Larry W. Moreland, MD; Michael H. Schiff, MD; Scott W. Baumgartner, MD; Elizabeth A. Tindall, MD; Roy M. Fleischmann, MD; Ken J. Bulpitt, MD; Arthur L. Weaver, MD; Edward C. Keystone, MD; Daniel E. Furst, MD; Philip J. Mease, MD; Eric M. Ruderman, MD; David A. Horwitz, MD; Daniel G. Arkfeld, MD; Leslie Garrison, MD, MPH; Daniel J. Burge, MD; Consuelo M. Blosch, MD; Mary L.M. Lange, MS; Neil D. McDonnell, PharmD; Michael E. Weinblatt, MD
In a phase II study, etanercept (recombinant human tumor necrosis factor receptor [p75]:Fc fusion protein) safely produced rapid, dose-dependent improvement in rheumatoid arthritis over 3 months.
To confirm the benefit of etanercept therapy of longer duration and simplified dosing in patients with rheumatoid arthritis.
Randomized, double-blind, placebo-controlled trial with blinded joint assessors.
13 North American centers.
234 patients with active rheumatoid arthritis who had an inadequate response to disease-modifying antirheumatic drugs.
Twice-weekly subcutaneous injections of etanercept, 10 or 25 mg, or placebo for 6 months.
The primary end points were 20% and 50% improvement in disease activity according to American College of Rheumatology (ACR) responses at 3 and 6 months. Other end points were 70% ACR responses at 3 and 6 months and other measures of disease activity at 3 and 6 months.
Etanercept significantly reduced disease activity in a dose-related fashion. At 3 months, 62% of the patients receiving 25 mg of etanercept and 23% of the placebo recipients achieved 20% ACR response (P < 0.001). At 6 months, 59% of the 25-mg group and 11% of the placebo group achieved a 20% ACR response (P < 0.001); 40% and 5%, respectively, achieved a 50% ACR response (P < 0.01). The respective mean percentage reduction in the number of tender and swollen joints at 6 months was 56% and 47% in the 25-mg group and 6% and −7% in the placebo group (P < 0.05). Significantly more etanercept recipients achieved a 70% ACR response, minimal disease status (0 to 5 affected joints), and improved quality of life. Etanercept was well tolerated, with no dose-limiting toxic effects.
Etanercept can safely provide rapid, significant, and sustained benefit in patients with active rheumatoid arthritis.
Moreland LW, Schiff MH, Baumgartner SW, Tindall EA, Fleischmann RM, Bulpitt KJ, et al. Etanercept Therapy in Rheumatoid Arthritis: A Randomized, Controlled Trial. Ann Intern Med. 1999;130:478–486. doi: 10.7326/0003-4819-130-6-199903160-00004
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Published: Ann Intern Med. 1999;130(6):478-486.
Prevention/Screening, Rheumatoid Arthritis, Rheumatology.
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