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Oral Budesonide Superior to Placebo for EoE
Oral budesonide was well tolerated and showed superiority to placebo in improving histologic, endoscopic, and symptomatic outcomes among patients with eosinophilic esophagitis (EoE) in a phase 3 trial, according to investigators.
There is no current pharmacologic therapy for EoE approved by the US Food and Drug Administration, the authors noted.
The double-blind, placebo-controlled, phase 3 trial included 318 patients aged 11 to 55 years who were diagnosed with EoE and dysphagia. The patients were randomized 2:1 to receive either budesonide oral suspension (BOS) 2.0 mg twice daily (n = 213) or placebo (n = 105) for 12 weeks at academic or community care practices.
“Coprimary endpoints were the proportion of stringent histologic responders (≤6 eosinophils/high-power field) or dysphagia symptom responders (≥30% reduction in Dysphagia Symptom Questionnaire [DSQ] score) over 12 weeks,” the authors wrote. “Changes in DSQ score (key secondary endpoint) and EoE Endoscopic Reference Score (EREFS) (secondary endpoint) from baseline to week 12, and safety parameters were examined.”
More patients treated with BOS than those treated with placebo achieved a stringent histologic response (53.1% vs 1.0%; Δ52% [95% confidence interval (CI), 43.3%–59.1%]; P < .001) or symptom response (52.6% vs 39.1%; Δ13% [95% CI, 1.6%–24.3%]; P = .024) over 12 weeks. Patients who received BOS also showed greater improvements in least-squares mean DSQ scores and EREFS over 12 weeks than placebo-treated patients. Most adverse events were mild or moderate in severity.
“In patients with EoE, BOS 2.0 mg twice daily was superior to placebo in improving histologic, symptomatic, and endoscopic outcomes over 12 weeks. BOS 2.0 mg twice daily was well tolerated,” the authors concluded.
--Rebecca Mashaw
Reference:
Hirano I, Collins MH, Katzka, DA, et al. Budesonide oral suspension improves outcomes in patients with eosinophilic esophagitis: Results from a phase 3 trial. Clin Gastroenterol Hepatol. 2022;(20)3: 525-534. DOI: https://doi.org/10.1016/j.cgh.2021.04.022
Dr Rita Knotts from NYU-Langone Health discusses diagnosing and treating EoE in this video.
