Real-World Effectiveness and Safety of Risankizumab in Crohn’s Disease
A long-term prospective study provided the largest real-world data set to date supporting the sustained effectiveness and favorable safety of risankizumab in Crohn's disease (CD), the investigators reported in Clinical Gastroenterology and Hepatology.
The real-world effectiveness and safety of risankizumab, a selective interleukin-23 inhibitor, was evaluated among patients with CD treated at a tertiary referral center. Patients with active luminal disease and ≥12 weeks of follow-up were included in the effectiveness analysis,. Outcomes were measured using the Harvey-Bradshaw Index, C-reactive protein, and fecal calprotectin. The primary endpoints were clinical remission and steroid-free clinical remission at weeks 12, 26, and 52. Logistic regression was used to identify predictors of steroid-free clinical remission at 1 year. Safety outcomes were assessed in all patients treated with risankizumab, irrespective of indication.
Among 134 patients evaluated, 52% had prior ustekinumab exposure. Clinical remission was achieved by 69%, 64%, and 54% of patients at weeks 12, 26, and 52, respectively. Steroid-free clinical remission occurred in 58% at weeks 12 and 26 and 50% at week 52. Outcomes did not differ significantly between ustekinumab-naïve and ustekinumab-experienced patients, and prior ustekinumab treatment was not an independent predictor of reduced remission in multivariate analysis.
Safety was assessed in 243 patients. Adverse events were consistent with the known safety profile of risankizumab and no new safety signals were identified.
Comparable outcomes observed regardless of prior ustekinumab exposure underscored risankizumab’s therapeutic utility in a broad spectrum of patients with refractory disease, the authors concluded.
Reference:
Zinger A, Choi D, Choi N, Fear E, Fine Z, Cohen RD, Rubin DT. Long-term effectiveness and safety of risankizumab in patients with Crohn’s disease. Clin Gastroenterol Hepatol. 2025;23(10):1817-1823.
