Ikuo Hirano, MD, FACG: Budesonide Oral Suspension for Eosinophilic Esophagitis

At the American College of Gastroenterology Annual Scientific Meeting (ACG 2019), Ikuo Hirano, MD, FACG, professor of medicine at Northwestern University, presented phase 3 results of budesonide oral suspension for the treatment of eosinophilic esophagitis. In an interview with MD Magazine®, Hirano discusses the current treatment landscape for eosinophilic esophagitis and why new treatment agents are needed.

MD Magazine®: What is the current treatment landscape for eosinophilic esophagitis, including the gaps in treatment?

Hirano: Currently there are a number of therapeutic options that we have for patients with eosinophilic esophagitis or EOE. Unfortunately, however, there are no FDA-approved medical therapies for eosinophilic esophagitis so all of our therapies are being done off-label. The therapeutic options do include elimination diets, getting rid of common food allergens from the patients’ diets as a way to treat patients. Another strategy is using proton pump inhibition, or PPIs, which are effective in about 30 to 50% of patients. And 1 of the mainstays for patients in 2019 is the use of swallow topical corticosteroids. But these medications were designed for asthma so they're being used off-label for eosinophilic esophagitis.

MD Magazine®: Can you summarize the key findings of the research presented at ACG 2019?

Hirano: The data that I presented today was on budesonide oral suspension. It is the first phase 3 trial ever to be conducted and completed in the United States. The study did demonstrate its 2 co-primary efficacy end points, that being a symptom improvement and histologic efficacy. It's the first phase 3 trial, again, to be conducted and completed in the US; it’s actually also the largest EOE trial ever conducted globally, and also the first trial to ever use a validated patient reported outcome instrument as a primary outcome for eosinophilic esophagitis.

MD Magazine®: What is the next step in this line of research?

Hirano: In terms of regulatory approval, this was an induction trial that I presented today, a 12-week trial showing the efficacy of the co-primary end points. The study is continuing now to a second phase, which is the maintenance trial that is going on for 36 weeks.

The study, Efficacy of Budesonide Oral Suspension for Eosinophilic Esophagitis in Adolescents and Adults: Results From a Phase 3, Randomized, Placebo-Controlled Trial, was presented Monday, October 28, 2019, at ACG 2019 in San Antonio, Texas.