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在IgA脏病中使用Iptacopan抑制替代补充途径.

Vlado Perkovic1, Jonathan Barratt2, Brad Rovin3

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概括

伊普塔科潘在IgA脏病患者中显著降低了蛋白尿. 这种口服药物针对替代补充途径,在3期试验中显示出具有临床意义的益处.

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科学领域:

  • 腎臟病學 (nephrology) 是一種醫學.
  • 免疫学 免疫学 免疫学
  • 药理学 药理学是指药理学的学科.

背景情况:

  • 替代补充途径与IgA脏病 (IgAN) 病原发生有关.
  • 伊普塔科潘是一种口服药物,通过与B因子结合来抑制替代补充路径.

研究的目的:

  • 评估伊普塔科班在降低成年IgA脏病患者蛋白尿的疗效和安全性.
  • 评估与安慰剂相比,伊普塔科潘对9个月后24小时尿蛋白与肌素的比率的影响.

主要方法:

  • 第三阶段,双盲,随机,安慰剂对照试验.
  • 活检确认的Igan和蛋白尿症 (24小时尿中蛋白与肌素比率≥1) 的成年人被随机分为1:1接受口服伊普塔科潘 (200毫克) 或安慰剂,每天两次,持续24个月.
  • 主要终点:第9个月24小时尿蛋白与肌素比率的变化.

主要成果:

  • 在9个月后对250名患者进行的一项临时分析显示,用iptacopan与安慰剂 (P<0.001) 治疗时,调整后的几何平均蛋白尿减少了38.3%.
  • 二级终点支持蛋白尿的减少.
  • 与安慰剂相比,伊普塔科潘的耐受性很好,没有意外的安全发现,与安慰剂相比,类似的不良事件发生率.

结论:

  • 与安慰剂相比,伊普塔科潘在IgA脏病患者中显著降低了蛋白尿症.
  • 观察到的减少在临床上是有意义的,这表明伊普塔科潘是IgAN的潜在治疗方法.