Comparative Assessment of VTE and Other Risks among Patients with Rheumatoid Arthritis treated with Baricitinib versus Tumor Necrosis Factor Inhibitors: A Multi-database Observational Cohort Study

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

• Name of medicine:
  OLUMIANT
• Medical condition to be studied:
  Rheumatoid arthritis

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:
  6000

Study design details

• Main study objective:
  Primary Objective: To compare the risk of VTE among patients with RA treated with baricitinib with the risk among similar patients treated with TNFi.
• Outcomes:
  Venous thromboembolism, - MACE - incident serious infection - tuberculosis requiring hospitalization
• Data analysis plan:
  The risk of each respective outcome will be calculated using Cox proportional hazards regression for patients with rheumatoid arthritis treated with baricitinib compared to those treated with TNFi. Results from each data source will be combined using meta-analysis.