Clinical Features at Baseline Cannot Predict Symptom Response to Placebo in Patients With Eosinophilic Esophagitis

Ikuo Hirano, Evan S. Dellon, Margaret H. Collins, James Williams, Lan Lan, David A. Katzka

Research output: Contribution to journalShort surveypeer-review

3 Scopus citations

Abstract

Eosinophilic esophagitis (EoE) is a chronic, immune-mediated disease characterized by ≥15 eosinophils per high-power field (eos/hpf) and esophageal dysfunction.1 One confounder in the assessment of drug efficacy in clinical trials for EoE2 and other gastrointestinal diseases3,4 has been the symptomatic response to placebo. In placebo-controlled, randomized trials of EoE therapies, placebo response rates as high as 78% have been reported.2 To mitigate placebo effect, a phase 2, randomized, double-blind, placebo-controlled trial of budesonide oral suspension (BOS) was designed with a single-blind, placebo run-in to attempt to screen out placebo responders before randomization.5 The aim of this post hoc analysis was to identify clinical factors associated with a symptom response during the placebo run-in.

Original languageEnglish (US)
Pages (from-to)2126-2128.e1
JournalClinical Gastroenterology and Hepatology
Volume17
Issue number10
DOIs
StatePublished - Sep 2019

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

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