Observational Secondary Database Study to Assess the Long-Term Safety of Mirikizumab (I6T-MC-B004)

Study type

• Study topic:
  Human medicinal product
• 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

• Study drug International non-proprietary name (INN) or common name:
  MIRIKIZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AC24) mirikizumab

  mirikizumab
• Medical condition to be studied:
  Colitis ulcerative

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:
  To examine the incidence of MACE, malignancies excluding non-melanoma skin cancer, serious and opportunistic infections, and severe liver injury among patients who are treated with mirikizumab relative to those treated with comparator biologic medications that are indicated for the treatment of moderate to severe ulcerative colitis.
• Outcomes:
  MACE, serious and opportunistic infections, malignancies, and severe liver injury
• Data analysis plan:
  Comparative analyses will employ Cox proportional hazards models of the relative hazard of study outcomes in mirikizumab patients versus their matched comparators, as well as descriptive analyses