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)
• Study drug International non-proprietary name (INN) or common name:
  ABROCITINIB

  BARICITINIB

  FILGOTINIB

  FILGOTINIB MALEATE

  TOFACITINIB

  TOFACITINIB CITRATE

  UPADACITINIB

  UPADACITINIB HEMIHYDRATE
• Anatomical Therapeutic Chemical (ATC) code:
  (D11AH08) abrocitinib

  abrocitinib

  (L04AF02) baricitinib

  baricitinib

  (L04AF04) filgotinib

  filgotinib

  (L04AF01) tofacitinib

  tofacitinib

  (L04AF03) upadacitinib

  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:
  A descriptive cohort study will be conducted using routinely collected health data from five European data ; sources.
• 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.;
• Setting:
  This study will be conducted using six data sources onboarded for DARWIN EU® network of data partners from six European countries.
• Outcomes:
  For Objective 1, the incident use of JAKi will be the outcome in the analyses. ; For the incidence of first JAKi ever initiation, the outcome will be defined as first prescription/dispensation ; of any JAKi. For incidence of individual JAKi ingredient ; (abrocitinib/baricitinib/filgotinib/tofacitinib/upadacitinib) initiation, the outcome will be defined as first ; prescription/dispensation of respective individual JAKi ingredient.