Severity Scores for Cutaneous Lupus Erythematosus

Area of Science:

• Dermatology
• Rheumatology
• Clinical Trial Methodology

Background:

• Cutaneous lupus erythematosus (CLE) presents a significant disease burden with no FDA-approved therapies for 65 years.
• Effective therapy advancement requires validated severity scores to assess disease activity, quality of life (QOL), and organ damage.

Purpose of the Study:

• To develop and describe provider- and patient-reported severity scores for cutaneous lupus erythematosus.
• To provide tools for evaluating treatment response and disease progression in CLE.

Main Methods:

• Development and validation of the provider-reported Cutaneous Lupus Disease Area and Severity Index (CLASI) over 20 years.
• Development and psychometric testing of the patient-reported Cutaneous Lupus Erythematosus Quality of Life (CLEQoL) instrument.
• Focus groups to identify key QOL aspects including symptoms, emotions, functioning, body image, and photosensitivity for CLEQoL.

Main Results:

• CLASI is a validated provider-reported measure distinguishing CLE activity and damage, utilized in clinical trials.
• CLEQoL is a reliable patient-reported measure assessing QOL impacts of CLE.
• Together, CLASI and CLEQoL offer comprehensive assessment of CLE severity from both provider and patient perspectives.

Conclusions:

• CLASI and CLEQoL are simple, reliable, and specific severity scores for cutaneous lupus erythematosus.
• These scores capture disease activity, damage, and QOL, facilitating clinical trial endpoints and patient management.
• The combined use of CLASI and CLEQoL supports the evaluation of novel CLE therapies and disease monitoring.