First New Drug Approved for Lupus in 56 Years

In March 2011, the FDA approved the first drug to treat lupus since President Eisenhower was in office. The drug, called Benlysta, is approved for people with active autoantibody-positive lupus who are also taking other lupus medications.

How Does It Work?

Benlysta is delivered intravenously, or through a vein. It targets a specific protein that B cells—white blood cells that produce inflammation-causing autoantibodies—need to function. Scientists believe the drug works by cutting down on the number of wayward B cells involved in lupus.

How Effective Is It?

Benlysta works best when combined with other medications for lupus, such as corticosteroids, antimalarials, immunosuppressives, and anti-inflammatories. Two clinical trials found that people who received Benlysta plus other lupus therapies experienced fewer symptoms of the disease than those who received a nonmedicated solution, known as a placebo, plus their regular lupus treatments. For some patients, the drug also may have reduced their risk of experiencing severe flares. Some patients were able to cut back on their steroid doses.

However, there is one caveat: symptoms did not seem to improve in African-Americans and those of African heritage who participated in the clinical trials and received Benlysta. Scientists are conducting additional studies in patients with those backgrounds.

Common side effects of Benlysta include nausea, diarrhea, and fever. Ask your doctor whether adding this brand-new medication to your treatment regimen could benefit you.