Drug Utilization Study Evaluating Additional Risk Minimization Measures for Upadacitinib in the Treatment of Atopic Dermatitis in Europe

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary data collection

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:
  200000012116

  upadacitinib
• Medical condition to be studied:
  Dermatitis atopic

Population studied

• Short description of the study population:
  The study population consists of all individuals with AD registered in the databases in the four countries who are treated with upadacitinib. Each individual will be followed from the initiation of upadacitinib to the end of the study period (i.e., 31 December 2024), study withdrawal, or death.
• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Hepatic impaired

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  3000

Study design details

• Study design:
  The study is a drug utilization, descriptive, non-interventional, population-based, cohort study of new users of upadacitinib (RINVOQ®) for the treatment of AD identified in electronic healthcare data from four European countries: Denmark, Germany, Spain, and Sweden.
• Main study objective:
  The objectives are to describe the baseline characteristics of individuals with AD who are new users of upadacitinib, and to the extent measurable, evaluate healthcare utilization in routine clinical care as an indicator of physician adherence to the aRMMs among individuals with AD 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.
• Setting:
  The study is based on electronic healthcare data from Denmark, Germany, Spain, and Sweden covering populations of approximately 5.8 million, 25 million, 5.8 million, and 10.2 million people, respectively.
• Outcomes:
  Indicator of physician adherence to the additional risk minimisation measures related to malignancy, MACE, GI perforation, VTE, serious and opportunistic infections including HZ, contraindications (pregnancy, and active TB) and posology. ; To describe the baseline characteristics of new users of upadacitinib.
• Data analysis plan:
  This will be a descriptive study. Upon upadacitinib initiation, baseline characteristics of individuals will be assessed. Proportions of the aRMM outcome variables will be assessed prior to upadacitinib initiation, at upadacitinib initiation and during continuous treatment of upadacitinib, depending on the outcome variable being reported. The proportion of the outcome variables will be calculated as the number of individuals for each specific outcome variable over the total number of individuals considered for that specific outcome. Utilization of upadacitinib will be stratified by the time period before and after the implementation of the revised aRMMs from the Article 20 referral procedure as well as by Coronavirus disease 2019 (COVID-19) pandemic time periods (COVID-19 pandemic and non-COVID-19 pandemic).