BEL116559 Pooled Analysis of Belimumab Elderly Patients

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Systematic review and meta-analysis

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  BELIMUMAB
• Medical condition to be studied:
  Systemic lupus erythematosus
• Additional medical condition(s):
  ANCA vasculitis

Population studied

• Age groups:
  • Adult and elderly population (≥18 years)

    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  219

Study design details

• Main study objective:
  To evaluate the safety of belimumab treatment on elderly subjects with SLE
• Outcomes:
  The incidence of treatment-emergent AEs, SLE Responder Index (SRI) response rate at Week 52
• Data analysis plan:
  Series of aggregated analyses performed by pooling subject-level data from studies of interest, and conducting the analyses on the pooled data.