多中心单盲随机对照试验Romiplostim生物类似药物
Anait L Melikyan1, Ekaterina A Protsenko2,3, Galina N Salogub4
1National Research Center for Hematology Moscow Russian Federation.
EJHaem
|July 25, 2025
概括
一种新的生物类似的罗米普洛斯蒂姆在治疗慢性免疫血小板缩 (ITP) 中,证明了与Nplate相当的疗效和安全性. 这一发现支持其作为ITP患者可比的治疗选择.
科学领域:
- 血液学 血液学 血液学
- 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:
- 免疫性血小板缺血 (ITP) 是一种慢性自身免疫性疾病,其特征是血小板数量较低.
- 罗米普洛斯蒂姆是一种用于增加ITP患者血小板生成的血小板受体激活剂.
- 生物类药物开发为更容易获得的治疗方案提供了潜力.
研究的目的:
- 与参考药物Nplate相比,评估罗米普洛斯生物类似剂 (GP40141) 的疗效和安全性.
- 确定生物类似药和参考药在患有持续性或慢性ITP的成年患者中的治疗等效性.
主要方法:
- 一个随机的,多中心的,单盲的,主动控制的III期等效性研究.
- 136名患有ITP的成年患者被随机分配1:1接受生物类似药或Nplate治疗26周.
- 主要终点:在第11周实现血小板反应 (≥50 × 109/L) 的患者比例.
主要成果:
- 在第11周,生物类似药组的78%患者和Nplate组的85%患者实现了血小板反应.
- 响应率的绝对差异为-0.06,处于[-0.225,0.225]的预定义等效率范围内.
- 两组之间没有观察到持久反应率,出血事件或安全性概况的显著差异.
结论:
- 罗米普洛斯蒂姆生物类似剂在治疗持续性或慢性ITP时,在治疗上相当于Nplate.
- 这项研究支持生物仿制药作为一种可比且有效的治疗选择.
- 生物仿制药的安全性概况与参考药物一致.
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