Effect of Tofacitinib on One-Year Colectomy Risk in Anti-TNF Refractory Ulcerative Colitis: A Prospective Multicenter Italian Study.

Autor: Carvalhas Gabrielli AM; Gastroenterology Unit, ASST Fatebenefratelli-Sacco, L. Sacco Hospital, Via Giovanni Battista Grassi, 74, 20157, Milan, MI, Italy. amcgabrielli@gmail.com., Ferretti F; Gastroenterology Unit, ASST Fatebenefratelli-Sacco, L. Sacco Hospital, Via Giovanni Battista Grassi, 74, 20157, Milan, MI, Italy., Monico CM; Gastroenterology Unit, ASST Fatebenefratelli-Sacco, L. Sacco Hospital, Via Giovanni Battista Grassi, 74, 20157, Milan, MI, Italy., Tombetti E; Internal Medicine and Rheumatology Unit, ASST Fatebenefratelli-Sacco, Milan, Italy.; Department of Biomedical and Clinical Sciences, University of Milan, Milan, Italy., Maconi G; Gastroenterology Unit, ASST Fatebenefratelli-Sacco, L. Sacco Hospital, Via Giovanni Battista Grassi, 74, 20157, Milan, MI, Italy.; Department of Biomedical and Clinical Sciences, University of Milan, Milan, Italy., Romeo S; Gastroenterology and Digestive Endoscopy Dept, ASST Ospedale Maggiore Di Crema, Crema, Italy., Piazza O Sed N; Gastroenterology and Endoscopy Unit, Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico Di Milano, Milan, Italy., Caprioli F; Gastroenterology and Endoscopy Unit, Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico Di Milano, Milan, Italy.; Department of Pathophysiology and Transplantation, University of Milan, Milan, Italy., Mazzola AM; Department of Clinical and Sperimental Sciences, University of Brescia, Brescia, Italy., Alicante S; Gastroenterology and Digestive Endoscopy Dept, ASST Ospedale Maggiore Di Crema, Crema, Italy., Bertè R; Gastroenterology and Digestive Endoscopy Dept, ASST Ospedale Maggiore Di Crema, Crema, Italy., Lolli E; Gastroenterology Department, Policlinico Tor Vergata, Rome, Italy., Scribano ML; Villa Stuart Multi-Speciality Clinic, Rome, Italy., Buscarini E; Gastroenterology and Digestive Endoscopy Dept, ASST Ospedale Maggiore Di Crema, Crema, Italy., Ricci C; Department of Clinical and Sperimental Sciences, University of Brescia, Brescia, Italy.; Gastroenterology Unit, Spedali Civili Di Brescia, Brescia, Italy., Carmagnola S; Gastroenterology Unit, ASST Fatebenefratelli-Sacco, L. Sacco Hospital, Via Giovanni Battista Grassi, 74, 20157, Milan, MI, Italy., Ardizzone S; Gastroenterology Unit, ASST Fatebenefratelli-Sacco, L. Sacco Hospital, Via Giovanni Battista Grassi, 74, 20157, Milan, MI, Italy., Cannatelli R; Gastroenterology Unit, ASST Fatebenefratelli-Sacco, L. Sacco Hospital, Via Giovanni Battista Grassi, 74, 20157, Milan, MI, Italy.
Jazyk: angličtina
Zdroj: Digestive diseases and sciences [Dig Dis Sci] 2024 May; Vol. 69 (5), pp. 1785-1792. Date of Electronic Publication: 2024 Mar 26.
DOI: 10.1007/s10620-024-08394-w
Abstrakt: Background: Tofacitinib is an oral Janus kinase inhibitor recently approved to induce and maintain remission in ulcerative colitis (UC).
Aims: Considering the number of anti-TNF non-responders, this study aims to assess the effectiveness and safety of tofacitinib in a cohort of multi-failure patients with moderate-to-severe UC at 52 weeks.
Methods: From January 2021 to March 2023, we performed a prospective multicenter study observing adult patients with moderate-to-severe UC starting tofacitinib after an anti-TNF failure for a 52-week-long period. Effectiveness and safety were assessed in terms of colectomy rate, clinical remission and response, endoscopic remission, steroid-free clinical remission, and rate of adverse events.
Results: We included 58 patients with UC with an age of 42 ± 14.4 years, 59% males, 96.6% left-sided or pancolitis, who were failure to a single (65.5%) or more than one anti-TNF (34.5%). Only 6 (10.3%) patients underwent colectomy. Colectomy was clinically associated with the necessity and the number of extra cycles of tofacitinib 10 mg bid at W8 (p = 0.023) and W24 (p = 0.004), and with a higher partial Mayo score at W8 (p = 0.025). At W52, clinical remission, clinical response, and steroid-free clinical remission were 53.4%, 43.1%, and 48.3%, respectively. Of 22 performed colonoscopies at W52, 11 (50%) showed endoscopic remission. Adverse events occurred in 14 (24.1%) patients, but only 2 (3.4%) led to tofacitinib discontinuation.
Conclusions: In a real-life setting of patients with anti-TNF refractory UC, tofacitinib has proved to be effective in preventing colectomy and inducing clinical and endoscopic remission at 52 weeks with a good safety profile.
(© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
Databáze: MEDLINE
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