Rheumatology Advance Access published online on January 31, 2008
Rheumatology, doi:10.1093/rheumatology/kem342
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Testosterone patches in the management of patients with mild/moderate systemic lupus erythematosus
1Department of Rheumatology, Division of Immunity and Infection, The University of Birmingham, Birmingham, UK, 2Cedars-Sinai Medical Center, Los Angeles, CA, 3University of Southern California, Los Angeles, CA and 4University of California, San Diego, La Jolla, CA, USA.
Correspondence to:
C. Gordon, Department of Rheumatology, Division of Immunity and Infection (East Wing), The Medical School, University of Birmingham, Birmingham B15 2TT, UK. E-mail: p.c.gordon{at}bham.ac.uk
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Abstract |
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Objectives. Androgen deficiency has been associated with the development of systemic lupus erythematosus (SLE). The aim of this study was to test the efficacy of testosterone patches vs placebo in female SLE patients with baseline mild-to- moderate disease activity in a randomized, double-blind, single-centre placebo-controlled trial.
Methods. Patients received testerosterone (150 µg) or placebo transdermal patches for 12 weeks. Patients were assessed at 4-weekly intervals for disease activity using the Safety of Oestrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index (SELENA-SLEDAI), Systemic Lupus Activity Measure-Revised (SLAM-R) and The British Isles Lupus Assessment Group (BILAG) indices, physican global assessment (PGA), quality of life using the SF-36 survey and sexual functioning using the Derogatis score. Data were analysed using two sample t-tests to compare the mean difference from baseline to week 12 in the testosterone patch and placebo groups.
Results. Thirty-four patients were recruited in to each group. There was no significant baseline difference between the groups in age, race or marital status. There was no significant difference between treatment groups in the mean change in SELENA-SLEDAI (0.547 ± 3.72, P > 0.60), nor in PGA or BILAG system scores. The mean change in SLAM-R score was statistically different (2.06, S.D. 3.3, P = 0.01) but was not considered clinically meaningful. Health transition also showed a small change (P < 0.03). There was no significant difference in the Derogatis scores or toxicity.
Conclusions. Testosterone patches were safe but did not significantly affect disease activity, quality of life or sexual functioning. Increased use of steroids in the placebo group may have confounded the study results.
KEY WORDS: SLE, Lupus, Testosterone, Disease activity index, Treatment
Submitted 11 June 2007;
revised version accepted 19 November 2007.
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