The Cutaneous Lupus Erythematosus Disease Area and Severity Index

Objective: To assess the clinical responsiveness of the CLASI (Cutaneous Lupus Erythematosus [CLE] Disease Area and Severity index). Design: Validation cohort. Setting: Tertiary referral center. Patients: Eight patients with CLE. Intervention: Assessment of patients with CLE from baseline until day 56 after starting a new standard of care therapy. Main Outcome Measures: Correlation of the baseline to day-56 change in 2 CLASI scales (disease activity and damage), with baseline to day-56 change in the physicians' and patients' assessments of patient's global skin health scores, and the patients'assessments of pain and itch. Results: The change in CLASI activity score highly correlated with the changes in 3 clinical validation measures: physicians' assessment of skin health (r=0.97; P=.003; n=7), patients' global skin health score (r=0.85; P=.007; n=8), and pain (r=0.98; P=.004; n=5). Using the Wilcoxon signed-rank test, paired baseline to day-56 changes in CLASI activity and damage scores were analyzed for the 2 subgroups (meaningful change vs nonmeaningful change) composing each validation variable. Change in CLASI activity was significantly different for patients who had a meaningful change in their global skin self-ratings (Z = 1.07; P=.03) and approached statistical significance for patients who had a meaningful change in their level of itching (Z= 1.83; P=.06) and their physicians' global skin rating (Z= 1.84; P=.06). The CLASI activity score decreases after successful therapeutic intervention, whereas the damage score may increase in scarring forms of CLE. Conclusion: The activity score of the CLASI correlates with the improvement of global skin health, pain, and itch and is thus a useful tool to measure clinical response.