Post Marketing Safety Surveillance of Baricitinib in Three European Registries (I4V-MC-B012)

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:
  BARICITINIB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AA37) baricitinib

  baricitinib

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:
  2500

Study design details

• Main study objective:
  To monitor the incidence rate and profile of the following aggregate outcomes serious infections and opportunistic infections, MACE, malignancies, and VTE among patients with long-term exposure to baricitinib compared to patients with long-term exposure to other medications for moderate to severe RA. Also to monitor the occurrence of more rare individual outcomes.
• Outcomes:
  Primary outcomes: -serious infections (including herpes zoster) and opportunistic infections (including TB, Candida infections, and PML).-MACE-Malignancies (including lymphoma and typically virus-induced malignancies such as cervical and many oropharyngeal cancers)-venous thromboembolism; Secondary outcomes: -rhabdomyolysis-arganulocytosis-PML-gastrointestinal perforations-drug induced liver injury
• Data analysis plan:
  Analysis of BSRBR, RABBIT, and ARTIS data is under the control of each individual registry and will not (with the exception of ARTIS) include input from Lilly. In general, each registry will provide incidence rates and outcomes and a final comparative report.