Effectiveness and Safety of Risankizumab in Crohn Disease After Failure of a First Line of Advanced Therapy: A Long-Term, Real-Life Study
Year: 2026
Type: article
Study design: Observational Study
Abstract: BACKGROUND: Risankizumab (RZB) is an anti-interleukin 23 (anti-IL-23) approved for the treatment of Crohn disease (CD). STUDY QUESTION: We aimed to evaluate the effectiveness and safety of RZB in the treatment of CD in real-world settings. STUDY DESIGN: We performed a retrospective review of a multicentre consortium of patients with CD treated with RZB. MEASURES AND OUTCOMES: Coprimary outcomes were clinical remission at week 12, 24, and 52 (Harvey-Bradshaw Index score of ≤4), and safety. Secondary outcomes included steroid-free clinical remission, clinical response, and endoscopic remission at 52 weeks. RESULTS: A total of 487 patients were included. The median follow-up was 24 (interquartile range: 16-38) weeks. A total of 372 (76.4%) patients achieved clinical remission at maximal follow-up. According to the treatment line in which RZB was administered, clinical remission occurred in 115/134 (85.8%) patients on second-line therapy, 112/153 (73.2%) on third-line therapy, and 145/200 (72.5%) on fourth-line therapy, with a significant difference ( P = 0.010). Adverse events occurred in 60 patients (12.6%) during follow-up; most of them were mild (50/60, 83.3%). Regarding the secondary outcomes: steroid-free clinical remission was achieved in 342 (71.8%) patients, and clinical response was observed in 443 (91.0%) patients. Six (1.2%) patients underwent surgery during follow-up. Mucosal healing was achieved in 34/67 (50.7%) patients. CONCLUSIONS: In this extensive, real-world study, RZB was effective and well tolerated in an advanced-therapy-exposed population of patients with CD and associated with favorable clinical and endoscopic outcomes.
Source: American Journal of Therapeutics
Authors: Antonio Tursi, Giammarco Mocci, Franco Scaldaferri, Daniele Napolitano, Federica Gaiani, Gianluigi De' Angelis, Davide Giuseppe Ribaldone, Eleonora Schillaci, Edoardo V. Savarino, Caterina D. E. Barba, Emanuele Bendia, Laura Bolognini, Daniele Balducci, Claudia Quatraccioni, Francesco Martini, Michele Montori, Giovanni Maconi, Giovanni Cataletti, Alessandro Massari, Elena Del Zanna, Francesco Costa, Linda Ceccarelli, Antonietta G. Gravina, Raffaele Pellegrino, Giorgia Bodini, Andrea Pasta, Manuela Marzo, Agnese Miranda, Antonio Cuomo, Laura Donnarumma, Giovanni Lombardi, Marta Patturelli, Mariaelena Serio, Antonella Scarcelli, Giuseppe Pranzo, Chiara Maria Palmisano, Rocco Spagnuolo, Francesco Luzza, Domenico Morano, Giuliana Vespere, Silvia Sedda, Leonardo D. E. Luca, Walter Elisei, Rita Monterubbianesi, Michela Di Fonzo, Libera Fanigliulo, Roberta Pica, Claudio Cassieri, Andrea Cocco, Elisa Stasi, Laurino Grossi, Lorenzo Bertani, Fabio Cortellini, Simona Piergallini, Patrizio Scarozza, Girolamo Bevevino, Giulia Zerboni, Federico Iacopini, Stefano Rodino', Ladislava Sebkova, Davide Checchin, Francesca Lamboglia, Francesco Ferrara, Nicola Della Valle, Raffaele Colucci, Francesco Bachetti, Domenico Catarella, Dario D'agostino, Elisabetta D. I. Bartolo, Ileana Luppino, Mario Erboso, Giulia Rocco, Carlotta Sacchi, Costantino Zampaletta, Giacomo Forti, Serafina Fiorella, Gabrio Bassotti, Elisabetta Antonelli, Caterina Mucherino, Elvira D'Antonio, Laura Montesano, Maurizio Giovannone, Giuseppina Vincoli, Alessandro Gigliozzi, Berardino D'Ascoli, Marina Rizzi, Pietro Capone, Giovanni Aragona, Patrizia Perazzo, Leonardo Allegretta, Paolo Tonti, Viviana Neve, Cristiano Pagnini, Antonio Grandolfo, Francesco Gatti, Antongiulio Bucci, Massimiliano Rizzi, Marcello Picchio, Francesca Maria Onidi, Paolo Usai Satta, Alfredo Papa
Institutions: Università Cattolica del Sacro Cuore, Ospedale L. Bonomo, Azienda Ospedaliera G. Brotzu, Agostino Gemelli University Polyclinic, Istituti di Ricovero e Cura a Carattere Scientifico, University of Parma, Azienda Ospedaliera Citta' della Salute e della Scienza di Torino, University of Turin, University of Padua, Azienda Ospedale - Università Padova, Azienda Ospedaliero-Universitaria delle Marche, Luigi Sacco Hospital, University of Pisa, Azienda Ospedaliera Universitaria Pisana, University of Campania "Luigi Vanvitelli", Ospedale Policlinico San Martino, University of Genoa, Ospedale Veris Delli Ponti Scorrano, Ospedale Monaldi, Ospedale Antonio Cardarelli, San Salvatore Hospital, Magna Graecia University, Azienda Ospedaliera San Camillo-Forlanini, Ospedale Sandro Pertini, Ospedale Vito Fazzi, University of Chieti-Pescara, Azienda USL Toscana Nord Ovest, Ospedale Infermi di Rimini, Azienda Ospedaliera Pugliese Ciaccio, Ospedali Riuniti di Foggia, Ospedale di Spoleto, Ospedale Garibaldi, Ospedale Annunziata di Cosenza, Ospedale di Belcolle, Ospedale Santa Maria Goretti, University of Perugia, Ospedale Madonna Delle Grazie, Guglielmo da Saliceto Hospital, Ospedale A. Perrino, Azienda Ospedaliera San Giovanni Addolorata, Ospedale San Paolo, ASL Roma
Language: English
Topic: Inflammatory Bowel Disease
Subfield: Genetics
Domain: Life Sciences
Open Access status: hybrid
OpenAlex ID: W7170131458