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ECB-ART-54491
J Clin Med 2025 Nov 03;1421:. doi: 10.3390/jcm14217801.
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Upadacitinib's Effectiveness and Safety as a Second- or Third-Line Therapy in Patients with Ulcerative Colitis: Data from a Real-World Study.

Mocci G , Tursi A , Scaldaferri F , Napolitano D , Pugliese D , Maconi G , Cataletti G , Pica R , Cassieri C , Savarino EV , De Barba C , Costa F , Ceccarelli L , Marzo M , Elisei W , Monterubbianesi R , Faggiani R , Lombardi G , Patturelli M , Ribaldone DG , Bertani L , Rodinò S , Sebkova L , Bodini G , Pasta A , Pranzo G , Serio M , Scarcelli A , Luppino I , Ferronato A , Spagnuolo R , Luzza F , Gravina AG , Pellegrino R , Vespere G , Sedda S , D'Onofrio V , De Luca L , Allegretta L , Cazzato AI , Fanigliuolo L , Grossi L , Cortellini F , Forti G , Tonti P , Neve V , Piergallini S , Di Fonzo M , Iacopini F , Capone P , Gaiani F , Kayali S , Mucherino C , D'Antonio E , Montesano L , Cocco A , D'Ascoli B , Colucci R , Bachetti F , Orrù G , Onidi FM , Usai Satta P , Picchio M , Papa A .


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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.

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???displayArticle.link??? J Clin Med