针对亚托皮性皮炎的严重程度范围:来自成人dupilumab随机临床试验的分析
Andreas Wollenberg1,2,3, Eric L Simpson4, Yael A Leshem5,6
1Department of Dermatology and Allergy, University Hospital Augsburg, Augsburg, Germany.
概括
通过使用临床试验数据,开发了针对亚托皮炎 (AD) 的新严重程度范围. 这些带有助于解释中度至重度AD的成年人疾病严重程度和分层.
科学领域:
- 皮肤病学 皮肤病学
- 临床试验 临床试验
- 生物统计学 生物统计学
背景情况:
- 亚托匹性皮肤炎 (AD) 的严重程度是用数值表来衡量的,用于更好地理解疾病负担,将其转换为严重程度的频段.
- 临床医生报告的结果 (ClinROs),如SCORAD和EASI,以及患者报告的结果 (PROs),如DLQI和POEM,是评估AD严重性的重要工具.
研究的目的:
- 建立针对亚托皮性皮肤炎 (AD) 措施的新型严重程度范围.
- 利用来自全球,随机,安慰剂控制的临床试验的大量数据集,对中度至重度AD的成年人进行dupilumab的临床试验.
主要方法:
- 从五项临床试验中收集了2822名成年人的疾病严重程度数据.
- 将ClinROs和PROs定在5级调查员全球评估和患者全球评估问卷上.
- 采用线回归和频率分析来定义五个严重程度类别的值;评估了适合性和一致性.
主要成果:
- 所有测量都显示出高度的适合性和与的强烈一致性 (R2: 0.981-0.999).
- 患者报告的结果 (PROs) 与先前的频段保持一致,而临床医生报告的结果 (ClinROs) 显示了不同的分层.
- 对于SCORAD睡眠损失视觉模拟尺度 (VAS) 的严重程度频段首次建立.
结论:
- 使用新的方法和强大的数据集,在中度至重度的AD成年人中开发了ClinROs和PROs的严重程度波段.
- 这些发现可以改善成人临床试验中AD严重程度的解释和分层.
- 生活质量与临床阿尔茨海默氏症严重程度指标的相关性中等,需要进一步验证临床实践.
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