FDA approves drug to treat lupus
March 10th, 2011
12:06 PM ET

FDA approves drug to treat lupus

The Food and Drug Administration on Wednesday approved the drug Benlysta (belimumab) for the treatment of lupus, a chronic, potentially fatal autoimmune disease that affects about 5 million people across the world and, specifically, about 1.5 million Americans.

“This is a historic day for the millions of people with lupus and their families around the world who have waited more than 52 years for a treatment breakthrough for lupus," said Sandra C. Raymond, president and chief executive officer of the Lupus Foundation of America, in a statement. "Today marks the beginning of a new era of improved diagnosis, prevention, and treatment for the disease."

The disease, in which the immune system attacks healthy tissue, can damage any part of the body. It mostly affects women in their childbearing years, but the LFA says it can also affect men, children and teenagers and people of all races and ethnicities. The condition is diagnosed in African-American women three times as often as Caucasian women.

Before the approval of Benlysta, the FDA last approved Plaquenil, corticosteroids, and aspirin for the treatment of lupus in the mid-1900s.

Lupus symptoms can come and go. When symptoms flare, they can appear as painful or swollen joints, hair loss, extreme fatigue, fever and sensitivity to light. More serious complications involve the body's major organ systems, including the kidneys, arteries and lungs.

Serious infection could also cause death. In the drug studies, 6% of patients on Benlysta had serious- and sometimes fatal-infections from pneumonia, urinary tract infection, cellulitis (a skin infection) and bronchitis. The number of patients on placebo who saw severe infections was 5.2%. A total of 14 deaths occurred out of 2133 patients in all the trials.

But results of the two clinical studies found those patients treated with Benlysta, which is given by monthly infusion, had less disease activity than those on a standard course of medication or a placebo. The results only suggested that some patients had less of a chance of severe flares, and some were able to receive less steroids.

In addition, African-Americans receiving the drug did not respond, and therefore the researchers could not draw a conclusion about the safety and effectiveness. Further study of this population is in the works.

The drug, like any, is not without side effects. In the studies, patients experienced nausea, diarrhea and fever. Reactions at the time of administration of the drug were common, so the FDA suggests considering pre-treatment with an antihistamine.

The label also indicates the drug is not for everyone with lupus. The drug should be available within about two weeks.

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