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Tofacitinib in Ulcerative Colitis: Real-world Evidence From the ENEIDA Registry.
- Source :
-
Journal of Crohn's & colitis [J Crohns Colitis] 2021 Jan 13; Vol. 15 (1), pp. 35-42. - Publication Year :
- 2021
-
Abstract
- Aim: To evaluate the effectiveness and safety of tofacitinib in ulcerative colitis [UC] in real life.<br />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.<br />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.<br />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.<br /> (© The Author(s) 2020. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
- Subjects :
- Dose-Response Relationship, Drug
Drug Monitoring methods
Female
Humans
Male
Middle Aged
Patient Acuity
Protein Kinase Inhibitors administration & dosage
Protein Kinase Inhibitors adverse effects
Recurrence
Registries statistics & numerical data
Spain epidemiology
Treatment Outcome
Colitis, Ulcerative diagnosis
Colitis, Ulcerative drug therapy
Colitis, Ulcerative epidemiology
Piperidines administration & dosage
Piperidines adverse effects
Pyrimidines administration & dosage
Pyrimidines adverse effects
Remission Induction methods
Subjects
Details
- Language :
- English
- ISSN :
- 1876-4479
- Volume :
- 15
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Journal of Crohn's & colitis
- Publication Type :
- Academic Journal
- Accession number :
- 32969471
- Full Text :
- https://doi.org/10.1093/ecco-jcc/jjaa145