Organ damage in patients treated with belimumab versus standard of care: a propensity score-matched comparative analysis

Ann Rheum Dis. 2019 Mar;78(3):372-379. doi: 10.1136/annrheumdis-2018-214043. Epub 2019 Jan 4.


Objectives: The study (206347) compared organ damage progression in patients with systemic lupus erythematosus (SLE) who received belimumab in the BLISS long-term extension (LTE) study with propensity score (PS)-matched patients treated with standard of care (SoC) from the Toronto Lupus Cohort (TLC).

Methods: A systematic literature review identified 17 known predictors of organ damage to calculate a PS for each patient. Patients from the BLISS LTE and the TLC were PS matched posthoc 1:1 based on their PS (±calliper). The primary endpoint was difference in change in Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) score from baseline to 5 years.

Results: For the 5- year analysis, of 567 (BLISS LTE n=195; TLC n=372) patients, 99 from each cohort were 1:1 PS matched. Change in SDI score at Year 5 was significantly lower for patients treated with belimumab compared with SoC (-0.434; 95% CI -0.667 to -0.201; p<0.001). For the time to organ damage progression analysis (≥1 year follow-up), the sample included 965 (BLISS LTE n=259; TLC n=706) patients, of whom 179 from each cohort were PS-matched. Patients receiving belimumab were 61% less likely to progress to a higher SDI score over any given year compared with patients treated with SoC (HR 0.391; 95% CI 0.253 to 0.605; p<0.001). Among the SDI score increases, the proportion of increases ≥2 was greater in the SoC group compared with the belimumab group.

Conclusions: PS-matched patients receiving belimumab had significantly less organ damage progression compared with patients receiving SoC.

Keywords: disease activity; systemic lupus erythematosus; treatment.

Publication types

  • Comparative Study
  • Meta-Analysis
  • Research Support, Non-U.S. Gov't
  • Systematic Review

MeSH terms

  • Adult
  • Antibodies, Monoclonal, Humanized / therapeutic use*
  • Disease Progression
  • Female
  • Humans
  • Immunosuppressive Agents / therapeutic use*
  • Lupus Erythematosus, Systemic / drug therapy*
  • Lupus Erythematosus, Systemic / pathology*
  • Male
  • Middle Aged
  • Propensity Score
  • Severity of Illness Index
  • Standard of Care
  • Treatment Outcome


  • Antibodies, Monoclonal, Humanized
  • Immunosuppressive Agents
  • belimumab