An Observational Cohort Study to Investigate the Risk of Malignancies Among Patients Exposed to Baricitinib Using the Medical Data Vision (MDV) Database in Japan (I4V-JE-B020)

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:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  4500

Study design details

• Main study objective:
  The main objective is to assess and compare the risk of overall malignancies (including nonmelanoma skin cancer) in the patients exposed to baricitinib with those in the patients with rheumatoid arthritis who newly started any bDMARD. In addition to overall malignancies, evaluation of solid tumor and hematological cancer will be conducted.
• Outcomes:
  The primary objective of this study is to assess and compare the risk of overall malignancies (including nonmelanoma skin cancer) in the patients exposed to baricitinib with those in the patients with rheumatoid arthritis who newly started any bDMARD. In addition to overall malignancies, evaluation of solid tumor and hematological cancer will be conducted. The secondary objectives of the study is to describe incidence of malignancies in elderly patients (aged ≥65 years).
• Data analysis plan:
  For the primary objective, the analysis will be comparison of 2 hazards of incident malignancy cases 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. The incidence rate of malignancy in elderly patients (aged ≥65 years) for both cohorts will be calculated. The adjusted analysis for confoundings among elderly patients (aged ≥65 years) will be conducted. The Kaplan-Meier method will be used to display the time until patients develop the first event (event-free period).