March 9, 2011 -- The FDA has approved Benlysta, the first new lupus drug since 1955.
Benlysta is approved for the treatment of patients with active, autoantibody-positive lupus who are getting standard therapy. Standard therapy includes corticosteroids, antimalarial drugs, immunosuppressive agents, and NSAID anti-inflammatory drugs.
As many as 1.5 million Americans have systemic lupus erythematosus (SLE), commonly called lupus. Lupus is an autoimmune disease in which a particular type of white blood cell -- B lymphocytes -- turn the body's immune defenses against the body's own cells.
Benlysta inhibits the maturation of these B cells. Because B cells are crucial elements of the immune system, Benlysta carries serious risks. There were more deaths and serious infections among patients taking Benlysta than among patients taking placebo.
The drug may work best for patients with moderate disease, says lupus expert Eric L. Greidinger, MD, chief of rheumatology and immunology at the University of Miami Miller School of Medicine.
"The hope is that Benlysta may allow some of these patients who have persistently active lupus who are using substantial doses of steroids to bring their disease under better control, so they have less lupus activity and can take less steroids, exposing them to fewer of the many steroid-associated side effects," Greidinger tells WebMD.
Lupus is particularly common among African-American women. In clinical trials, African-American patients did not appear to respond to Benlysta as well as other patients -- so the manufacturer, Human Genome Sciences, has agreed to conduct a new study of the drug in this subgroup of patients.