title: Update on belimumab for the management of systemic lupus erythematosus.
abstract: BACKGROUND
  Belimumab is a fully humanised mAb against B lymphocyte stimulator (B-LyS). It is the first biological drug to be licensed and approved by the US FDA and the European Medicines Evaluation Agency for use in combination with standard immunosuppressants in autoantibody-positive systemic lupus erythematosus (SLE). The clinical effectiveness and impact of this drug on lupus morbidity and mortality is evaluated in this review.
  
  
  METHODS
  An overview of the efficacy and safety of belimumab based on 7-year longitudinal continuation study data from SLE patients enrolled in the Phase II double-blind, randomised, placebo-controlled, 52-week study of belimumab 1, 4 and 10 mg/kg doses and an overview of the open-label 24-week extension of belimumab plus standard immunosuppressant therapy. A review of the current belimumab clinical trials, the experience of belimumab in real-world settings and a description of the impact that belimumab has had on the healthcare quality of life of SLE patients.
  
  
  CONCLUSIONS
  The emerging clinical data have shed light on the areas in which belimumab is of greatest benefit and areas for further evaluation in clinical trials. It is anticipated that regular updates from ongoing trials of belimumab in SLE, practising physicians, data from the continuation arms of clinical trials and data from international biologics registries will have an influence on the role of belimumab in the management of SLE.
authors.affiliation: St Thomas' Hospital, Guy's and St Thomas' Hospitals NHS Foundation Trust, Louise Coote Lupus Unit , Westminster Bridge Road, London SE1 7EH , UK.
authors.forename: Pamela M K
authors.initials: PM
authors.lastname: Lutalo
authors.forename: David P
authors.initials: DP
authors.lastname: D'Cruz
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D053264:B-Cell Activating Factor / Q000627:therapeutic use; D001688:Biological Products / Q000627:therapeutic use; D002986:Clinical Trials as Topic / Q000639:trends; D019468:Disease Management; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D008180:Lupus Erythematosus, Systemic / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D053264:B-Cell Activating Factor; D001688:Biological Products; D007166:Immunosuppressive Agents; C511911:belimumab
keywords: B cell depletion; B lymphocyte stimulator; belimumab; systemic lupus erythematosus