Effectiveness and safety of tofacitinib for the treatment of ulcerative colitis: A single-arm meta-analysis of observational studies

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: Effectiveness; Meta-analysis; Real-world; Safety; Tofacitinib.