An Observational Longitudinal Post-authorization Safety Study of STELARA® in the Treatment of Psoriasis and Psoriatic Arthritis: Analysis of Major Adverse Cardiovascular Events (MACE) using Swedish National Health Registers (QUANTIFY STELARA MACE)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  USTEKINUMAB

  ADALIMUMAB

  ETANERCEPT

  SECUKINUMAB
• Medical condition to be studied:
  Psoriasis

  Psoriatic arthropathy

Population studied

• 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)
• Estimated number of subjects:
  11600

Study design details

• Main study objective:
  Estimate and compare the risk of MACE in PsO and PsA patients initiating treatment with ustekinumab relative to patients initiating treatment with etanercept in routine clinical practice in Sweden.
• Outcomes:
  MACE (composite outcome of myocardial infarction, ischemic stroke, and CV death), as measured by: Stabilized propensity score-weighted hazard ratios (primary endpoint), Cumulative incidence, unadjusted (secondary endpoint), Incidence rates, unadjusted (secondary endpoint). Incidence rates will also be estimated for each component of MACE, Estimate and compare risk of MACE in PsO and PsA patients initiating treatment with ustekinumab vs adalimumab, ustekinumab vs secukinumab, adalimumab vs etanercept, secukinumab vs etanercept in routine clinical practice in Sweden.
• Data analysis plan:
  Patient characteristics will be reported for each cohort in the overall incident user and bionaïve population. Primary outcome of MACE will be analyzed using time-to-event methodology. Cumulative incidence and incidence rates of MACE and total amount of available FU will be reported for each cohort. Cox proportional hazards regression with stabilized IPTW by PS will be used to adjust for confounding by treatment selection. To test the robustness of the results, additional sensitivity analysis will be performed.