title: Disease control and safety of belimumab plus standard therapy over 7 years in patients with systemic lupus erythematosus.
abstract: OBJECTIVE
  To evaluate the efficacy/safety of belimumab plus standard therapy in patients (n = 449) with active systemic lupus erythematosus (SLE) treated up to 7 years (n = 177 currently ongoing).
  
  
  METHODS
  Patients (n = 345) who completed a double-blind, placebo-controlled, 52-week study of belimumab 1, 4, or 10 mg/kg and 24-week extension of belimumab (placebo switched to 10 mg/kg; belimumab same dose or switched to 10 mg/kg) could receive belimumab 10 mg/kg in an open-label continuation study (n = 296). Disease activity was analyzed in patients with active SLE at baseline of the initial study. Biomarker and SLE medication changes were evaluated, and adverse events (AE) were monitored throughout the study.
  
  
  RESULTS
  Total belimumab exposure over 7 years (double-blind and open-label periods): 1746 patient-years. SLE Responder Index (SRI) response rates at Week 52 in autoantibody-positive patients: placebo, 29%; belimumab, 46% (p < 0.05). In the continuation study, 57% of auto-antibody-positive patients had an SRI response by Year 2 and 65% by Year 7; severe flares occurred in 19% with placebo and 17% with belimumab during the first year, with the annual rate declining to 2%-9% during years 2-7. Anti-dsDNA autoantibodies in patients positive for them at baseline had a progressive decline of 40%-60% from baseline over 2-7 years with belimumab. Corticosteroid use decreased over time with ≥ 50-55% reduction in median dose during years 5-7. Serious and overall annual AE rates, including infections, were generally stable or decreased during 7-year treatment.
  
  
  CONCLUSIONS
  Disease control and safety profile were maintained in patients with active SLE taking belimumab plus standard therapy for up to 7 years. [ClinicalTrials.gov numbers: NCT00071487 and NCT00583362].
authors.affiliation: From the State University of New York (SUNY) Downstate Medical Center, Brooklyn, New York; Cedars-Sinai Medical Center/David Geffen School of Medicine at the University of California at Los Angeles; Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma; North Shore-Long Island Jewish Health System, Lake Success, New York; Los Angeles County + University of Southern California Medical Center and University of Southern California Keck School of Medicine, Los Angeles, California; University of Alabama at Birmingham, Alabama; MedStar Washington Hospital Center, Washington, DC; Oklahoma Center for Arthritis Therapy and Research, Tulsa, Oklahoma; University of Michigan, Ann Arbor, Michigan; Human Genome Sciences Inc., Rockville; Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
authors.forename: Ellen M
authors.initials: EM
authors.lastname: Ginzler
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Wallace
authors.forename: Joan T
authors.initials: JT
authors.lastname: Merrill
authors.forename: Richard A
authors.initials: RA
authors.lastname: Furie
authors.forename: William
authors.initials: W
authors.lastname: Stohl
authors.forename: W Winn
authors.initials: WW
authors.lastname: Chatham
authors.forename: Arthur
authors.initials: A
authors.lastname: Weinstein
authors.forename: James D
authors.initials: JD
authors.lastname: McKay
authors.forename: W Joseph
authors.initials: WJ
authors.lastname: McCune
authors.forename: Z John
authors.initials: ZJ
authors.lastname: Zhong
authors.forename: William W
authors.initials: WW
authors.lastname: Freimuth
authors.forename: Michelle A
authors.initials: MA
authors.lastname: Petri
mesh_terms: D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001323:Autoantibodies; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008137:Longitudinal Studies; D008180:Lupus Erythematosus, Systemic / Q000188:drug therapy* / Q000276:immunology; D008297:Male; D008875:Middle Aged; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D001323:Autoantibodies; D007166:Immunosuppressive Agents; C511911:belimumab
keywords: BELIMUMAB; SELENA-SLEDAI; SLE RESPONDER INDEX; SYSTEMIC LUPUS ERYTHEMATOSUS