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

2020; Oxford University Press; Volume: 15; Issue: 1 Linguagem: Inglês

10.1093/ecco-jcc/jjaa145

1876-4479

María Chaparro, A Garre, Francisco Mesonero, Cristina Rodríguez, Manuel Barreiro‐de Acosta, J Martínez-Cadilla, M Arroyo, Noemí Manceñido, Mónica Sierra‐Ausín, Isabel Vera-Mendoza, María José Casanova, Pilar Nos, Carlos González‐Muñoza, Teresa Martínez, Marta Maia Boscá-Watts, Margalida Calafat, David Busquets, Eva Girona, Jordina Llaó, María Dolores Martín‐Arranz, Marta Piqueras, Laura Ramos, Gerard Surís, Fernando Bermejo, Ana Yaiza Carbajo, Diego Casas Deza, A Fernández-Clotet, María José García, Daniel Ginard, Ana Gutiérrez, Luis Hernández, Alfredo J. Lucendo, Lucía Márquez, Olga Merino-Ochoa, Francisco Rancel, Carlos Taxonera, Antonio López Sanromán, S Rubio, Eugeni Domènech, Javier P. Gisbert,

Diagnosis and treatment of tuberculosis

To evaluate the effectiveness and safety of tofacitinib in ulcerative colitis [UC] in real life.Patients 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.A 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.Tofacitinib 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.