Study type

Study type

Non-interventional study

Scope of the study

Disease epidemiology
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

DUPIXENT

Medical condition to be studied

Conjunctivitis
Dermatitis atopic
Keratitis
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)

Estimated number of subjects

1400
Study design details

Main study objective

An observational retrospective cohort study will be conducted within a US claims database. Algorithms to identify individuals with moderate-to-severe AD, conjunctivitis, and keratitis will be developed within the claims data and validated using medical record review. (See Brief Description for individual main objectives).

Outcomes

Conjunctivitis and keratitis cases will be identified among the following populations: • AD source population (Objective 1/algorithm validation) • Moderate-to-severe AD study population (Objective 2) • Dupilumab initiators and other AD therapy users among the moderate-to-severe AD patients (Objectives 3 and 4)

Data analysis plan

To assess the exposure and outcome algorithms, positive predictive value (PPV) and conditional sensitivity along with 95% confidence intervals will be calculated. The key variables for each propensity score matched study group will be summarized using descrip tive statistics. Incidence rates of the outcomes will be reported with 95% confidence intervals and adjusted rate ratios will be used for comparisons.