A Retrospective Evaluation of Conjunctivitis and Keratitis Among Individuals with Moderate-to-severe Atopic Dermatitis Treated with Dupilumab in the United States (US)

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:
  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)
• 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.

Documents

Study results

CON2052_EADV+Abstract_Final+Draft_05222023 clean_