A study has found twice-daily Budesonide Oral Suspension (BOS) to be effective in improving histologic, endoscopic and combined histologic and symptomatic outcomes in children with eosinophilic oesophagitis (EoE) aged 11-17.

The research was presented at the American Academy of Allergy, Asthma and Immunology Annual Meeting 2021.

Methods

The study pooled data from a Phase 2 and a Phase 3 trial, both 12-week, double-blind and placebo-controlled.

• Histologic outcomes were measured with peak eosinophil counts
• Symptomatic outcomes were measured with the Dysphagia Symptom Questionnaire (DSQ)
• Endoscopic outcomes were measured with EoE Endoscopic Reference Score (EREFS).

In total, 45 patients across the two trials were treated with BOS and 31 were treated with placebo.

More info on the Phase 3 trial, ORBIT1, can be found here.

Results

A significantly greater number of patients in the BOS groups showed histologic responses vs the placebo groups:

• <15 eosinophils per high-power field: 53.3% BOS vs 9.7% placebo
• ≤6 eos/hpf: 46.7% vs 6.5%
• ≤1 eos/hpf: 42.2% vs 0%

(all p<0.001)

BOS patients also had significantly greater reductions in least-squares mean EREFS, at -4.1 vs -2.1 in patients taking the placebo (p=0.021)

More BOS patients had symptom responses (≥30% reduction in their DSQ score), at 68.9% vs 58.1%, but this difference was not statistically significant (p=0.314). However, the BOS patients showed significantly greater combined symptom and histologic responses (≥30% reduction DSQ and ≤6 eos/hpf), at 31.1% BOS vs 3.2% placebo (p=0.003).

BOS was generally well tolerated, with no significant differences in adverse affects compared to the placebo.

Overall, the proportion of BOS-treated patients who achieved a full response in this pooled analysis was similar to that observed in each individual trial, highlighting the reproducibility and consistency of these findings

- Sandeep Gupta MD, Lead Author

Links

• Abstract in Journal of Allergy and Clinical Immunology
• Phase 3 ORBIT1 ClinicalTrials.gov listing
• Phase 2 study ClinicalTrials.gov listing
• Takeda granted Priority Review in US for BOS

Page updated 27th March 2021