Testosterone patches in the management of patients with mild/moderate systemic lupus erythematosus.
OBJECTIVE
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 testosterone (150 microg) 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, physician 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.
Gordon
C
C
Department of Rheumatology, Division of Immunity and Infection (East Wing), The Medical School, University of Birmingham, Birmingham B15 2TT, UK. p.c.gordon@bham.ac.uk
Wallace
D J
DJ
Shinada
S
S
Kalunian
K C
KC
Forbess
L
L
Braunstein
G D
GD
Weisman
M H
MH
D000279:Administration, Cutaneous; D000328:Adult; D003692:Delayed-Action Preparations / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008180:Lupus Erythematosus, Systemic / Q000175:diagnosis* / Q000188:drug therapy*; D008875:Middle Aged; D011336:Probability; D012016:Reference Values; D018570:Risk Assessment; D012720:Severity of Illness Index; D012869:Skin Absorption / Q000187:drug effects; D013739:Testosterone / Q000627:therapeutic use*; D016896:Treatment Outcome
D003692:Delayed-Action Preparations; D013739:Testosterone