title: Belimumab is approved by the FDA: what more do we need to know to optimize decision making?
abstract: The March 2011 approval of belimumab (Benlysta) by the US Food and Drug Administration has left rheumatologists in a bit of a quandary regarding its use. It is officially intended for adult patients with autoantibody-positive systemic lupus erythematosus whose disease remains active despite receipt of standard-of-care therapy. The approved indication is broad and leaves interpretation to individual rheumatologists. Analyses of the phase 2 and 3 clinical trials of belimumab help answer some of the commonly asked questions, such as the following: 1) Who is the appropriate patient for belimumab? 2) How does one measure response? 3) When should results be expected in a patient newly treated with belimumab? 4) When should belimumab be discontinued?
authors.affiliation: Division of Rheumatology and Allergy-Clinical Immunology, Hofstra North Shore-LIJ School of Medicine, Manhasset, NY, USA. dhorowitz@nshs.edu
authors.forename: Diane Lewis
authors.initials: DL
authors.lastname: Horowitz
authors.forename: Richard
authors.initials: R
authors.lastname: Furie
mesh_terms: D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D001323:Autoantibodies / Q000097:blood; D003657:Decision Making; D017277:Drug Approval; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D008180:Lupus Erythematosus, Systemic / Q000188:drug therapy* / Q000276:immunology; D018579:Patient Selection; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D001323:Autoantibodies; D007155:Immunologic Factors; C511911:belimumab