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Prasterone Therapy Appears to Benefit Women With Lupus

NEW YORK, NY -- September 9, 2004 -- Systemic lupus erythematosus (SLE), commonly known as lupus, is a serious disease of the immune system. Although chronic, lupus can wax and wane in severity. Even for patients with mild disease activity, the common signs--fatigue, rash, and arthritis--can make living with lupus difficult. While much about this condition is still open to speculation and research, lupus is more likely to affect women--9 times more than men. Among women with lupus, researchers have found abnormalities in the metabolism of two hormones: estrogen and androgen.

Chemically similar to estrogen and androgen, and a precursor to both, DHEA (dehydroepiandrosterone) is a natural steroid hormone produced by the adrenal glands of both sexes, in greatest amounts during early adulthood. While DHEA supplements have been touted for everything from anti-aging to weight loss to depression, such claims have not been supported by well-controlled clinical trials. However, the pharmaceutical form of this hormone, known generically as prasterone, does have validated medical properties. Currently being developed by Genelabs Technologies, Inc. as a treatment for SLE, Prasterone was recently shown to be safe and effective for stabilizing the activity and alleviating the symptoms of lupus in women. The results of a year-long, multi-center study, directed by Michelle A. Petri, M.D., M.P.H, of Johns Hopkins University, are featured in the September 2004 issue of Arthritis & Rheumatism.

To determine the potential of prasterone to reduce lupus disease activity and symptoms, 381 women with active lupus were selected for a clinical trial conducted at 27 sites, including Duke University Medical Center, Northwestern University Feinberg School of Medicine, and Stanford University School of Medicine. Participants were divided into two treatment groups. Roughly equal in number, the treatment groups were also balanced with regard to age, race, menopause status, disease severity, and current drug therapy. One group received 200 milligrams of prasterone daily. The other group received the same daily dose of a placebo. Women in both groups were allowed to continue their course of standard lupus medications, usually some combination of a glucocorticoid, like prednisone, and an immunosuppressive agent, like methotrexate.

The researchers set out to assess prasterone's effectiveness across three measures: disease activity, organ damage, and health-related quality of life. Factoring in the scores for each key domain, 59 percent of the women in the prasterone group demonstrated improvement or stabilization of lupus symptoms without clinical deterioration, compared with 45 percent of the women taking placebo. "The high response rate in the placebo treatment group should be interpreted in the context that this was not a true placebo-controlled trial, since most patients were treated with standard SLE therapies during the study," Dr. Petri makes clear. "Thus, the statistically significant improvement in the prasterone group is both statistically and clinically meaningful."

Although androgen levels increased in the prasterone-treated patients, especially among post-menopausal women, adverse effects associated with hormonal imbalances, such as blood clots or weight gain were similar between groups. The most common side effects--acne and facial hair--were mild. Among health benefits, the prasterone group experienced reductions in total cholesterol and triglyceride levels. Also importantly for lupus management, women treated with prasterone showed trends toward a lower number of active disease flares and longer periods of time between them.

As Dr. Petri notes, lupus patients have few treatment options tailored for their painful symptoms during active disease flares. Physicians routinely increase the dosage of standard lupus medications, such as prednisone, which can have significant side effects. "Prasterone could bring benefits to patients who cannot or do not wish to take additional therapies of immunosuppressive agents or large doses of glucocorticoids," Dr. Petri concludes.


SOURCE: John Wiley & Sons, Inc.

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