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

Aim: To evaluate the effectiveness and safety of tofacitinib in ulcerative colitis [UC] in real life. Methods: 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 May...

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Detalhes bibliográficos
Autores: Chaparro, M, Garre, A, Mesonero, F, Rodriguez, C, Barreiro-de Acosta, M, Martinez-Cadilla, J, Arroyo, MT, Mancenido, N, Sierra-Ausin, M, Vera-Mendoza, I, Casanova, MJ, Nos, P, Gonzalez-Munoza, C, Martinez, T, Bosca-Watts, M, Calafat, M, Busquets, D, Girona, E, Llao, J, Martin-Arranz, MD, Piqueras, M, Ramos, L, Suris, G, Bermejo, F, Carbajo, AY, Casas-Deza, D, Fernandez-Clotet, A, Garcia, MJ, Ginard, D, Gutierrez-Casbas, A, Hernandez, L, Lucendo, AJ, Marquez, L, Merino-Ochoa, O, Rancel, FJ, Taxonera, C, Sanroman, AL, Rubio, S, Domenech, E, Gisbert, JP
Tipo de documento: artigo
Estado:Versão publicada
Data de publicação:2021
País:España
Recursos:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
Repositório:r-FISABIO. Repositorio Institucional de Producción Científica
OAI Identifier:oai:fisabio.fundanetsuite.com:p11800
Acesso em linha:https://fisabio.portalinvestigacion.com/publicaciones/11800
Access Level:Acceso aberto
Palavra-chave:Ttofacitinib
ulcerative colitis
Descrição
Resumo:Aim: To evaluate the effectiveness and safety of tofacitinib in ulcerative colitis [UC] in real life. Methods: 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. Results: 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. Conclusions: 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.

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