FIGHTING LUPUS AH: MUSC involved in clinical testing of 4 drugs

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FIGHTING LUPUS AH: MUSC involved in clinical testing of 4 drugs

HERB FRAZIER Of The Post and Courier Staff

The Medical University of South Carolina is among a group of medical

centers that is conducting a worldwide clinical trial of four drugs

to expand the treatment options for people who suffer from lupus, an

autoimmune disease that affects mostly women.

If one of the drugs is approved, for the first time in 50 years, it

will give lupus patients more than just two drugs to choose from to

relieve the pain caused by inflammation in the joints and vital organs.

MUSC rheumatologist Gilkeson said the university is one of 25

medical centers in the Lupus Clinical Trial Consortium that is

testing the drugs on 500 patients in North America, Mexico, Western

Europe and China. The consortium is based at the Hospital for Special

Surgery in New York City.

Lupus, which can be fatal, affects one out of every 2,000 Americans,

and women are nine times more likely to get lupus than men. Black

women are at a greater risk of contracting the disease and dying as a

result of it. In South Carolina, North Carolina, Georgia, Alabama and

Mississippi, one out of every 100 black women has lupus compared with

one out of every 1,000 white women.

Four drug manufacturers will spend $1 million to test Cellcept,

Rituximab, Abatacept and an antibody to IL10, a protein the body

overproduces in response to lupus. " Each of the drugs has the

specific goal to reduce inflammation, decrease symptoms and preserve

organ function, especially the kidney and the brain, " said Gilkeson,

who leads a team of 22 clinical and basic researchers at MUSC.

The U.S. Food and Drug Administration has approved Cellcept for renal

transplant rejection. Rituximab has been approved for treating

lymphoma. " We already know that they are effective in treating lupus,

but the trials are necessary to prove it to the FDA, " he said.

Cellcept will be tested for five years. Trials for the other drugs

will end in two years. The testing began six months ago, he said.

The companies that are supporting the research are Aspreva,

Genentech, Schering Plough and Bristol Meyers Squibb.

A steroid called prednisone and the anti-

malarial drug plaquenil are the only prescription drugs specifically

approved to treat the lupus symptoms of joint and chest pain, joint

swelling, fever, fatigue, skin rash, anemia and sun sensitivity. But

the side effects of prednisone include bone loss, weight gain,

diabetes and hypertension.

Although relatively safe, Gilkeson said, plaguenil can, in some

cases, cause vision problems. " The main problem is that neither of

those drugs are effective alone in severe lupus, " he said.

In an autoimmune disease, the body's defense system turns against

itself. Lupus is not infectious, cancerous or related to AIDS. It is

difficult to detect. Sometimes a sufferer can have symptoms three to

10 years before the disease is diagnosed.

Barbara Baker of North ton didn't learn that she has lupus

until she gave birth in July 1999 to her daughter, Angel. During her

pregnancy, Baker said, her joints hurt and she was anemic. After her

physician did a biopsy of her kidney, Baker was told she has lupus.

" After that, everything started going wrong with me, " she said.

But medication and a change in diet have the disease under control,

she said. " I take my medicine like I'm supposed to, " she said. " I am

on a diet. I can't eat salty, processed food, such as chips and

chocolate. I don't like that part, " she said, laughing.

Baker is not part of the drug trials, but she takes Cellcept in

addition to prednisone. Gilkeson said that even though the FDA hasn't

approved Cellcept as a treatment for lupus, it can be used as an " off-

label " medication to control the disease.

Baker said she would not change her drug therapy to match the results

of the drug trials. " I think the drugs I am taking now have helped me

out a lot, " she said.

Newton's 19-year-old daughter suffers from lupus. Newton is a

facilitator of Lupus Life, a ton area lupus support group.

Newton said most people have heard of lupus, but it is still

misunderstood. In addition to medical research, more education is

necessary to dispel the misconceptions people have about the illness,

she said.

Her daughter was diagnosed with the disease when she was 15. A lupus

sufferer, she said, looks perfectly fine, but " this is a very serious

illness. That is why we are so hopeful with the progress being made

in research. "

" The lupus support group is here to offer hope and encouragement for

lupus sufferers and their families, " she said. " I feel that

oftentimes illnesses come our way and we feel isolated. We want to

let other sufferers know we are here to support them. "

Lupus Life is affiliated with the South Carolina Chapter of the Lupus

Foundation of America. The state chapter is based in Easley.

Mia Barron, a lupus clinical nurse coordinator at MUSC, said, " Even

though a person has lupus, it does not mean a death sentence. People

live with it for a number of years with lifestyle and behavior

changes. You can go through a period of remission and exacerbation.

You can control it with a low-fat, low-sodium diet that is high in

fiber. It is also about controlling the stress. " Newton and Barron

are co-facilitators of Lupus Life.

Gilkeson said lupus research also is seeking answers to why the

disease affects black women more than white women. MUSC and the

University of Oklahoma are doing a genetic study that involves 170

women with the disease and 170 women who do not have it. All of the

participants are black, and they live on the Sea Islands along the

South Carolina coast.

It is unknown what causes lupus. Scientists believe that people are

born with a gene that gives them a predisposition for it. It is

possibly triggered by environmental factors, such as infections,

antibiotics, stress and hormones.

" Our emphasis has been trying to understand why there is this ethnic

disparity and try to correct that especially in the Sea Island

population, " he said. " Very little work on the genetics of lupus has

been done on African-Americans, and this is an important step forward. "

October 25, 2005