Multicenter Real-World Outcomes of Risankizumab in Crohn's Disease: The RESOLVE IG-IBD Study
Year: 2026
Type: article
Study design: Observational Study
Abstract: INTRODUCTION: To assess the effectiveness and safety of Risankizumab (RZB) in a large, nationwide real-world cohort of patients with Crohn's disease (CD). METHODS: We conducted a multicenter, retrospective observational cohort of adults initiating RZB with assessments at weeks 12, 26, and 52. Coprimary end points were (i) week-12 steroid-free clinical remission (SFCR) (Harvey-Bradshaw Index <5 in the absence of systemic corticosteroids or budesonide) and (ii) week-52 endoscopic remission (Simple Endoscopic Score-CD 0-2 or Rutgeerts i0-i1 postoperatively). The main effectiveness analysis was as-observed; a preplanned sensitivity analysis included patients expected to reach week-52 before database lock and applied nonresponder imputation. RESULTS: We included 520 patients, 45.0% failed ≥3 and 54.8% were ustekinumab (UST)-exposed. At week 12, clinical response was 76.5% and 60.8% achieved SFCR. By week 52, SFCR was 65.6%; endoscopic remission occurred in 37.5%, whereas radiologic remission and transmural healing were 24.6% and 9.8%, respectively. UST-naïve patients showed significantly superior early clinical outcomes (week-12 SFCR: 69.8% vs 53.3%) and a higher rate of endoscopic remission at week 52 (56.5% vs 28.6%) compared with UST-exposed patients. Notably, week-52 effectiveness was comparable between patients with 2 and those with ≥3 previous failures. Extraintestinal manifestations decreased over time, whereas perianal disease improved modestly. In the sensitivity cohort (N = 213), SFCR was 47% at week-52. RZB was well-tolerated with no new safety signals identified. DISCUSSION: In a large, refractory, real-world CD population, RZB induced rapid and sustained favorable clinical, endoscopic, and radiologic outcomes. Importantly, one-year effectiveness was similar in patients with 2, and ≥3 previous failures, supporting RZB as a valuable option for a refractory population.
Authors: Franco Scaldaferri, Federica Di Vincenzo, Marina Aloi, Marta Ascolani, Paola Balestrieri, Lorenzo Bertani, Cristina Bezzio, Giorgia Bodini, Fabrizio Bossa, Emma Calabrese, Rosanna Cannatelli, Flavio Caprioli, Marica Cappello, Michele Cicala, Ferdinando D'Amico, Silvio Danese, Alice De Bernardi, Francesca Romana De Filippo, Federico Desideri, Dhanai Di Paolo, Antonio Di Sario, Massimo Claudio Fantini, Concetta Ferracane, Stefano Festa, Gionata Fiorino, Roberto Gabbiadini, Andrea Geccherle, Viviana Gerardi, Emiliano Giangreco, Antonietta Gerarda Gravina, Lucrezia Laterza, Loris Riccardo Lopetuso, Irene Marafini, Mauro Mastronardi, Marco Mendolaro, Manuela Merli, Giammarco Mocci, Sara Onali, Maria Francesca Onidi, Luca Pastorelli, Alessandra Piagnani, Maria Beatrice Principi, Daniela Pugliese, Davide Giuseppe Ribaldone, Antonio Rispo, Fernando Rizzello, Fabrizio Santagata, Edoardo Vincenzo Savarino, Rocco Spagnuolo, Antonio Tursi, Alba Panarese, Silvia Mazzuoli, Angela Variola, Chiara Viganò, Alessandro Armuzzi, on behalf of the RESOLVE Study Group
Institutions: Università Cattolica del Sacro Cuore, Agostino Gemelli University Polyclinic, Istituti di Ricovero e Cura a Carattere Scientifico, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Ca' Foncello Hospital, Università Campus Bio-Medico, Campus Bio Medico University Hospital, Humanitas University, IRCCS Humanitas Research Hospital, Ospedale Policlinico San Martino, University of Genoa, Casa Sollievo della Sofferenza, University of Rome Tor Vergata, University of Milan, Luigi Sacco Hospital, ASST Fatebenefratelli Sacco, University of Palermo, Vita-Salute San Raffaele University, IRCCS Ospedale San Raffaele, Aziende Socio Sanitaria Territoriale Rhodense, AOU San Giovanni di Dio e Ruggi d'Aragona, Ospedale Valduce, University of Cagliari, Azienda Ospedaliero-Universitaria Cagliari, Azienda Ospedaliero Universitaria Policlinico "G.Rodolico - San Marco", ASL Roma, Ospedale San Filippo Neri, Azienda Ospedaliera San Camillo-Forlanini, Ospedale Sacro Cuore Don Calabria, Fondazione Poliambulanza Istituto Ospedaliero, Ospedale Maria Vittoria, University of Campania "Luigi Vanvitelli", Link Campus University, Gastroenterology Hospital "Saverio de Bellis", Sapienza University of Rome, Azienda Ospedaliera G. Brotzu, Azienda Socio Sanitaria Territoriale Santi Paolo e Carlo, Alessandro Manzoni Hospital, University of Bari Aldo Moro, Azienda Ospedaliera Citta' della Salute e della Scienza di Torino, University of Turin, Federico II University Hospital, University of Naples Federico II, IRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola, University of Padua, Azienda Ospedale - Università Padova, Magna Graecia University, Ospedale L. Bonomo, University of Milano-Bicocca
Language: English
Topic: Inflammatory Bowel Disease
Subfield: Genetics
Domain: Life Sciences
Open Access status: hybrid
Estimated APC paid: $4,390
Funder: Pfizer
OpenAlex ID: W7130384642