Real-world experience with tofacitinib in ulcerative colitis - a systematic review and meta-analysis

Abstract

Background and aims Evidence on the outcomes of tofacitinib therapy in real world ulcerative colitis (UC) patients is needed, as a number of these patients would not match the inclusion criteria for clinical trials. We have therefore summarised data derived from observational, real-world evidence (RWE) studies on the effectiveness and safety of tofacitinib in moderate to severe ulcerative colitis (UC) patients. Methods We searched the PubMed, EMBASE, Scopus, Web of Science and Cochrane databases for observational studies on the use of tofacitinib in UC patients, published between 30/05/2018 and 24/01/2021. Pooled induction (8-14 weeks) and maintenance (16-26 weeks) clinical response and remission rates were calculated, as well as the proportion of reported adverse events using random effects models. Results Nine studies were included, comprising 830 patients, of which 81% were previously treated with anti-TNF and 57% with vedolizumab. Induction of clinical response and remission were achieved in 51% (95% CI 41-60%) and 37% (26-45%) of patients, after a median follow-up of 8 weeks. At the end of a median follow-up of 24 weeks, maintenance of clinical response and remission were met in 40% (31-50%) and 29% (23-36%) of patients, respectively. Thirty-two percent of the patients had at least one adverse event, the most commonly reported being mild infection (13%) and worsening of UC, requiring colectomy (13%). A third of the patients (35%) discontinued tofacitinib, most frequently due to primary non-response (51%). Conclusions Tofacitinib is a safe and effective therapy in real-world UC patients, as previously reported by clinical trials.

Real‐world comparison of effectiveness between tofacitinib and vedolizumab in patients with ulcerative colitis exposed to at least one anti‐TNF agent

“…We reported a crude rate of CFREM of 33% in patients treated with tofacitinib, which is in line with prior real‐world cohorts reporting a rate of CFREM ranging from 26% to 44% 15–21 . While a dose reduction from 10 mg to 5 mg b.i.d.…”

“…We reported a crude rate of CFREM of 33% in patients treated with tofacitinib, which is in line with prior real-world cohorts reporting a rate of CFREM ranging from 26% to 44%. [15][16][17][18][19][20][21] While a dose reduction from 10 mg to 5 mg b.i.d. is recommended for the patients achieving clinical remission at week 8, we observed a very high rate of relapse after a such de-escalation as almost one half of the patients (48.1%) were no more in remission at week 16.…”