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Comparison of 2 Doses of Etanercept (50 vs 100 mg) in Active Rheumatoid Arthritis: A Randomized Double Blind Study ALYSSA K. JOHNSEN, MICHAEL H. SCHIFF, PHILIP J. MEASE, LARRY W. MORELAND, AGNES L. MAIER, JONATHAN S. COBLYN, SIMON M. HELFGOTT, JONATHAN A. LEFF, and MICHAEL E. WEINBLATT ABSTRACT. Methods. Seventy-seven patients with RA were randomized in an unequal allocation (2:1) in a blinded fashion to receive either 50 mg (51 patients) or 25 mg (26 patients) of etanercept twice a week for 24 weeks. Results. The primary outcome measure, the ACR-N AUC at 24 weeks, showed no difference between the 2 dose groups. In addition, there was no difference in ACR 20, 50, and 70 responses or in EULAR response criteria by Week 24. There were no statistically significant differences between the 2 groups in the proportion of patients with any non-infectious adverse event. The proportion of patients with upper respiratory tract infections was significantly higher in patients receiving 50 mg etanercept compared with those receiving 25 mg (26% vs 4%, p = 0.027). Conclusion. Etanercept as a monotherapy at 50 mg twice weekly does not provide increased efficacy when compared to the standard dose of 25 mg twice weekly in TNF-a blocker-naïve patients. (First Release Feb 15, 2006; J Rheumatol 2006;33;659–64)
Key Indexing Terms: RHEUMATOID ARTHRITIS
From the Division of Rheumatology, Immunology, and Allergy, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; Denver Arthritis Clinic, Denver, CO; Minor and James Medical Center, Seattle, WA; Division of Rheumatology, University of Alabama at Birmingham, Birmingham, AL, and Amgen, Inc., Thousand Oaks, CA, USA. Supported by Amgen, Inc. A.K. Johnsen, MD, PhD, Division of Rheumatology, Immunology, and Allergy, Brigham and Women's Hospital, Harvard Medical School; M.H. Schiff, MD, Denver Arthritis Clinic; P.J. Mease, MD, Minor and James Medical Center; L.W. Moreland, MD, University of Alabama at Birmingham; A.L. Maier; J.S. Coblyn, MD; S.M. Helfgott, MD, Division of Rheumatology, Immunology, and Allergy, Brigham and Women's Hospital, Harvard Medical School; J.A. Leff, MD, Amgen, Inc.; M.E. Weinblatt, MD, Division of Rheumatology, Immunology, and Allergy, Brigham and Women's Hospital, Harvard Medical School. Address reprint requests to Dr. M.E. Weinblatt, Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, 75 Francis Street, Boston, Ma 02115. E-mail: mweinblatt@partners.org Accepted for publication November 9, 2005.
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