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Analysis of uveitis rates across all etanercept ankylosing spondylitis clinical trials
  1. Joachim Sieper (joachim.sieper{at}charite.de)
  1. University Clinic Benjamin Franklin, Germany
    1. Andrew S Koenig (koeniga2{at}wyeth.com)
    1. Wyeth Research, United States
      1. Scott Baumgartner (sbaumgar{at}amgen.com)
      1. Amgen Inc, United States
        1. Carole Wishneski (wishnec{at}wyeth.com)
        1. Wyeth Research, United States
          1. Joanne Foehl (foehlj{at}wyeth.com)
          1. Wyeth Research, United States
            1. Bonnie Vlahos (vlahosb{at}wyeth.com)
            1. Wyeth Research, United States
              1. Bruce Freundlich (freundb{at}wyeth.com)
              1. Wyeth Research, United States

                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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