Gastroenterology
Risankizumab Safe, Effective in Crohn's Disease
Sep 07, 2025

AT A GLANCE
A new study published in Clinical Gastroenterology and Hepatology presents long-term real-world data suggesting the safety and effectiveness of risankizumab in Crohn's disease (CD).1
“Risankizumab is a selective interleukin-23 inhibitor approved for the treatment of CD. We report a large long-term real-world experience with risankizumab in CD,” explain study authors Zinger et al.
In a prospective monitoring study, the authors assessed a total of 134 patients with active luminal disease who had at least 12 weeks of follow-up were included for drug effectiveness. The Harvey–Bradshaw Index, along with C-reactive protein and fecal calprotectin levels, were used to monitor disease activity, and primary outcomes included clinical remission and steroid-free clinical remission rates at Weeks 12, 26, and 52. Univariate analysis followed by a multivariate analysis using a logistic regression model was performed to identify predictors of steroid-free clinical remission at 1 year.
According to the authors, clinical remission rates were 69%, 64%, and 54% at Weeks 12, 26, and 52, respectively, with corresponding steroid-free clinical remission rates being 58%, 58%, and 50%, respectively. Remission rates in ustekinumab-experienced patients (52%) were not statistically lower compared to those in naïve patients, and prior ustekinumab treatment was not associated with reduced odds of achieving steroid-free clinical remission at 1 year in a multivariate analysis. Adverse effects were assessed in 243 patients and were consistent with previous findings.
“This large real-world experience with risankizumab with long-term follow-up demonstrates effectiveness and safety in patients with CD; there was comparable effectiveness in ustekinumab-naïve and ustekinumab-experienced patients,” conclude the authors.
Reference
1. Zinger A, Choi D, Choi N, et al. Long-term effectiveness and safety of risankizumab in patients with Crohn's disease. Clin Gastroenterol Hepatol. 2025;23(10):1817–1823.