Corporal Michael J. Crescenz Veterans Affairs Medical Center, Philadelphia, Pennsylvania; Department of Dermatology, University of Pennsylvania, Philadelphia, Pennsylvania.
Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, Pennsylvania.
J Am Acad Dermatol. 2021 Jun;84(6):1562-1567. doi: 10.1016/j.jaad.2020.07.047. Epub 2020 Jul 16.
Outcome measures of clinical trials in cutaneous lupus erythematosus (CLE) should reflect clinically meaningful improvement in disease activity, as measured by the Cutaneous Lupus Disease Area and Severity Index activity score (CLASI-A).
We aimed to define the degree of improvement in disease activity meaningful to a patient's quality of life.
The change in the CLASI-A in 126 patients needed to predict meaningful change in QoL, as defined by the Emotions and Symptoms subscales of the Skindex-29, was evaluated by linear regression models.
In patients with an initial CLASI-A of ≥8, a 42.1% or ≥7-point and a 31.0% or ≥5-point decrease in CLASI-A predicts meaningful improvement in the Emotions and the Symptoms subscales, respectively.
This is a retrospective study of prospectively collected data at a single site.
A CLASI-A score of ≥8 for trial entry allows for inclusion of patients with milder disease where CLASI-A improvement by ≥50% is clinically significant and meaningful.
皮肤红斑狼疮（CLE）临床试验的疗效指标应反映疾病活动度的临床意义改善，这可通过皮肤狼疮疾病面积和严重程度指数活动评分（CLASI-A）来衡量。
我们旨在确定对患者生活质量有意义的疾病活动改善程度。
通过线性回归模型评估了 126 例患者的 CLASI-A 变化，以预测 Skindex-29 的情绪和症状子量表定义的 QoL 有意义的变化。
在初始 CLASI-A≥8 的患者中，CLASI-A 降低≥7 分或≥42.1%，以及 CLASI-A 降低≥5 分或≥31.0%，分别预示情绪和症状子量表有意义的改善。
这是一项在单个地点前瞻性收集数据的回顾性研究。
试验纳入 CLASI-A 评分≥8 的患者可纳入疾病较轻的患者，CLASI-A 改善≥50%具有临床意义和重要性。
