Ikuo Hirano, MD, on Budesonide Oral Suspension in Eosinophilic Esophagitis
More therapeutic options are needed for patients with eosinophilic esophagitis (EoE).
Findings of a randomized, double-blind, placebo-controlled phase 3 clinical trial indicated that the use of budesonide oral suspension resulted in significant improvements in histologic, symptomatic, and endoscopic end points compared with placebo among a large cohort of patients with EoE.
Gastroenterology Consultant spoke with Ikuo Hirano, MD, a professor of medicine at the Northwestern University Feinberg School of Medicine and lead author of the study, about the research, which was presented at the American College of Gastroenterology (ACG) 2019 Annual Scientific Meeting and Postgraduate Course.
Gastroenterology Consultant: What do you think is the biggest challenge in the management of EoE?
Ikuo Hirano: While there has been tremendous progress in EoE over the past two decades, important challenges remain in the therapeutic arena. The lack of medications approved for use by the US Food and Drug Administration (FDA) is a major barrier to the treatment of our patients with EoE. While topical corticosteroids are a mainstay of treatment for EoE, we are currently limited to unapproved formulations indicated for asthma. It can be a challenge for patients to swallow and not inhale aerosolized medications. Furthermore, instructions that accompany the steroid Inhaler packaging, as well as from good-intentioned pharmacists, inform EoE patients on how to inhale rather than swallow the medication. Inhalation of steroids will not effectively control the esophageal allergic inflammation.
GASTRO CON: The treatment-related adverse events (AEs) reported in the study were mild to moderate. Were there any AEs that were unexpected that are important for a gastroenterologist to know?
IH: The AE that gastroenterologists can encounter in a small proportion of patients is oral or esophageal candidiasis. This AE has been described in most clinical trials of swallowed topical steroids for EoE. In this trial, occurrence of esophageal candidiasis occurred in less than 5% of patients. Potential effects on adrenal function are being carefully monitored in the ongoing maintenance trial.
GASTRO CON: What is the key message for gastroenterologists from the study?
IH: The key message is that budesonide oral suspension, a formulation specifically designed for esophageal delivery, significantly improved symptoms, endoscopic abnormalities, and histopathology in the largest clinical trial conducted in EoE. While several prior studies have demonstrated histologic efficacy of swallowed topical corticosteroids, this is the first phase 3 trial in the United States and the first to use a validated, disease-specific patient-reported outcome instrument to demonstrate symptom efficacy.
Hirano I, Collins MH, Katzka DA, et al. Efficacy of budesonide oral suspension for eosinophilic esophagitis in adolescents and adults: results from a phase 3, randomized, placebo-controlled trial [abstract 350]. Am J Gastroenterol. 2019;114(2019 ACG Annual Meeting Abstracts):S205-S206. doi:10.14309/01.ajg.0000590932.88962.0b.
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