Chaparro M, Acosta D, Rodríguez C, Mesonero F, Vicuña M, Barreiro-de Acosta M, Fernández-Clotet A, Hernández Martínez Á, Arroyo M, Vera I, Ruiz-Cerulla A, Sicilia B, Cabello Tapia MJ, Muñoz Villafranca C, Castro-Poceiro J, Martínez Cadilla J, Sierra-Ausín M, Vázquez Morón JM, Vicente Lidón R, Bermejo F, Royo V, Calafat M, González-Muñoza C, Leo Carnerero E, Manceñido Marcos N, Torrealba L, Alonso-Galán H, Benítez JM, Ber Nieto Y, Diz-Lois Palomares MT, García MJ, Muñoz JF, Armesto González EM, Calvet X, Hernández-Camba A, Madrigal Domínguez RE, Menchén L, Pérez Calle JL, Piqueras M, Dueñas Sadornil C, Botella B, Martínez-Pérez TJ, Ramos L, Rodríguez-Grau MC, San Miguel E, Fernández Forcelledo JL, Fradejas Salazar PM, García-Sepulcre M, Gutiérrez A, Llaó J, Sesé Abizanda E, Boscá-Watts M, Iyo E, Keco-Huerga A, Martínez Bonil C, Peña González E, Pérez-Galindo P, Varela P, and Gisbert JP
Introduction: The objective of this study was to assess the durability, short-term and long-term effectiveness, and safety of tofacitinib in ulcerative colitis (UC) in clinical practice., Methods: This is a retrospective multicenter study including patients with UC who had received the first tofacitinib dose at least 8 weeks before the inclusion. Clinical effectiveness was based on partial Mayo score., Results: A total of 408 patients were included. Of them, 184 (45%) withdrew tofacitinib during follow-up (mean = 18 months). The probability of maintaining tofacitinib was 67% at 6 m, 58% at 12 m, and 49% at 24 m. The main reason for tofacitinib withdrawal was primary nonresponse (44%). Older age at the start of tofacitinib and a higher severity of clinical activity were associated with tofacitinib withdrawal. The proportion of patients in remission was 38% at week 4, 45% at week 8, and 47% at week 16. Having moderate-to-severe vs mild disease activity at baseline and older age at tofacitinib start were associated with a lower and higher likelihood of remission at week 8, respectively. Of 171 patients in remission at week 8, 83 (49%) relapsed. The probability of maintaining response was 66% at 6 m and 54% at 12 m. There were 93 adverse events related to tofacitinib treatment (including 2 pulmonary thromboembolisms [in patients with risk factors] and 2 peripheral vascular thrombosis), and 29 led to tofacitinib discontinuation., Discussion: Tofacitinib is effective in both short-term and long-term in patients with UC. The safety profile is similar to that previously reported., (Copyright © 2023 by The American College of Gastroenterology.)