ELEVATE UC pivotal findings demonstrate etrasimod’s potentially best-in-class profile in ulcerative colitis.
Pfizer Inc. announced detailed results from two pivotal studies that make up the ELEVATE UC Phase III registrational program evaluating etrasimod, a once-daily, oral, selective sphingosine 1-phosphate (S1P) receptor modulator for the treatment of moderately-to-severely active ulcerative colitis (UC).
These data were presented as a late-breaker presentation (abstract number 968a) at Digestive Disease Week (DDW) 2022.
Both Phase III multi-center, randomized, placebo-controlled trials achieved all primary and key secondary endpoints, with etrasimod demonstrating a safety profile consistent with previous studies.
In the 52-week ELEVATE UC 52 study, clinical remission was 27.0% for patients receiving etrasimod compared to 7.4% for patients receiving placebo at week 12 (19.8% differential, P=?.001) and was 32.1% compared to 6.7% at week 52 (25.4% differential, P=?.001). In the 12-week ELEVATE UC 12 study, clinical remission was achieved among 24.8% of patients receiving etrasimod compared to 15.2% of patients receiving placebo (9.7% differential, P=.0264).
The 52-week ELEVATE UC 52 trial utilized a treat-through design which closely mimics real-world clinical practice. Statistically significant improvements were attained in all key secondary endpoints in ELEVATE UC 52. These included endoscopic improvement, symptomatic remission, and mucosal healing at weeks 12 and 52, and corticosteroid-free remission and sustained clinical remission at week 52. All key secondary endpoints were also met at week 12 in ELEVATE UC 12. These included endoscopic improvement, symptomatic remission, and mucosal healing.
Treatment-emergent adverse events (AEs), including serious AEs, were similar between treatment groups in both trials. The most common treatment-emergent AEs in 3% or more of etrasimod-treated patients and greater than placebo up to week 52 in either trial were headache, worsening of UC, COVID-19 infection, dizziness, pyrexia, arthralgia, abdominal pain and nausea. There were no reports of bradycardia or atrioventricular block as serious AEs.
The data from ELEVATE UC 52 & UC 12 are expected to form the basis for planned future regulatory filings, which will be initiated later this year. Additional information about the studies can be found at www.clinicaltrials.gov under the identifiers NCT03945188, NCT03996369, and NCT03950232.
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