Department of Dermatology, University of Texas Southwestern Medical Center, Dallas, Texas, USA.
Lupus Sci Med. 2020 Jan 27;7(1):e000364. doi: 10.1136/lupus-2019-000364. eCollection 2020.
The severity and disease course of cutaneous lupus erythematosus (CLE) are highly variable. Consequently, outcome measures for CLE clinical improvement are heterogeneous, complicating treatment decisions and therapeutic development. This study characterises CLE outcome measures and identifies the influence of clinical improvement thresholds on strengths of associations with patient demographic and clinical factors.
In this pilot cohort study, multivariable models identified factors associated with CLE activity and skin damage improvement, defined as relative decreases in Cutaneous Lupus Activity and Severity Index (CLASI) activity (CLASI-A) and damage (CLASI-D) scores, over ranges of response thresholds.
66 patients with 119 visit-pairs were included in the CLASI-A analysis. 74 patients with 177 visit-pairs were included in the CLASI-D analysis. Factors associated with CLE activity and damage improvement depended on the response threshold. Some associations were stronger at more stringent thresholds, including subacute CLE predominance with increased likelihood of CLASI-A improvement (=0.73; 50% reduction: OR 1.724 (95% CI 0.537 to 5.536); 75%: 5.67 (95% CI 1.56 to 20.5)) and African-American race with decreased likelihood of CLASI-D improvement (=0.80; 20%: 0.40 (95% CI 0.17 to 0.93); 40%: 0.25 (95% CI 0.08 to 0.82)). Other associations were stable across multiple thresholds, including older age of CLE development with increased likelihood of CLASI-A improvement (=0.25; 50%: 1.05 (95% CI 1.01 to 1.09]; 75%: 1.05 (95% CI 1.00 to 1.10)) and higher initial disease activity with decreased likelihood of CLASI-D improvement (=0.55; 20%: 0.91 (95% CI 0.84 to 0.98); 40%: 0.88 (95% CI 0.79 to 0.97)).
Examining a range of CLASI threshold outcomes can comprehensively characterise changes in disease course in patients with CLE. Insufficiently stringent thresholds may fail to distinguish meaningful clinical change from natural fluctuation in disease activity.
皮肤红斑狼疮（CLE）的严重程度和病程变化多样。因此，CLE 临床改善的疗效评估指标也各不相同，这使得治疗决策和治疗开发变得复杂。本研究对 CLE 的疗效评估指标进行了描述，并确定了临床改善阈值对与患者人口统计学和临床因素关联强度的影响。
在这项初步队列研究中，多变量模型确定了与 CLE 活动和皮肤损伤改善相关的因素，定义为 Cutaneous Lupus Activity and Severity Index（CLASI）活动（CLASI-A）和损伤（CLASI-D）评分的相对下降，这些评分的下降范围对应不同的反应阈值。
CLASI-A 分析纳入了 66 例患者的 119 对就诊数据，CLASI-D 分析纳入了 74 例患者的 177 对就诊数据。与 CLE 活动和损伤改善相关的因素取决于反应阈值。一些关联在更严格的阈值下更强，包括亚急性 CLE 为主与 CLASI-A 改善的可能性增加（=0.73；50%降幅：OR 1.724（95%CI 0.537 至 5.536）；75%：5.67（95%CI 1.56 至 20.5））和非裔美国人种族与 CLASI-D 改善的可能性降低（=0.80；20%：0.40（95%CI 0.17 至 0.93）；40%：0.25（95%CI 0.08 至 0.82））。其他关联在多个阈值下保持稳定，包括 CLE 发病年龄较大与 CLASI-A 改善的可能性增加（=0.25；50%：1.05（95%CI 1.01 至 1.09）；75%：1.05（95%CI 1.00 至 1.10））和初始疾病活动度较高与 CLASI-D 改善的可能性降低（=0.55；20%：0.91（95%CI 0.84 至 0.98）；40%：0.88（95%CI 0.79 至 0.97））。
检查一系列 CLASI 阈值结果可以全面描述 CLE 患者疾病过程的变化。不严格的阈值可能无法区分疾病活动的自然波动与有意义的临床变化。
