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阿杜卡奴单抗(商品名为 Aduhelm)的获批可能基于对 PET 成像数据的误解。

Aducanumab (Marketed as Aduhelm) Approval Is Likely Based on Misinterpretation of PET Imaging Data.

机构信息

Department of Nuclear Medicine, Odense University Hospital, Odense, Denmark.

Department of Clinical Research, University of Southern Denmark, Odense, Denmark.

出版信息

J Alzheimers Dis. 2021;84(4):1457-1460. doi: 10.3233/JAD-215275.

DOI:10.3233/JAD-215275
PMID:34657891
Abstract

According to the FDA, aducanumab (Aduhelm), the recently approved anti-Alzheimer drug, reduces the level of cerebral amyloid plaques-a hallmark finding in patients with Alzheimer's disease-and this will result in a reduction in clinical decline. The authors of this article are not convinced that amyloid deposits are a hallmark of Alzheimer's disease and are of the opinion that the apparent reduction in amyloid accumulation following aducanumab treatment is likely instead a result of continued and advanced cerebral cell death and, thus, not a sign of improvement but of an even more advanced disease.

摘要

根据 FDA 的说法,最近批准的抗阿尔茨海默病药物 aducanumab(Aduhelm)可降低脑淀粉样蛋白斑块的水平——这是阿尔茨海默病患者的一个标志性发现——并由此导致临床衰退的减少。本文的作者并不认为淀粉样沉积物是阿尔茨海默病的一个标志性特征,他们认为在接受 aducanumab 治疗后淀粉样蛋白堆积的明显减少可能是由于持续的、更严重的脑细胞死亡造成的,因此,这不是改善的迹象,而是疾病更严重的表现。

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引用本文的文献

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Evaluating clinical meaningfulness of anti-β-amyloid therapies amidst amyloid-related imaging abnormalities concern in Alzheimer's disease.在阿尔茨海默病中存在淀粉样蛋白相关成像异常问题的情况下,评估抗β-淀粉样蛋白疗法的临床意义。
Brain Commun. 2024 Dec 3;6(6):fcae435. doi: 10.1093/braincomms/fcae435. eCollection 2024.
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MAD-microbial (origin of) Alzheimer's disease hypothesis: from infection and the antimicrobial response to disruption of key copper-based systems.MAD-微生物(起源的)阿尔茨海默病假说:从感染和抗菌反应到关键铜基系统的破坏
Front Neurosci. 2024 Oct 2;18:1467333. doi: 10.3389/fnins.2024.1467333. eCollection 2024.
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Alzheimer's Amyloid Hypothesis and Antibody Therapy: Melting Glaciers?
阿尔茨海默病淀粉样蛋白假说和抗体疗法:冰川消融?
Int J Mol Sci. 2024 Mar 31;25(7):3892. doi: 10.3390/ijms25073892.
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MRI Monitoring of Anti-Alzheimer Therapy Amyloid-Related Imaging Abnormalities: Due Diligence or Overkill?抗阿尔茨海默病治疗中淀粉样蛋白相关成像异常的MRI监测:尽职调查还是过度检查?
AJNR Am J Neuroradiol. 2023 Jan;44(1):E4-E5. doi: 10.3174/ajnr.A7702. Epub 2022 Dec 8.
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Amyloid PET: A Questionable Single Primary Surrogate Efficacy Measure on Alzheimer Immunotherapy Trials.淀粉样蛋白 PET:阿尔茨海默病免疫疗法试验中一个有争议的单一主要替代疗效指标。
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