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, Ikuo Hirano, Evan S Dellon, Margaret H Collins, James Williams, Lan Lan, David A Katzka
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.
Trial registration: ClinicalTrials.gov NCT01642212.
Copyright © 2019 AGA Institute. Published by Elsevier Inc. All rights reserved.
Source: PubMed