Manuel Barreiro‐de Acosta, Yamile Zabana, Laura Nieto‐García, M Poncela, Mariam Aguas, C Martinez-Cuevas, Federico Argüelles‐Arias, Marta Calvo, Carla J. Gargallo-Puyuelo, Lucia Zabalza San Martin, Pilar Varela Trastoy, Maia M. Boscá‐Watts, Daniel Ceballos, Cristina Martínez Pascual, Francisco Rodríguez‐Moranta, M L De Castro Parga, Patricia Suárez, Blau Camps, Vanesa Royo, Iria Bastón‐Rey, Ruth de Francisco, Santiago García‐Lopez, María Dolores Martín‐Arranz, Fernando Bermejo, Inmaculada Alonso‐Abreu, Javier P. Gisbert, Montserrat Rivero, Beatriz Sicilia, Isabel Nicolás, Marta Téller, Ángel Ponferrada Díaz, E Ricart, María Algara, Paola Fradejas, Pilar Robledo, Lucía Madero, Ainara Elorza, Marta Piqueras, Mariana Fe García-Sepulcre, Eva Sesé, Alejandro Hernández-Camba, Sandra Izquierdo, Ana M. Trapero, Eva Iglesias, María Teresa Diz‐Lois Palomares, Eduard Brunet, Jesús Castro Poceiro, D Busquets, Miriam Manosa, Ramón Pajares, J Ferrer, Daniel Carpio, Francisco Mesonero, Luis Bujanda, Rufo Lorente, Javier Santos, Carlos Martínez Flores, Carlos González‐Muñoza, Daniel Martin, Margarita Menacho, Nuria Maroto, Martín Irabien, Sol Porto-Silva, E Domènech, Rocío Ferreiro‐Iglesias, ENEIDA project of GETECCU
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.