Shubha Bhat, PharmD: Understanding Etrasimod for Ulcerative Colitis

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Shubha Bhat, PharmD, MS, BCACP describes the ELEVATE UC program supporting the FDA approval of etrasimod and the current understanding of treatment positioning between etrasimod and ozanimod.

Among a flurry of US Food and Drug Administration (FDA) decisions this year was that of etrasimod (Velsipity), a sphingosine 1-phosphate (S1P) receptor modulator that was approved for adults with moderately to severely active ulcerative colitis (UC).

Announced by Pfizer on October 13, 2023, the approval was supported by data from the ELEVATE UC phase 3 registrational program, including the ELEVATE UC 52 and ELEVATE UC 12 trials, assessing the safety and efficacy of etrasimod 2 mg once-daily in patients with UC who had previously failed or were intolerant to at least 1 conventional, biologic, or Janus kinase (JAK) inhibitor therapy.

The fourth issue of Qazi Corner featured a summary of both ELEVATE studies as well as a review of their findings and potential directions for future research. Authored by Shubha Bhat, PharmD, MS, BCACP, the article details etrasimod’s superiority over placebo for achieving clinical remission in both ELEVATE UC 12 and ELEVATE UC 52, as well as key secondary endpoints for endoscopic improvement, symptomatic remission, and endoscopic improvement-histologic remission.

Beyond study design and results, Bhat also compared etrasimod to the only other currently available S1PR modulator, ozanimod, calling attention to multiple similarities and differences between the treatments.

“It’s interesting that they’re in the same drug class, but there’s definitely some stark differences between the 2 types of treatment,” Bhat said in an interview with HCPLive.

She went on to describe multiple clinical situations where differences between etrasimod and ozanimod may be important, including its use in patients heading into surgery and pregnant patients. In addition to differences in their half-lives, she also pointed out ozanimod has a titration period whereas etrasimod does not.

Although etrasimod and ozanimod are both S1PR modulators, Bhat called attention to the specific receptors targeted by each treatment, noting etrasimod targets S1PR 1, 4, and 5 whereas ozanimod only targets S1PR 1 and 5.

Bhat additionally suggested the value of a head-to-head study for further understanding treatment positioning: “I think a head-to-head trial would be useful for etrasimod and ozanimod so we can say directly, we’re comparing these 2 medications and we can see if there’s any additional benefit of hitting that additional receptor.”

Read Bhat’s original article from the fourth issue of Qazi Corner here