The CLASI, a validated tool for the evaluation of skin disease in lupus erythematosus: a narrative review

Abstract

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.

Oral tofacitinib citrate for recalcitrant cutaneous lupus

“…In this article, we describe the efficacy of tofacitinib in 3 patients with CLE, using the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), a scale that has been validated for the assessment of CLE. 6 …”

Cutaneous lupus erythematosus disease assessment: Highlighting CLE outcome measures

“…For damage score, points are given for presence of dyspigmentation and scarring including scarring alopecia to a maximum of 80 points. Dyspigmentation score is doubled when it has been present for more than 12 months (1,5).…”

“…The CLASI has shown excellent content validity, construct validity, and inter/intra-rater reliability in multiple studies and has been validated for use in the pediatric population (1,6). Additionally, the CLASI has shown to correlate with QoL.…”

“…Like the PASI, the CLASI uses erythema as a hallmark of disease activity by reflecting the hyperemia that accompanies inflammation. Since erythema can be transient or reflect underlying telangiectasia, using the CLASI requires training to be able to accurately score patients (1). Finally, in the original validation studies, it was found that the CLASI takes an average duration of 5.25 min to conduct (ranging from <1-11 min).…”

“…Even skin-limited disease can have a significant impact on patient's QoL and patients are often refractory to standard topical treatment and antimalarials. Despite this, there have been no skin-directed therapies approved by US Food and Drug Administration (FDA) in the past 50 years, and only two new biologics for SLE during this time frame (1,2). Patients with CLE are often excluded from clinical trials for SLE, likely due to disease heterogeneity and previously difficult to measure disease activity and QoL in these patients.…”