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Low incidence of inflammatory bowel disease adverse events in adalimumab clinical trials across nine different diseases

Arthritis Care & Research Feb 08, 2021

Elewaut D, Braun J, Anderson JK, et al. - Researchers conducted this post hoc analysis to describe the incidence of inflammatory bowel disease (IBD) adverse events (AEs) in adalimumab clinical trials across indications, with a particular emphasis on IBD occurrence in patients with axial spondyloarthritis (SpA), including patients with ankylosing spondylitis (AS) and nonradiographic axial SpA. IBD AE rates were analyzed in 75 adalimumab clinical trials in rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, pediatric enthesitis‐related arthritis, uveitis, hidradenitis suppurativa, adult and pediatric psoriasis, psoriatic arthritis, nonpsoriatic arthritis peripheral SpA, axial SpA, including nonradiographic axial SpA, and ankylosing spondylitis. This investigation involved 24,114 patients, representing 36,508 patient‐years of adalimumab exposure. The rates of IBD events were equivalent between adalimumab‐ and placebo‐treated patients in patients with axial spondyloarthritis, who are at elevated risk of IBD. In adalimumab clinical trials, the rates of IBD AEs were relatively low across the diseases examined, including axial SpA, with all incidents occurring in adult patients.

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