Rheumatoid arthritis RA

The rationale for androgen therapy in RA is that (a) the lower prevalence in men suggests a protective role for androgens, (b) active disease is associated with reduction in endogenous testosterone production, (c) androgen effects on muscle and bone may improve morbidity in RA and (d) androgen effects (e.g. fibrinolysis) may reduce disease activity.

The best designed and conducted studyofandrogen therapy involved 107 women with active RA according to American College of Rheumatology (ACR) criteria on stable standard (steroid, NSAID) treatment for at least 3 months who were randomised to treatment with fortnightly injections of either androgen therapy (testosterone propionate 50 mg plus progesterone 2.5 mg) or placebo for one year (Booij et al. 1996). The inclusion of a very low dose of progesterone, which the authors claim was biologically ineffective, was based on an old clinical practice aiming to reduce virilisation from testosterone. Evaluated on a double-blinded, intention-to-treat basis this study demonstrated significant improvement in the ESR, pain and disability scores and ACR improvement criteria, but not in the numbers of tender or swollen joint or joints requiring intra-articular steroid injections. There was a high dropout rate (39/107), mostly (28/39) due to inefficacy defined as any mid-study increase in anti-rheumatic medication, however, these were evenly distributed between treatment groups. As expected, virilisation was the major adverse effect reported but there were few other side-effects and tolerability was good as most androgen-treated patients (67% vs 37% on placebo) wished to continue their allocated medication at the end of the study. The significant benefits of androgen therapy over placebo were predominantly in subjective measures rather than objective signs of disease activity. This raises the possibility that androgen therapy may preferentially improve mood or tolerance of disability rather than actually modifying disease impact or natural history. This well designed study is a model for investigation of pharmacological androgen therapy in systemic disease.

Other studies of androgen therapy in RA are small, poorly designed and inconclusive. One uncontrolled study of seven men with RA treated with six months of androgen therapy (oral testosterone undecanoate 120 mg daily) observed a decline in disease activity (reduced numbers of tender joints and analgesic usage) together with minor immunological changes that were not correlated with disease activity. The lack of a placebo group in a disease with a remitting natural history renders such observations unconvincing (Cutolo et al. 1991). A larger study of 35 men with definite RA randomised them to injections of testosterone enanthate (250 mg monthly) or placebo for nine months (Hall etal. 1996). This study noted that overall disease activity (defined by biochemical variables and clinical scales) was not improved by androgen therapy and indeed, significantly more men on testosterone therapy experienced disease 'flare' during the study. The inclusion of men with inactive RA and initial use of an inadequate testosterone dose were limitations of this study. An older double-blind study randomised 40 patients with definite RA on stable NSAID to treatment with stanozolol 10 mg daily or placebo for six months on the basis that androgen therapy might increase fibrinolysis (Belch etal. 1986). This study found a significant improvement in the composite Mallaya disease activity index combining objective (ESR, hemoglobin, articular scores) and subjective (pain, morning stiffness) dimensions, despite the failure to influence measurable fibrinolysis. Adverse effects such as hepatotoxicity or virilisation in females were not reported.

Whether androgen therapy in men with RA can truly modify the natural history or whether it only improves mood and toleration of pain and disease remain to be clarified by further well designed studies. No controlled studies examining improved muscle strength, bone density and other androgen-sensitive variables can improve quality of life in RA are yet reported.

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