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New Study Shows Benefits in Women Treated with Steroid
Hormone
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, 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.
Visit our Lupus News page
to keep up to date with news on Prasterone.
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