Filgotinib effectiveness and safety as 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/AIMS: Real-world data on the use of filgotinib (FILGO) in patients with ulcerative colitis (UC) are limited. This study aims to provide consistent results on the effectiveness and safety of FILGO in treating UC. METHODS: A retrospective assessment of clinical and endoscopic activity was conducted in a cohort of patients with UC according to the full Mayo score. The primary co-endpoints of the study were the evaluation of the effectiveness and safety of FILGO. RESULTS: We enrolled 102 patients with a median follow-up of 24 weeks (interquartile range, 8-24 weeks). At 8 weeks and the end of follow-up, clinical remission was achieved by 38 (37.2%) and 47 (46.1%) patients, respectively. Clinical remission was achieved in 13 of 18 patients (72.2%) receiving first-line therapy, 7 of 19 patients (36.8%) receiving second-line therapy, and 27 of 65 patients (41.5%) receiving third-line therapy (P= 0.002). Clinical remission at 8 weeks predicted clinical remission at the end of follow-up (P= 0.021). Age > 40 years (P= 0.046) and being on second- or third-line of treatment (P= 0.005) were negative predictors for clinical remission. Seventy-one patients (69.6%) achieved a clinical response. At endoscopic evaluation, mucosal healing was observed in 18 out of 30 patients (60.0%). Steroid-free remission was present in 38 out of 46 patients (82.6%). Five patients (4.9%) needed colectomy. Adverse events were recorded in 6 patients (5.8%): 2 cases (2%) were severe, requiring discontinuation of FILGO. CONCLUSIONS: Our real-world data confirms that FILGO is safe and effective for patients with UC. Its efficacy is significantly improved when used as a first-line treatment.
Source: Intestinal Research
Authors: Antonio Tursi, Giammarco Mocci, Francesco Costa, Linda Ceccarelli, Edoardo Savarino, Caterina De Barba, Caterina Mucherino, Elvira D’Antonio, Laura Montesano, Manuela Marzo, Franco Scaldaferri, Daniele Napolitano, Daniela Pugliese, Antonietta Gerarda Gravina, Raffaele Pellegrino, Rocco Spagnuolo, Francesco Luzza, Antonio Cuomo, Laura Donnarumma, Giovanni Maconi, Giovanni Cataletti, Lorenzo Bertani, Giorgia Bodini, Andrea Pasta, Simona Piergallini, Mariaelena Serio, Antonella Scarcelli, Pietro Capone, Fabio Cortellini, Stefano Rodino, Ladislava Sebkova, Giuliana Vespere, Silvia Sedda, Vittorio D’Onofrio, Leonardo De Luca, Federica Gaiani, Stefano Kayali, Cristiano Pagnini, Maria Giovanna Graziani, Maria Carla Di Paolo, Leonardo Allegretta, Alessia Immacolata Cazzato, Stefano Scorza, Antonio Ferronato, Davide Giuseppe Ribaldone, Giovanni Aragona, Patrizia Perazzo, Giacomo Forti, Michela Di Fonzo, Federico Iacopini, Roberta Pica, Claudio Cassieri, Francesca Maria Onidi, Paolo Usai Satta, Walter Elisei, Marcello Picchio, Alfredo Papa
Institutions: Università Cattolica del Sacro Cuore, Ospedale L. Bonomo, Azienda Ospedaliera G. Brotzu, University of Pisa, Azienda Ospedaliera Universitaria Pisana, University of Padua, Azienda Ospedale - Università Padova, Ospedale Veris Delli Ponti Scorrano, Agostino Gemelli University Polyclinic, Istituti di Ricovero e Cura a Carattere Scientifico, University of Campania "Luigi Vanvitelli", Magna Graecia University, Luigi Sacco Hospital, Azienda USL Toscana Nord Ovest, Ospedale Policlinico San Martino, University of Genoa, San Salvatore Hospital, Ospedale Infermi di Rimini, Azienda Ospedaliera Pugliese Ciaccio, University of Parma, Azienda Ospedaliera San Giovanni Addolorata, Azienda Ospedaliera Citta' della Salute e della Scienza di Torino, University of Turin, Guglielmo da Saliceto Hospital, Ospedale Santa Maria Goretti, Ospedale Sandro Pertini, Azienda Ospedaliera San Camillo-Forlanini, ASL Roma
Language: English
Topic: Inflammatory Bowel Disease
Subfield: Genetics
Domain: Life Sciences
Open Access status: diamond
OpenAlex ID: W4414616250