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Extended report
Double-blind placebo-controlled trial of etanercept in the prevention of work disability in ankylosing spondylitis
  1. Nick Barkham,
  2. Laura C Coates,
  3. Helen Keen,
  4. Elizabeth Hensor,
  5. Alexander Fraser,
  6. Anthony Redmond,
  7. Lorna Cawkwell,
  8. Paul Emery
  1. Academic Unit of Musculoskeletal Disease, University of Leeds, Leeds, UK
  1. Correspondence to Professor Paul Emery, Academic Unit of Musculoskeletal Disease, University of Leeds, Chapel Allerton Hospital, Chapeltown Road, Leeds LS7 4SA, UK; p.emery{at}leeds.ac.uk

Abstract

Objectives Etanercept has been shown to be rapidly effective in suppressing disease activity in ankylosing spondylitis (AS). The aim of this study was to determine whether etanercept improves work instability as measured by the Ankylosing Spondylitis Work Instability Scale (AS-WIS).

Method Forty patients with active AS who were in work but were work unstable were recruited. Patients were randomised to receive 25 mg etanercept or placebo twice weekly for 12 weeks. The primary outcome was change in AS-WIS at week 12. The AS-WIS is a patient-derived outcome measure which allows stratification of the risk of job loss. Secondary outcomes included clinical outcomes and gait parameters.

Results The mean improvement in AS-WIS score at week 12 was 2.75 in the etanercept group and 0.68 in the placebo group (p=0.125). The risk of job loss decreased for 11 (55%) of the etanercept group compared with 7 (35%) in the placebo group. Conversely, the risk of job loss increased in 3 (15%) of the placebo group compared with 1 (5%) in the etanercept group. There was no statistically significant difference between treatment groups in change in WIS categories (Mann–Whitney U test=0.153, p=0.160). Significant improvement with etanercept was seen at week 12 in clinical outcomes and gait parameters. Etanercept was well tolerated, with no dropouts due to adverse events.

Conclusion This small study confirms the efficacy of etanercept on clinical outcome measures in patients with AS and suggests an effect on work instability which needs to be replicated in a larger controlled study.

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Footnotes

  • Funding Financial support for the study, and the study drug was provided by Wyeth Pharmaceuticals. Wyeth had no role in the study design, or in the collection, analysis, or interpretation of the data.

  • Competing interests None.

  • Ethics approval The local ethics committee approved the study and written informed consent was obtained from all patients prior to screening.

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

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