Etrasimod 2 mg reduces peak eosinophil count at week 16, improves symptom severity
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Key takeaways:
- Once-daily etrasimod 2 mg significantly improved peak eosinophil count at 16 weeks compared with placebo.
- Improvements in endoscopic features, overall symptom severity and dysphagia also were noted.
VANCOUVER, British Columbia — Once-daily etrasimod 2 mg was well-tolerated and reduced peak eosinophil count at week 16 in patients with eosinophilic esophagitis, according to data presented at the ACG Annual Scientific Meeting.
“This is the first study assessing a S1P receptor modulator in EoE,” Evan S. Dellon, MD, MPH, study author and director of the Center for Esophageal Diseases and Swallowing and Center for Gastrointestinal Biology and Disease at the University of North Carolina School of Medicine, told Healio.
Etrasimod is an investigational, once-daily, oral selective sphingosine 1-phosphate receptor modulator, Dellon told attendees during his presentation, and is “in development for the treatment of immune-mediated inflammatory disorders. Etrasimod may have efficacy in EoE, a T-cell mediated disease, due to its effects in regulating lymphocyte egress from secondary lymphoid organs.”
In the phase 2, randomized, double-blind, placebo-controlled VOYAGE trial, Dellon and colleagues investigated the efficacy and safety of once-daily oral etrasimod 1 mg (n = 39) and 2 mg (n = 41) compared with placebo (n = 28) for 24 weeks in adults with active EoE. A 28-week extension treatment period is ongoing.
The primary efficacy endpoint was percentage change from baseline in esophageal peak eosinophil count at week 16. Other outcomes included histological and endoscopic features and symptoms of EoE (proportion of patients who achieved peak eosinophil counts < 15 and 6 eosinophils/high power field and absolute change from baseline in EoE-Histology Scoring System [EoE-HSS] grade and stage scores, EoE-Endoscopic Reference Score [EREFS], Patient Global Impression of Severity [PGIS] and Dysphagia Symptom Questionnaire [DSQ] at week 24).
At baseline, the mean duration of EoE was 4.6 years. More than half of participants (56%) had a history of esophageal dilation and approximately 35% were corticosteroid refractory.
According to results, percentage change in peak eosinophil count in the etrasimod 2 mg group at week 16 was –38.3% (P = .0103) and –52.4% at week 24 (P < .0001), significant changes compared with placebo. In the etrasimod 1 mg group, a statistically significant percentage change of –27.4% was reported at week 24 (P = .0022) but not at week 16 (40.3%; P = .2861).
Additionally, there were statistically significant changes from baseline to week 24 in EOE-HSS grade and stage scores, EREFS and PGIS in the etrasimod 2 mg group compared with placebo. The change in DSQ scores in this group was significant at week 24 only in patients without history of baseline dilation.
Further, results showed that etrasimod was well-tolerated, with no serious treatment-emergent adverse events reported up to 24 weeks; however, one patient treated with placebo and one with etrasimod 2 mg discontinued participation due to treatment- emergent adverse events.
“In this randomized, placebo-controlled study, treatment with etrasimod met the primary endpoint of reduction in the peak eosinophil count compared to placebo, and also improved endoscopic severity and symptoms, especially those patients who have not had prior dilation,” Dellon told Healio.
He added: “This treatment class holds promise for EoE therapeutics, and further study of etrasimod in larger clinical trials is warranted. Were these results to be replicated in a phase 3 trial, this small molecule could be added to the EoE treatment algorithm.”
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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: Primary results from the phase 2 VOYAGE study. Presented at: ACG Annual Scientific Meeting; Oct. 20-25, 2023; Vancouver, British Columbia (hybrid meeting).
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