title: Improvements in health-related quality of life with belimumab, a B-lymphocyte stimulator-specific inhibitor, in patients with autoantibody-positive systemic lupus erythematosus from the randomised controlled BLISS trials.
abstract: OBJECTIVE
  Assess the effects of belimumab treatment plus standard systemic lupus erythematosus (SLE) therapy on health-related quality of life (HRQOL) in patients with active, autoantibody-positive SLE.
  
  
  METHODS
  Patients received standard therapy plus placebo or belimumab 1 or 10 mg/kg in two multicentre, randomised controlled trials of 52 (BLISS-52; N=865) and 76 (BLISS-76; N=819) weeks' duration. Responders were evaluated by SLE Responder Index at week 52. Patient-reported outcome assessments included SF-36, Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue, and EQ-5D.
  
  
  RESULTS
  Mean SF-36 Physical Component Summary (PCS) scores at week 24 was a major secondary endpoint. Baseline SF-36 scores were 1.5 SDs below age-/sex-matched US norms with similar improvement at week 24 across treatment groups. Mean changes from baseline in PCS scores were significantly (p<0.05) greater with belimumab 1 mg/kg (4.20) and 10 mg/kg (4.18) versus placebo (2.96) in BLISS-52, week 52. In BLISS-76, significantly (p<0.05) greater improvements were seen with belimumab 1 mg/kg in PCS (belimumab 1 mg/kg=4.37, 10 mg/kg=3.41 vs placebo=2.85) and Mental Component Summary (MCS) scores (belimumab 1 mg/kg=3.14, 10 mg/kg=2.70 vs placebo=1.40) at week 52, and in MCS score at week 76 (belimumab 1 mg/kg=3.05, 10 mg/kg=2.28 vs placebo=1.36). In pooled analysis, significantly greater improvements in PCS, SF-36 vitality domain, and FACIT-Fatigue scores at week 52 were evident with both belimumab doses.
  
  
  CONCLUSIONS
  The clinically meaningful improvements in HRQOL in autoantibody-positive patients with active SLE treated with belimumab and standard therapy are consistent with the reductions in disease activity observed in these trials.
  NCT00424476, NCT00410384.
authors.affiliation: Department of Medicine, Division of Immunology/Rheumatology, Stanford University School of Medicine, , Portola Valley, California, USA.
authors.forename: Vibeke
authors.initials: V
authors.lastname: Strand
authors.forename: Roger A
authors.initials: RA
authors.lastname: Levy
authors.forename: Ricard
authors.initials: R
authors.lastname: Cervera
authors.forename: Michelle A
authors.initials: MA
authors.lastname: Petri
authors.forename: Helen
authors.initials: H
authors.lastname: Birch
authors.forename: William W
authors.initials: WW
authors.lastname: Freimuth
authors.forename: Z John
authors.initials: ZJ
authors.lastname: Zhong
authors.forename: Ann E
authors.initials: AE
authors.lastname: Clarke
mesh_terms: D000328:Adult; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D001323:Autoantibodies / Q000097:blood; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008180:Lupus Erythematosus, Systemic / Q000097:blood / Q000188:drug therapy* / Q000276:immunology; D008297:Male; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D001323:Autoantibodies; D007166:Immunosuppressive Agents; C511911:belimumab
keywords: Autoimmune Diseases; Systemic Lupus Erythematosus; Treatment