The following is a summary of “Pooled Phase 2 and 3 Efficacy and Safety Data on Budesonide Oral Suspension in Adolescents with Eosinophilic Esophagitis,” published in the December 2023 issue of Pediatrics by Mukkada, et al.

For a study, researchers sought how well and safely budesonide oral suspension (BOS) worked for teens with eosinophilic esophagitis (EoE). They combined information from two 12-week studies of BOS 2.0 mg twice daily (b.i.d.) in 11–17-year-olds with EoE and dysphagia. The studies were randomized, double-blind, and placebo-controlled. After 12 weeks, the study looked at changes in the histology (≤6, ≤1, and <15 eos/hpf), dysphagia symptoms (≥30% reduction in Dysphagia Symptom Questionnaire [DSQ] scores from baseline), and the clinicopathologic (≤6 eos/hpf and ≥30% reduction in DSQ scores from baseline). 

They looked at how peak eosinophil counts, DSQ scores, EoEHSS grade (severity) and stage (extent) total score ratios (TSRs), and total EoE Endoscopic Reference Scores (EREFS) changed from the start of the treatment to week 12. Safety results were also looked at. Results: A total of 76 teens were enrolled (45 in the BOS group and 31 in the control group). There were a lot more histologic responses (≤6 eos/hpf: 46.7% vs 6.5%; ≤1 eos/hpf: 42.2% vs 0.0%; <15 eos/hpf: 53.3% vs 9.7%; P < 0.001) and clinicopathologic responses (31.1% vs 3.2%; P = 0.003) in the BOS group than in the control group at week 12. At week 12, more patients who were given BOS than those who were given a placebo had improvement in their dysphagia symptoms (68.9% vs. 58.1%; not statistically significant P = 0.314). 

Patients who were given BOS had much bigger drops in EoEHSS grade and stage TSRs (P < 0.001) and total EREFS (P = 0.021) from the start to week 12 than patients who were given a placebo. BOS was well taken, and there were no changes in side events that were clinically important compared to the placebo. Giving BOS 2.0 mg once a day helped most effectiveness results in teens with EoE significantly.

Source: journals.lww.com/jpgn/fulltext/2023/12000/pooled_phase_2_and_3_efficacy_and_safety_data_on.17.aspx