolerated in patients with active rheumatoid arthritis (RA) with an inadequate response to methotrexate alone Arthritis Rheum 58 2008 4030
18. Y Tanaka, M Suzuki, H Nakamura, S Toyoizumi, S Zwillich The oral JAK inhibitor CP-690,550 (CP) in combination with methotrexate (MTX) is efficacious, safe and well tolerated in Japanese patients (pts) with active rheumatoid arthritis (RA) with an inadequate response to MTX alone Ann Rheum Dis 68 suppl 3 2009 594
19. R Fleischmann, MC Genovese, D Gruben et al. Safety and efficacy after 24 week (wk) dosing of the oral JAK inhibitor CP-690,550 (CP) as monotherapy in patients (pts) with active rheumatoid arthritis (RA) Arthritis Rheum 60 suppl 10 2009 S718
20. R Fleischmann, J Kremer, CA Connell et al. Phase 3 study of oral JAK inhibitor CP-690,550 monotherapy in patients with active rheumatoid arthritis: sub-analysis of efficacy Ann Rheum Dis 70 2011 600 abs SAT0243.
21. J Kremer, ZG Li, S Hall et al. Tofacitinib (CP-690,550), an oral Janus kinase inhibitor, in combination with traditional DMARDs: a phase 3 efficacy and safety study in patients with active rheumatoid arthritis with an inadequate response to DMARDs Ann Rheum Dis 70 2011 170
22. RF van Vollenhoven, RM Fleischmann, SB Cohen et al. Tofacitinib (CP-690,550), an oral Janus kinase inhibitor, or adalimumab versus placebo in patients with rheumatoid arthritis on background methotrexate: a phase 3 study Arthritis Rheum 63 suppl 10 2011 S153
23. D van der Heijde, Y Tanaka, R Fleischmann et al. Tofacitinib (CP-690,550), an oral Janus kinase inhibitor, in combination with methotrexate reduced the progression of structural damage in patients with rheumatoid arthritis: a 24-month Phase 3 study Arthritis Rheum 63 suppl 10 2011 S107
24. MC Genovese, JC Becker, M Schiff et al. Abatacept for rheumatoid arthritis refractory to tumor necrosis factor alpha inhibition N Engl J Med 353 2005 1114 1123
25. SB Cohen, P Emery, MW Greenwald et al. Rituximab for rheumatoid arthritis refractory to anti-tumor necrosis factor therapy: results of a multicenter, randomized, double-blind, placebo-controlled, phase III trial evaluating primary efficacy and safety at twenty-four weeks Arthritis Rheum 54 2006 2793 2806
26. P Emery, E Keystone, HP Tony et al. 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 67 2008 1516 1523
27. JS Smolen, J Kay, MK Doyle et al. 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 374 2009 210 221