WEUKBRE5716: Steroid-related Damage in Systemic Lupus Erythematosus (Hopkins)
Status:
Completed
Trial end date:
2016-01-01
Target enrollment:
Participant gender:
Summary
The study is designed to assess the association between steroid exposure and five potentially
steroid-related adverse events within a cohort of individuals with systemic lupus
erythematosus (SLE). Study objectives are to quantify the fraction of the risk of new (i)
diabetes, (ii) hypertension, (iii) cataracts, (iv) osteoporosis and (v) avascular necrosis
that is attributable to cumulative corticosteroid exposure in SLE patients. The study will
consist of five matched case-control analyses nested within the Hopkins Lupus Cohort. Cases
will be incident SLE cases who have developed one of the case outcomes (diabetes,
hypertension, cataracts, osteoporosis with fracture or vertebral collapse or avascular
necrosis). Controls will be matched to cases on time since SLE diagnosis. The primary
exposures to be assessed are cumulative dose of steroid (g) and cumulative duration of
exposure to steroids. The extent of the risk associated with steroids will be explored
through modeling of the relationship and through calculation of attributable risks of
exposure (number of cases associated with the highest exposure quartile of each primary
exposure).