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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Authors: Chaparro, Maria, Garre, Ana, Mesonero, Francisco, Rodriguez, Cristina, Barreiro-de Acosta, Manuel, Martinez-Cadilla, Jesus, Arroyo, Maria T, Mancenido, Noemi, Sierra-Ausin, Monica, Vera-Mendoza, Isabel, Casanova, Maria Jose, Nos, Pilar, Gonzalez-Munoza, Carlos, Martinez, Teresa, Bosca-Watts, Maia, Calafat, Margalida, Busquets, David, Girona, Eva, Llao, Jordina, Martin-Arranz, Maria Dolores, Piqueras, Marta, Ramos, Laura, Suris, Gerard, Bermejo, Fernando, Carbajo, Ana Y, Casas-Deza, Diego, Fernandez-Clotet, Agnes, Garcia, Maria J, Ginard, Daniel, Gutierrez-Casbas, Ana, Hernandez, Luis, Lucendo, Alfredo J, Marquez, Lucia, Merino-Ochoa, Olga, Rancel, Francisco J, Taxonera, Carlos, Lopez Sanroman, Antonio, Rubio, Saioa, Domenech, Eugeni, Gisbert, Javier P
Format: article
Status:Published version
Publication Date:2021
Country:España
Institution:INCLIVA
Repository:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
OAI Identifier:oai:incliva.fundanetsuite.com:p15333
Online Access:https://incliva.portalinvestigacion.com/publicaciones/15333
Access Level:Open access
Keyword:Ttofacitinib
ulcerative colitis
Description
Summary: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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