This week, after 56 years, the Food and Drug Administration (FDA) approved Benlysta (belimumab), to treat patients who are receiving standard therapy, including corticosteroids, antimalarials, immunosuppressives, and nonsteroidal anti-inflammatory drugs. Lupus is a serious, potentially fatal, autoimmune disease that attacks healthy tissues. It disproportionately affects women, and usually develops between ages 15 and 44.

Plaquenil (hydroxychloroquine) and corticosteroids, were approved in 1955. Aspirin was approved to treat lupus in 1948.

Sandra C. Raymond, President and Chief Executive Officer of the Lupus Foundation of America (LFA), has issued the following statement regarding the FDA's decision:

"This is a historic day for the millions of people with lupus and their families around the world who have waited more than 50 years for a treatment breakthrough for lupus. We at the LFA applaud the FDA's decision to approve BENLYSTA. BENLYSTA is the first drug ever to be specifically developed to treat lupus, and is a significant first step toward reaching our goal of developing an arsenal of new, safe, effective, and tolerable treatments. Today marks the beginning of a new era of improved diagnosis, prevention, and treatment for the disease."

The disease affects many parts of the body including the joints, the skin, kidneys, lungs, heart, and the brain. When common lupus symptoms appear (flare) they can present as swelling in the joints or joint pain, light sensitivity, fever, chest pain, hair loss, and fatigue.

Estimates vary on the number of lupus sufferers in the United States ranging from approximately 300,000 to 1.5 million people. People of all races can have the disease; however, African American women have a 3 times higher incidence (number of new cases) than Caucasian women.

Benlysta is the first drug of its kind that is designed to target B-lymphocyte stimulator (BLyS) protein, which may reduce the number of abnormal B cells thought to be a problem in lupus. B lymphocyte stimulator (BLyS), a soluble ligand of the TNF cytokine family, is a prominent factor in B cell differentiation, homeostasis, and selection. BLyS levels affect survival signals and selective apoptosis of autoantibody-producing B cells. High levels of BLyS may relax B cell selection and contribute to autoantibody production, exacerbating the SLE disease state.

Patients treated with Benlysta and standard therapies experienced less disease activity than those who received a placebo and standard of care medicines. Results suggested, but did not definitively establish, that some patients had a reduced likelihood of severe flares, and some reduced their steroid doses.

In an interesting genetic note, African American patients and patients of African heritage participating in the two studies did not appear to respond to treatment with Benlysta. The studies lacked sufficient numbers to establish a definite conclusion. There will be an additional study of people with those backgrounds to further evaluate the safety and effectiveness of Benlysta for this subgroup of lupus patients.

Raymond continues:

"There are a number of pioneering biotechnology and pharmaceutical companies, involved in the research and development of new treatments for lupus, and our hope is that today's decision will further stimulate additional companies to invest in new therapies for lupus. To build on this momentum and encourage the development of new treatments, the LFA has launched new initiatives that help to strengthen clinical trials. These programs include the launch of a Web-based program designed to train clinical investigators on the instruments used in trials. As well, the LFA recently implemented the LFA Lupus Research Registry which enables individuals to be notified about new clinical trials in their geographic area.

Even though the good news is promising, those receiving Benlysta during clinical studies reported more deaths and serious infections compared with placebo. The most common side effects in the studies included nausea, diarrhea, and fever (pyrexia). Patients also commonly experienced infusion reactions, so pre-treatment with an antihistamine should be considered.

Curtis Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research concludes:

"Benlysta, when used with existing therapies, may be an important new treatment approach for health care professionals and patients looking to help manage symptoms associated with this disease."

Sources: Lupus Foundation of America and U.S. Food and Drug Administration

Sy Kraft, B.A.

View drug information on Benlysta.