Upadacitinib’s Effectiveness and Safety as a Second- or Third-Line Therapy in Patients with Ulcerative Colitis: Data from a Real-World Study
<b>Background:</b> 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. <b>Methods:</b> 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. <b>Results:</b> 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 (<i>p</i> = 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. <b>Conclusions:</b> This large real-world study shows that UPA is an effective and safe treatment for UC patients.
Authors
- Rita Monterubbianesi (ORCID: https://orcid.org/0000-0002-8647-7269)
- Fabio Cortellini
- P. Capone
- Raffaele Pellegrino (ORCID: https://orcid.org/0000-0001-5074-230X)
- Antonietta Gerarda Gravina (ORCID: https://orcid.org/0000-0001-8049-0115)
- Alessia Immacolata Cazzato
- Daniele Napolitano (ORCID: https://orcid.org/0000-0003-2481-5354)
- Roberta Pica (ORCID: https://orcid.org/0000-0002-1097-9430)
- V. D’Onofrio
- Antonio Tursi (ORCID: https://orcid.org/0000-0001-5767-5541)
- Marta Patturelli
- Michela Di Fonzo
- Francesco Bachetti
- A. Scarcelli
- Paolo Tonti
- Libera Fanigliuolo
- Andrea Pasta (ORCID: https://orcid.org/0000-0003-1791-4506)
- Giovanni Maconi (ORCID: https://orcid.org/0000-0003-0810-4026)
- Nataša Šebková (ORCID: https://orcid.org/0000-0002-0839-5620)
- Federica Gaiani (ORCID: https://orcid.org/0000-0001-9615-0086)
- Francesco Costa (ORCID: https://orcid.org/0000-0002-9150-3345)
- Mauro Allegretta (ORCID: https://orcid.org/0000-0002-2924-1639)
- Stefano Rodinò (ORCID: https://orcid.org/0009-0001-0361-6113)
- Caterina Mucherino
- E D'Antonio (ORCID: https://orcid.org/0000-0002-1921-5816)
- Ileana Luppino
- Laura Montesano (ORCID: https://orcid.org/0000-0003-3396-6533)
- Giovanni Cataletti
- Giuseppe Pranzo
- Marcello Picchio (ORCID: https://orcid.org/0000-0001-5070-8240)
- Francesco Luzza (ORCID: https://orcid.org/0000-0001-5120-1046)
- Franco Scaldaferri (ORCID: https://orcid.org/0000-0001-8334-7541)
- Gabriella Serio (ORCID: https://orcid.org/0000-0001-9021-4560)
- Alfredo Papa (ORCID: https://orcid.org/0000-0002-4186-7298)
- Viviana Neve
- Stefano Kayali (ORCID: https://orcid.org/0000-0003-4685-1276)
- Giammarco Mocci (ORCID: https://orcid.org/0000-0002-9263-7409)
- Giorgia Bodini (ORCID: https://orcid.org/0000-0002-8367-0338)
- G Lombardi (ORCID: https://orcid.org/0000-0002-5957-3132)
- Silvia Sedda
- Rocco Spagnuolo (ORCID: https://orcid.org/0000-0002-0871-4644)
- Walter Elisei (ORCID: https://orcid.org/0000-0003-4951-0194)
- Daniela Pugliese (ORCID: https://orcid.org/0000-0001-7930-5402)
- Francesca Maria Onidi
- Edoardo Vincenzo Savarino (ORCID: https://orcid.org/0000-0002-3187-2894)
- C. Cassieri (ORCID: https://orcid.org/0000-0003-1892-1687)
- Giacomo Forti (ORCID: https://orcid.org/0009-0006-4113-3899)
- Simona Piergallini
- Lorenzo Bertani (ORCID: https://orcid.org/0000-0001-8653-1790)
- Roberto Faggiani
- Davide Giuseppe Ribaldone (ORCID: https://orcid.org/0000-0002-9421-3087)
- Antonio Ferronato (ORCID: https://orcid.org/0009-0009-4890-1864)
- Federico Iacopini (ORCID: https://orcid.org/0000-0002-2371-5442)
- Berardino D’Ascoli
- Manuela Marzo (ORCID: https://orcid.org/0000-0001-6337-4411)
- Paolo Usai–Satta (ORCID: https://orcid.org/0000-0003-3344-927X)
- Giuliana Vespere (ORCID: https://orcid.org/0009-0007-1249-0309)
- Andrea Cocco
- Giorgia Orrù
- Raffaele Colucci
- Leonardo De Luca
- Laurino Grossi (ORCID: https://orcid.org/0000-0003-4654-0865)
- Linda Ceccarelli
- Caterina De Barba
Institutions
- Università Cattolica del Sacro Cuore (IT)
- University of Parma (IT)
- University of Padua (IT)
- University of Cagliari (IT)
- University of Campania "Luigi Vanvitelli" (IT)
- Martin University (US)
- Agostino Gemelli University Polyclinic (IT)
- Azienda Ospedaliera Citta' della Salute e della Scienza di Torino (IT)
- Ospedale Antonio Cardarelli (IT)
- Luigi Sacco Hospital (IT)
- ASL Roma (IT)
- Azienda Ospedaliera San Camillo-Forlanini (IT)
- AULSS 2 Marca Trevigiana (IT)
- San Salvatore Hospital (IT)
- Ospedale di Spoleto (IT)
- Ospedale A. Perrino (IT)
- Department of Medical Sciences (RU)
- Ospedale Veris Delli Ponti Scorrano (IT)
- Ospedale Madonna Delle Grazie (IT)
- Azienda Ospedaliera S.Maria (IT)
- Ospedale Infermi di Rimini (IT)
- IRCCS San Camillo Hospital (IT)
- Ospedale Annunziata di Cosenza (IT)
- Ospedale Sandro Pertini (IT)
- Nini Hospital (LB)
- Ospedale L. Bonomo (IT)
- Ospedale Santa Maria Goretti (IT)
- Ospedale Policlinico San Martino (IT)
- Azienda Ospedaliera Pugliese Ciaccio (IT)
- Ospedale D. Cotugno (IT)
- Ospedale SS. Annunziata (IT)
- Carlo Forlanini Hospital (IT)
- Istituti di Ricovero e Cura a Carattere Scientifico (IT)
- Ospedale Eugenio Morelli (IT)
- Azienda Usl Toscana Centro (IT)
- Villa Torri Hospital (IT)
- Azienda Ospedaliera G. Brotzu (IT)
- University of Genoa (IT)
Publication Details
- Journal
- Journal of Clinical Medicine
- Published
- 2025-11-03
- DOI
- https://doi.org/10.3390/jcm14217801
- Primary Topic
- Inflammatory Bowel Disease
- Type
- article
- Field-Weighted Citation Impact
- 0.00