Budesonide oral suspension effective against pediatric EoE

Twice-daily budesonide oral suspension, or BOS, improved outcomes in pediatric patients with eosinophilic esophagitis, according to research presented at this year’s virtual American Academy of Allergy, Asthma and Immunology Annual Meeting.

“In terms of safety assessments, BOS 2 mg twice daily was, overall, well-tolerated in this pediatric cohort,” Sandeep K. Gupta, MD, of the section of pediatric gastroenterology, hepatology and nutrition at Indiana University School of Medicine and Riley Hospital for Children at Indiana University Health, said during the presentation.

Gupta and colleagues pooled data from two previous trials evaluating BOS in eosinophilic esophagitis (EoE): one phase 2 trial and one phase 3 trial. The 12-week, double-blind, placebo-controlled trials included 76 patients aged 11 to 17 years with EoE and dysphagia.

In the efficacy analysis, the researchers evaluated the proportion of patients who achieved “a range of histologic response thresholds,” Gupta said, including one or fewer, six or fewer than 15 eosinophils per high-power field (eos/hpf). They also assessed dysphagia symptom response, which Gupta described as a 30% or greater reduction in Dysphagia Symptom Questionnaire (DSQ) score. A full response was recorded in patients who had a combined histologic and symptom response of 6 eos/hpf or fewer and a 30% or greater DSQ reduction.

After 12 weeks, more patients who were assigned to BOS experienced a histologic response compared with those assigned to placebo ( 1 eos/hpf, 42.2% vs. 0.%; 6 eos/hpf, 46.7% vs. 6.5%; < 15 eos/hpf, 53.3% vs. 9.7%). However, dysphagia symptoms did not significantly differ between the groups (68.9% for BOS vs. 58.1% for placebo). The researchers discovered that the proportion of patients with a full response was significantly higher in the BOS group vs. placebo group (31.1% vs 3.2%).

Gupta reported that 2-mg BOS twice daily was well-tolerated, “and all treatment-emergent adverse events were mild or moderate in severity.” The most common adverse event was nasopharyngitis (9.2%), followed by diarrhea, vomiting, abnormal adrenocorticotropic hormone test, proteinuria, oropharyngeal pain and headache (all 5.3%).

“In conclusion, BOS substantially improved histologic, endoscopic and full responses in pediatric patients with EoE vs. placebo in this post-hoc analysis,” Gupta said. “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.”