{"title":"我有什么好处?来卡尼单抗、多那尼单抗及其他抗β-淀粉样蛋白单克隆抗体对早期阿尔茨海默病的潜在临床影响。","authors":"Michelle Jin, James M Noble","doi":"10.1523/ENEURO.0088-24.2024","DOIUrl":null,"url":null,"abstract":"<p><p>A new era of disease-modifying therapy for Alzheimer's disease (AD) arrived in 2021 following the Food and Drug Administration's (FDA) decision to grant accelerated approval for aducanumab, an anti-β-amyloid (Aβ) monoclonal antibody designed to target Aβ aggregates, a biological component of AD. More recently, trial outcomes for lecanemab and donanemab, two additional antibodies of this drug class, have shown favorable and significant slowing of metrics for cognitive and functional decline. Lecanemab and donanemab have since received similar FDA approval to aducanumab in January 2023 and July 2024, respectively. Given that these therapies are a clearly emerging tool in the repertoire of clinicians treating AD and related dementias, a critical dialogue has been ongoing regarding the potential impacts and place for these therapies. Here, we seek to contextualize this debate by first considering factors involved in theoretically extrapolating current randomized control trial outcomes to estimate meaningful clinical impacts. In the process of this exercise, we outline a generally useful concept termed Summative Treatment-Associated Benefit measuring Long-term Efficacy/Effectiveness Area as a metric of summative benefits of treatment over the life course of an individual. Second, we consider current real-world factors, such as conditions of FDA approval and other points involved in clinical decision-making that will influence and/or temper the actual impacts of this drug class.</p>","PeriodicalId":11617,"journal":{"name":"eNeuro","volume":null,"pages":null},"PeriodicalIF":2.7000,"publicationDate":"2024-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11439562/pdf/","citationCount":"0","resultStr":"{\"title\":\"What's in It for Me? Contextualizing the Potential Clinical Impacts of Lecanemab, Donanemab, and Other Anti-β-amyloid Monoclonal Antibodies in Early Alzheimer's Disease.\",\"authors\":\"Michelle Jin, James M Noble\",\"doi\":\"10.1523/ENEURO.0088-24.2024\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>A new era of disease-modifying therapy for Alzheimer's disease (AD) arrived in 2021 following the Food and Drug Administration's (FDA) decision to grant accelerated approval for aducanumab, an anti-β-amyloid (Aβ) monoclonal antibody designed to target Aβ aggregates, a biological component of AD. More recently, trial outcomes for lecanemab and donanemab, two additional antibodies of this drug class, have shown favorable and significant slowing of metrics for cognitive and functional decline. Lecanemab and donanemab have since received similar FDA approval to aducanumab in January 2023 and July 2024, respectively. Given that these therapies are a clearly emerging tool in the repertoire of clinicians treating AD and related dementias, a critical dialogue has been ongoing regarding the potential impacts and place for these therapies. Here, we seek to contextualize this debate by first considering factors involved in theoretically extrapolating current randomized control trial outcomes to estimate meaningful clinical impacts. In the process of this exercise, we outline a generally useful concept termed Summative Treatment-Associated Benefit measuring Long-term Efficacy/Effectiveness Area as a metric of summative benefits of treatment over the life course of an individual. Second, we consider current real-world factors, such as conditions of FDA approval and other points involved in clinical decision-making that will influence and/or temper the actual impacts of this drug class.</p>\",\"PeriodicalId\":11617,\"journal\":{\"name\":\"eNeuro\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.7000,\"publicationDate\":\"2024-09-27\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11439562/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"eNeuro\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1523/ENEURO.0088-24.2024\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/9/1 0:00:00\",\"PubModel\":\"Print\",\"JCR\":\"Q3\",\"JCRName\":\"NEUROSCIENCES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"eNeuro","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1523/ENEURO.0088-24.2024","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/9/1 0:00:00","PubModel":"Print","JCR":"Q3","JCRName":"NEUROSCIENCES","Score":null,"Total":0}
引用次数: 0
摘要
2021 年,美国食品和药物管理局(FDA)决定加速批准阿杜单抗(aducanumab),这是一种抗β淀粉样蛋白(Aβ)的单克隆抗体,旨在靶向阿兹海默病(AD)的生物成分--Aβ聚集体,从而开启了阿尔茨海默病(AD)疾病改变疗法的新纪元。最近,莱卡奈单抗(lecanemab)和多那奈单抗(donanemab)这两款同类抗体的试验结果表明,认知和功能衰退的指标显著减缓,效果良好。莱卡奈单抗和多那奈单抗已分别于 2023 年 1 月和 2024 年 7 月获得类似于阿杜单抗的 FDA 批准。鉴于这些疗法显然是临床医生治疗注意力缺失症和相关痴呆症的新兴工具,关于这些疗法的潜在影响和地位的重要对话一直在进行。在此,我们首先考虑了从理论上推断当前随机对照试验结果以估计有意义的临床影响所涉及的因素,从而试图将这一争论背景化。在这一过程中,我们概述了一个普遍有用的概念,即衡量长期疗效/有效面积的总和治疗相关效益,作为个体生命过程中治疗总和效益的衡量标准。其次,我们考虑了当前的现实因素,如 FDA 批准条件和临床决策中涉及的其他要点,这些因素将影响和/或缓和该类药物的实际影响。
What's in It for Me? Contextualizing the Potential Clinical Impacts of Lecanemab, Donanemab, and Other Anti-β-amyloid Monoclonal Antibodies in Early Alzheimer's Disease.
A new era of disease-modifying therapy for Alzheimer's disease (AD) arrived in 2021 following the Food and Drug Administration's (FDA) decision to grant accelerated approval for aducanumab, an anti-β-amyloid (Aβ) monoclonal antibody designed to target Aβ aggregates, a biological component of AD. More recently, trial outcomes for lecanemab and donanemab, two additional antibodies of this drug class, have shown favorable and significant slowing of metrics for cognitive and functional decline. Lecanemab and donanemab have since received similar FDA approval to aducanumab in January 2023 and July 2024, respectively. Given that these therapies are a clearly emerging tool in the repertoire of clinicians treating AD and related dementias, a critical dialogue has been ongoing regarding the potential impacts and place for these therapies. Here, we seek to contextualize this debate by first considering factors involved in theoretically extrapolating current randomized control trial outcomes to estimate meaningful clinical impacts. In the process of this exercise, we outline a generally useful concept termed Summative Treatment-Associated Benefit measuring Long-term Efficacy/Effectiveness Area as a metric of summative benefits of treatment over the life course of an individual. Second, we consider current real-world factors, such as conditions of FDA approval and other points involved in clinical decision-making that will influence and/or temper the actual impacts of this drug class.
期刊介绍:
An open-access journal from the Society for Neuroscience, eNeuro publishes high-quality, broad-based, peer-reviewed research focused solely on the field of neuroscience. eNeuro embodies an emerging scientific vision that offers a new experience for authors and readers, all in support of the Society’s mission to advance understanding of the brain and nervous system.