Artur Menegaz de Almeida, Marianna Leite, Lucca Moreira Lopes, Pedro Gomes Lima, Maria Luísa Siegloch Barros, Samuel Rocha Pinheiro, Ítalo Andrade, Patrícia Viana, Victória Morbach, Gabriel Marinheiro, Ricardo de Oliveira, Agostinho C Pinheiro
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引用次数: 0
摘要
简介甘特宁单抗是一种针对早期阿尔茨海默病（AD）中淀粉样β蛋白（Aβ）的单克隆抗体。作者试图评估甘特宁单抗对早期AD患者的安全性和有效性：对MEDLINE、Embase和Cochrane数据库进行了系统检索，直至2023年12月2日。采用Mantel-Haenszel方法和95%置信区间（CI）对数据进行检验。进行了元回归分析，以评估基线临床痴呆评定量表-方框总和（CDR-SB）与随访时淀粉样蛋白相关成像异常（ARIA）之间可能存在的联系。统计分析使用 4.2.3 版 R：共纳入了 4 项 RCT 和 2848 名患者，其中 1580 人（55%）接受了皮下注射甘特纳单抗。在临床评分方面，安慰剂组的疾病评估量表（ADAS-Cog13）变化率更高（SMD -0.11；95% CI -0.19--0.03；p = 0.008569；I2 = 0%）。Gantenerumab与ARIA-E和ARIA-H的发生密切相关：分别为（19.67% vs. 2.31%；RR 9.46；95% CI 5.55-16.11；p = 2 = 10%）和（21.95% vs. 12.38%；RR 1.79；95% CI 1.50-2.13；p = 2 = 0%）：在这项荟萃分析中，一致的结果表明，甘特单抗对早期AD并不安全有效，对AD的临床评分没有改善，而且与ARIA-E和ARIA-H的发生有关。
Gantenerumab for early Alzheimer's disease: a systematic review and meta-analysis.
Introduction: Gantenerumab is a monoclonal antibody targeting amyloid β protein (Aβ) in early Alzheimer's disease (AD). The authors sought to evaluate gantenerumab safety and efficacy in early AD patients.
Methods: MEDLINE, Embase, and Cochrane databases were systematically searched until 2 December 2023. Data were examined using the Mantel-Haenszel method and 95% confidence intervals (CIs). Meta-regression analysis was conducted to evaluate a possible link between baseline Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) and amyloid-related imaging abnormalities (ARIA) at follow-up. R, version 4.2.3, was used for statistical analysis.
Results: A total of 4 RCTs and 2848 patients were included, of whom 1580 (55%) received subcutaneous gantenerumab. Concerning clinical scores, the placebo group achieved better rates of change in the Disease Assessment Scale (ADAS-Cog13) (SMD -0.11; 95% CI -0.19- -0.03; p = 0.008569; I2 = 0%). Gantenerumab was strongly associated with the occurrence of ARIA-E and ARIA-H: (19.67% vs. 2.31%; RR 9.46; 95% CI 5.55-16.11; p = <0.000001; I2 = 10%) and (21.95% vs. 12.38%; RR 1.79; 95% CI 1.50-2.13; p = <0.000001; I2 = 0%), respectively.
Discussion: In this meta-analysis, consistent results suggest that gantenerumab is not safe and efficient for early AD, showing no improvement in clinical scores for AD and being associated with the occurrence of ARIA-E and ARIA-H.
期刊介绍：
Expert Review of Neurotherapeutics (ISSN 1473-7175) provides expert reviews on the use of drugs and medicines in clinical neurology and neuropsychiatry. Coverage includes disease management, new medicines and drugs in neurology, therapeutic indications, diagnostics, medical treatment guidelines and neurological diseases such as stroke, epilepsy, Alzheimer''s and Parkinson''s.
Comprehensive coverage in each review is complemented by the unique Expert Review format and includes the following sections:
Expert Opinion - a personal view of the data presented in the article, a discussion on the developments that are likely to be important in the future, and the avenues of research likely to become exciting as further studies yield more detailed results
Article Highlights – an executive summary of the author’s most critical points
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