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ACR: Arava (Leflunomide) Improves Signs/Symptoms of Juvenile Rheumatoid Arthritis SAN FRANCISCO, CA -- November 12, 2001 -- Study results presented at the 65th Annual Scientific Meeting of the American College of Rheumatology (ACR) suggest that Arava® (leflunomide) Tablets may be beneficial in treating polyarticular course juvenile rheumatoid arthritis (JRA). In a preliminary study, Arava was shown to be beneficial in patients ranging in age from three to 17 years with active JRA who either failed or were intolerant to methotrexate, an older, more traditional rheumatoid arthritis (RA) medication. “This pilot clinical study suggests that Arava is potentially safe and effective in a younger patient population who is currently limited in treatment options," said Dr. Earl D. Silverman MD, lead study investigator, Division of Rheumatology of The Hospital for Sick Children in Toronto, Ontario. "This data is important because it suggests that juvenile rheumatoid arthritis could potentially be managed with a medication that has been an important component in active adult RA management for several years." According to the National Institutes of Health Department of Health and Human Services, JRA is a chronic autoimmune disease, and it is the most common type of arthritis in children. A 26-week, multicenter, open-label study examined 27 patients ranging from three to 17 years in age (mean, 12.6 years) with active JRA who either failed or were intolerant to methotrexate therapy. Efficacy was assessed in the intent-to-treat population by Giannini 30 percent response criteria and secondary outcomes included Childhood Health Assessment Questionnaire (CHA), active arthritis joint count (AJC), swollen joint count (SJC), severity score, laboratory values and adverse event assessments. Arava appeared beneficial and was well tolerated. Eighteen patients (66.7 percent) completed the 26-week study. According to the Giannini response criteria, more than half of the patients (51.9 percent) responded to Arava therapy. The Giannini 30 percent response criteria is defined as three of six (MD global, parent/patient global, number of active joints, number of joints with limited range of motion, functional ability and the erythrocyte sedimentation rate) improved by at least 30 percent and no more than one of six worsening by more than 30 percent. SOURCE: Aventis Pharmaceuticals E-mail this page to a friend or colleague! To print, use this version