Randomized, placebo controlled and double-blind trials of efficacy and safety of adalimumab for treating ankylosing spondylitis: a meta-analysis.

Adalimumab is a fully human, anti-TNF monoclonal antibody of proven efficacy and safety in the treatment of the signs, symptoms and functional disability of ankylosing spondylitis (AS). A systematic review and meta-analysis was performed to assess the efficacy and safety of adalimumab treatment, relative to a placebo, in adult patients with AS. In the efficacy meta-analysis, significantly more patients in the adalimumab group achieved Assessment in AS International Working Group (ASAS)20 and Bath AS Disease Activity Index (BASDAI)50 compared with patients in the placebo group. Patients in the adalimumab group also showed significant improvement in BASDAI and health-related quality of life. With regard to adverse events, any adverse events and injection-site reaction were significantly higher in the adalimumab group compared with the control group. This meta-analysis shows a higher efficacy of adalimumab relative to placebo, but clinicians should be careful regarding adverse events in adalimumab-treated patients.