Endoscopic, histologic improvements in EoE sustained at 52 weeks with etrasimod
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Key takeaways:
- Improvements in peak eosinophil counts reported at week 16 were maintained through week 52 with etrasimod 2 mg.
- Symptom improvement reported at week 24 was maintained through week 52 with etrasimod 1 mg and 2 mg.
WASHINGTON — Once-daily etrasimod 1 mg and 2 mg was well-tolerated and sustained improvements in histological and endoscopic features of eosinophilic esophagitis, as well as patient symptoms, through 52 weeks of treatment, according to data.
“Etrasimod is a an oral, once-daily selective sphingosine 1-phosphate receptor modulator for the treatment of moderately to severely active ulcerative colitis and it’s in development for the treatment of other immune-mediated inflammatory diseases,” Evan S. Dellon, MD, MPH, professor and director of the Center for Esophageal Diseases and Swallowing at University of North Carolina School of Medicine, told attendees at Digestive Disease Week. “Etrasimod regulates and decreases lymphocyte trafficking to inflamed mucosal tissue and sites of primary disease manifestation and is a potential novel treatment option for EoE.”
In the phase 2, randomized, double-blind VOYAGE study, Dellon and colleagues enrolled 108 adult patients with active EoE in a 24-week placebo-controlled treatment period, after which 85 patients entered the 28-week extension period and continued once-daily etrasimod 1 mg (n = 31) or 2 mg (n = 30) or were switched from placebo.
The primary endpoint was the percent change from baseline in esophageal peak eosinophil count at week 16. Secondary outcomes included the proportion of patients who achieved peak eosinophil counts less than 15 and no more than six eosinophils/high power field, change from baseline in EoE-Histology Scoring System (EoE-HSS) grade and stage, EoE-Endoscopic Reference Score (EREFS), Patient Global Impression of Severity (PGIS) and Dysphagia Symptom Questionnaire (DSQ) at weeks 16, 24 and 52, as well as safety data through week 52.
According to study results, treatment with etrasimod 2 mg resulted in a 46.1% decrease from baseline in peak eosinophil count at week 16, with improvement maintained at weeks 24 (–113.7%) and 52 compared with placebo.
Statistically significant improvement also was reported at weeks 16, 24 and 52 in the proportion of patients achieving peak eosinophil counts (< 15 eos/HPF: 22%, 31.7% and 34.6%, respectively; 6 eos/hpf: 12.2%, 24.4% and 23.1%) and in EREFS (2.4%, 2.4% and 1.9%) and EoE-HSS (0.2 for all) among those who received etrasimod 2 mg for the full study duration.
At week 24, there were statistically significant reductions in PGIS in the overall population, as well as in DSQ scores among patients without a history of dilation at baseline. These improved scores were maintained to week 52 among etrasimod-treated patients.
“These extension period results, while not placebo-controlled, are the first to show the long-term effects of etrasimod in EoE,” Dellon said. “Etrasimod was well-tolerated with a safety profile consistent with that observed in etrasimod ulcerative colitis studies and results support further investigation of etrasimod in EoE.”
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Dellon ES, et al. Efficacy and safety of the selective sphingosine 1-phosphate receptor modulator, etrasimod, in adult patients with eosinophilic esophagitis over 52 weeks in the phase 2 VOYAGE study. Presented at: Digestive Disease Week; May 18-21, 2024; Washington (hybrid).
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