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被动性阿尔茨海默氏症免疫疗法:一个有希望的还是不确定的选择?

Poul F Høilund-Carlsen¹, Mona-Elisabeth Revheim², Tommaso Costa³

¹Department of Nuclear Medicine, Odense University Hospital, Odense, Denmark; Department of Clinical Research, University of Southern Denmark, Odense, Denmark.

Ageing research reviews

|July 6, 2023

概括

美国食品和药物管理局 FDA

科学领域:

神经科学是一个神经科学.
药理学药理学是一个学科.
医疗成像医学成像

背景情况:

美国食品和药物管理局 (FDA) 对阿尔茨海默病 (AD) 治疗的两种抗粉样蛋白抗体 - - 阿杜卡努马布和莱卡内马布 (lecanemab) 给予了加速批准,引发了重大的辩论.
这些治疗向的是粉样质斑块,这是AD病理学的标志.
人们对这些新型治疗方法的有效性和安全性存在担忧.

研究的目的:

批判性地评估用于阿尔茨海默病随机临床试验中的抗粉样抗体的临床疗效和安全数据.
通过PET扫描测量粉样蛋白斑减少与实际临床益处之间的关系.
评估与粉样蛋白相关的成像异常 (ARIA) 和与这些治疗相关的大脑体积变化的发生率和影响.

主要方法:

随机临床试验的系统性文献综述,涉及八种针对阿尔茨海默病的抗粉样抗体.
分析的重点是报告的临床疗效,脑粉样蛋白去除 (PET扫描),ARIA (MRI) 和脑体积变化 (MRI).
评估粉样蛋白PET信号下降与报告的临床结果之间的相关性,考虑潜在的混因素.

主要成果:

多纳尼马布和莱卡尼马布显示了一些临床疗效,但结果伴随着显著的不确定性.
粉样蛋白PET信号的减少可能与粉样蛋白的去除没有直接相关,这可能反映了与治疗有关的脑损伤.
观察到ARIA的发病率增加和报告的大脑体积减少,这表明与这些治疗相关的潜在风险.

结论:

目前关于阿尔茨海默病抗粉样抗体的益处风险概况的证据仍然不确定.
建议FDA暂停目前的批准并推迟新的批准,直到第4期试验数据可用.
倡导在正在进行和未来的试验中优先考虑特定的成像技术 (FDG PET,MRI用于ARIA和大脑体积损失) 和神经病理学检查.

关键词:

阿里亚阿里亚是什么意思阿尔茨海默氏症是阿尔茨海默氏症的一种疾病.粉样蛋白PET是一种PET.粉样蛋白-β 是一种蛋白质.大脑体积的大脑体积临床试验临床试验是指临床试验的临床试验.免疫治疗是一种免疫疗法.

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