Tralokinumab real world clinical use: An observational cohort study of atopic dermatitis patients prescribed tralokinumab (TRACE)

Study type

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

  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  ADTRALZA
• Study drug International non-proprietary name (INN) or common name:
  TRALOKINUMAB
• Medical condition to be studied:
  Dermatitis atopic
• Additional medical condition(s):
  Atopic Dermatitis

Population studied

• 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)
• Estimated number of subjects:
  822

Study design details

• Main study objective:
  To assess changes in clinical signs and symptoms of AD in patients treated with tralokinumab.
• Outcomes:
  - Change from baseline of patients achieving clear or almost clear skin after 12 months ; - Mean change from baseline in peak pruritus NRS after 3, 6, 12 months; - AEs ; - Baseline characteristics and predictors of clinical response ; - Association between prior use of systemic treatment and time to switching treatment ; - Co-mediation: TCSs, TCIs and non-topical treatments ; - Mean treatment dose, regimen and time to switch in tralokinumab - Mean change in DLQI after 3, 6, and 12 months ; - Change in WPAI-GH and Sleep NRS ; - AD-associated use of healthcare
• Data analysis plan:
  This study is observational and epidemiological methods will be employed for data analyses. Descriptive analyses will be performed of all collected data. A subject disposition will be displayed showing all included subjects, reasons for withdrawal and completing the study. For the analysis of the primary and secondary objectives, the following methods will be used: ; - Descriptive statistics ; - Repeated measurement logistic regression models ; - Repeated measurement ANCOVA model ; - Cause-specific hazards and estimation of the Cumulative Incidence Function (CIF) Further details will be provided in a statistical analysis plan.