Tofacitinib in Ulcerative Colitis: Real-world Evidence From the ENEIDA Registry. (24th September 2020)

• Record Type: Journal Article
• Authors: Chaparro, María; Garre, Ana; Mesonero, Francisco; Rodríguez, Cristina; Barreiro-de Acosta, Manuel; Martínez-Cadilla, Jesús; Arroyo, María T; Manceñido, Noemí; Sierra-Ausín, Mónica; Vera-Mendoza, Isabel; Casanova, María José; Nos, Pilar; González-Muñoza, Carlos; Martínez, Teresa; Boscá-Watts, Maia; Calafat, Margalida; Busquets, David; Girona, Eva; Llaó, Jordina; Martín-Arranz, María Dolores; Piqueras, Marta; Ramos, Laura; Surís, Gerard; Bermejo, Fernando; Carbajo, Ana Y; Casas-Deza, Diego; Fernández-Clotet, Agnes; García, María J; Ginard, Daniel; Gutiérrez-Casbas, Ana; Hernández, Luis; Lucendo, Alfredo J; Márquez, Lucía; Merino-Ochoa, Olga; Rancel, Francisco J; Taxonera, Carlos; López Sanromán, Antonio; Rubio, Saioa; Domènech, Eugeni; Gisbert, Javier P;
• Is Part Of: Journal of Crohn's and colitis. Volume 15:Number 1(2021)
• Page Start: 35
• Page End: 42
• Publication Date: 2020-09-24
• Subjects: Ttofacitinib -- ulcerative colitis; Inflammatory bowel diseases -- Periodicals; 616.344005
• DOI: 10.1093/ecco-jcc/jjaa145
• Languages: English
• ISSNs: 1873-9946

Abstract

Abstract: 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.