The goal of this clinical trial is to compare a step-down strategy of spacing dupilumab injections with a standard maintenance treatment in adolescents and adults with controlled Atopic dermatitis (AD) for at least six months. The impact of dosage reduction strategies will be assessed with an innovative primary endpoint: the area under the curve of the weekly ADCT assessment.
For both groups: At inclusion visit : * Patient information and signature of consent form * Randomisation * Previous medical history * Clinical exam * Recording ADCT, EASI, IGA, NRS pruritus, DLQI or CDLQI, EQ-5D-5L Weekly during 12 months (by patients on https://hestia.chu-nantes.fr) : * Self-assessment of ADCT * Date of dupilumab injections * Batch number of dupilumab * Amount of topical corticosteroids Visits at M4, M8 and M12 will be performed for : * Clinical exam * Recording secondary end points (EASI, IGA, NRS pruritus, DLQI or CDLQI, EQ-5D-5L) and adverse events * Collect out-of-pocket expenses (M4 and M12).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
256
step down dupilumab injections
Amiens University hospital
Amiens, France
Area under the curve of Atopic Dermatitis Control Tool (ADCT)
to demonstrate the non-inferiority of a step down dosage strategy of dupilumab as compared with maintenance of initial treatment, on long-term control of the disease severity at one year in adolescents and adults patients with controlled AD.The primary endpoint is the Area under the curve of Atopic Dermatitis Control Tool (ADCT) score achieved by the patient every week during one year. As the ADCT score refers to the last 7 days, a weekly assessment is the most accurate to detect all variations in disease severity intensity.
Time frame: over 12 months
Mean difference in EASI score
to assess the efficacy of a tapering dosage strategy of dupilumab among patients (adolescents from 12 years old and adults) with controlled AD as compared to the standard maintenance strategy on the Eczema Area and Severity Index Mean difference in EASI score from baseline to month 4, month 8, month 12(EASI)
Time frame: every 4 months over 12 months
Mean difference in Investigator global assessment
to assess the efficacy of a tapering dosage strategy of dupilumab among patients (adolescents from 12 years old and adults) with controlled AD as compared to the standard maintenance strategy on the Investigator Global assessment (IGA) Mean difference in Investigator global assessment from baseline to month 4, month 8, month 12
Time frame: every 4 months over 12 months
Mean difference in Itch numerical rating scale
to assess the efficacy of a tapering dosage strategy of dupilumab among patients (adolescents from 12 years old and adults) with controlled AD as compared to the standard maintenance strategy on the Itch numerical rating scale Mean difference in Itch numerical rating scale from baseline to month 4, month 8, month 12
Time frame: every 4 months over 12 months
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The patient quality of life will be assessed with the DLQI (Dermatology Life Quality Index) measured at M4, M8, M12 or with the CDLQI (Children Dermatology Life Quality Index) for children under 16. Mean difference in DLQI (CDLQI for children <16)
The patient quality of life will be assessed with the DLQI (Dermatology Life Quality Index) measured at month 4, month 8, month 12 or with the CDLQI (Children Dermatology Life Quality Index) for children under 16. Mean difference in DLQI (CDLQI for children \<16) from baseline to month 4, month 8, month 12 will be assessed. to assess the efficacy of a tapering dosage strategy of dupilumab among patients (adolescents from 12 years old and adults) with controlled AD as compared to the standard maintenance strategy on the patient quality of life.
Time frame: every 4 months over 12 months
cost-utility analysis performed from a health care system perspective
The economic efficiency will be assessed by a cost-utility analysis performed from a health care system perspective (i.e. considering only direct health care costs) and a 1-year time horizon. Incremental cost-utility ratio (cost per Quality-Adjusted Life-Years, QALYs) from a health care system perspective and with a 1-year time horizon will be taken into account. to assess the efficacy of a tapering dosage strategy of dupilumab among patients (adolescents from 12 years old and adults) with controlled AD as compared to the standard maintenance strategy on the economic efficiency
Time frame: over 12 months
Incremental cost-utility ratio (cost per Quality-Adjusted Life-Years, QALYs) from a health care system perspective
The economic efficiency will be assessed by a cost-utility analysis performed from a health care system perspective (i.e. considering only direct health care costs) and a 1-year time horizon. Incremental cost-utility ratio (cost per Quality-Adjusted Life-Years, QALYs) from a health care system perspective and with a 1-year time horizon will be taken into account. to assess the efficacy of a tapering dosage strategy of dupilumab among patients (adolescents from 12 years old and adults) with controlled AD as compared to the standard maintenance strategy on the economic efficiency
Time frame: over 12 months