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在IgA脏病中使用sibeprenlimab - - 第三阶段试验的临时分析

Vlado Perkovic¹, Hernán Trimarchi², Vladimir Tesar³

¹University of New South Wales, Sydney.

The New England journal of medicine

|November 10, 2025

概括

西贝普伦利马布通过抑制细胞因子APRIL的作用显著降低了IgA脏病患者的蛋白尿症. 这种治疗显示出良好的安全性,为这种病提供了有前途的新疗法.

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 (IgA脏病) 是一种慢性病.
一种诱导增殖的配体 (APRIL) 是一个关键的细胞因子,与IgA瘤病变的发生有关.
西贝普伦利马布是一种新型单克隆抗体,旨在抑制APRIL.

研究的目的:

评估sibeprenlimab在IgA脏病患者的疗效和安全性.
评估西贝普伦利马布对蛋白尿和其他疾病标志物的影响.

主要方法:

一个第三期,多中心,双盲,随机,安慰剂对照试验.
活检确认的IgA脏病的成年人接受了西贝普伦利马布 (400毫克每4周一次皮下注射) 或安慰剂100周.
主要终点是9个月后24小时尿蛋白与肌素比率的变化.

主要成果:

与安慰剂相比,sibeprenlimab在9个月内显著降低了24小时泌尿蛋白与肌氨酸的比率,与安慰剂相比降低了50.2%.
用sibeprenlimab治疗导致APRIL和银河糖缺乏IgA1水平大幅降低.
西贝普伦利马布的安全性与安慰剂相当,没有报告死亡.

结论:

西贝普伦利马布有效地减少了IgA脏病患者的蛋白尿症.
药物抑制APRIL和致病性IgA1的能力表明有针对性的治疗机制.
西贝普伦利马布 (sibeprenlimab) 是IgA脏病的潜在新疗法,具有良好的安全性.

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