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Etanercept Therapy in Rheumatoid Arthritis: A Randomized, Controlled Trial

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; and Michael E. Weinblatt, MD
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From University of Alabama at Birmingham, Birmingham, Alabama; Denver Arthritis Clinic, Denver, Colorado; Physician's Clinic of Spokane, Spokane, Washington; Portland Medical Associates, Portland, Oregon; Metroplex Clinical Research Center, Dallas, Texas; University of California, Los Angeles, and University of Southern California, Los Angeles, California; Arthritis Center of Nebraska, Lincoln, Nebraska; The Wellesley Central Hospital, Toronto, Ontario, Canada; Virginia Mason Medical Center, Minor and James Medical, and Immunex Corp., Seattle, Washington; Rush Medical College, Chicago, Illinois; and Brigham and Women's Hospital, Boston, Massachusetts.

Ann Intern Med. 1999;130(6):478-486. doi:10.7326/0003-4819-130-6-199903160-00004
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Background: 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.

Objective: To confirm the benefit of etanercept therapy of longer duration and simplified dosing in patients with rheumatoid arthritis.

Design: Randomized, double-blind, placebo-controlled trial with blinded joint assessors.

Setting: 13 North American centers.

Patients: 234 patients with active rheumatoid arthritis who had an inadequate response to disease-modifying antirheumatic drugs.

Intervention: Twice-weekly subcutaneous injections of etanercept, 10 or 25 mg, or placebo for 6 months.

Measurements: 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.

Results: 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.

Conclusions: Etanercept can safely provide rapid, significant, and sustained benefit in patients with active rheumatoid arthritis.


Grahic Jump Location
Figure 1.
Study completion and withdrawal before 6 months.P

* < 0.001 for each etanercept group compared with the placebo group (likelihood ratio chi-square test).

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Figure 2.
Percentage of patients achieving a clinical response as defined by the American College of Rheumatology. Top.Bottom.

20% American College of Rheumatology response. 50% American College of Rheumatology response. Triangles represent patients receiving 25 mg of etanercept; squares represent patients receiving 10 mg of etanercept; circles represent patients receiving placebo.

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