Drug Utilization Study Evaluating Additional Risk Minimisation Measures for Upadacitinib in the Treatment of Ulcerative Colitis in Europe

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  RINVOQ
• Study drug International non-proprietary name (INN) or common name:
  UPADACITINIB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AA44) upadacitinib

  upadacitinib
• 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:
  2000

Study design details

• Main study objective:
  To describe the baseline characteristics and, to the extent measurable, evaluate healthcare utilization in routine clinical care as indicator of physician adherence to the aRMMs among patients with UC who are new users of upadacitinib. To describe the changes in the utilization of upadacitinib following the implementation of revised aRMMs from the Article 20 referral procedure (in Sweden only).
• Outcomes:
  Indicators of physician adherence to the additional risk minimisation measures related to malignancy, MACE, GI perforation, VTE, serious infections, contraindication and posology, Baseline characteristics
• Data analysis plan:
  All analyses will be descriptive; no statistical tests will be performed. Proportions of the outcome variables will be assessed prior to upadacitinib initiation, at upadacitinib initiation and during follow-up, depending on the outcome variable being reported.