Atopic dermatitis
Conditions
Interventions
Gradual dose reduction group:Reduced-dose dupilumab
Standard maintenance group:Standard-dose dupilumab
Sponsors
The First Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
All
Age
12 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Aged between 12 and 70 years; 2.Patients with moderate-to-severe atopic dermatitis (AD) meeting the Hanifin & Rajka diagnostic criteria, with a SCORAD score =25 prior to treatment initiation. 3.Have received standard-dose dupilumab treatment for no less than 24 weeks; 4.Consecutive two assessments (interval =4 weeks) simultaneously meeting the following criteria: Eczema Area and Severity Index (EASI) improvement of =90% from baseline (EASI-90), peak pruritus numeric rating scale (pp-NRS) score =1 point, and Investigator's Global Assessment (IGA) score of 0 or 1; 5.Participants met the eligibility criteria at the 12th week prior to enrollment, defined as simultaneous achievement of EASI-75, pp-NRS score = 2 points and IGA score of 0 or 1. Such clinical status should be maintained throughout the stable period before enrollment, with no escalation of topical or systemic treatment required due to disease fluctuation; 6.Voluntarily sign the informed consent form. For minors, the informed consent shall be signed by their parents or legal guardians, and the minors shall also sign the corresponding assent form; 7.Able to understand and comply with the research protocol and complete all follow-up schedules cooperatively;
Exclusion criteria
Exclusion criteria: 1.Have a definite history of allergy to dupilumab or its excipients; 2.Have contraindications to the use of dupilumab; 3.Complicated with other diseases requiring systemic immunosuppressive therapy (e.g., rheumatoid arthritis, inflammatory bowel disease); 4.Have uncontrolled active infections (including hepatitis B, tuberculosis, HIV, etc.) or concurrent malignant tumors; 5.Women planning pregnancy, during pregnancy or lactation period; 6.Receiving other systemic medications that may interfere with study outcomes; 7.Subjects with other medical or psychiatric conditions judged by the investigator to potentially increase study risks or interfere with result interpretation (e.g., severe mental illness, cognitive impairment);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-reduction success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment effectiveness: Comparison of scores at week 24, including SCORAD, EASI, IGA, pp-NRS, DLQI, ADCT; | — |
Countries
China
Contacts
Public ContactZhiqiang Song
The First Affiliated Hospital of Army Medical University
Outcome results
None listed