• J Crohns Colitis · Jan 2021

    Tofacitinib in Ulcerative Colitis: Real-world Evidence From the ENEIDA Registry.

    • María Chaparro, Ana Garre, Francisco Mesonero, Cristina Rodríguez, Manuel Barreiro-de Acosta, Jesús Martínez-Cadilla, María T Arroyo, Noemí Manceñido, Mónica Sierra-Ausín, Isabel Vera-Mendoza, María José Casanova, Pilar Nos, Carlos González-Muñoza, Teresa Martínez, Maia Boscá-Watts, Margalida Calafat, David Busquets, Eva Girona, Jordina Llaó, María Dolores Martín-Arranz, Marta Piqueras, Laura Ramos, Gerard Surís, Fernando Bermejo, Ana Y Carbajo, Diego Casas-Deza, Agnes Fernández-Clotet, María J García, Daniel Ginard, Ana Gutiérrez-Casbas, Luis Hernández, Alfredo J Lucendo, Lucía Márquez, Olga Merino-Ochoa, Francisco J Rancel, Carlos Taxonera, Antonio López Sanromán, Saioa Rubio, Eugeni Domènech, and Javier P Gisbert.
    • Gastroenterology Department, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (IIS-IP), Universidad Autónoma de Madrid, and Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain.
    • J Crohns Colitis. 2021 Jan 13; 15 (1): 35-42.

    AimTo evaluate the effectiveness and safety of tofacitinib in ulcerative colitis [UC] in real life.MethodsPatients from the prospectively maintained ENEIDA registry and treated with tofacitinib due to active UC were included. Clinical activity and effectiveness were defined based on Partial Mayo Score [PMS]. Short-term response/remission was assessed at Weeks 4, 8, and 16.ResultsA total of 113 patients were included. They were exposed to tofacitinib for a median time of 44 weeks. Response and remission at Week 8 were 60% and 31%, respectively. In multivariate analysis, higher PMS at Week 4 (odds ratio [OR] = 0].2; 95% confidence interval [CI] = 0].1-0.4) was the only variable associated with lower likelihood of achieving remission at Week 8. Higher PMS at Week 4 [OR = 0.5; 95% CI = 0.3-0.7] and higher PMS at Week 8 [OR = 0.2; 95% CI = 0.1-0.5] were associated with lower probability of achieving remission at Week 16. A total of 45 patients [40%] discontinued tofacitinib over time. Higher PMS at Week 8 was the only factor associated with higher tofacitinib discontinuation [hazard ratio = 1.5; 95% CI = 1.3-1.6]. A total of 34 patients had remission at Week 8; of these, 65% had relapsed 52 weeks after achieving remission; the dose was increased to 10 mg/12 h in nine patients, and five of them reached remission again. Seventeen patients had adverse events.ConclusionsTofacitinib is effective and safe in UC patients in real practice, even in a highly refractory cohort. A relevant proportion of patients discontinue the drug over time, mainly due to primary failure.© The Author(s) 2020. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: journals.permissions@oup.com.

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