Clinical Medicine Reviews in Therapeutics

In March 2011, the FDA approved belimumab (Benlysta) for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus who are receiving standard therapy. Belimumab is a fully human monoclonal antibody directed against BLyS (B lymphocyte stimulator). BLyS, a member of the TNF ligand super family, promotes the survival and maturation of B cells. For patients on standard of care therapy and without active severe renal or central nervous system lupus, belimumab has been shown to be effective and safe. Further information will be gathered in the open label extensions of the phase II and III trials and post-marketing experience.