Raloxifene for postmenopausal women with systemic lupus erythematosus: a pilot randomized controlled study

To study the effects of raloxifene on disease activity and bone mineral density (BMD) in postmenopausal women with systemic lupus erythematosus (SLE).

Postmenopausal women with osteopenia and inactive SLE were randomly assigned to receive either raloxifene (60 mg/day) plus elemental calcium (1,200 mg/day) or elemental calcium alone (control). Patients with a history of thromboembolism or antiphospholipid antibody positivity were excluded. BMD at various sites was serially measured, and lupus activity was serially assessed using the Safety of Estrogens in Lupus Erythematosus: National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI).

The study group comprised 33 patients (16 assigned to receive raloxifene and 17 controls, mean +/- SD age 53.8 +/- 5.3 years). Age, body mass index, and baseline BMD values did not differ significantly between the 2 groups of patients. All patients were receiving low-dose prednisolone. After 12 months, femoral neck BMD (mean +/- SD -2.6 +/- 1.0%; P = 0.02) and lumbar spine BMD (-3.3 +/- 0.8%; P = 0.001) decreased significantly in the controls but not in the raloxifene group. No patient had a major flare of lupus, but mild/moderate flares occurred in 4 raloxifene-treated and 6 control patients (P = 0.79). The total area under the curve of SELENA-SLEDAI scores was not significantly different between the 2 groups. A significant increase in the high-density lipoprotein cholesterol level and a reduction in the low-density lipoprotein cholesterol level were observed in the raloxifene group but not in controls. One patient in the raloxifene group (6%) withdrew from the study because of hot flushes. No thromboembolic events were reported.

Raloxifene was well tolerated in Chinese patients with SLE who had inactive disease and in whom hypercoagulability was not identified. Raloxifene maintained femoral neck and spinal BMD in patients receiving corticosteroids.