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| |  AAP MEETING: Enbrel Shows Promise For Juvenile Rheumatoid Arthritis PARK CITY, UT -- March 16, 1998 -- Immunex Corp. said preliminary safety data from an ongoing pediatric clinical trial for Enbrel(TM) (TNFR: Fc) indicate that the drug is generally well tolerated by patients with juvenile rheumatoid arthritis (JRA). Enbrel is Immunex's investigational new drug that has previously reported positive clinical results in Phase II and Phase III trials involving rheumatoid arthritis patients. The data from the first segment of an ongoing clinical trial of Enbrel in JRA patients was presented by Dr. Daniel Lovell, MD, MDH, associate professor of pediatrics, division of rheumatology at the Children's Hospital Medical Center of Cincinnati, OH, at the American Academy of Pediatrics' Pediatric Rheumatology Into the Next Century Meeting. In the open-label segment of the trial, Enbrel was generally well tolerated with the most common adverse event reported being mild infections, typical of those seen in an out-patient pediatric population. These resolved spontaneously or with antibiotic treatment. As seen in other Enbrel trials, injection site reactions were mild. Seventy-six percent of the 54 patients were responders to Enbrel, as defined by 30 percent or more improvement in at least three of the six JRA Core Set Variables. The six JRA Core Set Variables are a physician's assessment, a count of joints with active RA, a count of joints with loss of motion, a patient's or parent's global assessment, a functional ability test (Childhood Health Assessment Questionnaire) and a blood test used to assess inflammation (ESR). "This study breaks new ground for many reasons," said Dr. Edward Giannini, MSc, DrPH, Professor of Pediatrics at Children's Hospital Medical Center in Cincinnati, Ohio. "This is the first study of a biologic for treatment of JRA. In addition, it is the first anti-arthritis drug to be studied in children prior to FDA approval for use in adults." This study was designed to be conducted in two segments. The first segment was intended to evaluate safety of Enbrel for the treatment of JRA. In this three-month segment of the study, all patients received treatment with Enbrel twice a week, with dosing based on body size (0.4 mg/kg, maximum 25 mg dose). Responders were determined after three months of treatment using JRA Core Set Variables. In the ongoing second segment of the study, JRA patients who met criteria for response to Enbrel were randomised to receive continued treatment on a blinded basis with Enbrel or placebo twice weekly for four months, using the same dose as in the first segment of the study. The endpoint for this efficacy portion of the study is incidence of progression of disease. Patients qualifying for this study were required to have polyarticular course JRA -- including any onset type of the disease. Patients were required to be refractory or intolerant to methotrexate and to have active disease (greater than five active joints and three joints with loss of motion accompanied by pain and/or tenderness) prior to washout of all DMARDs for a minimum of two weeks. The duration of disease was not limited, but had to have been long enough for patients to have been given an adequate trial of NSAIDs and low dose methotrexate. NSAID and low dose prednisone therapy were permitted but held stable throughout the study. Enbrel is a protein-based drug comprising only human amino acid sequences, scientifically referred to as a recombinant version of the soluble p75 TNF receptor linked to the Fc portion of human IgG1. It competitively inhibits the binding of TNF to its cell surface receptors, and thereby inhibits TNF biological activity. Enbrel is thought to interfere specifically with the inflammatory process in RA, which may be driven by TNF. In RA, excess TNF combines with cell surface TNF receptors and produces a cascade of damaging and inflammatory effects on joints. Enbrel provides a soluble form of the receptor that acts like a sponge to absorb excess TNF.
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