Abstract
INTRODUCTION: The effect of esophageal dilation history on efficacy outcomes in patients with eosinophilic esophagitis (EoE) receiving swallowed corticosteroids is not well established. METHODS: This post hoc analysis assessed data from a 12-week, randomized, double-blind, placebo-controlled phase 3 study (NCT02605837) of budesonide oral suspension (BOS) 2.0 mg twice daily in patients aged 11-55 years with EoE and dysphagia. Coprimary efficacy outcomes were histologic (≤ 6 eosinophils per high-power field [eos/hpf]) and dysphagia symptom (≥ 30% reduction in Dysphagia Symptom Questionnaire scores from baseline) responses at week 12. Secondary efficacy outcomes included histologic response (< 15 eos/hpf) and change from baseline to week 12 in Dysphagia Symptom Questionnaire scores and EoE Endoscopic Reference Scores. Data were analyzed post hoc by esophageal dilation history (dilation history vs no dilation history). RESULTS: Of 318 patients who received ≥ 1 dose of study drug, 42.8% had a history of esophageal dilation (dilation history: BOS, n = 91; placebo, n = 45; no dilation history: BOS, n = 122; placebo, n = 60). Histologic responses (≤ 6 and < 15 eos/hpf) were similar regardless of dilation history. Fewer BOS-treated patients with dilation history than no dilation history achieved a dysphagia symptom response (44.0% vs 59.0%); conversely, a slightly greater improvement from baseline in total EoE Endoscopic Reference Scores was observed for BOS-treated patients with dilation history than no dilation history (least-squares mean [SE of the mean]: -4.1 [0.3] vs -3.4 [0.4]). DISCUSSION: Esophageal dilation history may confound the association between histologic outcomes and dysphagia symptom or endoscopic efficacy outcomes in patients with EoE receiving swallowed corticosteroids.