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. [ABSTRACT FROM AUTHOR]