Effect of randomized treatment withdrawal of budesonide oral suspension on clinically relevant efficacy outcomes in patients with eosinophilic esophagitis: a post hoc analysis.

ABSTRACT:

Background

Relapse after corticosteroid withdrawal in eosinophilic esophagitis is not well understood.

Objectives

Budesonide oral suspension (BOS) 2.0 mg twice daily (b.i.d.) was evaluated in two consecutive phase III studies (12 and 36 weeks, respectively). For clinicopathologic responders after 12 weeks of BOS treatment, we assessed randomized treatment withdrawal for up to 36 weeks of therapy.

Design

Post hoc analysis of a phase III, double-blind, randomized withdrawal study.

Methods

Clinicopathologic responders (⩽6 eosinophils per high-power field (eos/hpf) and ⩾30% reduction in Dysphagia Symptom Questionnaire (DSQ) score from baseline) after 12 weeks of BOS were randomized to continue BOS 2.0 mg b.i.d. (BOS-BOS) or withdraw to placebo (PBO; BOS-PBO) for up

SUBMITTER: Dellon ES 

PROVIDER: S-EPMC11672502 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature