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

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J Rheumatol. 2006 Apr;33(4):659-64. Epub 2006 Feb 15.

Comparison of 2 doses of etanercept (50 vs 100 mg) in active rheumatoid

arthritis: a randomized double blind study.

sen AK, Schiff MH, Mease PJ, Moreland LW, Maier AL, Coblyn JS, Helfgott

SM, Leff JA, Weinblatt ME.

Division of Rheumatology, Immunology, and Allergy, Brigham and Women's

Hospital, Harvard Medical School, Boston, MA 02115, USA.

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-alpha (TNF-alpha)

blocker-naive 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-alpha blocker-naive patients.

PMID: 16482646

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=PubMed & list_uids=1\

6482646 & dopt=Abstract

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