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A double-blind, placebo-controlled, clinical trial of dehydroepiandrosterone in severe systemic lupus erythematosus

Division of Immunology & Rheumatology, Stanford, University Medical Center; Department of Rheumatology, Karolinska Hospital, Stockholm, 17176 Sweden ronaldv{at}rheum.ks.se

J L Park

M C Genovese

J P West

Division of Immunology & Rheumatology, Stanford, University Medical Center

J L McGuire

Objective: To determine if dehydroepiandrosterone (DHEA) is beneficial in severe systemic lupus erythematosus (SLE).

Methods: A double-blinded, placebo-controlled, randomized clinical trial in 21 patients with severe and active SLE, manifestated primarily by nephritis, serositis or hematological abnormalities. In addition to conventional treatment with corticosteroids +/-immunosuppressives, patients received DHEA 200 mg/d vs placebo for 6 months, followed by a 6-month open label period. The primary outcome was a prospectively defined responder analysis, based on a quantitatively specified improvement of the principal severe lupus manifestation at 6 months.

Results: Nineteen patients were available for evaluation at 6 months. Baseline imbalance between the groups was noted, with the DHEA group having greater disease activity at baseline (P < 0.05 by physician's global assessment). Eleven patients were responders: 7/9 patients on DHEA vs 4=10 patients on placebo (P < 0.10). Of the secondary outcomes, mean improvement in SLE disease activity index (SLE-DAI) score was greater in the DHEA group (710.3 3.1 vs 73.9 1.4, P < 0.07). Bone mineral density at the lumbo-sacral spine showed significant reduction in the placebo group, but was maintained in the DHEA group.

Conclusion: DHEA therapy, when added to conventional treatment for severe SLE, may at most have a small added benefit with respect to lupus outcomes, but baseline imbalances in the study population limit the generalizability of the results. DHEA appears to have a protective effect with respect to corticosteroid-induced osteopenia in such patients.

Key Words: SLE • DHEA • treatment

Lupus, Vol. 8, No. 3, 181-187 (1999)
DOI: 10.1191/096120399678847588


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