Upadacitinib’s Effectiveness and Safety as a Second- or Third-Line Therapy in Patients with Ulcerative Colitis: Data from a Real-World Study
Year: 2025
Type: article
Study design: Observational Study
Abstract: Background: Upadacitinib (UPA), a selective anti-JAK1 agent, obtained refundability from the Italian National Health System in July 2023 for its use in patients with ulcerative colitis (UC) refractory to other therapies, including anti-TNF-α, anti-integrins, and ustekinumab. At present, no Italian data are available about its effectiveness and safety in the real world. Methods: A retrospective assessment of clinical and endoscopic activity was performed according to the Mayo score. The primary endpoints were to evaluate the effectiveness and safety of UPA. Results: We included 202 consecutive UC patients (M/F 119/83, median age 42). The clinical remission and clinical response rates were 45.5% (92/202) and 63.5% (128/202), respectively, at 8 weeks and 60.2% and 81.7%, respectively, at the end of the follow-up. Clinical remission was achieved more frequently when UPA was used as a first-line rather than a second-/third-line treatment (p = 0.609). Mucosal healing was reported in 84.6% of patients at the median follow-up time. Adverse events occurred in six patients (2.5%), whereas four patients (2%) underwent colectomy. Conclusions: This large real-world study shows that UPA is an effective and safe treatment for UC patients.
Source: Journal of Clinical Medicine
DOI: 10.3390/jcm14217801
Authors: Giammarco Mocci, Antonio Tursi, Franco Scaldaferri, Daniele Napolitano, Daniela Pugliese, Giovanni Maconi, Giovanni Cataletti, Roberta Pica, Claudio Cassieri, Edoardo Vincenzo Savarino, Caterina De Barba, Francesco Costa, Linda Ceccarelli, Manuela Marzo, Walter Elisei, Rita Monterubbianesi, Roberto Faggiani, Giovanni Lombardi, Marta Patturelli, Davide Giuseppe Ribaldone, Lorenzo Bertani, Stefano Rodinò, Ladislava Sebkova, Giorgia Bodini, Andrea Pasta, Giuseppe Pranzo, Mariaelena Serio, Antonella Scarcelli, Ileana Luppino, Antonio Ferronato, Rocco Spagnuolo, Francesco Luzza, Antonietta Gerarda Gravina, Raffaele Pellegrino, Giuliana Vespere, Silvia Sedda, Vittorio D’Onofrio, Leonardo De Luca, Leonardo Allegretta, Alessia Immacolata Cazzato, Libera Fanigliuolo, Laurino Grossi, Fabio Cortellini, Giacomo Forti, Paolo Tonti, Viviana Neve, Simona Piergallini, Michela Di Fonzo, Federico Iacopini, Pietro Capone, Federica Gaiani, Stefano Kayali, Caterina Mucherino, Elvira D’Antonio, Laura Montesano, Andrea Cocco, Berardino D’Ascoli, Raffaele Colucci, Francesco Bachetti, Giorgia Orrù, Francesca Maria Onidi, Paolo Usai Satta, Marcello Picchio, Alfredo Papa
Institutions: Azienda Ospedaliera G. Brotzu, Università Cattolica del Sacro Cuore, Ospedale L. Bonomo, Agostino Gemelli University Polyclinic, Istituti di Ricovero e Cura a Carattere Scientifico, Luigi Sacco Hospital, Ospedale Sandro Pertini, University of Padua, Azienda Ospedale - Università Padova, Azienda Ospedaliera Universitaria Pisana, Ospedale Veris Delli Ponti Scorrano, Azienda Ospedaliera San Camillo-Forlanini, Ospedale Antonio Cardarelli, Azienda Ospedaliera Citta' della Salute e della Scienza di Torino, University of Turin, Azienda USL Toscana Nord Ovest, Azienda Ospedaliera Pugliese Ciaccio, Ospedale Policlinico San Martino, University of Genoa, San Salvatore Hospital, Ospedale Annunziata di Cosenza, Magna Graecia University, University of Campania "Luigi Vanvitelli", University of Chieti-Pescara, Ospedale Infermi di Rimini, Ospedale Santa Maria Goretti, Ospedale A. Perrino, University of Parma, Ospedale Madonna Delle Grazie, Ospedale di Spoleto, University of Cagliari, ASL Roma
Language: English
Topic: Inflammatory Bowel Disease
Subfield: Genetics
Domain: Life Sciences
Open Access status: gold
Estimated APC paid: $3,137
OpenAlex ID: W4415823213