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.
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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.
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. https://doi.org/10.1080/14397595.2018.1525024.