biomarkers in Systemic Lupus Erythematosus

Systemic lupus erythematosus (SLE) is a systemic autoimmune disease with a wide
range of disease manifestations. Clinical manifestations may differ
considerably between patients, ranging from skin rash and arthritis to central
nervous system involvement and progressive glomerulonephritis resulting in
kidney failure. Very little is known of markers which are associated with
disease course, extend and severity of organ involvement, exacerbation
frequency and overall disease activity, co-morbidity and mortality. There is a
need of identifying bio-markers associated with clinical outcome measures.

Construction of a biobank of peripheral blood and skin biopsies from patients
with SLE, to evaluate gene polymorphisms, gene expression profiles, new
antigens and/or antibodies and to store material for analysis in future in case
of newly discovered relevant antigens, auto-antibodies, gene polymorphisms and
gene-expression profiles. The goal is to identify bio-markers associated with
clinical manifestations of SLE and identify subgroups of patients according to
presence and extend of organ involvement, disease activity, incidence and type
of exacerbations, co-morbidity and survival rates.

Observational, nested case-control and cohort study.

The risk and burden to the subject will be in proportion to the potential value
of the research. Research for bio-markers might lead to identification of
subgroups, improved diagnosis and prediction of exacerbation and better
understanding of the pathogenesis of SLE which could lead to the development of
new therapeutic targets or strategies for this disease.
Specified risk and burden: Number of extra institutional visits: none. Number
of blood samples: 28 ml (2-3 times a year) and maximum (once a year) 63ml. Skin
biopsies: 4-8 skinbiopsies at inclusion or at the time of excacerbation. Risks
associated with this study: none.