Abstract
BACKGROUND AND AIMS: Adverse events (AEs) are frequently reported in clinical trials of advanced therapies for ulcerative colitis (UC). It remains uncertain whether patients receiving concomitant corticosteroids experience higher AE rates. This study aimed to determine whether corticosteroid use is associated with increased AEs in UC trials. METHODS: This post-hoc analysis used participant-level data from several placebo-controlled trials (GEMINI-1, ULTRA-2, VARSITY, ACT-1, OCTAVE, and PURSUIT). The primary population included induction responders with or without baseline corticosteroid use. The primary outcome assessed the association between corticosteroid use and total AEs. Secondary outcomes included AE rates among those who achieved corticosteroid-free remission versus those who did not, and whether specific AEs were more common in corticosteroid users. RESULTS: Among 2339 patients who achieved clinical response after induction, 1159 (49.5%) used corticosteroids at baseline. By 1 year, AE incidence was higher among corticosteroid users than non-users (75.2% vs. 67.6%, P < .001). Patients who achieved corticosteroid-free remission had fewer AEs than those who did not (67.4% vs. 77.5%, P < .001). Moderate AEs were more frequent among corticosteroid users. Common AEs included infections (in both groups) and liver abnormalities (more in corticosteroid users). Multivariable logistic regression confirmed baseline corticosteroid use as an independent AE risk factor [odds ratio (OR) 1.5, 95% CI 1.3-1.8, P = .002]. Ongoing corticosteroid use at 1 year was associated with even higher AE risk (OR 4.6, 95% CI 2.1-6.8, P < .001). CONCLUSION: Corticosteroid use is independently associated with increased AEs in UC clinical trials. Continued monitoring and strategies for corticosteroid tapering may reduce AE burden.