RT Journal Article
SR Electronic
T1 Comparison of 2 doses of etanercept (50 vs 100 mg) in active rheumatoid arthritis: a randomized double blind study.
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP 659
OP 664
VO 33
IS 4
A1 Alyssa K Johnsen
A1 Michael H Schiff
A1 Philip J Mease
A1 Larry W Moreland
A1 Agnes L Maier
A1 Jonathan S Coblyn
A1 Simon M Helfgott
A1 Jonathan A Leff
A1 Michael E Weinblatt
YR 2006
UL http://www.jrheum.org/content/33/4/659.abstract
AB 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-naäve 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-naäve patients.