*EMBARGOED All research presented at the 2019 ACG Annual Scientific Meeting and Postgraduate Course is strictly embargoed until Monday, October 28, 2019, at 8:00 am CDT.
Oral 1 Efficacy of Budesonide Oral Suspension for Eosinophilic Esophagitis in Adolescents and Adults: Results From a Phase 3, Randomized, Placebo-Controlled Trial
Author Insight from Ikuo Hirano, MD, FACG, Northwestern University Feinberg School of Medicine
What’s new here and important for clinicians?
The Budesonide Oral Suspension (BOS) abstract presents exciting, phase 3 data demonstrating the therapeutic efficacy of a novel, oral suspension of budesonide specifically designed for esophageal delivery for eosinophilic esophagitis. While several trials have documented the histologic efficacy of swallowed topical corticosteroids in EoE, most have been small trials using formulations intended for asthma. The randomized, placebo-controlled clinical trial of BOS represents the first phase 3 trial of an EoE therapy completed in the US. It is also the first trial to utilize a validated patient reported outcome (PRO) instrument to measure symptom improvement and the largest clinical trial ever conducted in EoE. The co-primary endpoints of histopathology (defined by <=6 eos/hpf) and symptoms were significantly improved with BOS. Furthermore, 62% of BOS patients met the threshold of < 15 eos/hpf compared to 1% of placebo patients.
For the clinician, the results of this Phase 3 trial offer the promise of a highly effective therapeutic agent that reduces mucosal inflammation in most EoE patients and improves both symptoms of dysphagia as well as the endoscopic abnormalities of EoE. The side effect profile was generally comparable between BOS and placebo. Longer-term efficacy and safety of BOS are being closely monitored in the context of an ongoing maintenance study of EoE.
What do patients need to know?
Although the prevalence of eosinophilic esophagitis (EoE) continues to rise, no medical therapies have yet been approved by the US FDA. The completion of this trial of a novel, liquid formulation of budesonide (Budesonide Oral Suspension, BOS) represents a milestone in drug development of EoE by being the first Phase 3 EoE trial completed in the US as well as the largest EoE trial ever conducted. The results of the BOS trial showed that BOS successfully treated both the symptoms and signs of EoE. The positive results will hopefully lead to an approved, safe and effective therapy for EoE.
Ikuo Hirano, MD, FACG, Northwestern University Feinberg School of Medicine
i-hirano [at] northwestern [dot] edu
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