Hirano Ikuo, Collins Margaret H, Katzka David A, Mukkada Vincent A, Falk Gary W, Terreri Brian, Boules Mena, Zhang Wenwen, Desai Nirav K, Dellon Evan S
Department of Medicine, Division of Gastroenterology and Hepatology, Kenneth C. Griffin Esophageal Center, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Department of Pediatrics, Division of Pathology and Laboratory Medicine, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.
Am J Gastroenterol. 2024 Nov 12;120(7):1502-1510. doi: 10.14309/ajg.0000000000003197.
The effect of esophageal dilation history on efficacy outcomes in patients with eosinophilic esophagitis (EoE) receiving swallowed corticosteroids is not well established.
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).
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]).
Esophageal dilation history may confound the association between histologic outcomes and dysphagia symptom or endoscopic efficacy outcomes in patients with EoE receiving swallowed corticosteroids.
嗜酸性食管炎（EoE）患者接受吞咽皮质类固醇治疗时，食管扩张史对疗效结果的影响尚未明确。
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，该研究针对11至55岁患有EoE和吞咽困难的患者，每日两次服用2.0毫克布地奈德口服混悬液（BOS）。共同主要疗效指标为第12周时的组织学反应（每高倍视野嗜酸性粒细胞≤6个[eos/hpf]）和吞咽困难症状反应（吞咽困难症状问卷评分较基线降低≥30%）。次要疗效指标包括组织学反应（<15 eos/hpf）以及从基线到第12周吞咽困难症状问卷评分和EoE内镜参考评分的变化。根据食管扩张史（有扩张史与无扩张史）进行事后数据分析。
在接受≥1剂研究药物的318例患者中，42.8%有食管扩张史（有扩张史：BOS组，n = 91；安慰剂组，n = 45；无扩张史：BOS组，n = 122；安慰剂组，n = 60）。无论扩张史如何，组织学反应（≤6和<15 eos/hpf）相似。有扩张史的BOS治疗患者实现吞咽困难症状反应的比例低于无扩张史患者（44.0%对59.0%）；相反，有扩张史的BOS治疗患者从基线到第12周的总EoE内镜参考评分改善略大于无扩张史患者（最小二乘均值[均值标准误]：-4.1[0.3]对-3.4[0.4]）。
食管扩张史可能会混淆接受吞咽皮质类固醇治疗的EoE患者组织学结果与吞咽困难症状或内镜疗效结果之间的关联。
