The study protocol, including the questionnaires for assessment of environmental factors and the biosampling strategy, has been approved by all participating centres and IRBs.
Among more than 300 screened individuals, a total 254 at-risk individuals (93% women, 99% Caucasians, aged 36±12 years) have been included (complete data and biosampling) and enrolment/monitoring is still ongoing. Forty individuals (16%) have first-degree relative(s) with SLE. During follow-up of 15.2 ± 7.2 months, a total 15 individuals (5.9%) have progressed into classified (incident) SLE. An interim analysis of demographic, clinical and biological (RNA-seq) data is currently underway.