皮肤性狼试验的亚型和种族红疹变异
Lillian Xie1,2, Daniella Forman Faden1,2, Caroline J Stone1,2
1Corporal Michael J. Crescenz Veterans Affairs Medical Center, Philadelphia, Pennsylvania.
JAMA dermatology
|December 4, 2024
概括
皮肤性红斑狼 (CLE) 试验中的红斑得分因种族和亚型而异,可能不包括黑人患者. 通过与皮肤性狼红疹病区和严重性指数 (CLASI) 进行标准化,可以提高试验多样性.
科学领域:
- 皮肤病学 皮肤病学
- 临床研究 临床研究
- 免疫学 免疫学 免疫学
背景情况:
- 监管指导和标准化结果措施对于改善皮肤性红斑狼 (CLE) 临床试验设计至关重要.
- 在CLE试验中增强参与者多样性对于结果的概括性至关重要.
研究的目的:
- 评估CLE亚型和种族/族裔群体之间的红斑呈现变异性.
- 为了确定这些变化是否会影响患者在以红为重点的临床试验中的资格.
主要方法:
- 一项横截面研究分析了宾夕法尼亚大学CLE数据库 (2007-2023) 中377名CLE患者的数据.
- 红疹被量化使用皮肤性狼发疹疾病区域和严重性指数 (CLASI) -活动得分,分类为粉红色 (1.00-1.49) 或红色 (≥1.50) 作为皮肤性狼活动调查员全球评估 (CLA-IGA) 的替代品.
- 分析的重点是种族,种族和CLE亚型.
主要成果:
- 在CLE亚型中观察到显著的红血瘤差异 (SCLE和高变性CCLE主要是"红色").
- 与黑人患者和其他种族相比,白人患者的"红色"红血热得分较高,这些患者主要是"粉红色"的.
- 在符合CLASI入学标准的患者中 (得分≥8),较高比例的黑人患者患有"粉红色"红血热 (42%) 与白人患者 (24%) 相比,这表明可能会排除试验.
结论:
- 使用CLA-IGA尺度的平均红斑评分限制了试验资格,特别是按种族和亚型.
- 这些发现支持使用CLASI作为CLE试验中红血瘤评估的主要工具.
- 通过CLASI进行标准化,可以在皮肤性红斑狼研究中增强多样化的代表性.
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