Pharmacokinetic evaluation of donanemab for the treatment of Alzheimer's.

Tanya Song, Yunfei Wang, Bret David Silverglate, George T Grossberg
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Abstract

Introduction: Donanemab is a humanized monoclonal antibody that significantly reduces cerebral amyloid plaques in Alzheimer's Disease (AD). It can delay disease progression and cognitive decline, making it one of the most promising disease-modifying treatments in the current treatment landscape.

Areas covered: This paper covers the current literature available on pharmacokinetics, pharmacodynamics, safety, and tolerability of donanemab. Publications from PubMed and Google were reviewed. A summary of regulatory approvals and current clinical data is also provided.

Expert opinion/commentary: Donanemab as a therapy for AD has more effective disease-modifying effects compared to lecanemab. Donanemab appears generally well-tolerated; however, it may have higher rates of severe side effects, such as amyloid-related imaging abnormalities (ARIA), that could lead to death. Guidelines for frequency of MRI monitoring for ARIA/safety are pending but will be integral to determining its use. Despite some limitations, donanemab is expected to receive FDA approval, giving clinicians access to another disease-modifying drug. Overall, more data is needed about donanemab, especially relating to safety, efficacy, cost, and integration with other treatments, but its development signifies progress in AD treatment.

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多奈单抗治疗阿尔茨海默氏症的药代动力学评估。
简介多奈单抗是一种人源化单克隆抗体,能显著减少阿尔茨海默病(AD)的脑淀粉样斑块。它可以延缓疾病进展和认知能力下降,是目前治疗领域中最有前景的疾病改变疗法之一:本文涵盖有关多那尼单抗的药代动力学、药效学、安全性和耐受性的现有文献。本文查阅了 PubMed 和 Google 上的文献。本文还概述了监管部门的批准情况和当前的临床数据:专家意见/评论:与莱卡内单抗相比,多那尼单抗作为一种AD疗法具有更有效的疾病改变作用。多奈单抗的耐受性总体良好,但其严重副作用(如淀粉样蛋白相关成像异常 (ARIA))的发生率较高,可能导致死亡。针对 ARIA/安全性的核磁共振成像监测频率指南尚未出台,但这将是决定其用途不可或缺的因素。尽管存在一些局限性,但多奈单抗有望获得美国食品药品管理局的批准,使临床医生获得另一种改变病情的药物。总的来说,donanemab 还需要更多的数据,尤其是与安全性、疗效、成本以及与其他治疗方法的整合有关的数据,但它的开发标志着 AD 治疗的进步。
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