Eohilia

The approval of Eohilia was based on data from 2 double-blind, parallel-group, placebo-controlled 12-week phase 3 trials (Study 1: ClinicalTrials.gov Identifier: NCT02605837; Study 2: ClinicalTrials.gov Identifier: NCT01642212).

Patients were eligible for the studies if they had esophageal inflammation, defined as 15 or greater eosinophils/high-power field (hpf) from at least 2 levels of the esophagus at baseline following a treatment course of a proton pump inhibitor (PPI) either prior to, or during screening, and at least 4 days of dysphagia as measured by the Dysphagia Symptom Questionnaire (DSQ) over a 2-week period prior to randomization. The primary endpoints for both studies were histological remission (defined as a peak eosinophil count of ≤6/hpf across all available esophageal levels) and the absolute change from baseline in patient-reported DSQ combined score after 12 weeks of treatment.

Study 1 included 318 participants (277 adults and 41 children) who were randomly assigned to receive at least 1 dose of Eohilia (n=213) or placebo (n=105). The mean DSQ combined scores at baseline were 30.3 and 30.4 in the Eohilia and placebo groups, respectively. Over 80% were on concomitant PPI therapy. Findings showed 53.1% of the Eohilia group achieved histological remission compared with 1% of the placebo group (treatment difference, 52.4% [95% CI, 43.3-59.1]). The absolute change from baseline in DSQ combined score was -10.2 and -6.5 for the Eohilia and placebo groups, respectively (treatment difference, -3.7 [95% CI, -6.8, -0.6]).

Study 2 included 92 participants (58 adults and 34 children) who were randomly assigned to receive at least 1 dose of Eohilia (n=50) or placebo (n=42). The mean DSQ combined scores at baseline were 30.7 and 29.0 in the Eohilia and placebo groups, respectively. Over 65% were on concomitant PPI therapy. Results showed 38% of Eohilia-treated patients achieved histological remission vs 2.4% of those who received placebo (treatment difference, 35.8% [95% CI, 17.2-50]). The absolute change from baseline in DSQ combined score in the Eohilia vs placebo groups was -14.5 vs -5.9 (treatment difference, -8.6 [95% CI, -13.7, -3.5]).

Additional analysis showed that in the last 2 weeks of both trials, a greater proportion of Eohilia-treated patients experienced no dysphagia or only experienced dysphagia that “got better or cleared up on its own” compared with placebo. 

After completing the 12-week study, 48 patients from Study 1 were randomly assigned to receive Eohilia 2mg twice daily or placebo for up to an additional 36 weeks. Findings showed Eohilia did not demonstrate statistically significant difference compared with participants re-randomized to placebo based on eosinophil count and/or clinical symptoms (measured by DSQ) at 36 weeks. Based on these findings, the prescribing information for Eohilia notes that the treatment has not been shown to be safe or effective for longer than 12 weeks.