Lupus Omics Cutaneous Kidney Investigative Team: Skin Project 1 and Skin Project 2

Brief description of study

Cutaneous lupus erythematosus (CLE) includes three main subsets: acute CLE (ACLE), subacute CLE (SCLE) and chronic CLE (CCLE), the latter including discoid lupus erythematosus (DLE). Lesion progression may lead to significant scarring and dyspigmentation and overall, patients with CLE have poor quality of life with high levels of depression and anxiety. Differentiation of CLE subsets is largely based on clinical features. This study will allow to better understand the differential pathogenesis between CLE subsets which may help in appropriate diagnosis and impact treatments. In CLE, response to therapies is variable and unpredictable in conventional practice, and only 50% of CLE patients respond to the first-line therapy hydroxychloroquine leading to a delay in selecting appropriate treatment while increasing disease severity. Presently, the only way to identify response is by stepping through sequential therapies that can have a slow onset of action. Identifying differential molecular skin expression between responders and non-responders across CLE subsets may help in identifying responders to corresponding treatment and personalize management with the help of predictive markers. SP1: ACLE, SCLE and CCLE will be studied in a cross-sectional fashion. Treatment-naïve lesional and non-lesional skin biopsies, peripheral blood mononuclear cells (PBMCs) and other body fluids will be obtained. Comparisons of tissue omics between CLE subsets are expected to yield insights related to differential expression of cells and pathways. SP2: SCLE and CCLE (not ACLE) will be evaluated routinely every 3 months for 6 months. Patients enrolled in SP1 with these skin lesions may be enrolled in SP2 based on inclusion criteria. Clinical response of skin disease to standard of care therapies will be evaluated using the CLASI score. Lesional and non-lesional skin biopsies, PBMCs and other body fluids will be obtained at baseline and during follow up visits at 3-month intervals to determine differences in cells and pathways that account for the variation in response to therapies. Comparisons of serum, tissue omics and skin/stool/saliva microbiome between treatment response groups across CLE subsets are expected to yield several insights.


Clinical Study Identifier: s23-00685
Principal Investigator: Jill P Buyon.


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