The CLASI (Cutaneous Lupus Erythematosus Disease Area and Severity Index): An Outcome Instrument for Cutaneous Lupus Erythematosus

Abstract

We developed and validated a measurement instrument (CLASI-Cutaneous Lupus Erythematosus Disease Area and Severity Index) for lupus erythematosus that could be used in clinical trials. The instrument has separate scores for damage and activity. A group of seven American Dermato-Rheumatologists and the "American College of Rheumatology Response Criteria Committee on SLE (systemic lupus erythematosus)" assessed content validity. After a preliminary session, we conducted standardized interviews with the raters and made slight changes to the instrument. The final instrument was evaluated by five dermatologists and six residents who scored nine patients to estimate inter- and intra-rater reliability in two sessions. Consultation with experts has established content validity of the instrument. Reliability studies demonstrated an intra-class correlation coefficient (ICC) for inter-rater reliability of 0.86 for the activity score (95% confidence interval (CI) = 0.73-0.99) and of 0.92 for the damage score (95% CI = 0.85-1.00). The Spearman's rho (Sp) for intra-rater reliability for the activity score was 0.96 (95% CI = 0.89 to 1.00) and for the damage score Sp was 0.99 (95% CI = 0.97-1.00). Clinical responsiveness needs to be evaluated in a prospective clinical trial, which is ongoing.

Effects of Hydroxychloroquine in Patients With Cutaneous Lupus Erythematosus: A Multicenter, Double‐Blind, Randomized, Parallel‐Group Trial

“…Prior to enrollment, steroid pulse therapy, intravenous immunoglobulin therapy, biologic therapies, and intravenous cyclophosphamide had to be discontinued for a sufficient period of time. The dosages of steroids and immunosuppressive agents were allowed to be reduced after week 16.…”

Mycophenolate Mofetil in Refractory Cutaneous Lupus Erythematosus: No Definitive Evidence

“…However, it does not include severity within an organ system and it is not useful for judging activity of the different subtypes of CLE. Other scores are available, such as the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) assessing activity and damage of CLE with inaccurate assessment of the severity of all disease subtypes 4 . Therefore, the Revised CLASI (RCLASI) was proposed, scoring the activity and damage, taking into account the anatomical region (face, chest, arms) and morphological aspects (erythema, scaling/hyperkeratosis, edema/infiltration, scarring/atrophy) of skin lesions 5 .…”

Study of dexamethasone cyclophosphamide pulse therapy in systemic lupus erythematosus

“…Also the novel aspect of this study is that the clinical improvement of dermatological manifestations will be based on well validated skin scoring system called CLASI (cutaneous lupus area & severity index). 6 …”