仑卡奈单抗在新加坡：早期阿尔茨海默病的适当使用建议。
完整摘要 · 中文译文
引言：Lecanemab是一种靶向β-淀粉样蛋白寡聚体、原纤维和不溶性纤维的单克隆抗体，基于3期Clarity AD研究，已在新加坡获批用于阿尔茨海默病（AD）的治疗。本文中，新加坡本地化的适当使用建议（AURs）旨在帮助新加坡医生识别可能从治疗中获益的患者，同时确保有效的监测。 方法：AURs基于新加坡获批的处方信息，结合lecanemab 2期和3期临床试验及截至2026年4月的真实世界数据制定。 结果：启动lecanemab治疗的决定应基于对个体的仔细评估，包括使用新加坡验证的认知状态测试来识别由AD所致的轻度认知障碍（MCI）和轻度AD痴呆。其他重要评估包括基线脑磁共振成像（MRI）、载脂蛋白E ε4（APOEε4）基因型评估以及淀粉样蛋白病理学确认。本文提供了关于识别治疗期间淀粉样蛋白相关影像学异常（ARIA）风险增加的患者以及其他需要额外谨慎的患者特征的指导。文中还包括对患者监测、输注相关反应管理以及确定lecanemab停药情况的建议。 结论：Lecanemab仅应在仔细的临床评估确认AD病理后，用于由AD所致的MCI或轻度AD痴呆患者，对ARIA风险增加的患者（如APOEε4基因携带者）应谨慎使用。在治 治疗期间，患者应接受对ARIA症状的定期监测，包括随访MRI扫描。未来方向包括建立新加坡专属登记系统以监测患者并收集长期数据，从而支持一个共识驱动的框架，为在新加坡告知和优化lecanemab的使用提供依据。
完整摘要 · 英文原文
INTRODUCTION: Lecanemab, a monoclonal antibody targeting β-amyloid oligomers, protofibrils, and insoluble fibrils, has been approved for Alzheimer's disease (AD) treatment in Singapore, based on the phase 3 Clarity AD study. In this paper, the Singapore-adapted Appropriate Use Recommendations (AURs) serve to assist Singapore physicians in identifying patients who will likely benefit from treatment while ensuring effective monitoring. METHOD: The AURs are based on the Singaporeapproved prescribing information combined with lecanemab phase 2 and 3 clinical trials and real-world data up to April 2026. RESULTS: The decision to initiate lecanemab should be based on careful evaluation of individuals, including Singapore-validated cognitive status tests to identify mild cognitive impairment (MCI) due to AD and mild AD dementia. Other important evaluations include baseline brain magnetic resonance imaging (MRI), assessment of the apolipoprotein E ε4 (APOEε4) genotype, and amyloid pathology confirmation. Guidance on identifying patients at increased risk of amyloid-related imaging abnormalities (ARIA) during treatment and other patient profiles warranting additional caution is provided. Recommendations for monitoring patients, managing infusion-related reactions, and identifying lecanemab discontinuation scenarios are included. CONCLUSION: Lecanemab should only be prescribed for patients with MCI due to AD or mild AD dementia following careful clinical evaluation confirming AD pathology, with caution exercised in patients at increased ARIA risk (e.g. APOEε4 gene carriers). During treatment, patients should receive regular monitoring for ARIA symptoms including follow-up MRI scans. Future directions include the development of a Singapore-specific registry to monitor patients and gather long-term data to support a consensus-driven framework to inform and optimise the use of lecanemab in Singapore.