Approval was based on favorable data from two ELEVATE UC phase 3 clinical trials.
The FDA has approved oral, once-daily etrasimod (Velsipity), a selective sphingosine-1-phosphate (S1P) receptor modulator for adults with moderately to severely active ulcerative colitis (UC), according to a news release from Pfizer.1
This chronic, debilitating condition affects the lives of approximately 1.25 million individuals in the United States. Symptoms include chronic diarrhea with blood and mucous, abdominal pain, and urgency.
FDA approval was based on results of the ELEVATE UC Phase 3 program, which included the ELEVATE UC 52 (NCT03945188) and ELEVATE UC 12 studies (NCT03996369) evaluating the efficacy and safety of once-daily etrasimod 2 mg on clinical remission in UC in a patient population who had previously failed treatment with, or were intolerant to, at least 1 conventional biologic or Janus kinase (JAK) inhibitor.
ELEVATE UC 52 was a randomized, double-blind, placebo-controlled trial utilizing a treat-through design, with a 12-week induction period and a 40-week maintenance period. The primary goal of the study was assessing the safety and efficacy of once-daily etrasimod 2 mg on clinical remission at weeks 12 and 52. ELEVATE UC 12 was a randomized, double-blind, placebo-controlled trial to evaluate etrasimod 2 mg safety and efficacy. Nearly two-thirds of patients in each trial were naïve to treatment with biologic or JAK inhibitor therapies.
Both ELEVATE UC 52 and ELEVATE UC 12 achieved all primary and key secondary efficacy endpoints; the safety profile of etrasimod was favorable, and consistent with previous studies of the drug.
Results of ELEVATE UC 52 demonstrated 27% clinical remission in the etrasimod group vs the placebo group (7%) at week 12 (20% differential); by week 52, clinical remission was achieved in 32% vs 7% of patients in the treatment and placebo groups, respectively (26% differential). Results were similar in the ELEVATE UC 12 trial, with 26% of patients in the treatment group achieving clinical remission vs 15% of those in the placebo group (11% differential). At week 12, all key secondary endpoints—including endoscopic improvement and mucosal healing—were met. The most common adverse reactions in were headache, elevated liver tests, and dizziness, with an incidence of 5% or less.
“Because of the unpredictable nature of UC, people living with the disease can cycle through several different treatments over time. Patients may also be apprehensive about using injectable therapies, like biologics,” said Michael Chiorean, co-director of the IBD Center at the Swedish Medical Center and an investigator with the ELEVATE registrational program. “It is important to have new, effective options like [etrasimod] for those patients who may require an advanced treatment option and prefer the convenience of a once-daily pill.”
“UC can affect patients differently and many people living with this disease struggle with ongoing symptoms,” added Michael Osso, president and CEO of the Crohn’s and Colitis Foundation. “The introduction of a new treatment for UC could increase options for patients, and we look forward to seeing the impact of [etrasimod] for patients across the U.S.”