HOPE FOR LUPUS
A new treatment for the devastating disease of lupus may be LJP 394, a drug currently being tested at Texas Tech University Health Sciences Center to help those whose bodies are attacking them.
Written by Andrea Watson
Lupus is a disease in which the body attacks itself, often leading to devastating consequences. The disease can affect the skin, joints, lungs, kidneys and virtually every other organ. Lupus can subside for months or even years and then attack again without any warning.
While the disease is most commonly associated with a distinctive butterfly-shaped rash that appears across the face, one of the most commonly affected organs is the kidney, involved in nearly 80 percent of all patients’ illnesses.
Lupus is an autoimmune disease in which the body essentially becomes allergic to itself. The body begins to produce antibodies to its own DNA, although reasons why are not yet understood by investigators. Researchers at Texas Tech University Health Sciences Center are involved in a human drug trial that goes to the heart of the mechanism of the disease of Lupus.
When a patient is stricken with lupus, the cells’ DNA becomes an antigen, or a substance that induces the body to form antibodies against the substance identified as a threat, said Neil Kurtzman, M.D., a University Distinguished Professor, Arnett Professor of Medicine and professor of physiology at Texas Tech University Health Sciences Center. When the antigens and antibodies combine, they often get stuck in various blood vessels, inducing an inflammatory response.
Lupus primarily affects women of childbearing age, at a rate of three or four times more than men. Although as people age, new diagnoses of lupus in both men and women occur at a similar rate, he said.
"There are five grades of lupus nephritis according to the World Health Organization, each with a different prognosis," Kurtzman said. "The worst type is diffuse proliferative glomerulonephritis, which is actually grade 4. Untreated, 75 percent of these people will be on dialysis or need a kidney transplant within five years."
Kurtzman said that while there are treatments available for lupus nephritis, such as steroids and immunosuppressive agents, they could have very severe side effects including bone loss, gastrointestinal bleeding and depression of bone marrow. Because of these severe side effects, researchers have begun looking for new treatments that would be less damaging to the body.
One new treatment may be LJP 394, a drug currently being tested at Texas Tech University Health Sciences Center and 77 other sites throughout the United States and Europe. LJP 394, created by La Jolla Pharmaceuticals, is designed to fool the immune system by binding to specific cells and making them inactive. Essentially, the drug tries to get to the basic mechanism that causes lupus, Kurtzman said.
"By fooling the immune system, this drug may be able to keep the body from producing antibodies against a person’s DNA," he said.
Currently, only one person is enrolled in the 22-month study from the Health Sciences Center, but 16 patients have been screened. Throughout the testing sites, 590 people have been screened, with 210 actually enrolled in the trial.
"The overall goal is 330 people enrolled nationwide," said Betty Lonis, Texas Tech University Health Sciences Center study coordinator for the drug trial. "The screening criteria are very complex and very strict. It’s hard to find people that qualify for each part of the criteria."
Lonis said the first test done for any lupus patient wanting to be involved in the trial is a blood test to determine the double-stranded DNA level. This test is a measurement of the antibodies to the person’s DNA found in the blood. For a person to be allowed into the trial the level must be above 15, she said.
If the DNA level is high enough, other tests are done as the patient begins the trial. Lonis said the trial is a double-blinded study so the one patient currently enrolled doesn’t know whether she is receiving the new drug or a placebo.
The patient said she has had lupus for several years, although her flare-ups have been relatively mild since her initial diagnosis and early flare-ups, and she said she has been feeling fairly healthy for some time. She said she became interested in participating in the trial because of the benefit it could have on her grade 4 lupus nephritis.
"I hope it’s the medication they’re giving me," she said. "I know it’s supposed to stop the development of the antibodies that have caused the decline in my kidneys. If I have any more flares, I’ll be close to dialysis. If this medication can stop or slow the damage to my kidneys, I can live the rest of my life like I am and be OK. If it can help me, maybe it can help someone else."
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