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

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 diseases^3,4 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.