An Observational Cohort Study to Investigate the Risk of Serious Infections Among Patients Exposed to Baricitinib Using the Medical Data Vision (MDV) Database in Japan (4V-JE-B019)

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:
  Adolescents (12 to < 18 years)

  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:
  2726

Study design details

• Main study objective:
  The primary objective of this study is to assess and compare the risk of serious infection in the patients exposed to baricitinib with those in the patients with RA who newly started any bDMARD. The secondary objectives of the study are: To describe incidence of SIs in elderly patients (aged ≥65 years). To describe the incidence rates of herpes zoster.
• Outcomes:
  The primary objective of this study is to assess and compare the risk of serious infection in the patients exposed to baricitinib with those in the patients with RA who newly started any bDMARD. The secondary objectives of the study are: To describe incidence of SIs in elderly patients (aged ≥65 years). To describe the incidence rates of herpes zoster.
• Data analysis plan:
  For the primary objective, the analysis will be comparison of 2 hazards of incident serious infection (SI) in patients initiating baricitinib relative to a reference group of patients initiating bDMARDs using Cox proportional hazards regression models. The propensity score matching and IPTW method will be used in attempt to achieve the balance of potential confounding variables between 2 groups. For secondary objectives, the incidence rate of SI in elderly patients (aged ≥65 years) for both cohorts will be calculated. In addition, the incidence rate of herpes zoster will also be calculated and the hazard ratio of SI among baricitinib group relative to a reference group of patients initiating bDMARDs adjusting confounding factors will also be conducted . The Kaplan-Meier method will be used to display the time until patients develop the first event (event-free period).