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Second Oral Treatment For Juvenile Rheumatoid Arthritis Works

Leflunomide, used in adult joint disease, is also effective for kids

WEDNESDAY, April 20, 2005 (HealthDay News) -- Youngsters with juvenile rheumatoid arthritis now have a new oral treatment option to help control their symptoms.

After comparing the current gold standard of treatment, oral methotrexate, to an oral medication used in adult rheumatoid arthritis, leflunomide, researchers found that while methotrexate was the more effective of the pair, leflunomide also worked and, in some cases, was tolerated better than methotrexate.

"We had a very high response rate in both groups, and both performed better than we had predicted," said lead researcher Dr. Earl Silverman, a rheumatologist at the University of Toronto/Hospital for Sick Children in Toronto.

"Methotrexate still remains the first drug of choice, and we found that we can start at a higher dose," said Silverman. "We also now have an oral alternative therapy (leflunomide) for children with polyarticular juvenile rheumatoid arthritis who are intolerant or unresponsive to methotrexate."

Results of the study appear in the April 21 issue of the New England Journal of Medicine.

About 300,000 U.S. children have arthritis or rheumatic disease, according to the Arthritis Foundation. Polyarticular juvenile rheumatoid arthritis is one of three types of the disease and means that more than five joints are affected, according to the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Common symptoms include joint swelling, pain and stiffness. Depending on the severity of the disease, some children may have limitations in their movement.

Silverman said methotrexate is the current front-line treatment for these kids. If oral methotrexate isn't effective, he said, doctors might use methotrexate injections or turn to a "biologic agent" such as etanercept.

Dr. Patience White, chief public health officer for the Arthritis Foundation, said the problem with those treatment options is that children, even more so than adults, don't like getting shots. And some children can't tolerate methotrexate, leaving them even fewer options for controlling their painful symptoms.

Adults have more options, including leflunomide, which has been shown to be a safe and effective therapy in older patients, according to the researchers. An early trial of leflunomide in children showed a significant response, which prompted the current study comparing leflunomide to methotrexate.

Nearly 100 children between the ages of 3 and 17 with juvenile rheumatoid arthritis were recruited from 13 countries for the study. The children were randomly assigned to receive either oral methotrexate or oral leflunomide.

To assess efficacy, the researchers used the American College of Rheumatology's (ACR) core set of disease-activity measures for a pediatric population. Dubbed the ACR Pedi 30, this composite index looks for at least a 30 percent improvement in at least three of six response variables, including swollen joints, the number of joints with active arthritis, parent assessment of disease, physician assessment of disease, laboratory findings and patient or parent assessment of physical function. Additionally, Silverman explained, the composite index also looks for no more than a 30 percent worsening in any one of the six variables.

After 16 weeks of treatment, 89 percent in the methotrexate group scored positively on the ACR Pedi 30 compared to 68 percent in the leflunomide group. The trial continued for another 32 weeks and the improvements seen at 16 weeks were still maintained at 48 weeks.

Both drugs were well-tolerated, according to Silverman. Those in the leflunomide group had less nausea than the children in the methotrexate group, he said.

"For children for polyarticular juvenile rheumatoid arthritis, there's another option that is shown to be effective and safe," White said.

More information

To learn more about juvenile rheumatoid arthritis, read this information from the National Institute of Arthritis and Musculoskeletal and Skin Diseases.

SOURCES: Earl Silverman, M.D., rheumatologist, senior associate scientist, and professor, pediatrics and immunology, University of Toronto/Hospital for Sick Children, Toronto; Patience White, M.D., chief public health officer, Arthritis Foundation; April 21, 2005, New England Journal of Medicine
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