Table 3

Data being collected in PEDISTAD

TypeCollected data
Patient and disease characteristics
  • Patient demographics and medical history.

  • Personal and family history of AD and selected atopic comorbidities.

  • Prior and concomitant medications for AD and comorbidities—all prior systemic therapy ever used, all topical and ultraviolet therapy in the previous 3 months as well as treatment(s) for other diseases, including name, dose, route, frequency and start/stop date.

  • Selected comorbidity presence throughout the study (as diagnosed by an HCP).

Patient-reported/caregiver-reported outcomes
  • POEM

  • CDLQI/IDQOL

  • DFI

  • Peak Pruritus NRS/worst scratching NRS

  • CGAD

  • Days missed from school for the patient and days missed from work for the primary caregiver due to AD since last visit.

  • TNSS

Physician assessments of AD disease activity
  • EASI

  • BSA (%) affected by AD.

Safety data
  • All adverse events regardless of seriousness.

Other data
  • Visits to HCPs—type of HCP and reason for the visit.

  • Investigator specialty and setting.

  • Photography of a representative area affected by AD—optional (at select centres).

  • Reason for end of study.

Biomarker data
  • Serial blood samples for protein and RNA expression.

  • Cheek swabs for DNA genomic biomarkers.

  • AD, atopic dermatitis; BSA, body surface area; CGAD, Caregiver Global Assessment of Disease; CDLQI, Children's Dermatology Life Quality Index; DFI, Dermatitis Family Impact; EASI, Eczema Area and Severity Index; HCP, healthcare professional; IDQOL, Infant's Dermatitis Quality of Life; NRS, Numerical Rating Scale; POEM, Patient-Oriented Eczema Measure; TNSS, Total Nasal Symptom Score.