Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

Budesonide orodispersible tablets maintained remissions in EoE

Key clinical point: Long-term maintenance therapy with budesonide orodispersible tablets was safe and maintained clinicohistologic remissions of eosinophilic esophagitis.

Major finding: After 48 weeks, 51 patients in the 1-mg group (75%) and 50 patients in the 0.5 mg group (73.5%) remained in remission, compared with only three patients in the placebo group (4.4%; both P less than .0001).

Study details: Randomized, double-blind, placebo-controlled phase 3 trial of 204 adults in clinicohistologic remission after 6-12 weeks of twice-daily 1.0-mg budesonide orodispersible tablet induction therapy.

Disclosures: The study and editorial support were funded by Dr. Falk Pharma GmbH, a pharmaceutical company in Germany. Dr. Falk Pharma was involved in the study design and data collection, analysis, and interpretation and approved the final manuscript. Dr. Straumann disclosed fees from several pharmaceutical companies, including Dr. Falk Pharma and AstraZeneca, which makes budesonide. Several other coinvestigators also disclosed ties to Dr. Falk Pharma, AstraZeneca, and other pharmaceutical companies.

Citation:

Straumann A et al. Gastroenterology. 2020 July 25. doi: 10.1053/j.gastro.2020.07.039.

Commentary:

Eosinophilic esophagitis (EoE) continues to rise in prevalence and prescription steroid therapy is limited to off-label use leading to a call for action for directed therapy for EoE and understanding long-term remission rates. In this phase 3 study, Straumann and colleagues studied budesonide orodispersible tablets (BOTs) and their ability to maintain remission, compared with placebo, at two doses specifically designed for EoE in adults with proton pump inhibitor–refractory EoE. Regardless of dose, at either 1.0 mg twice a day or 0.5 mg twice a day, there was an improvement in maintaining remission (73.5% for low dose and 75% for high dose, compared with 4.4% with placebo) at 48 weeks of therapy. Common side effects studied include an increase in candidiasis (12%-16% of patients), but there was no statistical change in morning cortisol.

Given the need for maintenance therapy for EoE, this study proves long-term efficacy and safety for the treatment of this chronic condition with a targeted esophageal formulation. We now have evidence of maintaining remission for EoE with a safe side-effect profile. Future research will be needed to look at long-term steroid use on bone health and immune dysregulation, especially in the pediatric population, which was not studied in this cohort. Moreover, future studies are needed to determine a minimally effective dose to help prevent potential side effects that can maintain remission while allowing discontinuation of all stable proton pump inhibitor doses to ensure no confounding effect.

Rishi D. Naik, MD, MSCI, is an assistant professor, department of medicine, section of gastroenterology & hepatology, Esophageal Center at Vanderbilt University Medical Center, Nashville, Tenn. He has no conflicts.