Risk of Cardiovascular Events in Patients Using Tocilizumab as Compared With Other Biologics in Multiple Large Healthcare Databases (EUPAS16133)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Retrospective study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  TOCILIZUMAB
• Medical condition to be studied:
  Rheumatoid arthritis

Population studied

• Short description of the study population:
  The study focused on risk of cardiovascular events in patients with rheumatoid arthritis received tocilizumab as compared with other biologics identified from the large U.S. health insurance claims databases.
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with rheumatoid arthritis
• Estimated number of subjects:
  76000

Study design details

• Main study objective:
  To compare the cardiovascular risk in RA patients treated with tocilizumab versus RA patients treated with other biologic disease modifying anti-rheumatic drugs (DMARDs) in real world settings.
• Outcomes:
  Time to First Event of Myocardial Infarction (MI) or Stroke with Tocilizumab Versus Tumor Necrosis Factor Inhibitor, - Time to First Event of MI or Stroke with Tocilizumab Versus Non-TNFi Therapies - Time to Hospitalization for Coronary Revascularization Procedure - Time to Hospitalization for Acute Coronary Syndrome (ACS) - Time to First Event of MI, Stroke, Coronary Revascularization Procedure, or ACS - Time to Heart Failure (HF) Requiring Hospitalization - Time to All-Cause Death
• Data analysis plan:
  For each cohort, two analysis sets will be defined and applied to the proposed analyses as specified: the as treated (AT) and the intention to treat (ITT). Each analysis set is defined below: •Primary analysis – AT: Patients are included from the index date (drug exposure) until the earliest date of death, disenrollment, outcome development, end of the database time period, or discontinuation of the given drug. The last drug available date will be defined as the last drug dispensing date + days of supply for subcutaneous or oral agents. For intravenously administrated drugs, we will define the last drug available date as the drug infusion date + 30 days for abatacept and tocilizumab, and 56 days for golimumab and infliximab. •Secondary analysis – ITT: Patients are included from the index date until the earliest date of 180 pr 365 days of followup, death, disenrollment, or outcome development. First defined drug exposure will be carried forward.