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

Abstract

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.