Placebo-controlled trial of tofacitinib monotherapy in rheumatoid arthritis

New England Journal of Medicine

Volumn 367, Issue 6, 2012, Pages 495-507

  Fleischmann, Roy ^a   Kremer, Joel ^c   Cush, John ^b   Schulze Koops, Hendrik ^d   Connell, Carol A ^e   Bradley, John D ^e   Gruben, David ^e   Wallenstein, Gene V ^e   Zwillich, Samuel H ^e   Kanik, Keith S ^e  

^a METROPLEX CLINICAL RESEARCH CENTER   (United States)

^b BAYLOR RESEARCH INSTITUTE   (United States)

^c ALBANY MEDICAL COLLEGE   (United States)

^d UNIVERSITY OF MUNICH   (Germany)

^e PFIZER INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

C REACTIVE PROTEIN; DISEASE MODIFYING ANTIRHEUMATIC DRUG; LOW DENSITY LIPOPROTEIN CHOLESTEROL; PLACEBO; TOFACITINIB;

ADULT; ARTICLE; ASYSTOLE; BLOOD DISEASE; BREAST DISEASE; BRONCHITIS; CELLULITIS; CHOLECYSTITIS; CHRONIC OBSTRUCTIVE LUNG DISEASE; CONGESTIVE HEART FAILURE; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DIABETES MELLITUS; DIARRHEA; DISEASE ACTIVITY; DISEASE DURATION; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; EAR DISEASE; ENDOMETRIUM POLYP; ERYTHROCYTE SEDIMENTATION RATE; FEMALE; GASTROINTESTINAL DISEASE; GENITAL SYSTEM DISEASE; HEADACHE; HEALTH ASSESSMENT QUESTIONNAIRE; HEART ARREST; HEART ATRIUM FIBRILLATION; HEART DISEASE; HEART INFARCTION; HUMAN; HUMERUS FRACTURE; HYPERKALEMIA; HYPOGLYCEMIA; HYPONATREMIA; INNER EAR DISEASE; KIDNEY FAILURE; LIMB FRACTURE; LIVER ABSCESS; LUNG FIBROSIS; LUNG NON SMALL CELL CANCER; LYMPHATIC SYSTEM DISEASE; MAJOR CLINICAL STUDY; MALE; MEDIASTINUM DISEASE; METABOLIC DISORDER; MONOTHERAPY; NEUTROPENIA; NEUTROPHIL COUNT; NUTRITIONAL DISORDER; OUTCOME ASSESSMENT; PATELLA FRACTURE; PHASE 3 CLINICAL TRIAL; PLEURA EFFUSION; PRIORITY JOURNAL; PYELONEPHRITIS; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT DISEASE; RHEUMATOID ARTHRITIS; SIDE EFFECT; SLEEP APNEA SYNDROME; THORAX DISEASE; THROMBOCYTOPENIA; TREATMENT DURATION; TUBERCULOUS PLEURA EFFUSION; UPPER RESPIRATORY TRACT INFECTION; UTERUS MYOMA; VERTIGO; VOMITING;

EID: 84864716411     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa1109071     Document Type: Article

References (21)

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-S251.
2. Meyer DM, Jesson MI, Li X, et al. Antiinflammatory activity and neutrophil reductions mediated by the JAK1/JAK3 inhibitor, CP-690,550, in rat adjuvant-induced arthritis. J Inflamm (Lond) 2010;7:41.
3. Kremer JM, Bloom BJ, Breedveld FC, 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 2009;60:1895-905.
4. Fleischmann R, Cutolo M, Genovese MC, 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.
5. Kremer JM, Cohen S, Wilkinson BE, 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 inadequate response to methotrexate alone. Arthritis Rheum 2012;64:970-81.
6. Arnett FC, Edworthy SM, Bloch DA, et al. The American Rheumatism Association 1987 revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 1988;31:315-24. (Pubitemid 18091653)
7. Felson DT, Anderson JJ, Boers M, et al. American College of Rheumatology: preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum 1995;38:727-35.
8. 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.
9. Hochberg MC, Chang RW, Dwosh I, Lindsey S, Pincus T, Wolfe F. The American College of Rheumatology 1991 revised criteria for the classification of global functional status in rheumatoid arthritis. Arthritis Rheum 1992;35:498-502.
10. 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 1995;38:44-8.
11. Disease Activity Score in rheumatoid arthritis. Nijmegen, the Netherlands: University Medical Center (http://www.das-score.nl).
12. van Gestel AM, Haagsma CJ, van Riel PL. Validation of rheumatoid arthritis improvement criteria that include simplified joint counts. Arthritis Rheum 1998;41:1845-50. (Pubitemid 28465539)
13. Cella D, Yount S, Sorensen M, Chartash E, Sengupta N, Grober J. Validation of the Functional Assessment of Chronic Illness Therapy Fatigue Scale relative to other instrumentation in patients with rheumatoid arthritis. J Rheumatol 2005;32:811-9. (Pubitemid 40676488)
14. Fleischmann R, Kremer J, Connell CA, et al. Oral Solo (A3921045): a phase 3 study of oral JAK inhibitor tofacitinib (CP-690,550) monotherapy in patients with active rheumatoid arthritis: subgroup analysis of efficacy. Ann Rheum Dis 2011;70:Suppl 3:600. abstract.
15. Strand V, Scott DL, Emery P, et al. Physical function and health related quality of life: analysis of 2-year data from randomized, controlled studies of leflunomide, sulfasalazine, or methotrexate in patients with active rheumatoid arthritis. J Rheumatol 2005;32:590-601. (Pubitemid 40524689)
16. Barton JL. Patient preferences and satisfaction in the treatment of rheumatoid arthritis with biologic therapy. Patient Prefer Adherence 2009;3:335-44.
17. Kanik K, Fleischmann R, Cutolo M, et al. Phase 2B dose ranging monotherapy study of the oral JAK inhibitor CP-690,550 (CP) or adalimumab (ADA) vs placebo (PBO) in patients (pts) with active rheumatoid arthritis (RA) with an inadequate response to DMARDs. Ann Rheum Dis 2009;68:Suppl 3:123. abstract.
18. Tanaka Y, Suzuki M, Nakamura H, Toyoizumi S, Zwillich SH. 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 2009;68: Suppl 3:594. abstract.
19. Simon TA, Smitten AL, Franklin J, et al. Malignancies in the rheumatoid arthritis abatacept clinical development program: an epidemiological assessment. Ann Rheum Dis 2009;68:1819-26.
20. Wolfe F, Michaud K. Biologic treatment of rheumatoid arthritis and the risk of malignancy: analyses from a large United States observational study. Arthritis Rheum 2007;56:2886-95. (Pubitemid 47502734)
21. van Vollenhoven RF, Fleischmann R, Cohen S, et al. Tofacitinib or adalimumab versus placebo in rheumatoid arthritis. N Engl J Med 2012;367:508-19.