COMPARATIVE SAFETY OF TOCILIZUMAB VERSUS OTHER BIOLOGIC DMARDS IN PATIENTS WITH RHEUMATOID ARTHRITIS: A LARGE MULTI-DATABASE COHORT STUDY

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

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:
  Patients with rheumatoid arthritis treated with Tocilizumab or other biologics.
• 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:
  Immunocompromised
• Estimated number of subjects:
  0

Study design details

• Main study objective:
  The main objective of this NIS is to compare rates of different safety events including malignancy excluding non-melanoma skin cancer NMSC, serious bacterial or viral infection, opportunistic infection and herpes zoster, between tocilizumab and tumor necrosis factor-alpha inhibitors.
• Outcomes:
  - To examine the rate of malignancy excluding NMSC in RA patients starting TCZ versus TNFi.- To investigate the rate of serious bacterial, viral or opportunistic infection in RA patients starting TCZ versus TNFi
• Data analysis plan:
  The primary analysis will be propensity score (PS) matched time to event safety analyses for each outcome comparing risk in TCZ compared with a specified comparator. Analyses will be performed per each of the three databases separately and then, if deemed appropriate, pooled for a weighted hazard ratio. Additional analyses include descriptive statistics, incorporation of time-varying confounders, and pre-specified sensitivity analyses to evaluate the robustness of some of the parameter assumptions .