Department of Neuropathology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Unit for Early and Exploratory Clinical Development, The University of Tokyo Hospital, Tokyo, Japan.
J Alzheimers Dis. 2024;101(4):1127-1132. doi: 10.3233/JAD-240623.
Anti-amyloid drugs for early Alzheimer's disease, including lecanemab, are associated with adverse events (AEs), such as amyloid-related imaging abnormalities (ARIA)-edema/effusion (E), ARIA-hemorrhage, and infusion-related reactions, which can indicate allocated arms in clinical trials. Herein, we evaluated the predictive value of AEs using a meta-analysis to estimate their incidence and simulated positive predictive value (PPV). The PPV for ARIA-E was high (0.915), but that for ARIA hemorrhage was low (0.630). Infusion-related reactions had a high PPV of 0.910, but with a wide confidence interval. Our results suggest the need to ameliorate the unblinding effects of AEs, particularly ARIA-E in trials.
用于早期阿尔茨海默病的抗淀粉样蛋白药物，包括 lecanemab，与不良事件 (AE) 相关，如淀粉样蛋白相关成像异常 (ARIA)-水肿/渗出 (E)、ARIA 出血和输注相关反应，这些反应可以指示临床试验中的分配臂。在此，我们使用荟萃分析评估 AE 的预测价值，以估计其发生率并模拟阳性预测值 (PPV)。ARIA-E 的 PPV 较高（0.915），但 ARIA 出血的 PPV 较低（0.630）。输注相关反应的 PPV 较高，为 0.910，但置信区间较宽。我们的研究结果表明，有必要减轻 AE 的去盲效果，特别是在试验中减轻 ARIA-E 的去盲效果。
