EoE Module 10 References-Hirano et al Clin Gastroenterol Hepatol 2022 BOS improves outcomes in patients with EoE Results from a phase 3 trial

Hirano et al Clin Gastroenterol Hepatol 2022 BOS improves outcomes in patients with EoE Results from a phase 3 trial

Pdf Summary

The phase 3 clinical trial investigated the efficacy and safety of Budesonide Oral Suspension (BOS) in treating Eosinophilic Esophagitis (EoE), a chronic immune-mediated esophageal condition. EoE currently lacks FDA-approved pharmacologic treatments, typically utilizing off-label asthma medications. Conducted across 66 centers in the U.S. from 2015 to 2019, the study included 318 patients aged 11–55, who were randomized to receive either BOS (2.0 mg twice daily) or placebo over 12 weeks.<br /><br />The trial's co-primary outcomes assessed stringent histologic responders (with ≤6 eosinophils per high-power field) and dysphagia symptom responders (≥30% reduction in the Dysphagia Symptom Questionnaire [DSQ] score). Results showed that BOS significantly improved both histologic response (53.5% vs 1.0% for placebo) and dysphagia symptom response (52.6% vs 39.1% for placebo). BOS treatment also bettered DSQ scores and Eosinophilic Esophagitis Endoscopic Reference Scores (EREFS) compared to placebo, showcasing significant enhancements in histologic, symptomatic, and endoscopic parameters.<br /><br />BOS demonstrated good tolerability, with most adverse events rated as mild or moderate. These included nasopharyngitis, sinusitis, and candidiasis, among others. Serious adverse events were scarce and unrelated to BOS treatment. A minority of patients showed reduced cortisol levels or adrenal function, common in corticosteroid therapies, emphasizing the need for monitoring.<br /><br />The study confirms that BOS is effective in improving outcomes for patients with EoE, addressing a significant unmet need for FDA-approved treatments in the U.S. The findings from this comprehensive trial provide crucial insights into the management of this chronic esophageal disorder, indicating BOS as a promising therapeutic option for adults and adolescents with EoE.

Keywords

Budesonide Oral Suspension

Eosinophilic Esophagitis

clinical trial

FDA-approved treatment

histologic response

dysphagia symptoms

adverse events

corticosteroid therapy

endoscopic parameters

therapeutic option