An Active Surveillance Study to Monitor the Safety of Abrocitinib Among Real-World Patients with Atopic Dermatitis (AD) in the European Union (EU)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  CIBINQO
• Study drug International non-proprietary name (INN) or common name:
  ABROCITINIB
• Anatomical Therapeutic Chemical (ATC) code:
  (D11AH08) abrocitinib

  abrocitinib

Population studied

• Short description of the study population:
  The study population will include patients with AD receiving abrocitinib or a comparator treatment as recorded in the participating databases in Denmark, France, and Sweden.

Study design details

• Study design:
  This will be a longitudinal, register-based, non-interventional post-authorisation safety cohort study using routinely collected (secondary) population-based data.
• Main study objective:
  The primary objective of the study is to estimate the incidence rates (IRs) of safety events of interest among patients with AD receiving abrocitinib and patients with AD receiving biologic and/or non-biologic (non- Janus Kinase inhibitor [non JAKi]) chronic systemic treatments for AD (comparator treatments) in a real-world setting.; ; An exploratory objective of this study is to compare the risk of the safety events of interest among patients with AD receiving abrocitinib and patients with AD receiving dupilumab or other anti-IL-4/13 monoclonal antibodies
• Setting:
  The study population will include patients with AD receiving abrocitinib or a comparator treatment as recorded in the participating databases in Denmark, France, and Sweden following the authorization of abrocitinib on 09 December 2021, through to 31 December 2031. ; All participating countries have universal healthcare, which contributes routinely collected secondary data to the participating nationwide databases.
• Comparators:
  The comparator treatments include non-biologic and biologic treatments.
• Outcomes:
  The following are the safety events of interest in relation to the primary objective: ; • Venous thromboembolism (VTE); • Herpes zoster (HZ); • Serious infections and opportunistic infections ; • Rhabdomyolysis; • Gastrointestinal (GI) perforation; • Major adverse cardiovascular events (MACE); • Fractures; • Malignancy excluding non-melanoma skin cancer (NMSC); • NMSC; • All-cause mortality; • Height as a measure of impaired bone growth in adolescents (Denmark only)
• Data analysis plan:
  Distributions of the baseline characteristics of patients with AD will be reported by exposure cohort, using appropriate summary statistics: counts and proportions for categorical variables, and mean and standard deviations (or median with interquartile range (IQR), where appropriate) for continuous variables. ; The primary analysis will comprise estimation of IRs with 95% CIs for the safety events of interest (except the adolescent height metrics, which will be reported using means, medians or percentiles as appropriate) documented among patients with AD initiating abrocitinib and patients with AD receiving comparator treatments.