Etrasimod in moderately to severely active ulcerative colitis: a profile of its use in the EU

Declarations

Funding The preparation of this review was not supported by any external funding.

Authorship and conflict of interest A. Zhuang-Yan and M. Shirley are salaried employees of Adis International Ltd/Springer Nature and declare no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.

Ethics approval, Consent to participate, Consent for publication, Availability of data and material, Code availability Not applicable.

Additional information about this Adis Drug Review can be found here.

Abstract

Oral etrasimod (Velsipity^®), a sphingosine-1-phosphate (S1P) receptor modulator that selectively binds to receptors S1P1, S1P4 and S1P5, is a useful therapeutic option that is approved in the EU for patients aged ≥ 16 years with moderately to severely active ulcerative colitis, who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biological agent. In phase 3 clinical trials in patients aged 16–80 years with moderately to severely active ulcerative colitis, induction and maintenance therapy with oral etrasimod once daily resulted in a significantly greater proportion of patients achieving clinical remission at weeks 12 and 52 versus placebo. Relative to placebo, induction therapy with etrasimod provided significant improvements in clinical, symptomatic and endoscopic outcomes that were sustained with maintenance therapy. Etrasimod was generally well tolerated for up to 52 weeks, with most adverse events being mild or moderate in severity.

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