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Again, my apologies for the lateness of this newsletter! Shar is,
at present, unwell due to the lupus, and I'm sure you'll join me
in wishing her a speedy recovery. I have put pen to paper, or rather
finger to keyboard, to write about new drug treatments that are
being developed for lupus.
Please feel free to pass this newsletter (in its entirety)
onto a friend. If you have received this newsletter from a friend
& would like to receive it on a regular basis, please go to www.uklupus.co.uk/luplist.html
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NEW DRUG TREATMENTS FOR LUPUS
ASLERA
Aslera is a new drug, which combines prasterone &
DHEA. The medication aims at reducing the severity of several minor
lupus symptoms.
Many of you will have heard of DHEA, which is available
in the US as an over-the-counter supplement.
DHEA (Dehydroepiandrosterone) is a natural substance
which is produced by the adrenal gland, and has been available for
more than 50 years. It is a hormone with male-like properties.
Investigators have been interested in male hormones
(androgens) because in animal studies they tend to decrease the
immune response while female hormones (such as oestrogen) tend to
amplify it.
Levels of DHEA decrease with age, and lupus patients
at any age have less DHEA than one might expect.Side effects of
DHEA include acne and facial hair growth, headaches and fluid retention,
although it appears to be well tolerated.
Current treatments for lupus come with major side
effects. Corticosteroids (prednisone, prednisolone) can be life
saving to lupus patients, yet can also produce unwanted, and sometimes
serious, side effects, including diabetes, osteoporosis, and heart
disease.
Doctors hope that DHEA will enable patients to take
lower doses of steroids and, they hope, decrease the side effects
of prednisone.
In clinical trials of Aslera (then known as GL701),
women with mild to moderate lupus were given either a pure form
of DHEA or a placebo. The women who were given the DHEA had less
muscle pain, fewer mouth and nose ulcers, and less hair loss (alopecia)
than the placebo patients, but the good HDL cholesterol fell in
these patients as well.
In April this year, Genelabs Technologies (the company
that developed the drug) reported that the U.S. Food and Drug Administration's
(FDA) Arthritis Advisory Committee met to review Aslera for the
treatment of patients with mild to moderate systemic lupus erythematosus.
The result of the review should be known soon.
One reader of Butterfly News says this of DHEA- "My
physician started me on 200 mg of DHEA a day and I am currently
taking 300 mg. I started it because of the Brain fog. It has kept
me on an even keel. If I don't take the DHEA I can tell the difference
and so can the people around me. I will audio the beginning and
ending of sentences but forget the middles. I can tell that I am
not doing well, I get "those" looks from family and friends. :-)
I have not had any side effects, but I am currently taking steroids
and Imuran. How can anything else give me more side effects?? DHEA
is NOT a fountain of youth, but it gave my brain a boost that I
really needed."
LJP394
Another new drug, currently known as LJP 394 (LJP
stands for La Jolla Pharmaceuticals, the company developing the
drug) is currently undergoing a Phase III clinical trial.
The purpose of this clinical trial is to demonstrate
the safety and efficacy of an investigational drug candidate for
lupus nephritis, LJP 394. LJP 394 is designed to reduce the levels
of antibodies to double-stranded DNA, which are believed to be responsible
for lupus kidney disease.
In the first large-scale study of the drug in SLE
patients showed an almost 40% reduction in anti-DNA antibodies in
treatment groups receiving 50mg of LJP394 weekly.
In the Phase II/III trial, results showed that as
the dose of LJP394 was increased, the number of renal (kidney) flares
decreased.
On June 11, La Jolla Pharmaceutical Company announced
that it had enrolled it's first patient in Europe for its Phase
III clinical trial for LJP394. More than 100 patients have already
enrolled in the trial, which now involves more than 60 clinical
trial sites in the United
States, Canada, Mexico and Europe. In Europe, ten
of the 14 planned clinical trial sites are currently active.
The clinical trial is designed to repeat the positive
results from the Phase II/III trial for individuals with high-affinity
antibodies to LJP 394. The trial is currently screening individuals
who meet the following entrance criteria: 12 years old or older,
diagnosis of SLE, experienced at least one episode of active kidney
disease in the past 4 years; but not within the past 4 months.
The Company plans to enrol approximately 330 individuals
with lupus nephritis to evaluate the potential of LJP 394 to prevent
or delay renal flares, reduce the need for treatment with high-dose
corticosteroids and/or chemotherapy drugs, and improve an individual's
quality of life. Participants will be randomly assigned (by chance)
to receive weekly treatments of 100mg doses of either LJP 394 or
placebo (an inactive substance that has no medicinal value) for
the duration of the trial (between 6 and 22 months).
If you are interested in finding out more information
about this clinical or to pre-screen for participation, you are
encouraged to call the toll-free information line at 1-888-305-8787or
visit the company's web site, http://www.ljpc.com.
Any news on either of these drugs, or indeed any other
new drugs, will be posted on the Lupus News page - http://www.uklupus.co.uk/lupusnews.html
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Butterfly News is copyright Joanne Forshaw, and may
not be reproduced either electronically or otherwise without prior
permission. The Lupus Site http://www.uklupus.co.uk
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