Real-world evidence of tofacitinib effectiveness and safety in patients with refractory ulcerative colitis.
Adult
Antibodies, Monoclonal, Humanized
/ therapeutic use
Colectomy
/ statistics & numerical data
Colitis, Ulcerative
/ drug therapy
Female
France
Humans
Janus Kinase Inhibitors
/ adverse effects
Kaplan-Meier Estimate
Male
Medication Adherence
/ statistics & numerical data
Middle Aged
Piperidines
/ adverse effects
Pyrimidines
/ adverse effects
Remission Induction
Retrospective Studies
Tumor Necrosis Factor Inhibitors
/ therapeutic use
Janus kinase inhibitor
Refractory ulcerative colitis
Journal
Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver
ISSN: 1878-3562
Titre abrégé: Dig Liver Dis
Pays: Netherlands
ID NLM: 100958385
Informations de publication
Date de publication:
03 2020
03 2020
Historique:
received:
07
08
2019
revised:
07
10
2019
accepted:
08
10
2019
pubmed:
17
11
2019
medline:
21
1
2021
entrez:
17
11
2019
Statut:
ppublish
Résumé
Phase III trials demonstrated effectiveness of tofacitinib, an oral Janus kinase inhibitor, to induce and maintain remission in patients with moderate-to-severe active ulcerative colitis (UC). We report the real-world effectiveness and safety of tofacitinib in patients with UC in France. From February 2017 to December 2018, we performed a national French cohort study, which included all consecutive patients with an active UC refractory to anti-TNF and vedolizumab, who received tofacitinib. Outcomes were survival without colectomy, survival without tofacitinib discontinuation and steroid-free clinical remission at weeks 14, 24 and 48. Thirty-eight patients were included, with a median follow-up of 41.5 (18.5-56.8) weeks. Survival without colectomy was 77% [95% confidence interval (95%CI): 59.3-87.9] at week 24 and 70% (95%CI: 50.9-82.8) at week 48. Survival without treatment discontinuation was 70% (95%CI: 52.6-82.3) at week 24. Steroid-free clinical remission was observed in 13 (34%) patients at week 48. Adverse events occurred in 14 (37%) patients, including 6 severe adverse events and three herpes zoster infections. In a highly refractory UC population, one third of patients treated with tofacitinib achieved steroid-free clinical remission at week 14 and 70% of patients avoided colectomy at one year, with an acceptable safety profile. These data confirm tofacitinib effectiveness in UC, especially after multiple biologic failures.
Sections du résumé
BACKGROUND
Phase III trials demonstrated effectiveness of tofacitinib, an oral Janus kinase inhibitor, to induce and maintain remission in patients with moderate-to-severe active ulcerative colitis (UC).
AIMS
We report the real-world effectiveness and safety of tofacitinib in patients with UC in France.
METHODS
From February 2017 to December 2018, we performed a national French cohort study, which included all consecutive patients with an active UC refractory to anti-TNF and vedolizumab, who received tofacitinib. Outcomes were survival without colectomy, survival without tofacitinib discontinuation and steroid-free clinical remission at weeks 14, 24 and 48.
RESULTS
Thirty-eight patients were included, with a median follow-up of 41.5 (18.5-56.8) weeks. Survival without colectomy was 77% [95% confidence interval (95%CI): 59.3-87.9] at week 24 and 70% (95%CI: 50.9-82.8) at week 48. Survival without treatment discontinuation was 70% (95%CI: 52.6-82.3) at week 24. Steroid-free clinical remission was observed in 13 (34%) patients at week 48. Adverse events occurred in 14 (37%) patients, including 6 severe adverse events and three herpes zoster infections.
CONCLUSION
In a highly refractory UC population, one third of patients treated with tofacitinib achieved steroid-free clinical remission at week 14 and 70% of patients avoided colectomy at one year, with an acceptable safety profile. These data confirm tofacitinib effectiveness in UC, especially after multiple biologic failures.
Identifiants
pubmed: 31732444
pii: S1590-8658(19)30844-8
doi: 10.1016/j.dld.2019.10.003
pii:
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Janus Kinase Inhibitors
0
Piperidines
0
Pyrimidines
0
Tumor Necrosis Factor Inhibitors
0
tofacitinib
87LA6FU830
vedolizumab
9RV78Q2002
Types de publication
Journal Article
Multicenter Study
Observational Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
268-273Informations de copyright
Copyright © 2019 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.