Year 2022 / Volume 114 / Number 9
Original
Efficacy and safety of tofacitinib in the treatment of ulcerative colitis: real-life experience in Andalusia

516-521

DOI: 10.17235/reed.2022.8380/2021

Alvaro Hernández Martínez, Pilar Navajas Hernández, María del Mar Martín Rodríguez, Marta Lázaro Sáez, Raúl Olmedo Martín, Andrea Núñez Ortiz, Federico Argüelles Arias, María Carmen Fernández Cano, Francisco Gallardo Sánchez, Sandra Marín Pedrosa, Javier González García, Juan María Vázquez Morón,

Abstract
Background: tofacitinib is a Janus kinase inhibitor approved for the treatment of moderate-severe ulcerative colitis (UC). This study aimed to evaluate its efficacy in a real-life setting. Methods: a retrospective and multicenter observational study was performed with UC patients treated with tofacitinib. Short and long-term treatment effectiveness, treatment survival, need for dose escalation and safety were analyzed. Clinical response and remission were defined in accordance with the partial Mayo score. Results: seventy-four patients were included, 98.3 % had received prior biological treatment, 55.4 % with three or more biologicals and up to 64.9% with two or three different mechanisms of action. Clinical remission and response rates were 37.8 % and 77 % at eight weeks, and 41.8 % and 70.1 % at 16 weeks. With regard to non-responders at eight weeks, 37.5 % achieved a delayed clinical response at 16 weeks. Mean treatment duration was 19 months (95 % CI: 16-22), with a treatment survival of 56 % at 28 months, and remission and response rates at 24 months of 53.8 % and 61.5 %. Twenty-three treatments were withdrawn, most of them (18) during the induction period. There were adverse events in a quarter of the patients; only four were severe and led to treatment discontinuation. Conclusion: tofacitinib has a demonstrated efficacy in clinical practice to induce and maintain clinical response in treatment-refractory UC patients, with an acceptable safety profile.
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Hernández Martínez A, Navajas Hernández P, Martín Rodríguez M, Lázaro Sáez M, Olmedo Martín R, Núñez Ortiz A, et all. Efficacy and safety of tofacitinib in the treatment of ulcerative colitis: real-life experience in Andalusia. 8380/2021


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Publication history

Received: 09/10/2021

Accepted: 09/12/2021

Online First: 10/01/2022

Published: 07/09/2022

Article revision time: 52 days

Article Online First time: 93 days

Article editing time: 333 days


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