Budesonide Oral Suspension Improves Multiple Outcomes in Pediatric Eosinophilic Esophagitis

Budesonide oral suspension (BOS) improved histologic, endoscopic, and both histologic and symptomatic outcomes in children with eosinophilic esophagitis (EoE) compared with placebo, according to study findings presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) Virtual Annual Meeting held February 26 to March 1, 2021.

The findings were based on a pooled analysis of data that researchers conducted from 2 randomized, double-blind, 12-week placebo-controlled trials, examining the use of twice-daily 2.0 mg BOS (Clinical Trials.gov Identifiers: NCT01642212 and NCT02605837) in patients with EoE and dysphagia between the ages of 11 and 17 years.

In these studies, investigators assessed peak eosinophil counts. The Dysphagia Symptom Questionnaire (DSQ) evaluated symptomatic outcomes and the EoE Endoscopic Reference Score (EREFS) evaluated endoscopic outcomes.

A total of 45 patients in these studies were treated with at least 1 dose of BOS, while 31 patients were treated with placebo. A significantly greater number of patients treated with BOS demonstrated histologic responses, including 6 or fewer eosinophils/high-power field (eos/hpf; 46.7% vs 6.5%), fewer than 15 eos/hpf (53.3% vs 9.7%), and 1 or fewer eos/hpf (42.2% vs 0.0%) after 12 weeks (all P <.001).

While more patients in the BOS group compared with the placebo group had at least a 30% reduction in the DSQ score after 12 weeks of treatment (68.9% vs 58.1%, respectively), this difference was not statistically significant (P =.314). A greater number of patients treated with BOS had a combined response, defined as 6 or fewer eos/hpf and at least a 30% reduction in DSQ score (31.1% vs 3.2%; P =.003) following the 12-week treatment course.

Treatment with BOS was also associated with significantly greater reductions in least-squares mean EREFS compared with placebo from baseline to week 12 (-4.1 vs -2.1, respectively; P =.021). Overall, treatment with BOS was generally well-tolerated. There were no significant differences between BOS and placebo in terms of adverse events.

Disclosure:  Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.

Reference

Gupta S, Mukkada V, Dellon E, et al. Efficacy and safety of budesonide oral suspension in a pediatric population: pooled data from a phase 2 and phase 3 trial in patients with eosinophilic esophagitis. Presented at: American Academy of Allergy, Asthma & Immunology (AAAAI) Virtual Annual Meeting 2021; February 26-March 1, 2021. Abstract 291.