Clinical Edge

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

Topical budesonide effective for eosinophilic esophagitis in pivotal trial

Key clinical point: A novel swallowed formulation of budesonide resulted in significant histologic, symptomatic, and endoscopic improvement in eosinophilic esophagitis in a pivotal phase 3 trial.

Major finding: Of patients randomized to budesonide oral suspension, 53% went from an average of 75 eosinophils per high-power field at baseline to 6 or fewer after 12 weeks of treatment, compared with 1% of placebo-treated controls.

Study details: This was a pivotal, phase 3, double-blind, placebo-controlled randomized trial including 318 adolescents and adults with eosinophilic esophagitis.

Disclosures: The presenter reported receiving research funding from and serving as a consultant to Takeda, the study sponsor, as well as a handful of other pharmaceutical companies.


Hirano I. ACG 2019, Abstract 1.