验证3分和5分严重程度尺度来评估ARIA-E的有效性
Luc Bracoud1, Gregory Klein2, Marco Lyons3
1Clario, Inc. (formerly Bioclinica, Inc.) Lyon France.
Alzheimer's & dementia (Amsterdam, Netherlands)
|November 29, 2023
概括
新的评级尺度SSAE-3和SSAE-5准确地评估了接受抗粉样β单克隆抗体治疗的阿尔茨海默病患者的ARIA-E严重程度. 这些尺度表现出读者高度认可,支持其在临床实践中的使用.
科学领域:
- 神经学 神经学
- 放射学 放射学是一门学科.
- 药理学 药理学是指药理学的学科.
背景情况:
- 抗粉样β (Aβ) 单克隆抗体 (mAbs) 是新兴的阿尔茨海默病 (AD) 治疗方法.
- 这些疗法需要MRI监测粉样蛋白相关的成像异常- (ARIA-E).
- 对于临床和研究环境,需要一个简单的,标准化的ARIA-E严重性评级系统.
研究的目的:
- 提交和验证ARIA-E的3分严重程度尺度 (SSAE-3) 和ARIA-E的5分严重程度尺度 (SSAE-5).
- 评估这些尺度的读者间和读者内部可靠性,以对ARIA-E进行分级.
主要方法:
- 分析了75名参与甘鲁马布AD试验 (SCarlet RoAD,Marguerite RoAD) 的MRI数据.
- 三位经验丰富的神经放射学家独立使用SSAE-3和SSAE-5对ARIA-E进行了评级.
- 一位评级人员进行了第二次读取,以评估读取器内可重复性.
主要成果:
- 在SSAE-3和SSAE-5的三个评级者之间观察到高度一致.
- 对于SSAE-3来说,读者间一致性 (Cohen/Fleiss kappa) 是0.79,而对于SSAE-5来说是0.73.
- 读者内部一致性 (kappa) 很高,SSAE-3的0.94和SSAE-5的0.90.
结论:
- 在临床实践中,SSAE-3和SSAE-5是评估ARIA-E严重性的有效和可靠的工具.
- 这些尺度有助于在阿尔茨海默病中持续监测抗Aβ mAb疗法.
- 广泛采用SSAE-3/-5可以支持扩大抗粉样蛋白抗体用于AD治疗的使用.
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