Effect of Budesonide Oral Suspension on Time to First Dysphagia Symptom Response and Dysphagia Symptom Resolution Outcomes in Patients With Eosinophilic Esophagitis.

BACKGROUND AND AIM: We examined post hoc the effect of budesonide oral suspension (BOS/Eohilia) 2.0 mg twice daily (b.i.d.) on dysphagia symptom outcomes in patients with eosinophilic esophagitis (EoE).

METHODS

Patients aged 11-55 years who received BOS 2.0 mg b.i.d. or placebo during phase 2 or phase 3, 12-week, double-blind, placebo-controlled clinical trials (MPI 101-06 and SHP621-301) were included. The Kaplan-Meier method captured time to first dysphagia symptom response (≥ 30% reduction in the Dysphagia Symptom Questionnaire [DSQ] score from baseline). Efficacy outcomes using the DSQ at weeks 4, 8, and 12 of therapy were: the proportion of patients with complete dysphagia symptom resolution; change from baseline in the number of dysphagia-free days; and the proportion of patients with dysphagia symptoms, but without adaptive behaviors or pain. Each outcome was measured based on daily DSQ records in the 2 weeks before each study visit.

RESULTS

Overall, 411 patients from MPI 101-06 (BOS, n = 51; placebo, n = 42) and SHP621-301 (BOS, n = 213; placebo, n = 105) were included. Median time to first dysphagia symptom response was significantly shorter for BOS- than placebo-treated patients (MPI 101-06, p = 0.0239; SHP621-301, p = 0.0156), with separation between groups at week 2, the earliest time point measured. At all time points, higher proportions of BOS- than placebo-treated patients had complete dysphagia symptom resolution or had dysphagia symptoms but no adaptive behaviors or pain. BOS- versus placebo-treated patients also had greater improvements from baseline in the number of dysphagia-free days.

CONCLUSIONS

BOS is efficacious in managing dysphagia in EoE across several symptom metrics.

CLINICALTRIALS: gov: NCT01642212; NCT02605837.