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

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