At ACG 2019, Ikuo Hirano, MD, FACG, presents phase 3 results of budesonide oral suspension for the treatment of 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.