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| |  DG DISPATCH - ACR: Enbrel Offers Hope For JRA Patients Unresponsive To Methotrexate By Maria Bishop Special to DG News BOSTON, MA -- November 15, 1999 -- There is now solid hope of improvement for children and teenagers with severe polyarticular juvenile rheumatoid arthritis (JRA) who fail to respond to treatment with the gold standard of therapy: methotrexate.
Pediatric rheumatologist Dr. Daniel Lovell noted that, in the United States alone, 30 to 40 percent of the nation’s 70,000 JRA patients stand to benefit from treatment with Enbrel (etanercept), a soluble, tumor necrosis factor (TNF)-alpha receptor. As lead investigator of the Pediatric Rheumatology Collaborative Study Group (PRCSG), in Cincinnati, OH, Dr. Lovell presented results of the group’s recent open-label trial during a plenary session of the 63rd Annual Scientific Meeting of the American College of Rheumatology (ACR), in Boston, MA. As a result of this research, the U.S. Food and Drug Administration approved Enbrel to treat severe to moderate RA on Nov. 2. A similar decision, to approve etanercept for the treatment of polyarticular-course JRA, was made last spring (May 28). The PRCSG’s 12-month study of Enbrel in youths with severe JRA began as an open-label study coordinated at Children’s Hospital Medical Center of Cincinnati, comprising a population of 69 patients with polyarticular JRA who were known to have failed in their response to methotrexate. The age of study participants ranged from four to 17 (mean age, 11), and the mean duration of the disease was six years. At the end of three months in the study, 74 percent of the study population had met the response criteria and were randomized to either continue Enbrel treatment or to receive placebo in a blinded trial. In the Enbrel vs. placebo part of this study, the goal was to observe for how many of the 51 enrolled patients the JRA flared. The response rate of those patients receiving Enbrel dipped slightly (28 percent showed a flaring of the disease), but the rate for those on placebo dipped significantly, with the disease flaring in 80 percent of those patients. "At the end of the twelve months," noted Dr. Lovell, "over 70 percent of patients who continued on etanercept showed a profound improvement in seven out of ten parameters (including effects on the joint, as well as morning stiffness, pain and erythrocyte sedimentation rate)." Added Lovell, "[Patients in] the group showed a tremendous potential to normalize their disease; over 30 percent of them no longer have joints with active arthritis, and, in 70 percent, the disease process has been significantly suppressed [at least 50 percent improvement in disease-activity measures]." As well, over 30 percent of patients have been relieved of all joint pain. A third portion of this study, an open-label extension trial comprised of 59 patients, is presently ongoing, allowing patients who had been on placebo during the second part of the study to regain their improvement when Enbrel treatment was restored. In addition, noted Dr. Lovell, "some patients who had been nonresponders [in the initial part of the trial] are showing that, [with treatment] beyond three months, they are able to respond well when they receive long-term treatment." Throughout the study, no irreversible side effects of were demonstrated with Enbrel and the frequency of side effects was no greater than in the placebo group. The frequency of adverse events did not accumulate with time. "Etanercept, at present, represents a well-tolerated treatment with profound clinical benefit to JRA patients in all aspects of their lives," noted Dr. Lovell. He pointed out, however, that the "true long-term potential and impact of entanercept still remains to be shown." The current extension trial will continue for at least three years.
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