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Drug Fails Against Autoimmune Disease

Etanercept offers no benefit for people with Wegener's

WEDNESDAY, Jan. 26, 2005 (HealthDayNews) -- The drug etanercept shows no benefit against the autoimmune disorder Wegener's granulomatosis, according to results of a clinical trial led by Johns Hopkins researchers.

The study was designed to evaluate the ability of the drug, also called Enbrel, to maintain disease remission. The study included 180 patients with Wegener's -- 89 of them received etanercept and 91 received a placebo. The patients were followed for an average of 27 months.

There was no significant difference in the percentages of patients in the two groups who achieved at least six months of disease remission -- 69.7 percent in the group that received the drug and 75.3 percent in the control group.

The study also found no difference between the two groups in the numbers of patients who experienced severe or limited flare-ups of their disease.

The findings appear in the Jan. 27 issue of the New England Journal of Medicine.

Etanercept, the first of a class of drugs called tumor necrosis factor inhibitors approved by the U.S. Food & Drug Administration for the treatment of rheumatoid arthritis, is also known to be effective in psoriasis, psoriatic arthritis and juvenile rheumatoid arthritis.

"We had hoped that this approach to the treatment of Wegener's granulomatosis would be useful in preventing disease relapses," lead investigator Dr. John H. Stone, an associate professor of medicine and director of the Johns Hopkins Vasculitis Center, said in a prepared statement.

"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," Stone said.

In people with Wegener's, the body's immune system attacks its own blood vessels. This limits blood flow to lungs, kidneys, upper airways and other organs, resulting in damage.

More information

The Cleveland Clinic Foundation has more about Wegener's granulomatosis.

SOURCE: Johns Hopkins Medicine, news release, Jan. 26, 2005
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