Post-authorisation safety study (PASS): observational cohort study of PAH patients newly treated with either Uptravi (selexipag) or any other PAH-specific therapy, in clinical practice (EXPOSURE)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  UPTRAVI
• Study drug International non-proprietary name (INN) or common name:
  SELEXIPAG
• Anatomical Therapeutic Chemical (ATC) code:
  (B01AC27) selexipag

  selexipag
• Medical condition to be studied:
  Pulmonary arterial hypertension

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:
  3034

Study design details

• Main study objective:
  To describe demographics, disease characteristics and clinical course in PAH patients newly treated with either Uptravi, or any other PAH-specific therapy, who were never treated with Uptravi, further characterise the safety profile of Uptravi in clinical practice, compare rates of MACE and all-cause.
• Outcomes:
  - Outcomes related to PAH clinical course. Occurrence of all-cause death; - Outcomes related to the Uptravi safety profile. Occurrence of: 1. the identified or potential risks 2. any other AEs 3. Discontinuation of Uptravi and reason for stopping; - Outcomes to compare rates of MACE and all-cause death. Occurrence of: 1. MACE 2. all-cause death
• Data analysis plan:
  Exposure to Uptravi will be described in terms of duration, maximum dose received in the titration period, maintenance dose and maintenance dose changes in all exposed patients. Uptravi safety profile will be described with the frequency and incidence rates of important identified and potential risks as described in the Risk Management Plan and all-cause death during the exposure period will be calculated in the Uptravi exposed patients. MACE and all-cause death incidence rates observed in Uptravi exposed patients will be compared with the rates observed in Uptravi unexposed patients using a propensity score weighting analysis.