In several large-scale, placebo-controlled clinical trials, prasterone reduced the risk of autoimmune flare in women with SLE.
A multi-center, double-blinded, placebo-controlled study used a study population (n = 381) balanced to reflect the racial mix of the SLE patient population in the United States and treatment for up to twelve months.[1] Treatment reduced the risk of flare viz placebo. The effect was most easily observed in women with active (SLEDAI >2) SLE: the percentage of such patients experiencing at least one flare during the study period was 34% (50/146) in the placebo group and 25% (36/147) in the treatment group (p = 0.07). The data similarly showed a