Abstract
Background
Several observational studies on Tofacitinib (TOFA) in ulcerative colitis (UC) have
been published over the last 2 years.
Aims
To estimate effectiveness and safety of TOFA arising from real-world experience.
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
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
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.
Keywords
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Article info
Publication history
Published online: May 16, 2021
Accepted:
April 16,
2021
Received:
March 2,
2021
Identification
Copyright
© 2021 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.
