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| |  Safety of Etanercept for Juvenile Arthritis Demonstrated ATLANTA, GA -- November 14, 2007 -- Etanercept is safe in the long-term treatment of juvenile rheumatoid arthritis, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in Boston, Mass. Juvenile rheumatoid arthritis is the most common form of arthritis in 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. Etanercept (Enbrel) is an injectable drug used to block tumor necrosis factor alpha -- a protein produced in the body that causes the pain and tenderness associated with rheumatic disease. Researchers recently studied the long-term safety and effectiveness obtained in a double-blind, randomized controlled trial of etanercept in children with JRA. 69 patients were enrolled in the original controlled trial, and 84 percent continued on in the open extension study. Researchers assessed safety and effectiveness in those patients who received at least one dose of etanercept during the extension. Safety assessments included the incidence of serious adverse events, including medically important infections, malignancies, lymphomas and deaths. Effectiveness was assessed by using the Childhood Health Assessment Questionnaire (a tool used in the evaluation of functional outcomes in children with chronic arthritis), physician global assessment of the patient's wellbeing, patient's and parent's global assessment (an assessment completed by the patient or parent by evaluating the patient's functional ability), number of swollen joints, pain upon movement or limitation in movement, and C-reactive protein (a marker of inflammation in the blood). A total of 42 patients continued taking etanercept for 4 years, and 26 continued for eight years. The most common reason patients stopped the therapy was due to a parent's or guardian's desire to remove the patient from the study. Additional reasons for discontinuing use of etanercept included suboptimal treatment response, adverse effects, and physician decision. 23 percent of patients reported a total of 39 serious adverse events; however, the overall rate of serious adverse events did not increase with long-term exposure to the drug. In addition, no cases of lupus, demyelinating disorders, tuberculosis, malignancies, lymphomas, or deaths were reported. "The drug had a sustainable efficacy profile with very a beneficial safety profile. Only one serious infection, pyelonephritis, was observed in the remaining patients during the past four years, said Dr. Andreas Reiff, MD; head, division of rheumatology, Keck School of Medicine; University of Southern California; Children's Hospital Los Angeles; and an investigator in the study.
SOURCE: American College of Rheumatology
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