药物开发 药物开发
Armen Moughamian1, Shawn Kile2, Jane Kim1
1Ray Dolby Brain Health Center, Sutter Health, San Francisco, CA, USA.
Alzheimer's & dementia : the journal of the Alzheimer's Association
|December 25, 2025
概括
与临床试验相比,Lecanemab是一种新的阿尔茨海默氏症治疗方法,在社区环境中,与粉样蛋白相关的成像异常 (ARIA) 的发生率较低. 这表明lecanemab可以在专业中心之外安全地使用.
科学领域:
- 神经学 神经学
- 药理学 药理学是指药理学的学科.
- 临床医学 临床医学
背景情况:
- 莱卡尼马布是第一个FDA批准的阿尔茨海默氏症疾病修饰疗法.
- 与粉样蛋白相关的成像异常 (ARIA) 是与lecanemab治疗相关的显著副作用.
- 关于ARIA在临床实践中的真实频率和严重程度存在不确定性.
研究的目的:
- 总结在社区医疗保健系统中使用lecanemab治疗的经验.
- 评估lecanemab在现实患者队列中的安全性和耐受性.
- 将社区环境中的ARIA率与CLARITY-AD第三阶段试验的发现进行比较.
主要方法:
- 从2023年7月至2024年6月期间接受lecanemab的患者收集的数据.
- 符合条件是由FDA标签和适当使用建议决定的.
- 专注于至少6个月治疗lecanemab的患者,以捕捉ARIA的最高风险时期.
主要成果:
- 210名患者接受治疗 (平均年龄75岁,52%为女性);70%轻度认知障碍,30%轻度痴呆.
- 36%的人经历了输液反应 (大多是轻微的);14%的人停止了lecanemab.
- 15.7%的人经历了ARIA (13.8%的ARIA-H,7.6%的ARIA-E);8例严重的放射性ARIA;3例症状性ARIA病例.
结论:
- 莱卡尼马布可以在一个大型的社区医疗保健系统中安全地使用.
- 与CLARITY-AD试验相比,观察到更高的输液反应率,但较低的ARIA率.
- 在ApoE4非携带者和异构体中较低的ARIA率表明在社区环境中进行安全的管理.
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