Risankizumab Data in Crohn’s Disease Show Remission, Durable Response and Low Switch Rates

Risankizumab data in Crohn’s disease showed clinical remission and endoscopic response in the Phase 3 AFFIRM study, durable efficacy through 148 weeks in the SEQUENCE study, and the lowest estimated switch rate over 24 months in a U.S. claims analysis. The findings covered predominantly treatment-refractory patients, anti-TNF–exposed patients, and real-world patients initiating biologics.

In the Phase 3 AFFIRM study, 55% of patients treated with risankizumab achieved clinical remission at week 12, compared to 30% in the placebo group. Endoscopic response was achieved by 44% of patients, compared to 14% in the placebo group. The study included a predominantly treatment-refractory population, with 65% of participants having failed two or more advanced therapies.

New long-term data from the SEQUENCE program presented at the 2026 Congress of the European Crohn’s and Colitis Organisation included 224 patients who completed part 1 of the study at week 48 and could receive risankizumab 360 mg subcutaneously every 8 weeks in part 2, the open-label maintenance period, starting at week 52. Patients with moderate-to-severe Crohn’s disease and prior anti-TNF failure demonstrated durable clinical remission, endoscopic response, endoscopic remission, and mucosal healing through 148 weeks of risankizumab treatment.

Most patients who achieved clinical remission at week 8 maintained clinical remission throughout later time points, and clinical remission at week 148 was achieved by 98.5% by CDAI and 88.1% by SF/APS of week 8 clinical remitters. Of patients who achieved endoscopic response, endoscopic remission, or mucosal healing at week 24, 84.7%, 78.2%, and 67.3% of patients, respectively, maintained the corresponding endpoint at week 148. Similar results at week 148 were observed for patients who achieved these endoscopic endpoints at week 48.

A claims-based analysis presented at Digestive Disease Week 2026 drew on the Merative Marketscan database and identified 5,434 patients 18 years of age or older with at least 1 inpatient or 2 outpatient claims for Crohn’s disease who initiated a new biologic between January 2022 and July 2025. All patients had a minimum of 6 months of follow-up. Nonswitching rates, defined as no claim for another advanced therapy, were assessed using Kaplan-Meier analysis over 24 months across the full population and the biologic-naïve subgroup, and a Cox proportional hazards model adjusted for baseline differences including age, comorbidity burden, prior surgery, and prior biologic exposure.

At 24 months, risankizumab demonstrated the lowest estimated switch rate of any biologic assessed, at 14.0% across all patients and 13.4% in the biologic-naïve subgroup. Ustekinumab followed at 21.1% and 19.3%, respectively, with vedolizumab, infliximab, and adalimumab trailing further behind, and adalimumab reaching a switch rate of 36.0% in the overall population. The advantage of risankizumab was most pronounced in biologic-naïve patients, and it persisted among patients with prior biologic exposure.

The claims data did not capture the reasons behind individual switching decisions. The SEQUENCE findings were published in the Journal of Crohn's and Colitis.