Analysis of uveitis rates across all etanercept ankylosing spondylitis clinical trials.
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.
Sieper
J
J
Universitätsmedizin Berlin, Campus Benjamin Franklin, Med Klinik I - Rheumatologie, Hindenburgdamm 30, 12200 Berlin, Germany. Joachim.sieper@charite.de
Koenig
A
A
Baumgartner
S
S
Wishneski
C
C
Foehl
J
J
Vlahos
B
B
Freundlich
B
B
D000328:Adult; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D000068800:Etanercept; D005260:Female; D006801:Humans; D007074:Immunoglobulin G / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D018124:Receptors, Tumor Necrosis Factor / Q000627:therapeutic use*; D012107:Research Design; D013167:Spondylitis, Ankylosing / Q000150:complications / Q000188:drug therapy*; D014605:Uveitis / Q000209:etiology / Q000517:prevention & control*
D018501:Antirheumatic Agents; D007074:Immunoglobulin G; D018124:Receptors, Tumor Necrosis Factor; D000068800:Etanercept