Study affirms effectiveness of medication for juvenile rheumatoid arthritis

Juvenile rheumatoid arthritis (JRA) is a chronic autoimmune disease that strikes children between the ages of newborn to 16 years. All children with JRA have joint pain, stiffness, and swelling and some also have fever and skin rashes. JRA can impede growth, damage joints, and lead to disability in adulthood. Traditionally, children with JRA have been treated with the same drugs prescribed to adults with inflammatory diseases: corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), and disease-modifying antirheumatic drugs (DMARDs) such as methotrexate (MTX). Unfortunately, these medications fail to improve disease activity for many children with JRA.

Tumor necrosis factor (TNF) plays a key role in the inflammatory process. In the past decade, TNF-blockers have brought dramatic gains in treatment for rheumatoid arthritis patients. Etanercept, the only FDA-approved biologic for JRA patients until very recently, has also been proven highly effective and safe for children in short-term trials. Yet, since many children with JRA have active disease that lasts for many years, past adolescence and into adult life for many, assurance of the effectiveness and safety of long-term anti-TNF treatment is essential.

Toward that goal, the Pediatric Rheumatology Collaborative Study Group—comprised of over 70 pediatric rheumatology centers in the US and Canada has been conducting a trial of etanercept in JRA patients for more than 8 years. The group shares reassuring news for pediatricians, parents, and, above all, children afflicted with JRA in the May 2008 issue of Arthritis & Rheumatism (www.interscience.wiley.com/journal/arthritis).

To evaluate the long-term therapeutic value of etanercept, the study group began with a randomized controlled trial, focusing on 69 JRA patients between the ages of 4 and 17 years. Treatment with MTX and other DMARDs was discontinued a minimum 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 patient’s 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.