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Background and aimsEvidence 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.MethodsWe 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.ResultsNine 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%).ConclusionsTofacitinib is a safe and effective therapy in real-world UC patients, as previously reported by clinical trials.WHAT YOU NEED TO KNOWBackgroundTofacitinib is the first Janus kinase inhibitor (JAKi) approved for the treatment of moderate to severe ulcerative colitis (UC). Real-world data is needed to understand clinical effectiveness of new therapies.FindingsClinical response rates were consistent with those reported by OCTAVE Induction trials, showing clinical efficacy similar in real-world and controlled clinical trial cohorts. There were no major safety concerns reported.Implications for patient careThe results of this meta-analysis confirm the effectiveness and acceptable safety profile of tofacitinib in a real-world, highly refractory UC population, and further support its use in clinical practice. |
