RESEARCH - Comparison of 2 doses of Enbrel (50 vs 100 mg) in active RA

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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.

Objective. To assess the safety and efficacy of etanercept 50 mg

administered twice weekly versus 25 mg administered twice weekly as

monotherapy in patients with tumor necrosis factor-a (TNF-a) blocker-naïve

active rheumatoid arthritis (RA).

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)

http://www.jrheum.com/abstracts/abstracts06/659.html

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