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Clinical and epidemiological research
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Analysis of uveitis rates across all etanercept ankylosing spondylitis clinical trials
  1. J Sieper1,
  2. A Koenig2,
  3. S Baumgartner3,
  4. C Wishneski2,
  5. J Foehl2,
  6. B Vlahos2,
  7. B Freundlich2
  1. 1
    Charité Medical University, Berlin, Germany
  2. 2
    Wyeth Pharmaceuticals, Collegeville, Pennsylvania, USA
  3. 3
    Amgen, Thousand Oaks, California, USA
  1. Correspondence to Professor J Sieper, Universitätsmedizin Berlin, Campus Benjamin Franklin, Med Klinik I – Rheumatologie, Hindenburgdamm 30, 12200 Berlin, Germany; Joachim.sieper{at}charite.de

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.

https://doi.org/10.1136/ard.2008.103192

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    Footnotes

    • Funding This study was funded by Wyeth Pharmaceuticals, Collegeville, Pennsylvania, USA and Amgen Inc, Thousand Oaks, California, USA.

    • All studies were approved by the appropriate institutional review board or independent ethics committee.

    • Competing interests JS has received reimbursement for attending a symposium, fees for speaking, funds for research and fees for consulting for the following companies: Abbott, Schering-Plough, Wyeth. SB is a full-time employee of Amgen Inc, and as such owns stock and stock options. Before that, SB received funds for speaking, research, consulting and attending educational programmes. AK, CW, JF, BV and BF are employees of Wyeth and own stock and stock options in the company.

    • Provenance and Peer review Not commissioned; externally peer reviewed.