Comparative assessment of venous thromboembolism and other risks among patients with rheumatoid arthritis treated with baricitinib versus tumor necrosis factor inhibitors - French part of the study program (Safety Outcomes in Patients Treated for RA)

Study type

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

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L04AA29) tofacitinib

  (L04AA37) baricitinib

  (L04AB01) etanercept

  (L04AB02) infliximab

  (L04AB04) adalimumab

  (L04AB05) certolizumab pegol

  (L04AB06) golimumab
• 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:
  5000

Study design details

• Main study objective:
  The main objective is to compare the risk of venous thromboembolism (VTE) among patients with RA treated with baricitinib with the risk among similar patients treated with TNFi.
• Outcomes:
  Occurrence of venous thromboembolism VTE. Occurrence of major adverse cardiovascular events (MACE), Occurrence of serious infection, Occurrence of tuberculosis.
• Data analysis plan:
  The following analyses will be performed: - Descriptive analyses of demographic and clinical characteristics, outcomes, drug exposure for patients with baricitinib and with TNFi. - Comparative analyses using propensity score matching - If the power of the study is sufficent, cox proportional hazards regression models will be used to compare the risk of an outcome among patients treated with baricitinib versus with TNFi. Any variables that remain unbalanced after propensity score matching may also be included in the regression model. Follow-up time will begin at treatment initiation and continue until censoring. Patients will be censored upon occurrence of an incident event, discontinuation of the study medication plus 30 days, the end of the study period or death. - Sensitivity analyses to examine the effect of varying the case definition for VTE and to evaluate the existence of a class effect of Janus Kinase (JAK) inhibitors.