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Clinical trial supports better treatment for lupus nephritis

CHAPEL HILL -- Treating lupus patients suffering from kidney inflammation with a medicine known as mycophenolate mofetil may be more effective in inducing remission than treating them with the standard regimen of intravenous cyclophosphamide (Cytoxan), a new clinical trial indicates.

The study, published in Thursday's issue (Nov. 24) of the New England Journal of Medicine, also showed that mycophenolate mofetil produced fewer complications, researchers found.

Such results could be an important step forward in protecting patients from Cytoxan's side effects, including loss of child-bearing ability, the doctors say. Since 90 percent of lupus patients are women, and the average age when the disease is diagnosed is 32 years old, loss of fertility remains an important concern.

Authors of the report include Drs. Ellen M. Ginzler, chief of rheumatology at SUNY Downstate Medical Center in Brooklyn, and Mary Anne Dooley, associate professor of medicine and a Thurston Arthritis Research Center investigator at the University of North Carolina at Chapel Hill School of Medicine.

"This is the first nationwide randomized clinical trial comparing the newer agent, approved for about 10 years for kidney transplant patients, with the long-time standard of care, which has been Cytoxan," said Dooley, who helped design the FDA orphan disease branch-funded study, get it approved and recruit medical centers and patients. "Our results are very promising, but we need to do longer follow-up to see if the new medicine produces long-lasting improvement."

Oral mycophenolate mofetil worked faster in relieving inflamed kidneys, a condition doctors call nephritis, in half of the 140 patients enrolled in the trial, she said. At the end of the six months, patients taking it were doing significantly better than the other half, who were getting monthly intravenous doses of the standard medication.

"Lupus nephritis is a severe manifestation of lupus, which
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Contact: David Williamson
rdtokids@email.unc.edu
919-962-8596
University of North Carolina at Chapel Hill
23-Nov-2005


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