Effectiveness and safety of tofacitinib for the treatment of ulcerative colitis: A single-arm meta-analysis of observational studies.
Adult
Colitis, Ulcerative
/ drug therapy
Drug-Related Side Effects and Adverse Reactions
/ epidemiology
Female
Humans
Incidence
Induction Chemotherapy
Janus Kinase Inhibitors
/ therapeutic use
Maintenance Chemotherapy
Male
Middle Aged
Observational Studies as Topic
Piperidines
/ therapeutic use
Pyrimidines
/ therapeutic use
Treatment Outcome
Effectiveness
Meta-analysis
Real-world
Safety
Tofacitinib
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:
Feb 2022
Feb 2022
Historique:
received:
02
03
2021
revised:
15
04
2021
accepted:
16
04
2021
pubmed:
21
5
2021
medline:
12
2
2022
entrez:
20
5
2021
Statut:
ppublish
Résumé
Several observational studies on Tofacitinib (TOFA) in ulcerative colitis (UC) have been published over the last 2 years. To estimate effectiveness and safety of TOFA arising from real-world experience. PubMed Central/Medline and Embase were systematically searched for real-world observational studies on TOFA for the treatment of UC through November 2020. Seven studies comprising 759 patients met the inclusion criteria. The pooled estimate rates were 49% for clinical response, 40% for clinical remission, and 34% for corticosteroid-free clinical remission at induction, while the rates of endoscopic response and endoscopic remission were 37% and 19%, respectively. At maintenance, the pooled estimate rates of clinical response, clinical remission, and corticosteroid-free clinical remission were 36%, 35%, and 24%, respectively. The pooled estimate of incidence rate of adverse events was 53.0 per 100 person-years (PY), while the pooled estimate of incidence rate of withdrawal of TOFA due to adverse events was 9.3 per 100 PY, with a pooled rate of infections of 17.6 per 100 PY. Cumulative analysis of data from real-world studies confirmed the good efficacy of TOFA in UC shown by randomized controlled trials for both induction and maintenance, while the safety profile was consistent with previous reports.
Sections du résumé
BACKGROUND
BACKGROUND
Several observational studies on Tofacitinib (TOFA) in ulcerative colitis (UC) have been published over the last 2 years.
AIMS
OBJECTIVE
To estimate effectiveness and safety of TOFA arising from real-world experience.
METHODS
METHODS
PubMed Central/Medline and Embase were systematically searched for real-world observational studies on TOFA for the treatment of UC through November 2020.
RESULTS
RESULTS
Seven studies comprising 759 patients met the inclusion criteria. The pooled estimate rates were 49% for clinical response, 40% for clinical remission, and 34% for corticosteroid-free clinical remission at induction, while the rates of endoscopic response and endoscopic remission were 37% and 19%, respectively. At maintenance, the pooled estimate rates of clinical response, clinical remission, and corticosteroid-free clinical remission were 36%, 35%, and 24%, respectively. The pooled estimate of incidence rate of adverse events was 53.0 per 100 person-years (PY), while the pooled estimate of incidence rate of withdrawal of TOFA due to adverse events was 9.3 per 100 PY, with a pooled rate of infections of 17.6 per 100 PY.
CONCLUSIONS
CONCLUSIONS
Cumulative analysis of data from real-world studies confirmed the good efficacy of TOFA in UC shown by randomized controlled trials for both induction and maintenance, while the safety profile was consistent with previous reports.
Identifiants
pubmed: 34011482
pii: S1590-8658(21)00203-6
doi: 10.1016/j.dld.2021.04.018
pii:
doi:
Substances chimiques
Janus Kinase Inhibitors
0
Piperidines
0
Pyrimidines
0
tofacitinib
87LA6FU830
Types de publication
Journal Article
Meta-Analysis
Systematic Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
183-191Informations de copyright
Copyright © 2021 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.