This prospective, multicenter study aims to evaluate whether patients with moderate-to-severe atopic dermatitis who achieve optimal disease control during treatment with abrocitinib 200 mg once daily can maintain disease control following dose reduction to 100 mg once daily.
Adult patients who have achieved Minimal Disease Activity (MDA) at two consecutive visits at least one month apart will undergo abrocitinib dose tapering from 200 mg/day to 100 mg/day. Patients will be evaluated at Weeks 4, 16, and 32 after dose reduction. The primary objective is to determine the proportion of patients maintaining MDA following dose tapering and to explore clinical factors associated with successful maintenance of disease control.
Additional outcomes include changes in disease severity, itch, sleep disturbance, quality of life, treatment adherence, involvement of difficult-to-treat anatomical areas, use of topical therapies, and treatment safety and tolerability.
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Single group
Abrocitinib
DrugParticipants who have achieved sustained Minimal Disease Activity while receiving abrocitinib 200 mg once daily will undergo dose reduction to abrocitinib 100 mg once daily at study baseline. Treatment with abrocitinib 100 mg once daily will be continued during follow-up. In case of clinically relevant loss of disease control, the dose may be re-escalated to 200 mg once daily according to physician judgment.
Proportion of Participants Maintaining Minimal Disease Activity at Week 16
Proportion of participants who maintain Minimal Disease Activity (MDA) 16 weeks after abrocitinib dose reduction from 200 mg/day to 100 mg/day without dose re-escalation. MDA is defined as the concurrent achievement of at least one predefined clinician-reported optimal target (EASI ≤3 or EASI-90) and at least one predefined patient-reported optimal target (peak pruritus NRS ≤1, sleep NRS ≤1, or DLQI 0-1).
Proportion of Participants Maintaining Minimal Disease Activity at Week 32
Proportion of participants who maintain Minimal Disease Activity (MDA) 32 weeks after abrocitinib dose reduction from 200 mg/day to 100 mg/day without dose re-escalation. MDA is defined as the concurrent achievement of at least one predefined clinician-reported optimal target (EASI ≤3 or EASI-90) and at least one predefined patient-reported optimal target (peak pruritus NRS ≤1, sleep NRS ≤1, or DLQI 0-1).
Change in Eczema Area and Severity Index
Change in EASI score following abrocitinib dose tapering. EASI ranges from 0 to 72, with higher scores indicating greater disease severity.
Maintenance of EASI-50, EASI-75, and EASI-90 Responses
Proportion of participants maintaining at least 50%, 75%, or 90% improvement in EASI relative to the pretreatment baseline assessment.
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