LONDON – Raloxifene did not increase lupus activity or flares in a 1-year trial of post-menopausal women who had systemic lupus erythematosus without hypercoagulability risk factors, Dr. Chi Chiu Mok reported.
Raloxifene has been shown in previous studies to preserve bone mineral density (BMD) after menopause in women with systemic lupus erythematosus (SLE). However, mild to moderate disease flares occurred in some patients in these small studies. Lupus flares are rare in postmenopausal women, so this finding suggested a possible association between raloxifene (Evista) and disease activity, explained Dr. Mok of Tuen Mun Hospital in Hong Kong.
Dr. Mok and his colleagues analyzed subgroup data from a 12-month randomized controlled trial that assessed bone turnover and BMD in 62 postmenopausal women who had no risk factors for arterial or venous thromboembolism and were being treated with glucocorticoids. The women were randomized to receive either 60 mg/day of raloxifene (30) or placebo (32) in addition to 1,000 mg/day of calcium and 0.25 mcg/day of calcitriol, Dr. Mok explained. “The primary study outcome was bone mineral density of the hip and spine, and secondary outcomes were bone-turnover markers and new vertebral fractures at 12 months,” he said.
In the overall study population, the mean duration of menopause was 7.2 years, the mean duration of treatment with prednisolone (mean daily dose of 6.8 mg) was 87 months, and the mean Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score at entry was 1.8, Dr. Mok said. The basic clinical characteristics were similar between the two groups, he noted.
After 12 months, “there was a significant gain in bone mineral density at the lumbar spine in the raloxifene patients but not in the placebo group. And there was a gain, though not significant, in the bone mineral density of the hip in the raloxifene-treated patients,” Dr. Mok reported. Similarly, markers of bone resorption and formation decreased significantly in the treatment group, he said.
At 12 months, there was no significant difference in the mean area under the curve SLEDAI scores, which were 18.7 in the raloxifene group and 20.3 in the placebo group, or in the mean area under the curve patient global assessments, which were 2.2 for raloxifene patients and 2.3 for placebo patients, Dr. Mok said.
Regarding disease flares, “there were three episodes of mild to moderate flares in the raloxifene patients, compared with nine in the placebo group,” he stated.
The researchers also assessed the effect of raloxifene on homocysteine and high-sensitivity C-reactive protein (hsCRP) levels and changes in atherosclerotic risk factors. They observed a trend of decrease in homocysteine level in raloxifene patients only, no statistically significant changes in hsCRP levels in either group, significant increases in total and LDL cholesterol in the placebo-treated patients only, and no significant changes in systolic and diastolic blood pressure values in either group, Dr. Mok stated. “In the treatment group, [raloxifene] was well tolerated and there were no thromboembolic complications,” he said.
“As previous studies have shown, raloxifene offers protection against bone mineral density loss in postmenopausal women with lupus receiving long-term glucocorticoids,” Dr. Mok said in an interview. “These results show that it's safe and well tolerated in this population and does not increase lupus disease activity or disease flares.”
Dr. Mok disclosed having no financial conflicts of interest.