Author(s): Moreland LW, Schiff MH, Baumgartner SW, Tindall EA, Fleischmann RM,
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Abstract 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.
This article was published in Ann Intern Med
and referenced in Journal of Arthritis