Sep. 10, 1998 GAINESVILLE, Fla.---In a marked departure from the standard treatment for lupus, University of Florida researchers are testing whether an experimental medication will halt the immune system attack the body often launches on these patients' kidneys.
The new approach relies on injecting a fragment of DNA known as an immune modifier, or tolerizer, in an attempt to shut down or at least minimize the body's assault on itself.
"We want to see what impact this study medication has on the preservation of renal function as well as on the number of flares of the disease," said Dr. Roland Staud, an associate professor of rheumatology at UF's College of Medicine.
Systemic lupus erythematosus is a chronic autoimmune condition that inflames the body's connective tissues and targets many systems as if they were foreign, including the joints. More than half of all lupus patients develop kidney problems that worsen over time; many experience flare-ups that require frequent treatment. An estimated 1 in 1,000 individuals have the incurable and sometimes life-threatening disease, which afflicts women nine times more often than men, usually those of child-bearing age.
Standard medical care aims at reducing the inflammation and alleviating symptoms, which include fatigue, fever, nausea, loss of appetite, joint pain and weight loss. But the medications most commonly used to quell the damage -- corticosteroids and cytoxan -- often have many serious side effects, including infertility and an increased susceptibility to infection, Staud said.
The national, multicenter study is just getting under way and will continue for the next year and a half. Staud is the lead investigator at the UF site.
Study participants should not be acutely ill at the time they enroll and must have signs of kidney disease caused by lupus. They are randomly assigned to receive either a placebo or weekly injections of the medication for 12 weeks, alternating with eight weeks off the drug. About 240 people will be tracked nationwide. UF participants will be seen through the Diagnostic Physicians 1 Clinic at Shands at UF.
While researchers caution it is too soon to tell what effect, if any, the new medication will have on people with the disease, animal studies of the therapy have been successful, Staud said.
"There are good mouse models for systemic lupus and in these mouse models with kidney disease, this therapy has been shown to be exceedingly effective," he said. "It also has extremely few side effects."
The study is funded by San Diego-based LaJolla Pharmaceutic Co.
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