Cohort Study of Long-term Safety of Upadacitinib in the Treatment of Atopic Dermatitis in Denmark and Sweden

Study type

• Study type:
  Non-interventional study

Non-interventional study

• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  200000012116

  upadacitinib
• Medical condition to be studied:
  Dermatitis atopic

Population studied

• Age groups:
  Adolescents (12 to < 18 years)

  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)
• 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 wi
• 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.