Genomic Effects of Glucocorticoids in Patients With Systemic Lupus Erythematosus

Exclusion criteria

• . Body mass index (BMI) \< 18 or \> 40.
• . History of a severe allergic reaction to glucocorticoids.
• . History of a severe adverse cardiovascular or psychiatric event related to glucocorticoid administration.
• . Use of a glucocorticoid at a prednisone-equivalent dose 10 mg/day in the 15 days prior to screening (\> 15 mg/day if experiencing a flare on the day of the screening visit).
• . A previously established diagnosis of an active solid or hematologic malignancy.
• . A previously established diagnosis of untreated osteoporosis. For the purpose of this study, osteoporosis is defined as a dual-energy X-ray absorptiometry (DEXA) scan obtained within 2 years of screening demonstrating a hip or spine bone mineral density T score less than or equal to -2.5 in men or greater than or equal to 50 in postmenopausal women.
• . A previously established diagnosis of untreated osteopenia with a high fracture risk. For the purpose of this study, osteopenia is defined as a DEXA scan obtained within 2 years of screening demonstrating a hip or spine bone mineral density T score \< -1 and \> -2.5 in men or greater than or equal to 50 in postmenopausal women. For the purpose of this study, a high fracture risk is defined as a fracture risk assessment tool (FRAX) 10-year risk of major osteoporotic fracture \> 20%, or a FRAX 10-year risk of hip fracture \> 3%.
• . A previously established diagnosis of diabetes mellitus or a fasting blood glucose level greater than or equal to 125 mg/dL at the time of screening. For patients without a previously established diagnosis of diabetes mellitus and a fasting blood glucose level \< 125 mg/dL at the time of screening, no additional screening tests (e.g., HbA1c or oral glucose tolerance test) will be performed. A history of glucocorticoid-induced hyperglycemia that is not present at the time of screening in the absence of treatment will not be considered an exclusion criterion.