埃特拉西莫德作为对性食道炎 (VOYAGE) 的治疗方法:双盲,安慰剂控制,随机化,第二阶段试验
Evan S Dellon1, Margaret H Collins2, Albert J Bredenoord3
1Center for Esophageal Diseases and Swallowing, and Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA.
The lancet. Gastroenterology & hepatology
|May 17, 2025
概括
埃特拉西莫德显著改善了异氨基性食管炎,减少了异氨基细胞的峰值数量并改善了症状. 这项研究突出显示了黄素1-酸盐 (S1P) 受体调节作为这种疾病的有前途的治疗点.
科学领域:
- 免疫学和胃肠道学
- 药理学和药物开发领域
背景情况:
- 生性食管炎 (EoE) 是一种慢性免疫媒介炎症疾病,需要新的治疗策略.
- 埃特拉西莫德是一种选择性基-1-酸盐 (S1P) 1,4,5受体调节剂,正在开发用于免疫介导的炎症性疾病.
研究的目的:
- 评估与安慰剂相比,埃拉西莫德在患有性食道炎的成年患者中的疗效和安全性.
- 评估埃特拉西莫德在52周内对食道皮埃索诺菲尔数量峰值和疾病活性的影响.
主要方法:
- 这是一项为期24周,双盲,随机,安慰剂控制的第二阶段试验,涉及108名患有活性乙性食道炎的成年患者.
- 患者接受口服乙胺 (2毫克或1毫克) 或安慰剂,然后随意延长28周的时间.
- 主要终点是16周与基线相比,食道峰值乙酸细胞计数 (PEC) 的百分比变化.
主要成果:
- 与安慰剂相比,Etrasimod 2 mg在第16周显著降低了PEC (中位变化为-58.4%与-21.5%,p=0.010).
- 与安慰剂相比,Etrasimod 1 mg显示PEC的数值减少,但没有达到统计学意义.
- 胃肠道障碍是最常见的不良事件;胸肌梗塞事件是轻度/中度,没有报告严重的治疗不良事件或死亡.
结论:
- 埃特拉西莫德在52周的时间里显示出对酸性食道炎的持续性组织学和内学改善.
- 在没有食道扩张的患者中观察到症状改善,药物耐受性良好.
- 这项试验提供了S1P途径向的证据,作为一种可行的治疗策略,用于eosinophilic oesophagitis.
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