Double-blind placebo-controlled trial of etanercept in the prevention of work
disability in ankylosing spondylitis.
Author(s): Barkham N, Coates LC, Keen H, Hensor E, Fraser A, Redmond A, Cawkwell L, Emery P.
Affiliation(s): University of Leeds, UK.
Publication date & source: 2010, Ann Rheum Dis. , 69(11):1926-8
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
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.
Ann Rheum Dis. 2011 Aug;70(8):1519.