Real‐World Effectiveness of Risankizumab in Refractory Crohn's Disease: The RISANCROHN Study From the ENEIDA Registry

BACKGROUND AND AIMS: Risankizumab, a selective interleukin-23 p19 inhibitor, has demonstrated efficacy in clinical trials for moderate-to-severe Crohn's disease, but real-world data in highly refractory populations are limited. We evaluated the short-term effectiveness and outcomes at last follow-up of risankizumab and the impact of prior advanced therapy exposure. METHODS: This multicentre observational study included adult patients with predominantly refractory Crohn's disease treated with risankizumab and registered in the ENEIDA registry. Steroid-free clinical remission, defined as a Harvey-Bradshaw Index ≤ 4 without systemic corticosteroids, was assessed at weeks 8-12 and at the last available follow-up visit. Multivariable logistic regression was used to identify factors associated with remission at last follow-up. RESULTS: A total of 857 patients with predominantly refractory Crohn's disease were included. Steroid-free clinical remission was achieved in 56% of patients at weeks 8-12 and in 61% at last follow-up (mean follow-up: 7.4 months). Remission rates were higher in patients previously exposed to ≤ 2 biologic therapies than in those exposed to > 2 biologic therapies at both time points (p < 0.001). Prior ustekinumab exposure was associated with lower remission rates in unadjusted analyses but was not independently associated with remission at last follow-up. Treatment-related adverse events occurred in 8% of patients, with no serious adverse events. CONCLUSIONS: In this large real-world cohort of patients with refractory Crohn's disease, risankizumab achieved clinically meaningful steroid-free clinical remission, both at early assessment and at last follow-up, with effectiveness primarily influenced by cumulative biologic exposure and demonstrating a favourable safety profile.