Leflunomide therapy is well tolerated and benefits some patients with juvenile rheumatoid arthritis (JRA) resistant to the drug methotrexate, according to results of a new study. “The beneficial effect of leflunomide was maintained over the long term in the majority of patients,” the researchers report.

Leflunomide has been proven effective in treating adults with rheumatoid arthritis, the authors explain in the medical journal Arthritis & Rheumatism, but there have been no previous reports on the benefits of leflunomide in JRA.

Dr. Earl Silverman from the Hospital for Sick Children in Toronto, and colleagues, investigated the effectiveness and long-term safety of leflunomide in 27 patients with JRA who had not responded completely to or could not tolerate treatment with methotrexate.

Fifty-two percent of patients showed a treatment response to leflunomide by week 12 and this persisted through week 26, the team reports. A similar percentage of patients who participated in an extension phase of the study continued to show a response after 106 weeks of treatment.

The patients reported 13 serious adverse events, the researchers note, but only 7 of them were deemed possibly or probably related to leflunomide.

“The adverse effect profile was similar to that seen in studies of leflunomide in adults with rheumatoid arthritis,” the investigators write.

They conclude that “the findings of this study therefore support further evaluation of leflunomide for the treatment of…JRA.”

SOURCE: Arthritis and Rheumatism, February 2005.