A pan-European registry-based observational study of abrocitinib and conventional systemic therapies in moderate and severe atopic dermatitis (Dream to TREAT AD)

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Observational patient registries

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (D11AH08) abrocitinib

  abrocitinib

  (H02AB06) prednisolone

  prednisolone

  (L04AD01) ciclosporin

  ciclosporin

  (L04AX03) methotrexate

  methotrexate
• Medical condition to be studied:
  Dermatitis atopic

Population studied

• Short description of the study population:
  200 abrocitinib patients and 200 patients on conventional systemics (methotrexate, ciclosporin, prednisolone)
• Age groups:
  Children (2 to < 12 years)

  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:
  400

Study design details

• Main study objective:
  To describe abrocitinib and conventional systemic therapy patients’ demographic details, AD diagnosis, comorbidities, prior and concomitant AD therapies and AD severity, initially separately for the study registers but then also in aggregated form.
• Outcomes:
  Baseline disease severity measured with physician- and patient-reported outcomes (o EASI, vIGA-AD (where available), POEM,PP-NRS, (C)DLQI ,demographic characteristics of the cohort, number of past systemic eczema treatments, age of eczema onset, pattern of prescription of systemic eczema treatment of interest at baseline, change in disease severity with physician- (EASI, vIGA-AD) and patient-reported outcomes (POEM, PP-NRS, CDLQI/DLQI) from baseline at week 4, 16 and subsequent visits (every 3-6 months) up to month 36 in patients treated with abrocitinib and conventional systemics stratified by line of AD treatment and concomitant AD therapy use.
• Data analysis plan:
  Statistical assessments will be performed to describe study outcomes, using descriptive statistics, relative risks and/or odds ratos, 95% CI, P-values, or modelling where appropriate. ; In the aggregated data analyses, incremental increases in the patient population size during the three year follow up period will be described in interim and final analyses. ; For individual register dataset analyses, descriptive statistics will be provided separately, using a jointly developed standardized template. ; For the aggregated data analyses, the following will be performed: ; • Summary statistics will be presented for observed values of continuous endpoints at the baseline period, at each follow-up visit during the observation, and the changes from the baseline period. ; • For further details on the data analyses, see the SAP.