Analysis of uveitis rates across all etanercept ankylosing spondylitis clinical trials.

Abstract

OBJECTIVE:

To assess uveitis (including iritis and iridocyclitis) incidence from clinical trials of etanercept in patients with ankylosing spondylitis (AS).

METHODS:

Clinical trials of etanercept in AS (four placebo-controlled; one active-controlled; three open-label) were examined for reports of uveitis. Between-group differences with confidence intervals (CIs) 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 to 14.2)) was lower than that for placebo (19.3 (11.0 to 29.8), p = 0.03). In the active comparator trial, rates for etanercept and sulfasalazine were similar (10.7 (5.5 to 17.6) and 14.7 (6.4 to 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 to 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.

• Authors: J Sieper, A Koenig, S Baumgartner, C Wishneski, J Foehl, B Vlahos, B Freundlich
• Journal: Annals of the rheumatic diseases (Ann Rheum Dis) Vol. 69 Issue 1 Pg. 226-9 (Jan 2010) ISSN: 1468-2060 [Electronic] England
• PMID: 19465402 (Publication Type: Journal Article, Meta-Analysis, Research Support, Non-U.S. Gov't)

Chemical References

• Antirheumatic Agents
• Immunoglobulin G
• Receptors, Tumor Necrosis Factor
• Etanercept

Topics

• Adult
• Antirheumatic Agents (therapeutic use)
• Double-Blind Method
• Etanercept
• Female
• Humans
• Immunoglobulin G (therapeutic use)
• Male
• Middle Aged
• Randomized Controlled Trials as Topic (methods)
• Receptors, Tumor Necrosis Factor (therapeutic use)
• Research Design
• Spondylitis, Ankylosing (complications, drug therapy)
• Uveitis (etiology, prevention & control)