Introduction

Ulcerative colitis (UC) is a chronic immune-mediated inflammatory bowel disease with the potential for significant morbidity and impact on patients’ quality of life. The goals of UC treatment are to induce and then maintain remission, ideally with mucosal healing and prevention of disability.1 In the past twenty years, biologic therapies including TNF-alpha antagonists, anti-integrin and anti-interleukin therapies have demonstrated efficacy through randomized clinical trials (RCT) for patients with moderate to severe UC. However, it was previously noted that in an outpatient practice only 26% of patients with moderate to severe UC would qualify for pivotal RCTs from 2002-2012 era which raised concern regarding the external validity of RCTs due to stringent inclusion and exclusion criteria necessary to have greater internal validity of results.2 However, since 2012 additional advanced therapies for UC have been approved for moderate to severe UC patients including Janus kinase inhibitors (JAK), anti-interleukin 23 agents, and sphingosine-1 phosphate receptor agonists (S1P). This study’s aim was to provide an updated assessment of UC clinical trial eligibility based on inclusion and exclusion criteria of the clinical trials for these newer drugs with alternate mechanisms of action.