Initial Experience with Lecanemab and Lessons Learned in 71 Patients in a Regional Medical Center

L. B. E. Shields, H. Hust, S. D. Cooley, G. E. Cooper, R. N. Hart, B. C. Dennis, S. W. Freeman, J. F. Cain, W. Y. Shang, K. M. Wasz, A. T. Orr, C. B. Shields, S. S. Barve, Kenneth G. Pugh
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Abstract

Background and Objectives

On July 6, 2023 the U.S. Food and Drug Administration approved the anti-amyloid monoclonal antibody lecanemab (Leqembi®) for treatment of patients with mild cognitive impairment or mild dementia due to Alzheimer’s disease (AD). Our early experience and lessons learned with lecanemab in a regional community medical center are described.

Design, Setting, and Participants

This retrospective observational study highlights the first 71 patients treated with lecanemab at our multidisciplinary Norton Neuroscience Institute Memory Center. All patients had positive cerebrospinal fluid biomarkers for AD and underwent at least 1 lecanemab infusion. Two patients had additional amyloid PET scans which were positive.

Results

The mean age was 72 years (49–90 years), and 44 (62%) patients were female. Most were Caucasian (68 [96%]), and 54 [76%] were referred to our Memory Center by their primary care provider. Comorbidities were common, including hypertension (34 [48%]), hypercholesterolemia (51 [72%]), diabetes mellitus (17 [24%]), and cardiovascular disease excluding hypertension (22 [31%]). The mean body mass index was 27.0 (range: 17.8–45.0). A total of 36 (51%) patients were heterozygous for the ApoE4 genotype, and 9 (13%) were homozygous. A total of 61 [86%] patients had been treated with donepezil; 40 (56%) patients had received memantine. Of the 50 patients who completed 1 or more safety monitoring brain MRIs following infusion, 12 (24%) had amyloid-related imaging abnormalities (ARIA) detected: solitary ARIA-H (hemorrhage) in 5, solitary ARIA-E (edema) in 3, and both ARIA-H and ARIA-E in 4. Of the 12 patients with ARIA, 9 were asymptomatic, 4 were homozygous for the ApoE4 genotype, and 6 were heterozygous for the ApoE4 genotype. Of the 9 who were homozygous for the ApoE4 genotype in this study, 4 (44%) had evidence of ARIA. Of the 36 who were heterozygous for the ApoE4 genotype, 6 (17%) were diagnosed with ARIA. Twenty-six (37%) patients experienced infusion reactions after their first lecanemab infusion: headaches (12 patients) and shaking/chills/rigors (11 patients) were most common. Twenty-three (88%) of these 26 patients reported the side effects either at the infusion center or within the first 24 hours post-infusion. One patient died shortly after the first lecanemab infusion of a myocardial infarction. It is uncertain whether or not this death was related to lecanemab treatment.

Conclusion

Through our early experience with lecanemab, we have recognized several areas of improvement which have clarified and enhanced the lecanemab infusion experience.

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一家地区医疗中心 71 名患者使用来卡尼单抗的初步经验和汲取的教训
背景和目的2023年7月6日,美国食品和药物管理局批准了抗淀粉样蛋白单克隆抗体来卡尼单抗(Leqembi®),用于治疗阿尔茨海默病(AD)引起的轻度认知障碍或轻度痴呆患者。本回顾性观察研究重点介绍了诺顿神经科学研究所记忆中心多学科联合治疗的首批 71 例莱卡尼单抗患者。所有患者的 AD 脑脊液生物标志物均呈阳性,并接受了至少一次左卡尼单抗输注。结果平均年龄为 72 岁(49-90 岁),44 名(62%)患者为女性。大多数患者为白种人(68[96%]),54[76%]名患者由主治医生转介到我们的记忆中心。合并症很常见,包括高血压(34 [48%])、高胆固醇血症(51 [72%])、糖尿病(17 [24%])和心血管疾病(不包括高血压)(22 [31%])。平均体重指数为 27.0(范围:17.8-45.0)。共有 36 名患者(51%)为载脂蛋白 E4 基因型杂合子,9 名患者(13%)为同型杂合子。共有 61 名(86%)患者接受过多奈哌齐治疗;40 名(56%)患者接受过美金刚治疗。在输液后完成一次或多次安全性监测脑磁共振成像的 50 名患者中,有 12 人(24%)检测到淀粉样蛋白相关成像异常 (ARIA):5 人出现单发 ARIA-H(出血),3 人出现单发 ARIA-E(水肿),4 人同时出现 ARIA-H 和 ARIA-E。在 12 名 ARIA 患者中,9 人无症状,4 人是 ApoE4 基因型的同卵双生者,6 人是 ApoE4 基因型的异卵双生者。在本研究中,9 名 ApoE4 基因型的同卵双生者中,有 4 人(44%)有 ARIA 的证据。在 36 名 ApoE4 基因型杂合子患者中,有 6 人(17%)被诊断为 ARIA。26名患者(37%)在首次输注来卡尼单抗后出现了输注反应:最常见的反应是头痛(12名)和发抖/发冷/恶心(11名)。这 26 名患者中有 23 人(88%)在输液中心或输液后 24 小时内报告了副作用。一名患者在首次输注莱卡奈单抗后不久死于心肌梗死。结论通过使用利卡尼单抗的早期经验,我们认识到了几个需要改进的方面,这些改进澄清并改善了利卡尼单抗的输注体验。
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The Journal of Prevention of Alzheimer's Disease
The Journal of Prevention of Alzheimer's Disease Medicine-Psychiatry and Mental Health
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期刊介绍: The JPAD Journal of Prevention of Alzheimer’Disease will publish reviews, original research articles and short reports to improve our knowledge in the field of Alzheimer prevention including: neurosciences, biomarkers, imaging, epidemiology, public health, physical cognitive exercise, nutrition, risk and protective factors, drug development, trials design, and heath economic outcomes.JPAD will publish also the meeting abstracts from Clinical Trial on Alzheimer Disease (CTAD) and will be distributed both in paper and online version worldwide.We hope that JPAD with your contribution will play a role in the development of Alzheimer prevention.
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