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Study affirms effectiveness of medication for juvenile rheumatoid arthritis
Date:5/8/2008

m of 2 weeks before enrollment, while maintaining a low-dose regimen of corticosteroids or NSAIDs was allowed. Patients received injections of etanercept based on the patients body weight with a maximum weekly dosage of 50 milligrams. As the trial was extended beyond 1 year, participants were permitted to add low-dose MTX if recommended by their physician. At every 3 months during the first year of the extension phase, and then every 4 to 6 months during the following years, participants were assessed for improvement in overall disease status using the American College of Rheumatology Pediatric (ACR Pedi) criteria, as well as evaluated for changes in joint inflammation, mobility, pain, ability to perform routine daily tasks and C-reactive protein level. Patients were also monitored for frequency of serious adverse events (SAEs) such as those that required hospitalization, resulted in prolonged incapacity or death. Also medically important infections (MIIs) defined as those that required treatment with intravenous antibiotics were monitored.

58 JRA patients, 84 percent of the participants in the randomized controlled trial, enrolled in the long-term extension trial and received weekly treatment for a total of 318 patient years of etanercept exposure. Most patients were female (67 percent) and white (74 percent), and all had taken MTX prior to the study. At baseline, the mean age of the patients was 10 years and the mean duration of disease was 5.9 years. 42 of these patients (72 percent) entered the fourth year of continuous etanercept treatment, and 26 patients (45 percent) entered the eighth year. Heres an overview of the results:

  • 16 of the original 69 study participants reported 39 serious adverse events, for an overall exposure-adjusted rate of 0.12 SAEs per patient year. This rate did not increase with long-term exposure to etanercept.

  • 8 patients reported
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Contact: Sean Wagner
swagner@wiley.com
781-388-8550
Wiley-Blackwell
Source:Eurekalert

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