Balloon-Assisted Enteroscopy Assesses Endoscopic Remission and Mucosal Healing following Risankizumab Initiation in Crohn's Disease.

INTRODUCTION: Endoscopic control of inflammation is a key treatment goal in Crohn's disease. However, real-world endoscopic outcomes of risankizumab assessed by paired balloon-assisted enteroscopy (BAE) remain limited. We examined endoscopic outcomes at the visit closest to week 52 after risankizumab initiation using paired BAE. METHODS: We retrospectively studied adults with Crohn's disease who initiated risankizumab. The primary analysis set comprised 42 patients who underwent BAE at baseline and at the visit closest to week 52. Endoscopic activity was quantified using the Simple Endoscopic Score for Crohn's Disease (SES-CD). Endoscopic remission was defined as SES-CD ≤4 with a decrease of ≥2 points from baseline, and mucosal healing was defined as SES-CD ≤2. RESULTS: In the paired BAE cohort (n = 42), the median SES-CD improved from 9 at baseline to 2 at follow-up (p < 0.0001). At follow-up, 76.2% (32/42) achieved endoscopic remission and 52.4% (22/42) achieved mucosal healing. Endoscopic remission was more frequent in bio-naïve than bio-experienced patients (93.3% vs. 66.7%, p = 0.054), whereas mucosal healing rates were similar (53.3% vs. 51.9%, p = 0.92). CONCLUSION: In this real-world Japanese cohort, risankizumab was associated with significant endoscopic improvement assessed by paired BAE at follow-up. Endoscopic remission and mucosal healing rates were high in the paired BAE cohort, particularly for endoscopic remission among bio-naïve patients.