Comparing Upadacitinib with Dupilumab for atopic dermatitis

Inclusion

• +Dupilumab is medically inadvisable (e.g., allergy to a component of dupilumab, etc.) AND a documented history of inadequate response or intolerance to TCS and/or TCI.
• +A minimum weight of 10 kg and weight and height \> 5th percentile for their age according to local standard growth charts at the Baseline VisitBaselineYour starting measurements, taken before treatment begins.Read more →.
• +Atopic Dermatitis (AD), according to Hanifin and Rajka criteria, with onset of symptoms at least 6 months prior to Baseline.
• +Eczema Area and Severity Index (EASI) score \>= 16; vIGA-AD score \>= 3 (Note: In countries where dupilumab is only approved for severe AD, subjects to be included in the RandomizedRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → CohortCohortA group of participants sharing a characteristic, followed together.Read more → should have severe AD \[vIGA-AD = 4\]); \>= 10% Body Surface Area of AD involvement at the Baseline Visit; and Baseline weekly average of daily Worst Itch Scale (WIS) or Worst Scratch/Itch numerical rating scale (WSI-NRS) \>= 4.
• +Participant must satisfy at least one of the following criteria (Note: More than 1 criterion may apply to an individual participant. All applicable criteria for each individual participant should be reported):
• +To be included in the Randomized Cohort (Note: Participants must have severe AD \[vIGA-AD = 4\] in countries where dupilumab is approved only for severe AD.):
• +\[For all countries except US\] Documented history of inadequate response or intolerance to TCS and/or TCI OR for whom use of one or more of these topical treatments is medically inadvisable (e.g., high disease burden, Scoring Atopic Dermatitis (SCORAD) \> 50, EASI score \> 21, or vIGA-AD \> 3).
• +For dupilumab-naïve participants: History of inadequate response to a systemic therapy for AD other than dupilumab or oral corticosteroids or for whom the available systemic treatments are otherwise medically inadvisable (e.g., because of important side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more → or safety risks).
• +History of inadequate response to 2 or more courses of oral corticosteroid therapy given for \>= 14 days within 6 months prior to ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more → or history of oral corticosteroid rebound, defined as recurrence of AD symptoms within 4 months after its discontinuation.
• +For dupilumab-exposed participants: Prior exposure to dupilumab without documented history of inadequate response or intolerance (i.e., discontinuation of dupilumab for a non-medical reason, such as, but not limited to, non-coverage or loss of coverage for the drug by health insurance, or other logistic challenges \[not safety- or efficacy-related\] precluding the participants continued access to dupilumab).
• +To be included in the Dupi-IR/Dupi-Medically Inadvisable Cohort:
• +Previous inadequate response or intolerance to dupilumab OR