Real-world Persistency, Effectiveness, and Safety Among Patients with NMOSD Treated with Inebilizumab (20250110)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Descriptive longitudinal study

Study drug and medical condition

• Medicinal product name, other:
  Inebilizumab

Population studied

• 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)
• Estimated number of subjects:
  69

Study design details

• Study design:
  This is a descriptive longitudinal study of subjects diagnosed with NMOSD enrolled in the CorEvitas Synergy of Prospective Health & Experimental Research for Emerging Solutions (SPHERES) Registry from June 2, 2021 to December 31, 2025 or most recent data as of protocol approval date.
• Main study objective:
  The main objectives of this study are:; 1. To estimate persistence of inebilizumab use among participants with NMOSD in the CorEvitas SPHERES Registry.; 2. To estimate the time to first attack and annualized attack rate of NMOSD in participants while treated with inebilizumab. ; 3. To estimate the exposure adjusted incidence rate (EAIR) of adverse events (AEs) and adverse events of special interest (AESIs) and the event incidence rate (EIR) for AESIs in participants while treated with inebilizumab.
• Outcomes:
  The primary outcomes of this study are:; 1. Time from inebilizumab initiation to physician reported date of discontinuation of inebilizumab.; 2. Time from inebilizumab initiation to first attack, total attacks, annualized attack rate.; 3. For adverse events (AEs) and adverse events of special interest (AESIs), exposure-adjusted incidence rates (EAIRs) were computed as the number of patients with ≥1 event divided by the total person-years (PY) at risk, and event incidence rates (EIRs) were calculated as the total number of events divided by total PY of exposure.