title: Belimumab and the clinical data.
abstract: Benlysta (belimumab) is a fully human recombinant monoclonal IgG antibody that neutralizes soluble B-lymphocyte stimulator and inhibits its biologic activity. Benlysta was recently approved by the US Food and Drug Administration to treat systemic lupus erythematosus (SLE). The current review discusses the data from the belimumab clinical trials and the role of this new medication in the treatment of SLE. We propose that Benlysta should be used in antinuclear antibody-positive patients with active disease in whom the goal of therapy is to decrease SLE activity, reduce flares, and help lower background medications. With this being the first drug approved for treatment of SLE in 50 years, patients have more treatment options, while researchers have a greater understanding of SLE and clinical trial design in such a heterogeneous disease.
authors.affiliation: Department of Rheumatology, New York University School of Medicine, Seligman Center for Advanced Therapeutics, 333 East 38th Street, 4th Floor, New York, NY 10016, USA.
authors.forename: Katrina
authors.initials: K
authors.lastname: Shum
authors.forename: Anca
authors.initials: A
authors.lastname: Askanase
mesh_terms: D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D053264:B-Cell Activating Factor / Q000037:antagonists & inhibitors; D006801:Humans; D007155:Immunologic Factors / Q000009:adverse effects / Q000627:therapeutic use*; D008180:Lupus Erythematosus, Systemic / Q000188:drug therapy* / Q000276:immunology; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D053264:B-Cell Activating Factor; D007155:Immunologic Factors; C511911:belimumab