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Cited by 144Systemic Lupus Erythematosus ResearchAdrenal Hormones and DisordersSystemic Sclerosis and Related Diseases

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

van Vollenhoven, R F, Park, J L, Genovese, M C, West, J P, McGuire, J L·1999·Lupus
DOI 10.1191/096120399678847588
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Abstract

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 (-10.3+/-3.1 vs. -3.9+/-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.

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Authors
van Vollenhoven, R. F., Park, J. L., Genovese, M. C., West, J. P., & McGuire, J. L.
Affiliations
  • Division of Immunology & Rheumatology, Stanford, University Medical Center; Department of Rheumatology, Karolinska Hospital, Stockholm, 17176 Sweden
  • Stanford Medicine (US)
ORCID
Genovese, M C
Venue
Lupus
Publisher
SAGE Publications
Published
1999-03
Volume
8
Issue
3
Pages
181-187
ISSN
  • 0961-2033 (ISSN-L)
  • 1477-0962
DOI
10.1191/096120399678847588
OpenAlex
W2117480041
Cited by
144
References
23
Citations by year
2024: 1 · 2023: 6 · 2022: 4 · 2021: 5 · 2020: 3 · 2019: 3 · 2018: 3 · 2017: 4 · 2016: 3 · 2015: 1 · 2014: 3 · 2013: 2 · 2012: 4
FWCI
7.29
Type
journal article
Language
en
Open access
closed
Licence
journals.sagepub.com/page/policies/text-and-data-mining-license (tdm)
Locations
  • Lupus (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • National Institutes of Health (5p60ar020610-19)
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (AR-20610)
Topics
  • Health Sciences › Medicine › Rheumatology › Systemic Lupus Erythematosus Research
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Adrenal Hormones and Disorders
  • Health Sciences › Medicine › Pathology and Forensic Medicine › Systemic Sclerosis and Related Diseases
Keywords
dehydroepiandrosterone, systemic lupus erythematosus, lupus nephritis, serositis, hematological abnormalities, bone mineral density, SLE disease activity, adjunctive therapy, immunosuppressive therapy
MeSH terms
Adrenal Cortex Hormones, Adult, Dehydroepiandrosterone, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Immunosuppressive Agents, Lupus Erythematosus, Systemic, Male, Middle Aged, Prospective Studies, Bone Density, Treatment Outcome

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