Multicenter Real-World Outcomes of Risankizumab in Crohn's Disease: The RESOLVE IG-IBD Study

Area of Science:

• Gastroenterology
• Immunology
• Pharmacology

Background:

• Crohn's disease (CD) is a chronic inflammatory condition requiring effective long-term therapies.
• Refractory CD poses a significant challenge, necessitating novel treatment approaches.
• Real-world data is crucial for understanding treatment effectiveness in diverse patient populations.

Purpose of the Study:

• To evaluate the real-world effectiveness and safety of Risankizumab (RZB) in a large cohort of adult Crohn's disease patients.
• To assess clinical and endoscopic remission rates at multiple time points up to 52 weeks.
• To compare outcomes in ustekinumab-exposed versus ustekinumab-naïve patients and analyze effectiveness based on prior treatment failures.

Main Methods:

• A multicentre, retrospective observational cohort study of 520 adult patients initiating RZB.
• Co-primary endpoints included week-12 steroid-free clinical remission (SFCR) and week-52 endoscopic remission.
• Effectiveness was analyzed as-observed, with a sensitivity analysis using non-responder imputation.

Main Results:

• At week 12, 60.8% of patients achieved SFCR. By week 52, SFCR was 65.6%, and endoscopic remission was achieved by 37.5%.
• Ustekinumab-naïve patients demonstrated significantly better outcomes than ustekinumab-exposed patients.
• Effectiveness at week 52 was comparable between patients with 2 and ≥3 prior treatment failures. Risankizumab was well-tolerated.

Conclusions:

• Risankizumab (RZB) demonstrated rapid and sustained clinical, endoscopic, and radiologic improvements in a real-world, refractory CD population.
• RZB is a valuable therapeutic option for refractory CD, with comparable one-year effectiveness regardless of 2 or ≥3 prior treatment failures.
• The safety profile of RZB was favorable, with no new safety signals identified in this cohort.