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:
  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.

Documents

Study publications

D'Cruz D, Eriksson G, Green Y, Hammer A, Ji B, Meizlik P, Roth DA. Safety and e…

Wallace DJ, Atsumi T, Daniels M, Hammer A, Meizlik P, Quasny H, Schwarting A, Z…