Concise report |
Analysis of uveitis rates across all etanercept ankylosing spondylitis clinical trials
1 University Clinic Benjamin Franklin, Germany
2 Wyeth Research, United States
3 Amgen Inc, United States
* To whom correspondence should be addressed. E-mail: joachim.sieper{at}charite.de.
Accepted 30 April 2009
Abstract
Objective: Assess uveitis (including iritis and iridocyclitis) incidence from clinical trials of etanercept in ankylosing spondylitis (AS) subjects.
Methods: Clinical trials of etanercept in AS (4 placebo-controlled; one active-controlled; and three open-label) were examined for reports of uveitis. Between-group differences with confidence intervals (CI) in the uveitis rates were calculated for the double-blind, active-controlled, and long-term studies.
Results: In placebo-controlled trials, the uveitis rate per 100 subject years (95% CI) for etanercept (8.6 [4.5, 14.2]) was lower than that for placebo (19.3 [11.0, 29.8] p=0.03). In the active comparator trial, rates for etanercept and sulphasalazine were similar (10.7 [5.5, 11.6] and 14.7 [6.4, 26.5], respectively; p=0.49). The long-term rate for etanercept, estimated from both placebo-controlled and open-label extension studies was 12.0 (10.0, 14.1).
Conclusions: In subjects with AS, rates of uveitis events with etanercept were lower than with placebo in placebo-controlled trials and similar to sulfasalazine in an active-comparator trial.
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