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Clinical trial of Etanercept for Wegener's disease shows no benefit

A Johns Hopkins-led study designed to evaluate the ability of etanercept to maintain disease remissions in a serious autoimmune disorder has failed to show any benefit. Etanercept, also called Enbrel, is a common treatment for rheumatoid arthritis and other types of joint inflammation.

"We had hoped that this approach to the treatment of Wegener's granulomatosis would be useful in preventing disease relapses," says John H. Stone, M.D., associate professor of medicine, director of the Johns Hopkins Vasculitis Center, and lead investigator of the study published in the Jan. 27, 2005, issue of the New England Journal of Medicine.

"The study results, however, demonstrate unequivocally that etanercept was not effective for this purpose. Because of the disease's propensity to flare following remission and the high risk of treatment complications associated with conventional therapies for Wegener's, we must continue to look for safe, effective ways of achieving and maintaining disease remissions," said Stone.

Wegener's granulomatosis is an uncommon disorder in which the body's immune system attacks its own blood vessels, damaging vital organs by limiting the flow of blood to lungs, kidneys, upper airways and other organs. The disease can affect people of any age and occurs in men and women with equal frequency.

Although current medications used to treat Wegener's halt the disease temporarily in most patients, 60 to 80 percent of patients eventually suffer from disease flares. The need to treat many patients repeatedly with medications such as glucocorticoids (prednisone), cyclophosphamide, and methotrexate leads to mounting morbidity from treatments. At the same time, each disease flare has the potential to cause irreversible damage. Wegener's granulomatosis frequently leads to kidney failure, hearing loss, damage to the respiratory tract, peripheral nerve injury, and other complications, according to Stone.

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Contact: Trent Stockton
tstockt1@jhmi.edu
410-955-8665
Johns Hopkins Medical Institutions
26-Jan-2005


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