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Blood Filtering Aimed At Rheumatoid Arthritis

August 29th, 2011 Leave a comment Go to comments

Last week, at J.T. Mather Memorial Hospital in Port Jefferson, two needles were placed in either arm and units of blood and plasma were drawn out. The plasma was passed through a filter to remove antibodies thought to trigger the joint inflammation that characterizes the disease, and finally, after two hours, the patient’s blood and plasma were coursing again through his body. Then it became a waiting game.

His rheumatologist, Dr. Max Hamburger, says he’s the first on Long Island to use the new treatment for rheumatoid arthritis. Hamburger has had experience with the device, approved last spring by the Food and Drug Administration, during its development and testing stages. Now, people with arthritis will have access to the field’s first federally approved device for this condition.

The device, called Prosorba, is a blood-filtering machine made by Cypress Bioscience, Inc. that scientists say removes key immune components that play a role in joint inflammation. It sounds bizarre – the machine’s column is made up of Protein A, a material that supposedly binds to antibodies in plasma.

It has been tested successfully in one large study submitted to the Food and Drug Administration’s devices branch. Patients whose blood plasma was filtered through the column got well and stayed well for almost a year, compared with others whose plasma was not cleared of antibodies. Why it works has yet to be determined, said Dr. Jay Kranzler, chief operating officer of San Diego-based Cypress Bioscience.

It has only been in the last decade that scientists have begun to make progress in understanding and treating rheumatoid arthritis, an autoimmune disease that affects 1 to 2 percent of adults. The immune system mistakenly sends out disease-fighting substances to attack the cartilage and small joints. Symptoms include swollen, warm and tender wrists, knuckles or toe joints.

Now, doctors have blood tests to help make a diagnosis – there is a rheumatoid factor, an antibody, in the bloodstream that signals the condition. It’s found in 75 percent of rheumatoid arthritis patients. About 25 percent also have another antibody in their blood.

A handful of medicines control the disease process itself by preventing the immune system from chewing up cartilage. One is Methotrexate, which helps regulate cells such as inflammatory cells that reproduce often. Another half-dozen such drugs are in the pipeline. Corticosteroids also provide anti-inflammatory relief. And nonsteroid medicines such as ibuprofen also help relieve arthritis pain.

Then there’s the column. It first received the green light from the FDA back in 1987 for the treatment of a rare immune condition. Last summer, the studies on rheumatoid arthritis patients were so impressive that the FDA halted the trial, according to Hamburger, and shortly thereafter approved the device.

According to the doctor, 75 percent of patients say they have improved after the blood-cleansing. Some have stayed pain-free for well over a year. It isn’t cheap, however. It takes 12 sessions at $1,000 for each column. Hamburger says that treatment with some of the new arthritis drugs is also costly.

It is important to know that while this treatment was approved by the FDA as safe and effective, the standard for devices is not as strict as the one in place for drugs.

Protein A columns have been used by pharmaceutical companies to make antibody-based products. The protein is produced by bacteria and binds to antibodies in the bloodstream. If you have a broth produced by bacteria and you want to purify it, you pour it on the column and the antibody will stick to it.

In the early ’90s, a doctor in Idaho used the column to treat some of his rheumatoid arthritis patients. He published his study of 15 patients in the Journal of Rheumatology in 1995, and executives at Cypress Bioscience became intrigued.

“There was so much skepticism in its black box mechanism of action that we needed to do a large placebo-controlled trial,” Kranzler said. The FDA was concerned that exposing a patient’s blood to something else on the column (for the placebo group) would be tricky. So they decided to use a spigot that would bypass the column.

The plan was to test 300 people over three years. A data safety monitoring committee analyzed the results after the first 60 patients, and after only one year, the committee members were so impressed that they said they’d come back after 30 patients more went through the study. In January of 1998, after 90 patients, the trial was stopped.

Kranzler said patients don’t start feeling effects of the treatment for eight weeks. Then, the benefit can last for 40 weeks, or years.

“I think it should be saved for the most severe patients,” Kranzler said. Women of child-bearing age who are worried about taking drugs could also benefit.

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