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  • Title: Tofacitinib in Ulcerative Colitis: Real-world Evidence From the ENEIDA Registry.
    Author: Chaparro M, Garre A, Mesonero F, Rodríguez C, Barreiro-de Acosta M, Martínez-Cadilla J, Arroyo MT, Manceñido N, Sierra-Ausín M, Vera-Mendoza I, Casanova MJ, Nos P, González-Muñoza C, Martínez T, Boscá-Watts M, Calafat M, Busquets D, Girona E, Llaó J, Martín-Arranz MD, Piqueras M, Ramos L, Surís G, Bermejo F, Carbajo AY, Casas-Deza D, Fernández-Clotet A, García MJ, Ginard D, Gutiérrez-Casbas A, Hernández L, Lucendo AJ, Márquez L, Merino-Ochoa O, Rancel FJ, Taxonera C, López Sanromán A, Rubio S, Domènech E, Gisbert JP.
    Journal: J Crohns Colitis; 2021 Jan 13; 15(1):35-42. PubMed ID: 32969471.
    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.
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