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Title: Increased Methotrexate Dose Improves Response Rate in Juvenile Arthritis Patients: Presented at ACR

"Increased Methotrexate Dose Improves Response Rate in Juvenile Arthritis Patients: Presented at ACR"

By Rabiya S. Tuma NEW ORLEANS, LA -- October 28, 2002 -- Small increases in the dose of methotrexate, a standard treatment for juvenile idiopathic arthritis (JIA), substantially improve patient response rates, according to data from a randomised, multinational trial. Dr. Nicolino Ruperto, of the University of Pavia, in Pavia, Italy, presented the study here October 26 at the American College of Rheumatology (ACR) meeting here on behalf of the Pediatric Rheumatology International Trials Organization, based in Genova, Italy. The trial enrolled 633 patients, ages 2 to 18, who were recently diagnosed with JIA in a clinical trial designed to test whether patients who are refractory to the standard methotrexate dose of 12 mg/m²/week would respond to a higher dose. During the first six months of the trial, all patients were treated with the standard dose and 455 (72 percent) responded to treatment. Of the non-responders, 80 were randomised to receive one of two methotrexate regimens - an intermediate dose of 15-20 mg/m²/week or a high dose of 30-40 mg/m²/week -- for a second six-month period. Of those 80 patients, approximately 55 percent responded to the increased methotrexate dose. The response criteria for all doses were based on the recently approved ACR's paediatric 30 criteria. For example, treatment responders had about a 50 percent decrease in the number of joints with active disease. Similarly, the parent's evaluation of the children's overall health improved about two fold during the course of the study. The researchers saw no statistically significant difference in efficacy between the intermediate and high dose, although at the end of the study, they saw hints that the intermediate dose may be slightly more effective than the high dose. The number of drug-related adverse events was similar between all three doses. Thus the researchers concluded that increasing the dose of methotrexate is both a safe and effective treatment option for children who fail to respond to the standard methotrexate dose. Dr. Ruperto said that the results of the trial are clinically important. "If you look at the decrease in symptoms in the patients who responded to the standard dose during the initial phase, and then look at the patients in the randomised portion of the trial, you see they achieved nearly the same level of response."

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