A post-marketing registry-based prospective cohort study of long-term safety of risankizumab in Denmark and Sweden

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:
  Skyrizi
• Medical condition to be studied:
  Psoriasis

  Psoriatic arthropathy

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:
  45000

Study design details

• Main study objective:
  The objectives of the study are to estimate the risk of the following events in individuals with psoriasis exposed to risankizumab relative to individuals with psoriasis exposed to other systemic psoriasis treatments: overall malignancy excluding NMSC, NMSC, MACE, serious infections, serious hypersensitivity reactions, incident acute and chronic hepatitis B and hepatitis C.
• Outcomes:
  The study outcomes will be malignancies, MACE, serious infections, serious hypersensitivity reactions and incident hepatitis B and C. Incident malignancy will be identified via the linked national cancer registers in each country. The other outcomes will be captured through inpatient and specialist outpatient diagnoses in the patient registers.
• Data analysis plan:
  Appropriate statistical analyses in an active-comparator design will be used. Cox proportional hazards model will be used to calculate hazard ratios. Propensity score matching will be used to adjust for confounding.