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.

中文翻译：

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食管扩张史对接受布地奈德口服混悬液的嗜酸性粒细胞性食管炎患者疗效结果的影响。


引言 食管扩张史对接受吞咽皮质类固醇的嗜酸性粒细胞性食管炎 （EoE） 患者疗效结果的影响尚不明确。方法 这项事后分析评估了一项为期 12 周、随机、双盲、安慰剂对照的 3 期研究 （NCT02605837） 的数据，该研究在 11-55 岁的 EoE 和吞咽困难患者中口服混悬液 （BOS） 2.0 mg，每天两次。共同主要疗效结局是第 12 周的组织学 （≤ 6 个嗜酸性粒细胞/高倍视野 [eos/hpf]）和吞咽困难症状 ≥（吞咽困难症状问卷评分较基线降低 30%） 反应。次要疗效结局包括组织学反应 （<， 15 eos/hpf） 和吞咽困难症状问卷评分和 EoE 内窥镜参考评分从基线到第 12 周的变化。事后通过食管扩张史 （扩张史与无扩张史） 分析数据。结果 在接受 ≥ 1 剂研究药物的 318 例患者中，42.8% 有食管扩张史（扩张史：BOS，n = 91;安慰剂，n = 45;无扩张史：BOS，n = 122;安慰剂，n = 60）。无论扩张史如何，组织学反应 （≤ 6 和 < 15 eos/hpf） 都是相似的。与无扩张史相比，接受 BOS 治疗的有扩张史的患者获得吞咽困难症状反应的患者更少 （44.0% vs 59.0%）;相反，观察到有扩张史的 BOS 治疗患者的总 EoE 内窥镜参考评分较基线略大于无扩张史的患者（最小二乘平均值 [平均值的 SE]：-4.1 [0.3] vs -3.4 [0.4]）。 讨论 食管扩张史可能会混淆接受吞咽皮质类固醇的 EoE 患者的组织学结局与吞咽困难症状或内窥镜疗效结局之间的关联。