Drug utilisation study of upadacitinib (Rinvoq™) in Europe to evaluate the effectiveness of additional risk minimisation measures

Study type

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

  Effectiveness study (incl. comparative)

Study drug and medical condition

• Medicinal product name:
  RINVOQ
• Study drug International non-proprietary name (INN) or common name:
  UPADACITINIB
• Medical condition to be studied:
  Rheumatoid arthritis

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:
  2400

Study design details

• Main study objective:
  This study aims to characterise the use of upadacitinib (Rinvoq™) in routine clinical care.
• Outcomes:
  To describe the baseline characteristics of new users of upadacitinib (e.g. demographics, medical history, medical condition associated with upadacitinib use, and concomitant medication use), and in a similar manner, to describe new users of a selected biologic disease-modifying anti-rheumatic drug (bDMARD) for comparison. ; Evaluate the effectiveness of additional risk minimisation measures (aRMMs): quantify occurrence of upadacitinib in patients at high risk for a VTE and in patents currently being treated for active TB, quantify number of patients pregnant at time of initiation/become pregnant while taking upadacitinib, describe prescribing doctors' adherence to recommendations for patient screening/lab monitoring.
• Data analysis plan:
  All analyses will be descriptive, no statistical tests will be performed. ; Analyses will be performed separately for each registry and exposure group (i.e. upadacitinib cohort and selected bDMARD cohort). ; Baseline patient characteristics will be assessed at study drug initiation. ; To address important safety information communicated in the healthcare professional educational material and patient alert card, outcome indicators at the time of initiation will be evaluated in the upadacitinib cohort. Additional outcome indicators will be assessed in the upadacitinib cohort during their continuous treatment.