For the first time in more than 50 years a new drug has been approved for the treatment of lupus, a chronic inflammatory disease that can affect various parts of the body, especially the skin, joints, blood and kidneys. The U.S. Food and Drug Administration approved Benlysta (belimumab) on March 9, 2011, making it the first medication approved for lupus in the U.S. since 1955.
Millions of people worldwide have lupus, including at least 1.5 million Americans, according to the Lupus Foundation of America (LFA). Lupus strikes mostly women of childbearing age (15-44) but men, children and teenagers develop lupus, too. While people of all races and ethnic groups can develop lupus, women of color are two to three times more likely to develop the condition.
LFA President and Chief Executive Officer Sandra C. Raymond said, “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.” She called the action “a significant first step toward reaching our goal of developing an arsenal of new, safe, effective and tolerable treatments” and “the beginning of a new era of improved diagnosis, prevention and treatment for the disease.”
Patient Stephanie Kennedy described her reaction to the announcement on a page developed by LFA for patient responses. “We suffer in silence with a feeling of isolation and desperation. The approval of Benlysta is, in a word, hope. It embodies hope where there just was none. With increased awareness and continued strides forward, our voices will continue to be heard and lupus survivors can have something they have been denied....their lives.”
Why has it taken so long to develop a new treatment for lupus? According to LFA, the complexity of the disease makes finding effective new therapies challenging. Lupus can affect multiple organ systems and symptoms can range in severity from one day to the next. Also, lupus affects each person differently, with varying responses to treatment.
While the announcement was welcome news, there are still many drawbacks. Only about a third of the patients who took the drug during clinical trials saw benefits, and the drug showed no benefit for Blacks and people of African heritage. (The FDA has ordered Benlysta's manufacturer to conduct additional studies involving these patients.) The drug weakens the body's immune defenses, causing serious side effects which include infections, cancers, depression and suicide. The medication will cost patients around $35,000 a year compared to current costs of several hundreds of dollars per year for other treatments.
Benlysta was approved for the treatment of adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy. It is administered through an IV (intravenous) infusion directly into the vein. The drug was developed by Human Genome Sciences, will be co-marketed by GlaxoSmithKline, and is expected to become available in late March 2011.
Patients are urged to discuss the pros and cons of the drug with their doctor, as it is not effective for all patients. The most common side effects in clinical trials were nausea, diarrhea, and fever. More deaths and serious infections were also reported with the drug than with a placebo in the studies.
Lupus Foundation of America:
EmpowHER Lupus Community:
Benlysta Product Information:
FDA Press Release: FDA approves Benlysta to treat lupus