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.