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Sanofi-Aventis arthritis drug safe for children, study shows

An international team of researchers has found that Sanofi-Aventis' Arava and another arthritis medicine commonly used in adults are both safe and effective in children.

Patients three to 17 years of age with polyarticular-course rheumatoid arthritis were recruited to the study. The children were given either methotrexate (brand names include Stada Pharmaceuticals’ Rheumatrex and Barr’s Trexall) or leflunomide (Arava), medications that are DMARDs (disease-modifying anti-rheumatic drugs)that work by altering the immune system.

Methotrexate is the most commonly used DMARD in children. DMARDs are a stronger class of arthritis medications than NSAIDs (nonsteroidal anti-inflammatory drugs).

“Our study showed that both methotrexate and leflunomide can be used safely and effectively in children. In fact, in our study both drugs had a higher response rate in children than the response rate reported in studies in adults,” said Dr Earl Silverman, the study’s lead author, a rheumatologist and senior associate scientist at The Hospital for Sick Children, and a professor of paediatrics at the University of Toronto.

“A higher percentage of patients responded to methotrexate, so this would be the medication to try first in children, but leflunomide is a good alternative for patients where methotrexate doesn’t work or isn’t tolerated. Importantly, we have identified a new, safe, effective oral therapy for use in children with chronic arthritis,” he continued.

The study also showed that a higher dose of methotrexate than previously thought can be used safely in children and that at the increased dose there was increased efficacy. Establishing drug dosages in children is more complicated than adults due to the wide variation in weight between a baby and a teenager.