This article is part of Pulmonology Advisor‘s coverage of the ACAAI 2019 meeting, taking place in Houston, TX. Our staff will report on medical research related to allergies, asthma, and more conducted by experts in the field. Check back regularly for more news from ACAAI 2019.
HOUSTON — Budesonide oral suspension was associated with improvements in dysphagia in patients with eosinophilic esophagitis, according to phase 3 study results presented at the 2019 Annual Scientific Meeting of the American College of Allergy, Asthma, & Immunology, held November 7 to 11 in Houston, Texas.
Children and adults (age range, 11-55 years) with eosinophilic esophagitis and dysphagia were enrolled in the double-blind placebo-controlled trial (ClinicalTrials.gov Identifier: NCT02605837). During a 12-week treatment period, patients received either twice-daily budesonide 2.0 mg (n=213) or placebo (n=105). The coprimary efficacy end point in the study was a ≥30% reduction in the Dysphagia Symptoms Questionnaire (DSQ) combined score at the end of 12 weeks.
A significantly higher percentage of dysphagia symptom responders was observed in the budesonide group compared with the placebo group at 12 weeks (52.6% vs 39.1%, respectively; P =.024). In addition, there was a greater decrease in the mean DSQ score from baseline to 12 weeks in patients treated with budesonide relative to placebo-treated patients (30.3 vs 30.4 [baseline] to 19.5 vs 22.6 [week 12], respectively).
There were also significantly greater improvements in the mean DSQ score in the budesonide group vs placebo group from baseline to week 4 (-8.0 vs -4.0; P =.002), week 8 (-10.7 vs -6.0; P =.001), and week 12 (-13.0 vs -9.1; P =.015). There were few severe or serious treatment-emergent adverse events in either group.
There is an ongoing maintenance study examining the long-term response of budesonide in this patient population (ClinicalTrials.gov Identifier: NCT02736409).
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Hirano I, Collins M, Katzka D, et al. Budesonide oral suspension treatment improves dysphagia symptoms in patients with eosinophilic esophagitis. Presented at: American College of Allergy, Asthma, & Immunology Annual Scientific Meeting 2019; November 7-11, 2019; Houston, TX. Abstract P400.