prosorba

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article from rhuematoid athritis list.

i found it very interesting...

kay

FDA approves new therapy for rheumatoid arthritis

WASHINGTON (AP)--Americans who have run out of options to treat severe

rheumatoid arthritis won a new therapy Tuesday: A machine that filters their

blood for antibodies that may contribute to their painful, swollen joints.

The Prosorba column, made by Cypress Bioscience, works much like dialysis.

Once a week for 12 weeks, a patient's blood is slowly removed, the plasma

separated and treated by the Prosorba machine. The blood is then remixed and

retransfused back into the body.

The machine offers a 30 percent chance of improving the swelling and pain

that cripples patients' joints, Food and Drug Administration officials said

in approving Prosorba.

The FDA stressed that Prosorba is only for the small proportion of patients

with moderate to severe symptoms for whom all other treatments have failed.

" This is not a front-line therapy. ... It's clearly not for lots of people, "

said Miriam Provost, an FDA engineer and lead reviewer of the device. " It's

for patients who have basically failed everything. "

About 2 million Americans suffer rheumatoid arthritis, a debilitating

illness. This is not the kind of arthritis common in the elderly because of

the wear-and-tear of aging. Instead, rheumatoid arthritis is an autoimmune

disease, in which patients' immune systems go awry and attack their joints.

This causes inflammation and stiffness as rogue immune cells eat away

cartilage and eventually erode bone.

The disease mostly strikes women, usually between ages 25 and 50. Within 10

years, about half are too disabled to work.

A number of new drugs have been approved that help diminish the symptoms and

may slow progression of the disease, but about 10 percent of patients not

helped by drugs.

The machine is a column filled with silica and " protein A, " a protein from

the cell wall of a bacterium that clings to human antibodies. As plasma runs

through the column, the " protein A " separates out a small amount of

antibodies before the plasma is retransfused, Provost said.

Antibodies are immune cells that fight off infections in healthy people. In

rheumatoid arthritis, some antibodies are believed to go out of control.

Just how Prosorba works is unclear, because scientists do not know exactly

which antibodies it removes from blood. It doesn't remove enough to account

for all of the effect, so the company is doing further research to

understand how Prosorba helps, said Cypress chief executive Dr. Jay

Kranzler.

But Prosorba can work for about 30 percent of patients: In a study of 99

patients, half had their blood run through the machine and were compared

with " sham " patients, who merely had their blood removed but not treated.

Three months later, 15 Prosorba patients had a significant improvement,

compared with just five of the sham patients.

For Merrill Meyer of Tempe, Ariz., the improvement was dramatic. She went

from being bedridden to, after a year and two Prosorba treatments, an active

life.

" Now I'm taking care of my family and myself and looking now to return to

work on my art, " said Meyer, 48, who quit taking arthritis medicine in 1996

after a severe drug reaction. " It didn't seem radical to be taking part of

my blood and ... cleansing out what may be causing the disease. "

Kranzler said Prosorba's price has not been set, but it will cost less than

the $1,100 per treatment now charged to patients with a rare blood disorder

the machine is used to treat. To be treated, rheumatoid patients would go to

blood banks or other designated Prosorba centers with experience in

blood-filtering techniques.