Real-world Effectiveness and Safety of Tofacitinib in Multi-Refractory Ulcerative Colitis: insights from a Belgian Cohort with prior Anti-TNF and Vedolizumab Exposure.
A Cremer, A Mansour, T Lobaton, P Bossuyt, J Rahier, F Baert, O Dewit, E Macken, A Vijverman, P Van Hootegem, F Mana, B Willandt, E Humblet, F D'Heygere, A Verreth, A El Nawar, J Coenegrachts, S Dewit, S De Coninck, N Schoofs, S Delen, J Dutre, C Thienpont, S Vanden Branden, D Staessen, C Croonen, S Vieujean, D Franchimont
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引用次数: 0
Abstract
Background and aims: Tofacitinib has expanded treatment options for moderate-to-severe ulcerative colitis (UC). Longterm real-world data on its efficacy and safety remain limited, particularly in multi-refractory populations. This study evaluated the real-world effectiveness and safety of tofacitinib in Belgian UC patients with prior exposure to anti-TNF and vedolizumab.
Patients and methods: This retrospective multicentric observational study included consecutive adult UC patients from 26 Belgian centers who initiated tofacitinib through an early access program (November 2018-August 2019). Data were prospectively collected. Primary endpoint was clinical remission (partial adapted Mayo score≤1) at the end of follow-up (predefined as week 52). Secondary endpoints included endoscopic outcomes, treatment retention rate, colectomy-free survival, and adverse events (AEs).
Results: Seventy-five patients (59% men, median age 44 years) were included, with a median treatment duration of 45 weeks (IQR:19-51). At baseline, 96% had prior anti-TNF and 97% antiintegrin exposure, while 56% were on concomitant steroids. Clinical remission was achieved by 43% at the end of follow-up. Endoscopic response and remission were observed in 37% and 9% of patients, respectively. Fecal calprotectin <250μg/g at week 16 predicted clinical remission at the end of follow-up (OR:0.03, p=0.01). Overall, 34 patients (45%) discontinued tofacitinib, primarily due to primary non-response (62%). AEs were reported in 33% of patients, with the most common being arthralgia, respiratory tract infections, and herpes zoster. No major cardiovascular events or opportunistic infections occurred.
Conclusion: In a real-world Belgian cohort of multi-refractory UC patients, tofacitinib demonstrated effectiveness in achieving clinical remission by the end of follow-up with no new safety signals identified. These findings support its use in this challenging patient population.
期刊介绍：
The Journal Acta Gastro-Enterologica Belgica principally publishes peer-reviewed original manuscripts, reviews, letters to editors, book reviews and guidelines in the field of clinical Gastroenterology and Hepatology, including digestive oncology, digestive pathology, as well as nutrition. Pure animal or in vitro work will not be considered for publication in the Journal. Translational research papers (including sections of animal or in vitro work) are considered by the Journal if they have a clear relationship to or relevance for clinical hepato-gastroenterology (screening, disease mechanisms and/or new therapies). Case reports and clinical images will be accepted if they represent an important contribution to the description, the pathogenesis or the treatment of a specific gastroenterology or liver problem. The language of the Journal is English. Papers from any country will be considered for publication. Manuscripts submitted to the Journal should not have been published previously (in English or any other language), nor should they be under consideration for publication elsewhere. Unsolicited papers are peer-reviewed before it is decided whether they should be accepted, rejected, or returned for revision. Manuscripts that do not meet the presentation criteria (as indicated below) will be returned to the authors. Papers that go too far beyond the scope of the journal will be also returned to the authors by the editorial board generally within 2 weeks. The Journal reserves the right to edit the language of papers accepted for publication for clarity and correctness, and to make formal changes to ensure compliance with AGEB’s style. Authors have the opportunity to review such changes in the proofs.
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