Long-term Outcomes of Patients with Crohn’s Disease Treated with Risankizumab

Abstract Background Cumulative data suggest that risankizumab is an effective and safe treatment for patients with Crohn’s disease (CD). However, most of the data derive from randomized controlled trials or small retrospective studies with short- or mid-term follow-up. This study aimed to assess the long-term effectiveness and safety of risankizumab in a real-world cohort of patients with CD. Methods This single-center, retrospective, cohort study included consecutive patients with CD treated with risankizumab from October 2022 to August 2024. A time-to-event analysis was performed for treatment failure, treatment escalation, and CD-related health care utilization. Treatment failure was defined as the need for drug discontinuation due to primary nonresponse, loss of response, or a serious adverse event or the need for IBD (inflammatory bowel disease)-related surgery. Treatment escalation was defined as the need for shortening the dose interval or intravenous reinduction due to breakthrough CD-related symptoms and/or elevated biomarkers, such as C-reactive protein and fecal calprotectin. Health care utilization was defined as CD-related emergency department visit or hospitalization. Patients were followed from start of risankizumab until drug discontinuation or the end of follow-up (October 2024). Results The study population consisted of 106 patients with CD (74% receiving prior biological therapies). Patients were followed for a median of 12 interquartile range (IQR), 6.8-18.8 months; 14 (13%) patients had treatment failure; 24 (23%) had treatment escalation; and 17 (16%) had CD-related health care utilization. Multivariable Cox proportional hazards regression analysis identified penetrating CD as associated with treatment failure hazard ratio (HR), 5.2; 95% confidence interval (CI), 1.6-17.2; P = .007, while perianal fistulizing CD (HR, 3.3; 95% CI, 1.2-9.4; P = .023) and prior exposure to more than 2 biologics (HR, 5.8; 95% CI, 1.3-26.3; P = .022) were associated with treatment escalation. Conclusion In this real-world cohort with long-term follow-up, risankizumab was generally effective in patients with CD. Penetrating CD was associated with treatment failure, while perianal fistulizing CD and prior exposure to more than 2 biologics were associated with treatment escalation.