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Introduction <p>Tofacitinib, filgotinib, and upadacitinib are Janus kinase inhibitors (JAKis) available for ulcerative colitis (UC) refractory or intolerant to at least one advanced therapy; their comparative effectiveness in clinical practice remains uncertain.</p> Methods <p>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.</p> Results <p>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; <i>p</i> &lt; 0.001 at weeks 8 and 24; <i>p</i> = 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 <i>p</i> &lt; 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 (<i>p</i> = 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.</p> Conclusions <p>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.</p>

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Comparative Effectiveness and Safety of Tofacitinib, Filgotinib, and Upadacitinib in Ulcerative Colitis: A Multicenter Real-World Cohort Study

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  • 发表日期：

    2026年5月9日

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  • Antonio Tursi,
  • Andrea Pasta,
  • Walter Elisei,
  • Brigida Barberio,
  • Giammarco Mocci,
  • Edoardo V. Savarino,
  • Caterina de Barba,
  • Giovanni Maconi,
  • Giovanni Cataletti,
  • Franco Scaldaferri,
  • Daniele Napolitano,
  • Francesco Costa,
  • Linda Ceccarelli,
  • Manuela Marzo,
  • Rita Monterubbianesi,
  • Michela di Fonzo,
  • Giovanni Lombardi,
  • Marta Patturelli,
  • Davide Giuseppe Ribaldone,
  • Lorenzo Bertani,
  • Stefano Rodino’,
  • Ladislava Sebkova,
  • Giorgia Bodini,
  • Giuseppe Pranzo,
  • Mariaelena Serio,
  • Antonella Scarcelli,
  • Ileana Luppino,
  • Antonio Ferronato,
  • Rocco Spagnuolo,
  • Francesco Luzza,
  • Domenico Morano,
  • Antonietta Gerarda Gravina,
  • Raffaele Pellegrino,
  • Giuliana Vespere,
  • Silvia Sedda,
  • Leonardo Allegretta,
  • Libera Fanigliulo,
  • Laurino Grossi,
  • Fabio Cortellini,
  • Giacomo Forti,
  • Viviana Neve,
  • Simona Piergallini,
  • Patrizio Scarozza,
  • Girolamo Bevevino,
  • Federico Iacopini,
  • Pietro Capone,
  • Federica Gaiani,
  • Stefano Kayali,
  • Caterina Mucherino,
  • Elvira D’antonio,
  • Berardino D’ascoli,
  • Raffaele Colucci,
  • Francesco Bachetti,
  • Gian Marco Giorgetti,
  • Valeria Clemente,
  • Cristiano Pagnini,
  • Antonio Cuomo,
  • Laura Donnarumma,
  • Francesca Maria Onidi,
  • Paolo Usai Satta,
  • Marcello Picchio,
  • Alfredo Papa,
  • Greta Lorenzon,
  • Fabiana Zingone,
  • Davide Checchin,
  • Carla Felice,
  • Gabrio Bassotti,
  • Elisabetta Antonelli,
  • Costantino Zampaletta,
  • Giulia Rocco,
  • Carlotta Sacchi,
  • Maria Giovanna Graziani,
  • Maria Carla Di Paolo,
  • Roberta Pica,
  • Maddalena Zippi,
  • Andrea Cocco,
  • Claudio Cassieri,
  • Roberto Lorenzetti,
  • Giulia Zerboni,
  • Serafina Fiorella,
  • Vittorio D’Onofrio,
  • Laura Montesano,
  • Guido Daniele Villani,
  • Nicola Della Valle,
  • Paolo Tonti,
  • Alessia Immacolata Cazzato,
  • Stefano Scorza,
  • Giuseppina Grasso,
  • Domenico Catarella,
  • Dario D’Agostino,
  • Elisabetta Di Bartolo

摘要

Introduction

Tofacitinib, filgotinib, and upadacitinib are Janus kinase inhibitors (JAKis) available for ulcerative colitis (UC) refractory or intolerant to at least one advanced therapy; their comparative effectiveness in clinical practice remains uncertain.

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.