一项随机双盲安慰剂对照第二期研究的结果表明,伊普塔科班可以作为IgA脏病的替代补充途径抑制剂
Hong Zhang1, Dana V Rizk2, Vlado Perkovic3
1Renal Division, Peking University First Hospital, Peking University Institute of Nephrology, Beijing, People's Republic of China.
Kidney international
|November 1, 2023
概括
伊普塔科潘通过抑制替代补充途径,显著降低了IGAN患者的蛋白尿症. 这种口服药物表现出剂量依赖的效果,支持其在3期试验中的进一步评估.
科学领域:
- 腎臟病學 (nephrology) 是一種醫學專業.
- 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:
- 免疫球蛋白A脏病 (IgAN) 病原发生涉及替代补充路径.
- 准这种途径为IgAN提供了一个治疗机会.
- 伊普塔科潘是一种口服抑制剂,在替代补充途径中向B因子.
研究的目的:
- 评估伊普塔科潘与安慰剂对IgAN患者蛋白尿的剂量反应关系.
- 评估与伊普塔科潘治疗相关的疗效,安全性和生物标志物变化.
- 为了支持IgAN的iptacopan的进一步临床开发.
主要方法:
- 进行了一项随机,双盲,自适应的第二阶段研究 (NCT03373461).
- 活检确认IGAN的患者接受了伊普塔科班 (10-200毫克两次) 或安慰剂3个月或6个月.
- 主要终点是3个月后24小时尿蛋白与肌素比率 (UPCR) 的变化.
主要成果:
- 观察到一个统计学上显著的剂量反应效应,在3个月后,用iptacopan 200 mg bid.降低了23%的UPCR.
- 蛋白尿减少在较高的伊普塔科潘剂量组中持续了6个月.
- 发现了补充生物标志物的持续抑制和iptacopan耐受良好的安全概况.
结论:
- 伊普塔科潘在IGAN患者中显示出显著和持续的蛋白尿减少.
- 该药物有效地抑制了替代补充途径,具有有利的安全性.
- 这些发现支持伊普塔科潘进入IgAN治疗的第三阶段临床试验.
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