Response criteria for cutaneous SLE in clinical trials.

Overview

Systemic lupus erythematosus (SLE) is a complex phenotype characterized by a wide variety of clinical manifestations but the skin is involved in 70-80% of patients. Acute cutaneous lupus erythematosus lesions, like other organ manifestations of SLE wax and wane with other manifestations of active disease and quantifying it is a useful a "signal" to screen new therapies in SLE and pre- and post-treatment biopsies can be additionally informative. The ACR has recommended a priori response criteria for SLE Activity Measures (2) and that these be used along with organ specific response criteria in clinical trials. We review the literature on evaluation of skin manifestations in lupus erythematosus (LE) and propose the parameters of evaluating responsiveness and criteria for minimal clinically important changes in skin manifestations. The Committee presents two options for grading skin manifestations. These recommendations add to the tools of SLE trials.