DARWIN EU® - Characterising the use of JAK inhibitors in Europe: a Drug Utilisation Study Update

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name, other:
  JAK inhibitor (abrocitinib, baricitinib, filgotinib, tofacitinib, upadacitinib)

Population studied

• Short description of the study population:
  For treatment initiation incidence estimation (objective 1); All individuals available in the respective data sources during the study period, with at least 365 days of data visibility, will be included. ; Different exclusion criteria will be applied corresponding to each outcome of the JAKi exposure incidence rate analysis (as defined in Section 8.6.2.). For incidence of first JAKi ever initiation, individuals with any JAKi exposure before index date will be excluded. For incidence of individual JAKi ingredient (abrocitinib/baricitinib/filgotinib/upadacitinib/tofacitinib) initiation, only individuals with respective JAKi exposure before index date will be excluded.; For patients characterisation (objectives 2); All individuals available in the respective data sources during the study period who newly initiated JAKi and have at least 365 days of data visibility before JAKi initiation will be included. Individuals with specific JAKi exposure before the start of study period will be excluded.;
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Study design details

• Study design:
  This study will be conducted using six data sources onboarded for DARWIN EU® network of data partners from six European countries.
• Main study objective:
  1. To estimate the incidence of new JAKi initiation, overall and for each individual JAKi ingredient.; 2. To characterise new JAKi initiators for each individual JAKi, overall and stratified by indication.;