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

*Corresponding author for this work

Research output: Contribution to journalShort survey

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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