Severity Scores for Cutaneous Lupus Erythematosus.

Despite the significant disease burden of cutaneous lupus erythematosus (CLE), there have been no United States Food and Drug Administration-approved therapies for 65 years. To facilitate advancement of therapies, severity scores are needed to evaluate QOL, how patients feel, activity of disease, and organ-specific damage to assess response to therapies and disease progression. In this paper, we delineate the development process of provider- and patient-reported severity scores for CLE. Cutaneous Lupus Disease Area and Severity Index (CLASI), a provider-reported measure that distinguishes between activity and damage, has undergone rigorous validation and reliability testing for over 20 years. Its performance has been tested in clinical trials as a primary or secondary endpoint and tool to stratify patients. As an objective disease measure that captures a provider's perspective of disease activity and damage, the CLASI inherently does not assess disease impact on patients' QOL. Cutaneous Lupus Erythematosus Quality of Life (CLEQoL), a patient-reported measure, captures features elucidated through focus groups, including symptoms, emotions, functioning, body image, and photosensitivity. It has undergone psychometric property testing to ensure reliability and validity. Together, CLASI and CLEQoL are simple and reliable CLE-specific severity scores capturing disease activity, damage, and QOL from provider and patient perspectives.

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