表征早期阿尔茨海默病患者在美国开始莱卡耐单抗治疗的旅程：一个真实世界的证据研究。

IF 3.9 3区医学 Q1 CLINICAL NEUROLOGY

Neurology and Therapy Pub Date : 2025-06-01 Epub Date: 2025-05-04 DOI:10.1007/s40120-025-00756-4

Marwan N Sabbagh, Chenyue Zhao, Malena Mahendran, Se Ryeong Jang, François Laliberté, Hideki Toyosaki, Kaixin Zhang, Feride Frech, Kavita V Nair

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引用次数: 0

摘要

随着早期阿尔茨海默病（AD）疾病修饰疗法的出现，需要对美国启动lecanemab的患者进行全面表征，以了解其在现实环境中的应用。方法：这项回顾性观察性研究使用了科莫多研究数据库（2023年1月1日- 2024年6月30日）的行政声明。符合条件的患者有≥1次lecanemab给药（首次索赔定义索引日期），并且在索引日期之前有≥12个月的临床活动/保险资格。在索引日期（基线）前12个月内评估患者特征、诊断过程和ad相关药物，而在索引日期（随访）时或之后评估莱卡耐单抗治疗模式和伴随药物。使用描述性统计报告结果，使用Kaplan-Meier分析评估lecanemab的持久性。结果：纳入研究的3155例患者，平均年龄为75.0岁，女性55.8%，男性44.2%，大多数（93.3%）在城市环境中接受了他们的指数lecanemab给药。在基线时，AD（83.8%）和轻度认知障碍（60.8%）的诊断是常见的，67.6%的患者使用AD对症药物。在2023年1月（加速批准日期）或之后诊断的患者中，从最早诊断到首次给药的平均时间为4.9个月。平均随访138.8天，月平均给药次数为1.9次，连续给药时间平均为16.5天，至首次随访头部磁共振成像时间平均为47.4天。在治疗开始后4个月，莱卡耐单抗的持久性为87.6%。结论：根据美国食品和药物管理局批准的处方信息，在适当的患者人群中使用Lecanemab。我们的研究结果首次揭示了lecanemab在美国的实际使用情况，并阐明了增加和及时启动lecanemab以长期治疗早期AD的必要性。

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Characterizing the Journey of Early Alzheimer's Disease in Patients Initiating Lecanemab Treatment in the United States: A Real-World Evidence Study.

Introduction: With the advent of disease-modifying therapies for early Alzheimer's disease (AD), a comprehensive characterization of patients initiating lecanemab in the USA is needed to understand its use in real-world settings.

Methods: This retrospective observational study used administrative claims from the Komodo Research Database (1/1/2023-6/30/2024). Eligible patients had ≥ 1 lecanemab administration (first claim defined the index date) and ≥ 12 months of clinical activity/insurance eligibility before the index date. Patient characteristics, diagnostic process, and AD-related medications were evaluated within 12 months before the index date (baseline), whereas lecanemab treatment patterns and concomitant medications were evaluated on or after the index date (follow-up). Outcomes were reported using descriptive statistics and persistence to lecanemab was evaluated using Kaplan-Meier analysis.

Results: Of 3155 patients included in the study, mean age was 75.0 years, 55.8% were female, 44.2% were male, and most (93.3%) received their index lecanemab administration in an urban setting. Diagnoses of AD (83.8%) and mild cognitive impairment (60.8%) were common at baseline, and 67.6% of patients used AD symptomatic medications. Average time from earliest diagnosis to first lecanemab administration was 4.9 months among patients with a diagnosis in January 2023 (accelerated approval date) or onwards. Over a mean follow-up of 138.8 days, the monthly mean number of administrations of lecanemab was 1.9, with an average of 16.5 days between consecutive administrations and 47.4 days to the first follow-up head magnetic resonance imaging. Persistence to lecanemab was 87.6% at 4 months after treatment initiation.

Conclusion: Lecanemab was utilized in appropriate patient populations according to the prescribing information approved by the US Food and Drug Administration. Findings from our study provide first insights into the real-world use of lecanemab in the USA and shed light on the need for increased and timely lecanemab initiation for the long-term management of early AD.

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来源期刊

Neurology and Therapy CLINICAL NEUROLOGY-

CiteScore

5.40

自引率

8.10%

发文量

103

审稿时长

6 weeks

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