Aducanumab: Appropriate Use Recommendations.
Aducanumab: Appropriate Use Recommendations.
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DOI：
10.14283/jpad.2021.41
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发表时间：
2021
影响因子：
--
通讯作者：
Weiner M
中科院分区：
文献类型：
--
作者：
Cummings J;Aisen P;Apostolova LG;Atri A;Salloway S;Weiner M
Aducanumab已被美国食品和药物管理局批准用于治疗阿尔茨海默病（AD）。临床医生需要指导如何正确使用这种新疗法。组建了一个专家小组，以根据受试者人群、aducanumab关键试验的开展、更新的处方信息和专家共识构建适当使用建议。Aducanumab是一种淀粉样蛋白靶向单克隆抗体，通过每月静脉输注给药。关键性试验包括早期AD（AD所致轻度认知障碍和轻度AD痴呆）患者，他们已使用淀粉样蛋白正电子断层扫描证实脑淀粉样蛋白。专家组建议aducanumab的使用仅限于已研究疗效和安全性的人群。Aducanumab在6个月内滴定至10 mg/kg剂量。专家小组建议将aducanumab滴定至最高剂量，以最大限度地提高疗效。Aducanumab可显著增加淀粉样蛋白相关成像异常（ARIA）伴脑积液或出血的发生率。对于症状性ARIA和中重度ARIA，建议中断剂量或停止治疗。专家组建议在开始治疗前、药物滴定期间以及患者出现提示ARIA症状的任何时间进行MRI。建议的措施不那么繁琐，比那些在审判中使用的做法设置的有效性评估。专家小组强调，参与以患者为中心的知情决策过程至关重要，其中包括与患者和护理伙伴就治疗要求、治疗的预期结果、潜在风险和副作用、所需的安全性监测以及有关个人反应和获益的不确定性进行全面讨论和明确沟通。
Aducanumab has been approved by the US Food and Drug Administration for treatment of Alzheimer’s disease (AD). Clinicians require guidance on the appropriate use of this new therapy. An Expert Panel was assembled to construct Appropriate Use Recommendations based on the participant populations, conduct of the pivotal trials of aducanumab, updated Prescribing Information, and expert consensus. Aducanumab is an amyloid-targeting monoclonal antibody delivered by monthly intravenous infusions. The pivotal trials included patients with early AD (mild cognitive impairment due to AD and mild AD dementia) who had confirmed brain amyloid using amyloid positron tomography. The Expert Panel recommends that use of aducanumab be restricted to this population in which efficacy and safety have been studied. Aducanumab is titrated to a dose of 10 mg/kg over a 6-month period. The Expert Panel recommends that the aducanumab be titrated to the highest dose to maximize the opportunity for efficacy. Aducanumab can substantially increase the incidence of amyloid-related imaging abnormalities (ARIA) with brain effusion or hemorrhage. Dose interruption or treatment discontinuation is recommended for symptomatic ARIA and for moderate-severe ARIA. The Expert Panel recommends MRIs prior to initiating therapy, during the titration of the drug, and at any time the patient has symptoms suggestive of ARIA. Recommendations are made for measures less cumbersome than those used in trials for the assessment of effectiveness in the practice setting. The Expert Panel emphasized the critical importance of engaging in a process of patient-centered informed decision-making that includes comprehensive discussions and clear communication with the patient and care partner regarding the requirements for therapy, the expected outcome of therapy, potential risks and side effects, and the required safety monitoring, as well as uncertainties regarding individual responses and benefits.