Dehydroepiandrosterone treatment of women with mild-to-moderate systemic lupus erythematosus: A multicenter randomized, double-blind, placebo-controlled trial
Article first published online: 8 NOV 2002
Copyright © 2002 by the American College of Rheumatology
Arthritis & Rheumatism
Volume 46, Issue 11, pages 2924–2927, November 2002
How to Cite
Chang, D.-M., Lan, J.-L., Lin, H.-Y. and Luo, S.-F. (2002), Dehydroepiandrosterone treatment of women with mild-to-moderate systemic lupus erythematosus: A multicenter randomized, double-blind, placebo-controlled trial. Arthritis & Rheumatism, 46: 2924–2927. doi: 10.1002/art.10615
- Issue published online: 8 NOV 2002
- Article first published online: 8 NOV 2002
- Manuscript Accepted: 26 JUL 2002
- Manuscript Received: 6 FEB 2002
- Genelabs Biotechnology Company, Ltd.
- National Science Council. Grant Number: NSC90-2314-B-016-069
To evaluate the efficacy and tolerability of dehydroepiandrosterone (DHEA) at a dosage of 200 mg/day in adult women with active systemic lupus erythematosus (SLE).
In a multicenter randomized, double-blind, placebo-controlled trial, 120 adult women with active SLE received oral DHEA (200 mg/day; n = 61) or placebo (n = 59) for 24 weeks. The primary end point was the mean change from baseline in the Systemic Lupus Activity Measure (SLAM) score at 24 weeks of therapy. Secondary end points included time to first flare, change in SLE Disease Activity Index (SLEDAI) score, and physician's and patient's global assessment scores at week 24.
The two groups were well balanced for baseline characteristics. Mean reductions in SLAM scores from baseline were similar and were not statistically significantly different between treatment groups (DHEA −2.6 ± 3.4 versus placebo −2.0 ± 3.8, mean ± SD). The number of patients with flares was decreased by 16% in the DHEA group (18.3% of DHEA-treated patients versus 33.9% of placebo-treated patients; P = 0.044, based on time to first flare). The mean change in the patient's global assessment was statistically significant between the two groups (DHEA −5.5 versus placebo 5.4; P = 0.005). The number of patients with serious adverse events, most of which were related to SLE flare, was significantly lower in DHEA-treated patients compared with placebo-treated patients (P = 0.010). Expected hormonal effects, including increased testosterone levels and increased incidence of acne, were observed. No life-threatening reactions or serious safety issues were identified during this study.
The overall results confirm that DHEA treatment was well-tolerated, significantly reduced the number of SLE flares, and improved patient's global assessment of disease activity.