Comparative Effectiveness and Safety of Tofacitinib, Filgotinib, and Upadacitinib in Ulcerative Colitis: A Multicenter Real-World Cohort Study.
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Tursi Antonio, Pasta Andrea, Elisei Walter, Barberio Brigida, Mocci Giammarco, Savarino Edoardo V, de Barba Caterina, Maconi Giovanni, Cataletti Giovanni, Scaldaferri Franco, Napolitano Daniele, Costa Francesco, Ceccarelli Linda, Marzo Manuela, Monterubbianesi Rita, di Fonzo Michela, Lombardi Giovanni, Patturelli Marta, Ribaldone Davide Giuseppe, Bertani Lorenzo, Rodino' Stefano, Sebkova Ladislava, Bodini Giorgia, Pranzo Giuseppe, Serio Mariaelena, Scarcelli Antonella, Luppino Ileana, Ferronato Antonio, Spagnuolo Rocco, Luzza Francesco, Morano Domenico, Gravina Antonietta Gerarda, Pellegrino Raffaele, Vespere Giuliana, Sedda Silvia, Allegretta Leonardo, Fanigliulo Libera, Grossi Laurino, Cortellini Fabio, Forti Giacomo, Neve Viviana, Piergallini Simona, Scarozza Patrizio, Bevevino Girolamo, Iacopini Federico, Capone Pietro, Gaiani Federica, Kayali Stefano, Mucherino Caterina, D'antonio Elvira, D'ascoli Berardino, Colucci Raffaele, Bachetti Francesco, Giorgetti Gian Marco, Clemente Valeria, Pagnini Cristiano, Cuomo Antonio, Donnarumma Laura, Onidi Francesca Maria, Satta Paolo Usai, Picchio Marcello, Papa Alfredo, Italian Network for Inflammatory Bowel Diseases (IN-IBD)
Аннотация
METHODS: We conducted a multicenter retrospective study including adult UC patients initiating tofacitinib, filgotinib, or upadacitinib (September 2020-June 2025). Clinical remission (partial Mayo score ≤ 1), steroid-free clinical remission, biochemical remission, and endoscopic remission (Mayo endoscopic score = 0) were assessed at predefined time-points. Baseline differences were controlled using inverse probability of treatment weighting (IPTW), and time-to-event and longitudinal analyses were performed.
RESULTS: After IPTW, the pseudo-population included 627 patients (tofacitinib = 179, filgotinib = 138, upadacitinib = 310). In the weighted cohort, clinical remission probabilities at weeks 8, 24, and 52 were 17.5%, 40.7%, and 61.3% with upadacitinib, 11.8%, 33.8%, and 54.6% with tofacitinib, and 6.7%, 29.0%, and 52.0% with filgotinib, respectively; p < 0.001 at weeks 8 and 24; p = 0.040 at week 52. Steroid-free clinical remission showed a similar gradient (14.2%, 39.2%, and 59.8% with upadacitinib; 9.2%, 31.2%, and 50.8% with tofacitinib; 4.4%, 27.6%, and 49.8% with filgotinib, respectively; all p < 0.001. Biochemical remission was also achieved more frequently with upadacitinib at weeks 8 and 16, although differences between treatments were no longer significant during maintenance. At week 52, endoscopic remission was 18.8% with tofacitinib, 36.6% with upadacitinib, and 19.5% with filgotinib (p = 0.039). Overall adverse events, particularly infections and herpes zoster, were more frequent with tofacitinib, whereas filgotinib had fewer non-serious events; serious adverse events and colectomy risk were uncommon and similar across groups.
CONCLUSIONS: All three JAKis were effective, but upadacitinib yielded the highest remission rates, while tofacitinib and filgotinib differed mainly in safety, supporting individualized drug positioning according to efficacy needs and patient-specific risks.