Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Safety study (incl. comparative)

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

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

UPADACITINIB

Anatomical Therapeutic Chemical (ATC) code

(L04AF03) upadacitinib
upadacitinib

Medical condition to be studied

Dermatitis atopic
Population studied

Age groups

  • Paediatric Population (< 18 years)
    • Adolescents (12 to < 18 years)
  • 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)

Special population of interest

Hepatic impaired
Renal impaired

Estimated number of subjects

10000
Study design details

Main study objective

To describe and if possible compare the incidence of malignancy (excluding NMSC), including malignancy by type, NMSC, MACE, VTE, serious infections (incl. OI), HZ, EH/KVE, active TB, GI perforation, drug-induced liver injuries, fractures and all-cause mortality in adolescent and adult individuals with Atopic dermatitis (AD) treated with upadacitinib or other selected systemic AD treatments.

Outcomes

Malignancy (excluding non-melanoma skin cancer NMSC), including malignancy by type, NMSC, major adverse cardiovascular events, venous thromboembolic events, serious infections (including opportunistic infections), herpes zoster, eczema herpeticum/Kaposi’s varicelliform eruption, active tuberculosis, gastrointestinal perforations, drug-induced liver injuries, fractures and all-cause mortality.

Data analysis plan

Descriptive analyses will be conducted to characterize the users and the real-world utilization of upadacitinib and other select systemic AD treatments to assess suitability of treatment groups as potential comparators to the upadacitinib cohort.
Person-years at risk, number of safety outcomes and crude incidence rates for upadacitinib will be reported.
If suitable/comparable treatment cohorts can be identified, crude incidence rates for comparator treatments and hazard ratios between upadacitinib and comparator cohorts will be provided as well.
Cox proportional hazards model adjusting for confounding will be used to calculate hazard ratios.