A Retrospective study to analyse the treatment outcomes of patients with severe atopic dermatitis (AD) who were enrolled in the Early Access to Medicines Scheme (EAMS) for dupilumab

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  DUPILUMAB
• Medical condition to be studied:
  Rebound atopic dermatitis

Population studied

• Short description of the study population:
  Severe atopic dermatitis (AD) who have received treatment with dupilumab through the Early Access to Medicines Scheme (EAMS) for more than 3 months.
• Age groups:
  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:
  Other
• Special population of interest, other:
  Severe atopic dermatitis (AD)
• Estimated number of subjects:
  65

Study design details

• Main study objective:
  To retrospectively analyse the treatment outcomes of patients with severe Atopic Dermatitis (AD) who were enrolled in the Early Access to Medicines Scheme (EAMS) for dupilumab.
• Outcomes:
  To describe the change in EASI score compared to baseline (EAMS enrolment) in patients who have received ≥ 12 weeks of treatment with dupilumab, To describe the change in IGA score compared to baseline (EAMS enrolment) in patients who have received ≥ 12 weeks of treatment with dupilumab To qualitatively describe clinician opinion about patient response to dupilumab (from retrospective review of patient notes)
• Data analysis plan:
  The analysis mainly comprised descriptive statistics. Continuous variables were summarized using mean and standard deviation, with minimum and maximum values reported to provide the range. Categorical variables were summarized as frequency and proportion.Inferential statistics were used to assess the statistical significance of observed differences for the 16 +/-4 weeks’ timeframe. For continuous scale variables a paired samples t-test was performed. For ordinal variables a Wilcoxon Signed Ranks test was performed. Pearson’s correlations were performed to assess the relationships between different measures of severity. No imputation was performed for missing data. Missing values were excluded from relevant analyses. Precise sample sizes are reported for each analysis. The analysis was conducted using IBM SPSS Statistics software (version 24).

Documents

Study results

EAMS Outcomes Report FINAL_DUPILL09236 signed