A study under way at the University of Alabama at Birmingham (UAB) is testing the first drug designed to target and deactivate an immune system protein responsible for the overproduction of antibodies in autoimmune diseases such as lupus and rheumatoid arthritis.

Posted on April 30, 2002 at 2:46 p.m.

BIRMINGHAM, AL — A study under way at the University of Alabama at Birmingham (UAB) is testing the first drug designed to target and deactivate an immune system protein responsible for the overproduction of antibodies in autoimmune diseases such as lupus and rheumatoid arthritis. “In mouse models of lupus, disease progression is prevented or delayed by deactivating this protein,” says Dr. Winn Chatham, associate professor of medicine with the division of clinical immunology and rheumatology at UAB. “This study is the first step in determining if this also is true in humans.”

The study represents a significant advance in lupus research. “With rheumatoid arthritis, once specific immune system targets were identified, better, more effective therapies were developed to treat the disease. With lupus, we are only now beginning to identify targets and develop such therapies,” says Chatham.

The drug, LymphoStat-B, targets B-lymphocyte-stimulator (BLyS), an immune system protein that triggers growth and proliferation of cells that produce antibodies. “In autoimmune diseases, the immune system produces too many antibodies, which begin attacking and destroying the body’s own healthy cells and tissues,” says Chatham. “LymphoStat-B works by binding to and preventing BLyS from stimulating the immune system to produce these harmful antibodies.”

The drug’s ability to target BLyS is particularly important. “Current therapies such as corticosteroids and cytotoxic drugs lack the ability to specifically target immune system agents and are often are accompanied by undesirable side effects,” says Chatham. “This new therapy may offer us an effective treatment without many of these undesired effects.”

UAB is one of about 15 centers nationally participating in the study. “For this initial phase, each center will recruit five or six volunteers,” says Chatham. “If findings are favorable, a larger second phase study will be conducted to further assess the drug’s safety and effectiveness.”

Men and women over age 19 who have lupus may be eligible to participate in the six-month study. Following an initial screening, enrolled volunteers will be admitted to the hospital overnight and will receive an intravenous infusion of either the drug or a placebo. Some volunteers also will receive a second infusion later in the study. “The administration of the drug takes about two hours,” says Chatham. “Blood samples are drawn before, during and after the drug is administered.”

For more information about the study, please call (205) 934-4212.