Lecanemab: A Second in Class Therapy for the Management of Early Alzheimer's Disease.

Innovations in pharmacy Pub Date : 2024-03-18 eCollection Date: 2024-01-01 DOI:10.24926/iip.v15i1.5787
Connie H Yoon, Corey Groff, Olivia Criss
{"title":"Lecanemab: A Second in Class Therapy for the Management of Early Alzheimer's Disease.","authors":"Connie H Yoon, Corey Groff, Olivia Criss","doi":"10.24926/iip.v15i1.5787","DOIUrl":null,"url":null,"abstract":"<p><p>The Food and Drug Administration granted traditional approval of lecanemab for the treatment of Alzheimer's disease (AD). Lecanemab is a humanized anti-amyloid monoclonal antibody directed towards Aβ protofibrils. Lecanemab is the only drug that targets Aβ soluble protofibrils and has shown statistical differences in mild AD or mild cognitive impairment. In its landmark phase III trial, lecanemab was shown to slow the progression of clinical decline, and a reduction in amyloid protein accumulation. The difference in mean CDR-SOB score improvement between the treatment and placebo groups was -0.45, of which the clinical significance could be argued. Amyloid burden was also considerably reduced as well, but the true clinical consequence of this reduction remains to be seen. This beneficial impact on daily living is offset by rare but serious side effects including amyloid-related imaging abnormalities (ARIA) causing cerebral edema (ARIA-E) or cerebral microhemorrhages or hemosiderin deposits (ARIA-H). Benefits of therapy must be considered against the risk of cerebral microhemorrhages and edema. Affordability must also be taken into consideration. The current estimated yearly cost for twice monthly lecanemab infusion is $26,500. In addition to the significant cost challenges, the frequent infusions may pose concerns related to access. Additional agents within this class are in the pipelines with possibly increased efficacy or decreased adverse events.</p>","PeriodicalId":501014,"journal":{"name":"Innovations in pharmacy","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2024-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11107961/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Innovations in pharmacy","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.24926/iip.v15i1.5787","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/1/1 0:00:00","PubModel":"eCollection","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0

Abstract

The Food and Drug Administration granted traditional approval of lecanemab for the treatment of Alzheimer's disease (AD). Lecanemab is a humanized anti-amyloid monoclonal antibody directed towards Aβ protofibrils. Lecanemab is the only drug that targets Aβ soluble protofibrils and has shown statistical differences in mild AD or mild cognitive impairment. In its landmark phase III trial, lecanemab was shown to slow the progression of clinical decline, and a reduction in amyloid protein accumulation. The difference in mean CDR-SOB score improvement between the treatment and placebo groups was -0.45, of which the clinical significance could be argued. Amyloid burden was also considerably reduced as well, but the true clinical consequence of this reduction remains to be seen. This beneficial impact on daily living is offset by rare but serious side effects including amyloid-related imaging abnormalities (ARIA) causing cerebral edema (ARIA-E) or cerebral microhemorrhages or hemosiderin deposits (ARIA-H). Benefits of therapy must be considered against the risk of cerebral microhemorrhages and edema. Affordability must also be taken into consideration. The current estimated yearly cost for twice monthly lecanemab infusion is $26,500. In addition to the significant cost challenges, the frequent infusions may pose concerns related to access. Additional agents within this class are in the pipelines with possibly increased efficacy or decreased adverse events.

莱卡单抗治疗早期阿尔茨海默病的第二类疗法。
美国食品和药物管理局批准了来卡尼单抗治疗阿尔茨海默病(AD)的传统疗法。来卡尼单抗是一种针对 Aβ 原纤维的人源化抗淀粉样蛋白单克隆抗体。乐卡单抗是唯一一种针对 Aβ 可溶性原纤维的药物,并且在轻度 AD 或轻度认知障碍中显示出统计学差异。在其具有里程碑意义的 III 期试验中,莱卡奈单抗被证明可以减缓临床衰退的进展,并减少淀粉样蛋白的积累。治疗组和安慰剂组的平均 CDR-SOB 评分改善差异为-0.45,其临床意义不言而喻。淀粉样蛋白负荷也大大减少,但这种减少的真正临床后果仍有待观察。淀粉样蛋白相关成像异常(ARIA)导致脑水肿(ARIA-E)或脑微出血或血色素沉积(ARIA-H)等罕见但严重的副作用抵消了对日常生活的有益影响。必须将治疗的益处与脑微量出血和水肿的风险结合起来考虑。还必须考虑到经济承受能力。目前,每月两次输注莱卡奈单抗的估计年费用为 26,500 美元。除了成本方面的巨大挑战外,频繁输注还可能带来与获取相关的问题。该类别中的其他药物正在研发过程中,可能会提高疗效或减少不良反应。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
自引率
0.00%
发文量
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信