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Drug Effective and Safe for Kids With Severe Rheumatoid Arthritis

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By News Release • • January 22, 2000

CINCINNATI, OH -- More than 70 percent of children with severe long-standing juvenile rheumatoid arthritis (JRA) respond, often times dramatically, to Enbrel ® therapy, according to new results of an ongoing three-year clinical study coordinated at Children's Hospital Medical Center of Cincinnati. The results were presented today at a plenary session of the 63rd National Scientific Meeting of the American College of Rheumatology (ACR). The results conclude that Enbrel is safe and well tolerated with prolonged use in children and teenagers with polyarticular JRA.

In this clinical trial, 74 percent (51 of 69 children) aged four to 17 demonstrated clinically important improvement when treated with Enbrel for three months. In the second segment of the study, these 51 children were then randomly assigned to receive either Enbrel or placebo. In this segment, 72 percent of patients treated with Enbrel continued to improve on treatment without having their arthritis flare, compared to only 28 percent of patients treated with placebo. This was a statistically significant result.

"These findings show a significant -- often profound -- improvement for most children with JRA when treated with Enbrel over placebo," says Dr. Daniel J. Lovell, a pediatric rheumatologist at Cincinnati Children's and principal investigator of the study. "Before Enbrel treatment, many children with severe JRA had poor response to existing treatment options. Often, they had to stop attending school. They'd be stiff for hours in the morning and experience pain every time they'd walk. Now, because of Enbrel, there's hope for these children."

The third segment of this multi-center study, performed by the Pediatric Rheumatology Collaborative Study Group (PRCSG) and coordinated by investigators at Cincinnati Children's, is an open-label extension study of Enbrel to treat JRA. Results show that with continued treatment with Enbrel, 80 percent who demonstrated initial clinical response continued to do so for over one year.

Patients had an average of 29 active inflamed joints when starting this trial. Of those patients, 31 percent no longer have joints with active arthritis after one year of treatment with Enbrel. Additionally, 32 percent of patients have been relieved of all joint pain, and 76 percent no longer experience morning stiffness. In 70 percent of the patients, the disease process has been significantly suppressed (at least 50 percent improvement in disease activity measures). According to Dr. Lovell, these findings are significant because the study included children who had been diagnosed with JRA, on average, six years before and most had been poorly responsive to all other therapies previously used.

"The Pediatric Rheumatology Collaborative Study Group (PRCSG) is dedicated to innovative scientific clinical research that is changing the way diseases like JRA are treated. This trial will continue for at least three years, and we will learn more about how Enbrel is able to help children and families struggling with JRA," says Dr. Lovell.

The PRCSG is composed of pediatric rheumatologists located in over 45 leading academic and clinical centers who are actively engaged in the diagnosis and treatment of children with rheumatic diseases such as JRA. The PRCSG has completed and published over 30 studies in children with JRA.

Enbrel is a protein-based drug that inhibits the binding of tumor necrosis factor (TNF), a protein secreted by different types of cells that regulate the immune response. Normally, when a person gets a viral or bacterial infection, these proteins help fight off the infection. JRA, however, is an autoimmune disease in which these proteins create a cascade of inflammatory effects in joints that can actually destroy one's own joint tissue. Enbrel acts as a sponge to absorb TNF so that it does not bind to receptors on the surface of certain cells, thereby blocking TNF and suppressing the cascade reaction.

In the open-label extension study, there was no significant increase in adverse events with increased time on Enbrel. Of the 58 patients enrolled, eight prematurely discontinued (one remission, five loss of response, and one switched to marketed Enbrel). Only one of the patients who discontinued did so because of an adverse event. The types of infections seen in the Enbrel treated patients were those commonly seen in the outpatient setting, and the rate of infections did not increase with exposure to Enbrel. Hospitalization for adverse events, infections or flare of arthritis were infrequent, occurring 10 times in eight patients during the full 21 months of follow-up. There were no malignancies reported in the initial trial or the extension trial.

Based on the results of the first two segments of this trial, the U.S. Food and Drug Administration (FDA) approved Enbrel for the treatment of polyarticular course JRA -- a common form of the disease -- on May 28, 1999. On November 2, 1999 the FDA approved Enbrel to treat severe to moderate rheumatoid arthritis.

JRA often strikes during the prime growing years, destroying joints and causing significant pain, and can leave children with significant limitation in their ability to perform daily activities if not treated effectively, according to Dr. Lovell. JRA is the most common form of childhood arthritis, with about 71,000 cases in the United States, affecting about 134 children per 100,000 children, according to the Arthritis Foundation. Symptoms include swelling, pain, limitation of motion, and tenderness of the joints. In some cases, JRA can affect internal organs.

Source: Doctor’s Guide

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