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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
  1. Susan Manzi1,
  2. Jorge Sánchez-Guerrero2,
  3. Joan T Merrill3,
  4. Richard Furie4,
  5. Dafna Gladman5,
  6. Sandra V Navarra6,
  7. Ellen M Ginzler7,
  8. David P D'Cruz8,
  9. Andrea Doria9,
  10. Simon Cooper10,
  11. Z John Zhong10,
  12. Douglas Hough10,
  13. William Freimuth10,
  14. Michelle A Petri11
  15. on behalf of the BLISS-52 and BLISS-76 Study Groups
  1. 1Allegheny Singer Research Institute, West Penn Allegheny Health System, Temple University School of Medicine, Pittsburgh, Pennsylvania, USA
  2. 2Instituto Nacional de Ciencias Medicas y Nutricion “Salvador Zubiran,” Delegacion Tlalpan, Mexico City, Mexico
  3. 3Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma, USA
  4. 4North Shore–LIJ Health System, Lake Success, New York, USA
  5. 5Toronto Western Hospital, Toronto, Canada
  6. 6University of Santo Tomas Hospital, Manila, Philippines
  7. 7SUNY Downstate Medical Center, Brooklyn, New York, USA
  8. 8St Thomas' Hospital, London, UK
  9. 9University of Padova, Padova, Italy
  10. 10Human Genome Sciences, Rockville, Maryland, USA
  11. 11Johns Hopkins University, School of Medicine, Baltimore, Maryland, USA
  1. Correspondence to Susan Manzi, Allegheny Singer Research Institute, West Penn Allegheny Health System, Temple University School of Medicine, Pittsburgh, Pennsylvania 15224, USA; smanzi{at}


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.

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  • Collaborators BLISS-52 and BLISS-76 Study Groups.

  • Funding This study was supported by Human Genome Sciences, Rockville, Maryland, USA, and GlaxoSmithKline, Uxbridge, UK.

  • Competing interests SM has received grant support and payment for board membership from Human Genome Sciences. JTM and EMG have received consulting fees and grant support from HGS and GlaxoSmithKline. RF has received research or grant support, travel support, and payment for review activities, board membership, and consultancy from HGS and GSK. SVN has received consulting fees and travel support from HGS. DG has received consulting fees from HGS and GSK. DPD has received payment for board membership and consultancy from GSK. AD has received consulting and speaking fees from GSK. SC, ZJZ, DH and WF are employed by and own stock in HGS. MAP has received consulting fees from HGS and GSK, and is a member of their advisory boards. All other authors have no competing interests to disclose.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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