Comparison of 2 Doses of Etanercept (50 vs 100 mg) in Active Rheumatoid Arthritis: a Randomized Double Blind Study

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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.

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 [PubMed - as supplied by publisher]