Low Incidence of Inflammatory Bowel Disease Adverse Events in Adalimumab Clinical Trials Across Nine Different Diseases

Elewaut D1, Braun J2, Anderson JK3, Arikan D3, Chen S3, Hojnik M4, De Craemer AS1, Curtis JR5. Arthritis Care Res (Hoboken). 2020 Feb 26. doi: 10.1002/acr.24175. [Epub ahead of print]


Author information

Ghent University Hospital and VIB Center for Inflammation Research, Ghent University, Ghent, Belgium.

Rheumazentrum Ruhrgebiet, Herne, and Ruhr Universität Bochum, Bochum, Germany.

AbbVie Inc, North Chicago, IL, United States.

AbbVie Inc, Ljubljana, Slovenia.

University of Alabama at Birmingham, Birmingham, AL, United States.


OBJECTIVE: Adalimumab is approved for treatment of Crohn's disease and ulcerative colitis. Thus, we postulated that exacerbation or new-onset of inflammatory bowel disease (IBD) would be rare events in patients treated with adalimumab for non-IBD indications. This analysis evaluated the incidence of IBD adverse events (AEs) across adalimumab trials.

METHODS: IBD AE rates 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, non-psoriatic arthritis peripheral spondyloarthritis (pSpA), axial spondyloarthritis (axSpA), including non-radiographic axSpA and ankylosing spondylitis, were analyzed. Search terms for IBD AEs (new onset or worsening/flare) included IBD, ulcerative colitis, Crohn's disease, and ulcerative proctitis.

RESULTS: This analysis included 24,114 patients, representing 36,508 patient-years (PY) of adalimumab exposure. The overall rate (95% CI) of IBD AEs in adalimumab-treated patients was 0.1 (0.1-0.2)/100 PY (41 events), ranging from no events (psoriatic arthritis, uveitis, and pediatric trials) to 0.8 (0.2-2.2)/100 PY in pSpA; the rate of IBD in axSpA was 0.6 (0.4-1.0)/100 PY. During placebo-controlled trials, the overall IBD rate was 0.1 (0.0-0.3)/100 PY for adalimumab (3 events in 6781 patients; 2752 PY of exposure) and 0.1 (0.0-0.4)/100 PY for placebo (1 event in 3493 patients; 1246 PY of exposure) groups; IBD rates in axSpA were 0.5 (0.1-1.4)/100 PY and 0.6 (0.0-3.1)/100 PY, respectively.

CONCLUSION: The rates of IBD AEs in adalimumab clinical trials were generally low across the evaluated diseases, including axSpA; all events occurred in adult patients.

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