A real-world observational study of treatment patterns and outcomes for patients with neuromyelitis optica spectrum disorders (NMOSD) treated with inebilizumab (UPLIZNA) in Europe

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  UPLIZNA
• Study drug International non-proprietary name (INN) or common name:
  INEBILIZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AG10) inebilizumab

  inebilizumab
• Medical condition to be studied:
  Neuromyelitis optica spectrum disorder

Population studied

• Short description of the study population:
  The study population will be identified in national healthcare administrative databases, claim databases and disease-specific registries and will include adult (18 years old or more at the index date) female and male patients diagnosed with NMOSD and initiating inebilizumab during the study period.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Study design details

• Study design:
  A non-interventional multi-center cohort study of patients initiating inebilizumab conducted with secondary data sources in France, Germany, Italy, the Netherlands, and Spain.
• Main study objective:
  This study aims to characterize patients who initiate inebilizumab, describe treatment patterns and incidence of adverse events of special interest (AESI) in the first 12 months following treatment initiation.
• Setting:
  Data sources in 5 European countries: France, Germany, Italy, the Netherlands and Spain were selected for use in this study.
• Outcomes:
  Safety outcomes; ; The AESI evaluated in this study include the following categories:; • serious infections; • opportunistic infections including PML; • hepatitis B reactivations; • serious infusion related reactions; • malignancies