For the first time in more than 50 years, the US Food and Drug Administration (FDA) has approved a drug for the treatment of adult systemic lupus erythematosus (SLE). Although this action was hailed by patient advocacy groups, the drug's benefits appear to be modest and have yet to show efficacy in blacks, among whom the disease is disproportionately common and severe.
Also, evidence regarding the efficacy of the new drug, belimumab (Benlysta, Human Genome Sciences), is largely confined to effects on the musculoskeletal and mucocutaneous systems. Patients with active lupus involving the kidney or central nervous system—2 sites often severely affected by the disease—were excluded from the 2 key trials examining benefits of the drug.
Mitka M. Treatment for Lupus, First in 50 Years, Offers Modest Benefits, Hope to Patients. JAMA. 2011;305(17):1754-1755. doi:10.1001/jama.2011.548