Immunosuppressive Drug Is Safe in AS

The use of adalimumab is safe for the treatment of ankylosing spondylitis (AS), according to results of a safety analysis.

Previous clinical trials conferred adequate safety and efficacy of adalimumab. However, the researchers wanted to measure real-world effectiveness and safety for AS in Japan.


Ankylosing Spondylitis

Enthesitis Is Less Common in Ankylosing Spondylitis

For the analysis, 403 adults with AS were enrolled; 396 constituted a safety analysis set and 374 were an efficacy analysis set. In the safety set, the mean disease duration was 9.8 years, and 67.2% of patients were men.

Results indicated that 55.5% of 236 patients examined for human leukocyte antigen-B27 were positive. 

A total of 216 patients had Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores pre- and post-baseline.

In the efficacy set, the mean BASDAI score was 4.9 at baseline. At 24 weeks, 143 patients had available BASDAI scores. Of these, the mean decrease in BASDAI score was −2. 

Fifteen patients experienced 15 serious treatment-related adverse events. Thirty adverse events were treatment-related infections, of which 5 were serious.

“Safety and effectiveness of adalimumab in this postmarketing observational study were similar to that in previous clinical trials,” the researchers concluded.

—Melinda Stevens

Kobayashi S, Kashiwagi T, Kimura J. Real-world effectiveness and safety of adalimumab for treatment of ankylosing spondylitis in Japan [published online September 15, 2018]. Modern Rheumatol.