Tofacitinib (CP-690,550) in patients with rheumatoid arthritis receiving methotrexate: Twelve-month data from a twenty-four-month phase III randomized radiographic study

Arthritis and Rheumatism

Volumn 65, Issue 3, 2013, Pages 559-570

  Van Der Heijde, Désirée ^a   Tanaka, Yoshiya ^b   Fleischmann, Roy ^c   Keystone, Edward ^d   Kremer, Joel ^e   Zerbini, Cristiano ^f   Cardiel, Mario H ^g,h   Cohen, Stanley ^c   Nash, Peter ^h,i   Song, Yeong Wook ^j   Tegzová, Dana ^k   Wyman, Bradley T ^k   Gruben, David ^k   Benda, Birgitta ^l   Wallenstein, Gene ^k   Krishnaswami, Sriram ^k   Zwillich, Samuel H ^k   Bradley, John D ^k   Connell, Carol A ^k,l  

^a LEIDEN UNIVERSITY MEDICAL CENTER   (Netherlands)

^b UNIVERSITY OF OCCUPATIONAL AND ENVIRONMENTAL HEALTH   (Japan)

^c METROPLEX CLINICAL RESEARCH CENTER   (United States)

^d UNIVERSITY OF TORONTO   (Canada)

^e ALBANY MEDICAL COLLEGE   (United States)

^f Centro Paulista de Investigacao Clinica   (Brazil)

^g Centro de Investigacion Clinica de Morelia   (Mexico)

^h NAMBOUR GENERAL HOSPITAL   (Australia)

ⁱ Seoul National University Hospital   (South Korea)

^j INSTITUTE OF RHEUMATOLOGY   (Czech Republic)

^k PFIZER INC   (United States)

^l UNIVERSITY OF QUEENSLAND   (Australia)

more..

Author keywords

[No Author keywords available]

Indexed keywords

METHOTREXATE; PLACEBO; TOFACITINIB;

ADULT; ADULT RESPIRATORY DISTRESS SYNDROME; ANGINA PECTORIS; ARTICLE; BASAL CELL CARCINOMA; BRAIN INFARCTION; CAROTID ARTERY OBSTRUCTION; CONGESTIVE HEART FAILURE; CONTROLLED STUDY; CORONARY ARTERY DISEASE; CREATININE BLOOD LEVEL; CYTOMEGALOVIRUS INFECTION; DATA ANALYSIS; DISEASE ACTIVITY SCORE; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG WITHDRAWAL; ERYTHROCYTE SEDIMENTATION RATE; ESOPHAGUS CANDIDIASIS; FEMALE; HEALTH ASSESSMENT QUESTIONNAIRE; HUMAN; LACUNAR STROKE; MAJOR CLINICAL STUDY; MALE; NEUTROPHIL COUNT; NONHODGKIN LYMPHOMA; PHASE 3 CLINICAL TRIAL; PNEUMOCYSTIS PNEUMONIA; PRIORITY JOURNAL; REGRESSION ANALYSIS; RHEUMATOID ARTHRITIS; SIALOADENITIS; SIDE EFFECT; SQUAMOUS CELL CARCINOMA; STATISTICAL SIGNIFICANCE; STOMACH ADENOCARCINOMA; TUBERCULOUS LYMPHADENITIS; UTERINE CERVIX CARCINOMA;

ADULT; ANTIRHEUMATIC AGENTS; ARTHRITIS, RHEUMATOID; DISEASE PROGRESSION; DRUG RESISTANCE; FEMALE; HUMANS; JANUS KINASE 3; MALE; METHOTREXATE; MIDDLE AGED; MOTOR ACTIVITY; PYRIMIDINES; PYRROLES; TREATMENT OUTCOME;

EID: 84874402383     PISSN: 00043591     EISSN: 15290131     Source Type: Journal    
DOI: 10.1002/art.37816     Document Type: Article

References (29)

1. Strand V, Singh JA,. Improved health-related quality of life with effective disease-modifying antirheumatic drugs: evidence from randomized controlled trials. Am J Manag Care 2007; 13 Suppl 9: S237-51.
2. Ghoreschi K, Laurence A, O'Shea JJ,. Janus kinases in immune cell signaling. Immunol Rev 2009; 228: 273-87.
3. Ghoreschi K, Jesson MI, Li X, Lee JL, Ghosh S, Alsup JW, et al. Modulation of innate and adaptive immune responses by tofacitinib (CP-690,550). J Immunol 2011; 186: 4234-43.
4. Meyer DM, Jesson MI, Li X, Elrick MM, Funckes-Shippy CL, Warner JD, et al. Anti-inflammatory activity and neutrophil reductions mediated by the JAK1/JAK3 inhibitor, CP-690,550, in rat adjuvant-induced arthritis. J Inflamm (Lond) 2010; 7: 41.
5. Fleischmann R, Cutolo M, Genovese MC, Lee EB, Kanik KS, Sadis S, et al. Phase IIb dose-ranging study of the oral JAK inhibitor tofacitinib (CP-690,550) or adalimumab monotherapy versus placebo in patients with active rheumatoid arthritis with an inadequate response to disease-modifying antirheumatic drugs. Arthritis Rheum 2012; 64: 617-29.
6. Kremer JM, Cohen S, Wilkinson BE, Connell CA, French JL, Gomez-Reino J, et al. A phase IIb dose-ranging study of the oral JAK inhibitor tofacitinib (CP-690,550) versus placebo in combination with background methotrexate in patients with active rheumatoid arthritis and an inadequate response to methotrexate alone. Arthritis Rheum 2012; 64: 970-81.
7. Fleischmann R, Kremer J, Cush J, Schulze-Koops H, Connell CA, Bradley JD, et al. Placebo-controlled trial of tofacitinib monotherapy in rheumatoid arthritis. N Engl J Med 2012; 367: 495-507.
8. Burmester GR, Blanco R, Charles-Schoemann C, Wollenhaupt J, Zerbini CA, Benda B, et al, and the ORAL Step Investigators. Tofacitinib (CP-690,550), an oral Janus kinase inhibitor, in combination with methotrexate, in patients with active rheumatoid arthritis with an inadequate response to tumor necrosis factor-inhibitors: a 6-month phase 3 study [abstract]. Arthritis Rheum 2011; 63 Suppl: S279.
9. Van Vollenhoven RF, Fleischmann R, Cohen S, Lee EB, Garcia Meijide JA, Wagner S, et al. Tofacitinib or adalimumab versus placebo in rheumatoid arthritis. N Engl J Med 2012; 367: 508-19.
10. Burmester GR, Blanco R, Charles-Schoeman C, Wollenhaupt J, Zerbini C, Benda B, et al, on behalf of the ORAL Step investigators. 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 2013. Epub ahead of print.
11. Kremer JM, Li ZG, Hall S, Fleischmann R, Genovese M, Martin-Mola E, 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 [abstract]. Ann Rheum Dis 2011; 70 Suppl 3: 170.
12. Arnett FC, Edworthy SM, Bloch DA, McShane DJ, Fries JF, Cooper NS, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 1988; 31: 315-24.
13. Felson DT, Anderson JJ, Boers M, Bombardier C, Furst D, Goldsmith C, et al. American College of Rheumatology preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum 1995; 38: 727-35.
14. Van der Heijde DM,. How to read radiographs according to the Sharp/van der Heijde method. J Rheumatol 2000; 27: 261-3.
15. Fries JF, Spitz PW, Young DY,. The dimensions of health outcomes: the health assessment questionnaire, disability and pain scales. J Rheumatol 1982; 9: 789-93.
16. Radboud University Nijmegen Medical Centre. DAS28. URL: http://www.das-score.nl.
17. Felson DT, Anderson JJ, Boers M, Bombardier C, Chernoff M, Fried B, et al. The American College of Rheumatology preliminary core set of disease activity measures for rheumatoid arthritis clinical trials. Arthritis Rheum 1993; 36: 729-40.
18. Van der Heijde D, Simon L, Smolen J, Strand V, Sharp J, Boers M, et al. How to report radiographic data in randomized clinical trials in rheumatoid arthritis: guidelines from a roundtable discussion. Arthritis Rheum 2002; 47: 215-8.
19. Cella D, Lai JS, Chang CH, Peterman A, Slavin M,. Fatigue in cancer patients compared with fatigue in the general United States population. Cancer 2002; 94: 528-38.
20. Singh JA, Furst DE, Bharat A, Curtis JR, Kavanaugh AF, Kremer JM, et al. 2012 update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken) 2012; 64: 625-39.
21. Smolen JS, Landewe R, Breedveld FC, Dougados M, Emery P, Gaujoux-Viala C, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs. Ann Rheum Dis 2010; 69: 964-75.
22. Tanaka Y, Suzuki M, Nakamura H, Toyoizumi S, Zwillich SH, and the Tofacitinib Study Investigators. Phase II study of tofacitinib (CP-690,550) combined with methotrexate in patients with rheumatoid arthritis and an inadequate response to methotrexate. Arthritis Care Res (Hoboken) 2011; 63: 1150-8.
23. Lipsky PE, van der Heijde DM, St Clair EW, Furst DE, Breedveld FC, Kalden JR, et al for the Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group. Infliximab and methotrexate in the treatment of rheumatoid arthritis. N Engl J Med 2000; 343: 1594-602.
24. Klareskog L, van der Heijde D, de Jager JP, Gough A, Kalden J, Malaise M, et al, TEMPO (Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes) Study Investigators. 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 2004; 363: 675-81.
25. Keystone EC, Kavanaugh AF, Sharp JT, Tannenbaum H, Hua Y, Teoh LS, 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 2004; 50: 1400-11.
26. Finckh A, Choi HK, Wolfe F,. Progression of radiographic joint damage in different eras: trends towards milder disease in rheumatoid arthritis are attributable to improved treatment. Ann Rheum Dis 2006; 65: 1192-7.
27. Finckh A, Liang MH, van Herckenrode CM, de Pablo P,. Long-term impact of early treatment on radiographic progression in rheumatoid arthritis: a meta-analysis. Arthritis Rheum 2006; 55: 864-72.
28. Rahman MU, Buchanan J, Doyle MK, Hsia EC, Gathany T, Parasuraman S, et al. Changes in patient characteristics in anti-tumour necrosis factor clinical trials for rheumatoid arthritis: results of an analysis of the literature over the past 16 years. Ann Rheum Dis 2011; 70: 1631-40.
29. Kremer JM, Zerbini C, Lee EB, Gruben D, Krishnaswami S, Zwillich SH, et al. Tofacitinib (CP-690,550), an oral Janus kinase inhibitor: analysis of efficacy endpoints by subgroups in a pooled phase 2 and 3 rheumatoid arthritis study population [abstract]. Ann Rheum Dis 2012; 71 Suppl 3: 203.