Atopic Dermatitis, Eczema, Atopic
Conditions
Brief summary
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.
Detailed description
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).
Interventions
DRUGDupilumab step-down
step down dupilumab injections
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 12 years * Moderate to severe AD treated with dupilumab every 2 weeks * Written informed consent (patient and/or person who has parental authority) * Dupilumab treatment for at least one year * Controlled AD (ADCT\<7 and IGA ≤ 2) and assessed as controlled by the investigator since at least 6 months without tapering dosage of dupilumab * Amount of topical treatment (TCS or calcineurin inhibitor) stable for 6 months and less than 60 g/month
Exclusion criteria
* Patients with Side effects of dupilumab * Non controlled AD: ADCT ≥ 7 or IGA ≥ 3 * Female patient must not be pregnant\*, breastfeeding or considering becoming pregnant * Patient under judicial protection * Adults under guardianship or trusteeship
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the curve of Atopic Dermatitis Control Tool (ADCT) | over 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean difference in Investigator global assessment | every 4 months over 12 months | 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 |
| Mean difference in Itch numerical rating scale | every 4 months over 12 months | 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 |
| Mean difference in EASI score | every 4 months over 12 months | 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) |
| cost-utility analysis performed from a health care system perspective | over 12 months | 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 |
| Incremental cost-utility ratio (cost per Quality-Adjusted Life-Years, QALYs) from a health care system perspective | over 12 months | 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 |
| 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) | every 4 months over 12 months | 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. |
Countries
France, Reunion
Outcome results
None listed