Hormonal modulation in disseminated lupus erythematosus: the preliminary results with danazol and cyproterone acetate]

In an open prospective study, we have tested clinical efficacy and tolerance of two antigonadotropic drugs, that is danazol (D) and cyproterone-acetate (CA). This study was performed in 11 female patients ranging in age from 19 to 47 years, who suffered from midly-active SLE, during 12 therapeutic periods on the whole (that is 6 for each drug), the minimum period of which was one year. Because of side-effects, D had to be early withdrawn in 2 patients, whereas (the) AC appeared to be well-tolerated in all of them. On the whole, 16 clinical exacerbations of DLE were observed during the 12 months pre-treatment period, versus 9 exacerbations during the 12 months treatment period (p less than 0.05, Wilcoxon test), whereas the average dose of prednisone was reduced from 9.6 to 3.5 mg/day. A dramatic improvement was then observed in 3 patients suffering from mucous ulcerations. Increased plasma testosterone level without any change in estradiol level was observed in patients treated with D. Conversely, plasma estradiol decreased without any change in testosterone level in patients treated with CA. Both drugs induced reduction in plasma sex-hormone binding protein. These preliminary results suggest that D and CA may both reduce lupus disease activity, in parallel with an hormonal environment modification, towards a lower estrogen-androgen balance, along with a better tolerance as for CA.