Etrolizumab as induction and maintenance therapy in patients with moderately to severely active ulcerative colitis: a protocol of systematic review and meta-analysis of placebo-controlled, randomised clinical trials.

ABSTRACT

INTRODUCTION: Etrolizumab is a gut-targeted, anti-ß7 integrin, monoclonal antibody. Recently, data from phase 2 and 3 trials presented different results in patients with moderately to severely active ulcerative colitis. The aim of this study is to summarise the latest published trials to analysis the role of etrolizumab in treatment of moderately to severely active ulcerative colitis during induction and maintenance phases. METHODS: Eligible randomised controlled trials (RCTs) will be retrieved from following databases PubMed, Web of Science and the Cochrane Library. The last search time is May 2023. Two reviewers will independently identify RCTs according to inclusion and exclusion criteria. The primary outcome is clinical remission. The second outcomes are clinical response, endoscopic remission, endoscopic improvement, histological remission, any adverse event. The Grades of Recommendations, Assessment, Development and Evaluation tool will be established to estimate the evidence level of each outcome. All compute will be accomplished with Stata V.17.0 software. ETHICS AND DISSEMINATION This systematic review and meta-analysis will be disseminated through peer-reviewed journals. No ethical approval requirements are required because the results presented in this study are conducted based on published data. PROSPERO REGISTRATION NUMBER CRD42023415369.