Chakka Srita, Krain Rebecca L, Concha Josef Symon S, Chong Benjamin F, Merola Joseph F, Werth Victoria P
Corporal Michael J. Crescenz VAMC, Philadelphia, PA, USA.
Department of Dermatology, University of Pennsylvania, Philadelphia, PA, USA.
Ann Transl Med. 2021 Mar;9(5):431. doi: 10.21037/atm-20-5048.
Cutaneous lupus erythematosus (CLE) can present with or without features of systemic lupus erythematosus (SLE), with estimates of the incidence of isolated skin disease almost equaling the incidence of those with systemic disease. However, despite the impact CLE has on a patient's quality of life (QoL), there has been no US Food and Drug Administration (FDA) approved treatment for the disease in the past 50 years. In addition, patients with skin predominant LE are often excluded from clinical SLE trials. In the rare trials that include patients with skin predominant LE, disease activity and progression in the skin are often difficult to evaluate using multi-organ outcome measures. The need for new therapies for CLE and the lack of focus on skin outcomes has led to the development of the Cutaneous Lupus Disease Area and Severity Index (CLASI), a validated organ-specific outcome measure that is not only responsive to change in disease activity and damage but also correlated to changes in a patient's QoL. This paper will emphasize the extensive validation studies performed in developing the CLASI, as well as the importance of clinical trials using the CLASI to address the need for improved therapies for patients with lupus skin manifestations.
皮肤型红斑狼疮（CLE）可伴有或不伴有系统性红斑狼疮（SLE）的特征，据估计，单纯皮肤疾病的发病率几乎与系统性疾病的发病率相当。然而，尽管CLE对患者的生活质量（QoL）有影响，但在过去50年里，美国食品药品监督管理局（FDA）尚未批准针对该疾病的治疗方法。此外，以皮肤病变为主的红斑狼疮患者通常被排除在临床SLE试验之外。在极少数纳入以皮肤病变为主的红斑狼疮患者的试验中，使用多器官结局指标往往难以评估皮肤疾病的活动度和进展情况。对CLE新疗法的需求以及对皮肤结局缺乏关注，促使了皮肤狼疮疾病面积和严重程度指数（CLASI）的开发，这是一种经过验证的器官特异性结局指标，不仅能反映疾病活动度和损伤的变化，还与患者QoL的变化相关。本文将重点介绍在开发CLASI过程中进行的广泛验证研究，以及使用CLASI进行临床试验对于满足狼疮皮肤表现患者对改进疗法需求的重要性。
