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| |  Children With Juvenile Arthritis Experience Substantial Improvement During 2 Years of Adalimumab Treatment ATLANTA, GA -- November 14, 2007 -- Patients with juvenile rheumatoid arthritis experience marked improvements in their disease and less frequent flare-ups when being treated with adalimumab (Humira), according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in Boston, Mass. About one child in every 1,000 develops some type of juvenile arthritis. JRA is the most common rheumatic disease of childhood and is a common cause of disability among children. There are several different types of JRA. All cause joint inflammation and begin before the age of 16, but otherwise are often associated with distinct symptoms and complications and may require different approaches to treatment. JRA targets the lining of the joint, causing inflammation. When this persists, joint damage may occur. It is not known what causes JRA. These conditions are not regarded as hereditary and rarely affect more than one family member. Investigators enrolled 171 patients with active JRA in a multicenter, phase 3 study of adalimumab. During an open-label period, patients received adalimumab at a dose that was equivalent to the approved adult dose, but adjusted for the height and weight of a child. Patients who responded were entered into a double-blind, placebo-controlled withdrawal study to confirm the efficacy of adalimumab treatment. During the study, efficacy and safety of the treatment were assessed at routine intervals. After 16 weeks of adalimumab therapy, marked decreases in disease activity were observed: 77% of patients had a decrease of at least 50% in their disease symptoms, and 58% of patients had at least a 70% decrease in ACR Pedi Response (measurement criteria to assess disease activity in children with JRA). After the 32-week, placebo controlled period, patients receiving adalimumab had significantly fewer flare-ups versus the placebo group, and achieved better ACR Pedi responses. In an extension of the study, long-term efficacy was evaluated in patients who continued to receive adalimumab. The safety profile of adalimumab was favorable in the long-term treatment of JRA. Patients received substantial and sustained improvement during two years of treatment, even if they were not receiving concomitant methotrexate, an immunosuppressant commonly used to treat JRA. "The results of this two-year study of adalimumab were very positive," said Daniel J. Lovell, MD, MPH, Professor of Pediatrics at Children's Hospital Medical Center in Cincinnati, and the study's lead investigator. "JRA is a painful, progressive disease that can leave children with permanent disability if not treated appropriately, so it's critical that we continue to investigate new treatment options that will help patients over the long term."
SOURCE: American College of Rheumatology
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