Lecanemab Planning: Blueprint for Safe and Effective Management of Complex Therapies.

IF 2.3 Q3 CLINICAL NEUROLOGY

Neurology. Clinical practice Pub Date : 2024-12-01 Epub Date: 2024-08-30 DOI:10.1212/CPJ.0000000000200361

Rita Shane, Sarah Kremen, Zaldy S Tan, Hai Tran, Thanh G Tu, Nancy L Sicotte

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引用次数: 0

Abstract

Background: Approximately 6.9 million American individuals have Alzheimer dementia and 50% have mild disease. Lecanemab, an approved antiamyloid antibody, is associated with modest reduction in functional decline in patients with mild dementia or mild cognitive impairment. In Clarity-AD, 239 (26.6%) of patients experienced amyloid-related imaging abnormalities (ARIAs) overall (i.e., ARIAs associated with hemorrhages or edema). The complexity of treatment and risks of adverse events necessitate a multidisciplinary collaborative approach.

Recent findings: With limited treatment options, lecanemab approval generated significant interest among clinicians, patients, and families. Lecanemab treatment requires biweekly infusions along with ongoing imaging tests, laboratory monitoring, patient assessment, drug interaction screening, and cognitive function monitoring. Processes to support patient selection, access, and safety are important given the monitoring requirements and total cost of care.

Implications for practice: The planning process for lecanemab can serve as a blueprint to support safe and effective management of therapeutic innovation in neurology and other areas.

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来卡尼单抗规划：安全有效管理复杂疗法的蓝图。

背景介绍约有 690 万美国人患有阿尔茨海默痴呆症，其中 50% 患有轻度疾病。乐卡单抗是一种已获批准的抗淀粉样蛋白抗体，可适度减轻轻度痴呆或轻度认知障碍患者的功能衰退。在Clarity-AD中，239例（26.6%）患者总体上出现了淀粉样蛋白相关成像异常（ARIAs）（即与出血或水肿相关的ARIAs）。由于治疗的复杂性和不良事件的风险，有必要采取多学科合作的方法：最近的研究结果：由于治疗方案有限，莱卡单抗的批准引起了临床医生、患者和家属的极大兴趣。来卡尼单抗治疗需要每两周输注一次，同时进行持续的影像学检查、实验室监测、患者评估、药物相互作用筛查和认知功能监测。考虑到监测要求和护理总成本，支持患者选择、使用和安全的流程非常重要：Lecanemab 的规划过程可作为支持神经病学和其他领域安全有效管理治疗创新的蓝图。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Neurology. Clinical practice CLINICAL NEUROLOGY-

CiteScore

4.00

自引率

0.00%

发文量

期刊介绍： Neurology® Genetics is an online open access journal publishing peer-reviewed reports in the field of neurogenetics. The journal publishes original articles in all areas of neurogenetics including rare and common genetic variations, genotype-phenotype correlations, outlier phenotypes as a result of mutations in known disease genes, and genetic variations with a putative link to diseases. Articles include studies reporting on genetic disease risk, pharmacogenomics, and results of gene-based clinical trials (viral, ASO, etc.). Genetically engineered model systems are not a primary focus of Neurology® Genetics, but studies using model systems for treatment trials, including well-powered studies reporting negative results, are welcome.