Abstract
BACKGROUND AND AIMS: In phase 3 induction (ADVANCE and MOTIVATE) and maintenance (FORTIFY) trials, risankizumab was shown to benefit symptom and endoscopic defined outcomes in patients with Crohn's disease (CD). We examined the effects of risankizumab on the incidence of CD-related hospitalizations in these studies. METHODS: Patients with active CD were randomized to intravenous (IV) risankizumab 600 or 1200 mg, or placebo at weeks 0, 4, and 8 in the 12-week induction studies. Clinical responders were rerandomized to maintenance with subcutaneous (SC) risankizumab 180 or 360 mg or placebo every 8 weeks for 52 weeks. Incidence of CD-related hospitalizations was compared between groups, expressed as proportions with an event during induction and event/100 person-years (PYs) during maintenance. An integrated analysis incorporated exposure time and occurrence of CD-related hospitalizations in induction and maintenance periods for labeled doses. RESULTS: The incidence of CD-related hospitalizations was lower (3.2% or 1.9% vs 11.6%; P < .01) in the risankizumab IV 600- and 1200-mg groups vs placebo IV during induction. Through 52 weeks, the incidence rate per 100 PYs of CD-related hospitalizations was similar among treatment groups, with few events reported (n = 5-9 per group). In the integrated analysis, a lower incidence rate per 100 PYs of CD-related hospitalizations was observed in the risankizumab-treated groups (600 mg IV/360 mg SC: 9.6; 600 mg IV/180 mg SC: 7.9) vs placebo (40.0, P < .001). CONCLUSION: Risankizumab treatment resulted in reduced rates of CD-related hospitalization with treatment effect observed within 12 weeks of randomization.