Etanercept therapy in rheumatoid arthritis: A randomized, controlled trial

Larry W. Moreland*, Michael H. Schiff, Scott W. Baumgartner, Elizabeth A. Tindall, Roy M. Fleischmann, Ken J. Bulpitt, Arthur L. Weaver, Edward C. Keystone, Daniel E. Furst, Philip J. Mease, Eric M. Ruderman, David A. Horwitz, Daniel G. Arkfeld, Leslie Garrison, Daniel J. Burge, Consuelo M. Blosch, Mary L M Lange, Neil D. McDonnell, Michael E. Weinblatt

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

1359 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)478-486
Number of pages9
JournalAnnals of internal medicine
Issue number6
StatePublished - Mar 16 1999

ASJC Scopus subject areas

  • Internal Medicine


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