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Oral Budesonide Suspension Safely, Effectively Treated Children with EoE
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A new formulation of oral budesonide suspension was safe and effective for treatment of pediatric eosinophilic esophagitis, according to new research data.
Oral budesonide suspension is a corticosteroid designed to coat the esophagus to treat local eosinophilic inflammation associated with eosinophilic esophagitis (EoE), according to a press release.
“EoE patients struggle daily, as the damage to their esophagus makes swallowing and eating a formidable challenge,” Sandeep K. Gupta, MD, from Indiana University School of Medicine and Riley Hospital for Children, said in the release. “There is a dire need for a safe and effective EoE treatment, as currently, there are no FDA-approved treatments for this condition.”
Gupta and colleagues performed the Pediatric Eosinophilic Esophagitis Research (PEER) study, a prospective, placebo-controlled, dose-ranging study involving 71 patients aged 2 to 18 years with EoE symptoms and peak eosinophil counts of at least 20/high-power field at two or more levels of the esophagus. Participants aged 2 to 9 years were randomly assigned to 0.35 mg, 1.4 mg or 2.8 mg oral budesonide suspension or placebo for 12 weeks, and participants aged 10 to 18 years were randomly assigned to 0.5 mg, 2 mg or 4 mg oral budesonide suspension or placebo for 12 weeks. Doses and volumes were adjusted based on age and esophagus size.
At the end of the study period, a comparable percentage of patients had a compound histologic and symptom response to low-dose oral budesonide suspension (11.8%) compared with placebo (5.6%; P=.5282), but a higher percentage had compound response in the medium-dose group (52.6%; P=.0092) and the high-dose group (47.1%; P=.0174). The medium- and high-dose compound response rates were similar, and all groups had similarly high symptom response compared with placebo (P≥.1235). Oral budesonide suspension was well tolerated with comparable overall incidence of adverse events in all treatment groups, the most common of which were pyrexia and cough.
“Oral budesonide suspension demonstrated remarkable efficacy to reduce eosinophilic inflammation in our study, offering hope for EoE patients,” Gupta said.
Disclosure: See the study for a full list of relevant financial disclosures.
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