RESEARCH - Testosterone patches in the management of patients with mild/moderate SLE

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Rheumatology Advance Access published online on January 31, 2008

Rheumatology, doi:10.1093/rheumatology/kem342

Testosterone patches in the management of patients with mild/moderate

systemic lupus erythematosus

C. Gordon1, D. J. Wallace2, S. Shinada3, K. C. Kalunian4, L. Forbess2,

G. D. Braunstein2 and M. H. Weisman2

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.

Abstract

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.

http://rheumatology.oxfordjournals.org/cgi/content/abstract/kem342v1?papetoc

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