A 24-Month Prospective Observational Cohort Study Evaluating Oral Systemic Therapies in the Management of Adult Patients with Atopic Dermatitis in REAL-World Practice (AD-REAL)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  BARICITINIB

  METHOTREXATE

  MYCOPHENOLATE MOFETIL

  AZATHIOPRINE

  CICLOSPORIN

  UPADACITINIB

  ABROCITINIB
• Medical condition to be studied:
  Dermatitis atopic

Population studied

• 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)
• Estimated number of subjects:
  760

Study design details

• Main study objective:
  Post-launch prospective observational study to understand real-world treatment effectiveness over 24 months of AD patients who initiate or switch to a new oral systemic treatment
• Outcomes:
  To report descriptively the proportion of patients with all-cause treatment discontinuation at Week 24 after initiation of a new oral systemic treatment at baseline for (1) the baricitinib cohort and (2) the all other oral systemic treatment cohort, To characterize treatment patterns of oral systemic therapies used in clinical practice
• Data analysis plan:
  Kaplan-Meier analysis will be used to analyze the primary endpoint (ie, the proportion of patients discontinuing their initial treatment baricitinib, other oral systemic treatment) at Week 24 for assigned treatment cohorts at baseline.