Until recently, patients diagnosed with active, autoantibody-positive lupus, or systemic lupus erythematosus (SLE), were treated with decades-old sub-optimal therapies such as aspirin, anti-malarials (Plaquenil), corticosteroids and nonsteroidal anti-inflammatory drugs. But on Wednesday, the FDA approved Human Genome Sciences’ Benlysta, the first new drug on the market to treat lupus in over 50 years. The drug, an immunosuppressant delivered intravenously, aims to reduce the number of abnormal B cells in the body, which is believed to be a problem associated with lupus. Affecting 300,000 to 1.5 million people, lupus is a potentially fatal autoimmune disease that targets the joints, skin, kidneys, lungs, heart and brain.
In two randomized clinical trials, 1,684 lupus patients received either Benlysta plus standard therapy or an inactive infused placebo plus standard therapy. The results demonstrated that patients on Benlysta experienced fewer symptoms compared to the placebo group, although those with the most severe form of lupus were excluded from the study. According to the data, about 11 patients must be treated in order for one to benefit from the therapy.
Lupus typically develops between the ages of 15 and 44 and disproportionately affects women. In particular, African American women have a three-fold greater incidence of the disease compared to Caucasian women. Worse still, African American patients included in the clinical trials did not experience any benefit from taking Benlysta.
ACSH’s Dr. Gilbert Ross thinks that this new drug is far from a cure but may act as a harbinger of new research for the development of even more effective drugs against this devastating disease. “Unfortunately, only about 30 percent of patients in the clinical trials responded positively to Benlysta, and that statistic was even less formidable among African Americans.” Treatment with Benlysta was associated with a higher incidence of death and serious infection, indicating that “this drug will be used primarily for patients with the moderately active disease. Severe SLE — involving the brain or kidneys — requires more potent treatment.”