Real-World Data on the Effectiveness of Ustekinumab and Risankizumab for Crohn's Disease.

Introduction: No real-world studies have compared efficacy of ustekinumab (UST) and risankizumab (RZB) for the treatment of Crohn's disease (CD).

Methods: We retrospectively collected the data of patients with CD treated with UST or RZB between May 2017 and March 2024 at the Institute of Science Tokyo and analyzed clinical remission rate at weeks 8 and 28 using Harvey-Bradshaw Index (HBI), with remission defined as a HBI ≤4.

Result: A total of 111 patients who were treated with UST and 29 patients treated with RZB were included in the analysis. RZB had higher efficacy both at weeks 8 (82.8% vs. 62.2%, p = 0.0465) and 28 (79.3% vs. 56.8%, p = 0.0321) than UST in the full study cohort, and at weeks 8 (55.6% vs. 18.4%, p = 0.0352) and 28 (66.7% vs. 18.4%, p = 0.0083) in the patients with clinically active disease and anti-TNFα exposed patients. During the observation period, 1 patient with RZB (3.45%) experienced an adverse event that required hospitalization, and 1 patient in the UST group (0.900%) experienced an adverse event that led to treatment discontinuation.

Conclusion: RZB may offer greater short-term efficacy than UST, with an acceptable safety profile in real-world settings.