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Enbrel: The Long-Awaited TNF Inhibitor is Available
The FDA recently licensed a genetically engineered protein that helps reduce symptoms of moderate to severe, active Rheumatoid Arthritis (RA). RA affects over two million Americans and is an autoimmune disease in which the body attacks self-tissues. The new treatment, called Enbrel, binds to the tumor necrosis factor (TNF), a naturally occurring protein in the body, and inhibits its action. TNF, which is believed to promote inflammation in the body, is found at elevated levels in the fluid surrounding the affected joints of RA patients. Enbrel injections are currently available through your physician.

Enbrel is an entirely new approach to the management of RA. It is the first in a new class of drugs known as biologic response modifiers, which specifically interrupt the inflammatory process. In clinical studies, patients taking Enbrel had significantly reduced pain and the number of swollen and tender joints. The drug is intended for those RA patients with moderate to severe RA who have not been able to achieve relief with one or more disease modifying anti-rheumatic drugs (DMARDs), such as methotrexate. It may also be used in combination with methotrexate. Known side effects are: Mild to moderate injection site reactions. The long-term effects, on the development or course of serious infection, malignancy and autoimmune disease are unknown. Patients with a serious infection, or who are allergic to Enbrel or any of its components should not take this medicine.

For more information, please consult your physician, call the Immunex Corporation at 1-888-4ENBREL, or visit the company-sponsored web site, www.Enbrelinfo.com.

Arava approved for RA Treatment
In September, the FDA approved Arava (leflunomide) as a new treatment for adult RA. This drug, which is taken in tablet form, inhibits at least one enzyme in lymphocytes (cells of the immune system) and thereby interferes with the RA disease process. In clinical trials, patients taking Arava showed significant improvement in pain and swelling of joints and joint damage seemed to be retarded. Known side effects are: Not recommended for patients with significant liver disease, children, pregnant or nursing women. Patients may experience diarrhea or, rarely, liver problems, hair loss, skin rash or hypertension.

Cox-2 Inhibitors: Pain Relief without Stomach Upset?
Therapy expected to benefit those with osteoarthritis and rheumatoid arthritis
As many as 107,000 hospitalizations and 16,500 deaths occur each year in the United States as a result of the use of non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofren, naproxen and aspirin. These drugs help pain management of arthritis, but patients may develop moderate to severe gastrointestinal problems. One solution may be a new class of drugs which has been being developed by G.D. Searle & Co., and also by Merck & Co. These drugs are known as COX-2 inhibitors and are aimed at reducing the adverse effects on the gastrointestinal system. The test results are promising: the drugs seem to target the COX-2 enzyme, produced primarily at the site of inflammation, while not inhibiting the COX-1 enzyme, which is needed for proper digestive function. It is the inhibition of COX-1, which is believed to be the cause of serious gastro-intestinal side effects, such as ulcers, which have been associated with the use of NSAIDs.

Searle’s Celebrex received FDA approval in early January, 1999. The drug is still in the testing phase at this time. You can visit Searle at their web site to obtain current information: www.searlehealthnet.com. Vioxx is the COX-2 inhibitor drug which Merck & Co. is currently testing and is on the fast track for approval by the FDA.

Lyme Disease Vaccine receives FDA Approval
LYMErix, a vaccine for the prevention of Lyme disease, received approval for use from the U.S. Food and Drug Administration in December. Lyme disease, an illness borne by ticks, is a potentially serious multi-stage bacterial infection, with symptoms ranging from a skin rash and flu-like symptoms to arthritis and heart abnormalities.

The vaccine is manufactured by SmithKline Beecham and should be considered by people who live in or travel to tick-infested areas.

Just approved by the FDA!

Non-Drug Treatment Alternative: Prosorba Column

The FDA Gastroenterology and Urology Device Advisory Panel recommended approval for the treatment of moderate to severe rheumatoid arthritis of Prosorba Column. This treatment has been used to treat Idiopathic Thrombocytopenic Purpura (ITP), an immune blood disorder, since 1987. Prosorba Column will now be used to treat RA, as well.

Prosorba Column is a plastic cylinder that contains highly purified protein A immobilized on an inert silica matrix. The protein A Binds to and removes antibodies, including antigens that contribute to the symptoms of RA. The standard course of treatment involves 12 weekly outpatient sessions. Each session takes approximately two hours. In a process similar to kidney dialysis, blood is removed from the patient’s arm and passed through a machine that separates the blood cells from the plasma. The plasma is then passed through the Prosorba Column, recombined with the blood cells and finally returned to the patient through the other arm.

In clinical trials across the country, patients who had failed with DMARDs (such as methotrexate) underwent 12 Prosorba Column treatments. Nearly half showed significant clinical improvement as measured by stringent American College of Rheumatology criteria. Patients showed significant reduction in swollen and tender joint counts and the response was durable, some lasting as long as 75 weeks.

The information provided in the Arthritis National Research Foundation’s web page is for educational purposes only. It is not designed to provide medical advice. The foundation provides funding for young investigators seeking the causes and treatment of rheumatic diseases. Please consult your own healthcare provider regarding any medical issues relating to diseases, conditions, symptoms, diagnosis, treatments and side effects.

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