GI & Hepatology News, November 2023: FDA OKs two new treatments for UC
An excerpt:
In October, the FDA approved etrasimod (Velsipity, Pfizer) for moderate to severe active UC in adults. Etrasimod, an oral sphingosine-1-phosphate (S1P) receptor, binds with high affinity to receptors 1, 4, and 5. It is the second agent in the S1P class approved for UC. The other agent, ozanimod (Zeposia, Bristol-Myers Squibb), which was approved for moderate to severe active UC in May 2021, is an S1P receptor modulator that is selective for the S1P1 and S1P5 receptors located on endothelial cells and oligodendrocytes, respectively.
Etrasimod’s approval was based on safety and efficacy data from two randomized, double-blind, placebo-controlled phase 3 trials ― ELEVATE UC 52 trial, and ELEVATE UC 12 trial. The Lancet published full results from the two trials on March 2. Both trials enrolled patients with UC who had previously failed or were intolerant of at least one conventional, biologic, or Janus kinase (JAK) inhibitor therapy.
In ELEVATE UC 52, clinical remission at 12 weeks occurred in 27% of patients taking etrasimod, vs 7% of patients taking a placebo (20% difference; P ˂.001). At week 52, remission rates were 32% with active treatment, vs. 7% with placebo (26% difference;
P ˂ .001).
In ELEVATE UC 12, clinical remission was achieved among 26% of patients who received etrasimod, vs 15.0% of patients who received placebo (11% difference; P < .05).
The approved recommended dose is 2 mg once daily. The most common side effects of etrasimod are headache, elevated values on liver tests, worsening of UC, SARS-CoV-2 infection, dizziness, pyrexia, arthralgia, abdominal pain, and nausea
Reference: WJ Sandborn et al. The Lancet 2023; DOI:https://doi.org/10.1016/S0140-6736(23)00061-2. Open Access! Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies
My take: It is not exactly clear where etrasimod or ozanimod should be positioned for ulcerative colitis therapy as several other drug classes have much higher response rates.
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