title: Effects of belimumab, a B lymphocyte stimulator-specific inhibitor, on disease activity across multiple organ domains in patients with systemic lupus erythematosus: combined results from two phase III trials.
abstract: OBJECTIVE
  To evaluate the effects of belimumab versus placebo, plus standard systemic lupus erythematosus (SLE) therapy, on organ domain-specific SLE disease activity.
  
  
  METHODS
  Data obtained after 52 weeks of treatment from two phase III trials (BLISS-52 and BLISS-76) comparing belimumab 1 and 10 mg/kg versus placebo, plus standard therapy, in 1684 autoantibody-positive patients were analysed post hoc for changes in British Isles Lupus Assessment Group (BILAG) and Safety of Estrogens in Lupus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI) organ domain scores.
  
  
  RESULTS
  At baseline, the domains involved in the majority of patients were musculoskeletal and mucocutaneous by both BILAG and SELENA-SLEDAI, and immunological by SELENA-SLEDAI. At 52 weeks, significantly more patients treated with belimumab versus placebo had improvement in BILAG musculoskeletal and mucocutaneous domains (1 and 10 mg/kg), and in SELENA-SLEDAI mucocutaneous (10 mg/kg), musculoskeletal (1 mg/kg) and immunological (1 and 10 mg/kg) domains. Improvement was also observed in other organ systems with a low prevalence (≤16%) at baseline, including the SELENA-SLEDAI vasculitis and central nervous system domains. Significantly fewer patients treated with belimumab versus placebo had worsening in the BILAG haematological domain (1 mg/kg) and in the SELENA-SLEDAI immunological (10 mg/kg), haematological (10 mg/kg) and renal (1 mg/kg) domains.
  
  
  CONCLUSIONS
  Belimumab treatment improved overall SLE disease activity in the most common musculoskeletal and mucocutaneous organ domains. Less worsening occurred in the haematological, immunological and renal domains.
authors.affiliation: Allegheny Singer Research Institute, West Penn Allegheny Health System, Temple University School of Medicine, Pittsburgh, Pennsylvania 15224, USA. smanzi@wpahs.org
authors.forename: Susan
authors.initials: S
authors.lastname: Manzi
authors.forename: Jorge
authors.initials: J
authors.lastname: Sánchez-Guerrero
authors.forename: Joan T
authors.initials: JT
authors.lastname: Merrill
authors.forename: Richard
authors.initials: R
authors.lastname: Furie
authors.forename: Dafna
authors.initials: D
authors.lastname: Gladman
authors.forename: Sandra V
authors.initials: SV
authors.lastname: Navarra
authors.forename: Ellen M
authors.initials: EM
authors.lastname: Ginzler
authors.forename: David P
authors.initials: DP
authors.lastname: D'Cruz
authors.forename: Andrea
authors.initials: A
authors.lastname: Doria
authors.forename: Simon
authors.initials: S
authors.lastname: Cooper
authors.forename: Z John
authors.initials: ZJ
authors.lastname: Zhong
authors.forename: Douglas
authors.initials: D
authors.lastname: Hough
authors.forename: William
authors.initials: W
authors.lastname: Freimuth
authors.forename: Michelle A
authors.initials: MA
authors.lastname: Petri
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D053264:B-Cell Activating Factor / Q000037:antagonists & inhibitors* / Q000187:drug effects; D004311:Double-Blind Method; D005260:Female; D006304:Health Status; D006801:Humans; D008180:Lupus Erythematosus, Systemic / Q000188:drug therapy* / Q000276:immunology / Q000473:pathology; D008297:Male; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D053264:B-Cell Activating Factor; C511911:belimumab