Safety and efficacy of etrasimod in ulcerative colitis: Evidence from a meta-analysis

Etrasimod, a newly approved oral sphingosine-1-phosphate receptor modulator, treats moderate-to-severe ulcerative colitis (UC) by inhibiting lymphocyte migration and reducing intestinal inflammation. This meta-analysis evaluates its efficacy and safety to strengthen evidence for clinical decision-making in UC management.

PubMed, Scopus, and Web of Science servers were used to conduct a systematic search in compliance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The meta-analysis of pooled effect estimates is produced using Review Manager and R software. A random-effects model was used. Quality of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation approach and publication bias through funnel plots and Egger test.

A total of 2 studies (3 randomized controlled trials) comprising 943 participants were included in this analysis. Pooled effect estimates demonstrated that etrasimod significantly improved clinical response, endoscopic improvement, clinical remission, and histological remission. The most commonly reported adverse events were UC worsening or flare (5.73%), headache (5.26%), anemia (3.57%), pyrexia (2.96%), and arthralgia (2.42%).

Overall, etrasimod therapy demonstrates a favorable benefit-to-risk profile, with its therapeutic advantages outweighing the likelihood of associated side effects.