Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind,
William J Sandborn1, Séverine Vermeire2, Laurent Peyrin-Biroulet3
1Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA.
Lancet (London, England)
|March 5, 2023
Summary
Etrasimod demonstrated significant efficacy in achieving clinical remission for ulcerative colitis patients in phase 3 trials. This sphingosine 1-phosphate receptor modulator offers a promising new treatment option for moderate to severe disease.
Area of Science:
- Immunology
- Gastroenterology
- Pharmacology
Background:
- Etrasimod is an oral sphingosine 1-phosphate (S1P) receptor modulator targeting S1P subtypes 1, 4, and 5.
- It is under development for immune-mediated diseases, including ulcerative colitis (UC).
Purpose of the Study:
- To evaluate the safety and efficacy of etrasimod in adult patients with moderately to severely active ulcerative colitis.
- Assess etrasimod's effectiveness as both induction and maintenance therapy.
Main Methods:
- Two independent, randomized, double-blind, placebo-controlled phase 3 trials (ELEVATE UC 52 and ELEVATE UC 12) were conducted.
- Adults with moderate-to-severe UC received daily oral etrasimod (2 mg) or placebo.
- Primary endpoints included clinical remission rates at 12 and 52 weeks.
Main Results:
- Etrasimod significantly increased clinical remission rates compared to placebo at 12 weeks in both trials (ELEVATE UC 52: 27% vs 7%; ELEVATE UC 12: 25% vs 15%).
- In ELEVATE UC 52, sustained remission was observed at 52 weeks (32% vs 7%).
- Adverse event rates were higher in the etrasimod group but no deaths or malignancies were reported.
Conclusions:
- Etrasimod is an effective and well-tolerated treatment for induction and maintenance in moderate-to-severe ulcerative colitis.
- It presents a novel therapeutic option addressing unmet needs in UC management.
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