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This retrospective observational study included 180 patients receiving risankizumab over 2.5 years across eight centers in Japan.Median age was 38.5 years, 69% were men, and median follow-up was 52 weeks.Seventy-seven percent of the cohort had received advanced therapies, 58% had received at least two agents, and 46% had previously received ustekinumab.Almost half had undergone intestinal resection.The primary clinical-effectiveness analysis included only 51 patients with baseline Crohn's Disease Activity Index (CDAI) ≥220.Corticosteroid-free clinical remission required CDAI <150 without systemic corticosteroids or budesonide for at least 4 weeks.Endoscopic response required a ≥50% reduction in the Simple Endoscopic Score for Crohn's Disease (SES-CD); remission required SES-CD ≤2.Analyses used available observations without imputing missing outcomes.Among patients with moderate-to-severe active disease, corticosteroid-free remission occurred in 31% at week 12 (15/48), 52% at week 28 (22/42), and 57% at week 52 (16/28).Corresponding clinical-remission rates were 40, 55, and 61%, while clinical-response rates were 71, 74, and 75%.Outcomes generally favored patients without previous advanced-therapy exposure.At week 12, corticosteroid-free remission was 60% in treatment-naïve patients vs 18% in treatmentexposed patients.Ustekinumab-naïve patients also had better early outcomes, although differences between ustekinumab subgroups were not statistically significant at week 52.Paired endoscopic assessments were available for 45 patients.Overall, 58% achieved endoscopic response and 29% achieved endoscopic remission.Remission was more frequent in advanced-therapy-naïve than exposed patients (56 vs 14%) and in ustekinumab-naïve than exposed patients (44 vs 6%).Segmentbased analyses showed particularly favorable colonic outcomes in treatment-naïve groups.Similar trends in terminal ileal disease did not reach statistical significance.Inflammatory biomarkers, including C-reactive protein and leucine-rich α2-glycoprotein, generally decreased.Perianal outcomes were exploratory: among 20 evaluable patients at week
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Rimjhim Shrivastava (2026) studied this question.
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