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<p>Oral etrasimod (Velsipity<sup>®</sup>), a sphingosine-1-phosphate (S1P) receptor modulator that selectively binds to receptors S1P<sub>1</sub>, S1P<sub>4</sub> and S1P<sub>5</sub>, 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.</p><p><b>Plain Language Summary</b> Ulcerative colitis is a chronic condition in which the rectum and parts of the colon become inflamed, causing symptoms (e.g. bloody diarrhoea) that flare for a period of time and then ease. Etrasimod (Velsipity<sup>®</sup>), a selective sphingosine-1-phosphate receptor modulator, is thought to act in the treatment of ulcerative colitis by preventing lymphocytes from leaving lymph nodes and entering the bloodstream, thereby reducing inflammation in the colon. In clinical trials in patients aged ≥ 16 years with moderately to severely active ulcerative colitis, once daily oral etrasimod was more effective than placebo at achieving clinical remission, endoscopic improvement, symptomatic remission and endoscopic improvement-histological remission at weeks 12 and 52. Etrasimod was generally well tolerated for up to 52 weeks, with most adverse events being mild or moderate in severity. Etrasimod 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.</p>

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

  • 期刊论文

  • 发表日期：

    2025年7月15日

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  • Amy Zhuang-Yan,
  • Matt Shirley

摘要

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.

Plain Language Summary Ulcerative colitis is a chronic condition in which the rectum and parts of the colon become inflamed, causing symptoms (e.g. bloody diarrhoea) that flare for a period of time and then ease. Etrasimod (Velsipity®), a selective sphingosine-1-phosphate receptor modulator, is thought to act in the treatment of ulcerative colitis by preventing lymphocytes from leaving lymph nodes and entering the bloodstream, thereby reducing inflammation in the colon. In clinical trials in patients aged ≥ 16 years with moderately to severely active ulcerative colitis, once daily oral etrasimod was more effective than placebo at achieving clinical remission, endoscopic improvement, symptomatic remission and endoscopic improvement-histological remission at weeks 12 and 52. Etrasimod was generally well tolerated for up to 52 weeks, with most adverse events being mild or moderate in severity. Etrasimod 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.