P308 Effectiveness and Safety of tofacitinib for the Treatment of Ulcerative Colitis: A Single-Arm Meta-analysis of Observational Studies
Macaluso, F.S.(1);Maida, M.(2);Ventimiglia, M.(1);Orlando, A.(1);
(1)Ospedali Riuniti Villa Sofia-Cervello, Department of Medicine, Palermo, Italy;(2)“S.Elia-Raimondi” Hospital, Section of Gastroenterology, Caltanissetta, Italy
Several observational studies on Tofacitinib (TOFA) for the treatment of ulcerative colitis (UC) have been published over the last 2 years. The aim of this single-arm meta-analysis was to estimate the effectiveness and safety of TOFA arising from real-world observational studies.
PubMed Central/Medline and Embase, as well as reference lists of articles, were systematically searched for real-world observational studies of TOFA for the treatment of UC through November 2020.
Seven studies comprising 759 patients met the inclusion criteria. Almost all patients (range: 76.5-100%) had been previously exposed to anti-TNFs, and a variable proportion (range: 38.8-100%) had been previously treated with Vedolizumab 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 total 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.