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Getting the Jump on Juvenile Rheumatoid Arthritis

Pilot study shows drug could treat disease that strikes 500,000 U.S. children

MONDAY, Feb. 25, 2002 (HealthDayNews) -- A drug used to treat adults with rheumatoid arthritis may also help children who suffer from juvenile rheumatoid arthritis.

Recent research shows leflunomide, which goes by the brand name Arava, could be another option for children who suffer side effects from or don't respond to other medications used to treat juvenile rheumatoid arthritis (JRA).

"We had excellent results" with leflunomide, says Dr. Earl Silverman, lead author of the study and professor of pediatrics and immunology at the University of Toronto.

Leflunomide is a type of medication known as a disease-modifying anti-rheumatic drug (DMARD). These drugs are often used when nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, fail to help a patient.

DMARDs work on the immune system to reduce the inflammation that causes pain, swelling, stiffness and damage in the joints. Leflunomide received U.S. Food and Drug Administration (FDA) approval in 1998 for treating adults with rheumatoid arthritis.

Almost 500,000 American children under age 16 suffer from JRA. Inflammation causes redness, swelling and soreness in joints. Doctors classify JRA into three types, based on the number of joints involved, symptoms and the presence or absence of certain antibodies found by a blood test, says the U.S. National Institute of Arthritis and Musculoskeletal and Skin Diseases.

Treatments for JRA include physical therapy and drugs such as NSAIDs, DMARDs and corticosteroids.

Silverman says his research was a small pilot study meant to determine whether leflunomide was safe and effective enough in children to warrant a more definitive study. The results were presented at a recent meeting of the American College of Rheumatology.

The 26-week study began with 27 patients, ages 6 to 17, who suffered from JRA for an average of seven years and were being treated with another DMARD called methotrexate. The patients in this study either suffered side effects or didn't get relief from methotrexate.

Eighteen of the 27 patients completed the trial. Of the nine who dropped out, four left the study because they weren't getting any results and one left due to side effects. The other four patients left the study for reasons not related to efficacy or side effects.

Of the 18 patients who completed the study, 14 showed improvement using leflunomide, Silverman says.

He notes this was an "open-label" study, which meant all the patients knew they were receiving the drug.

The encouraging results have prompted Silverman to start an international trial comparing leflunomide to methotrexate. That study, which will include patients in North America, Europe and Australia, should be completed within a year.

Silverman says leflunomide could offer children with JRA another choice.

"[Methotrexate]'s a very good drug, but it does have some side effects. It can cause children to feel run-down and nauseated," he explains.

Any additional help for children with JRA would be welcome.

"We're talking about a significant disability. A lot of these children will go on to joint replacement," Silverman says. "The idea of having another oral drug is exciting."

Dr. Karen Hansen, assistant professor of medicine at the University of Wisconsin, says Silverman's research "is important because in children with arthritis, there's very little data saying what's safe and effective."

She notes drug studies in children can be difficult because many parents aren't willing to let their children participate.

"Yet, it's important to do. And this study was helpful to say this may be a way to treat juvenile rheumatoid arthritis," Hansen says.

What To Do: For more information on JRA, visit the American College of Rheumatology or the U.S. National Institute of Arthritis and Musculoskeletal and Skin Diseases.

SOURCES: Interviews with Earl Silverman, M.D., professor, pediatrics and immunology, University of Toronto; Karen Hansen, M.D., chief, rheumatology, Veterans Hospital, and assistant professor, medicine, University of Wisconsin, Madison, Wisc.
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