Atopic dermatitis
Conditions
Interventions
Systemic cyclosporine A or dupilumab for 6 months
Sponsors
Erasmus MC
Eligibility
Inclusion criteria
Inclusion criteria: - Children and adolescents, aged between 2 and 18, with moderate to severe atopic dermatitis (diagnosed according to the UK working party criteria) - Patients and parents/guardians able to participate in the study and willing to give written informed consent - EASI (Eczema Area Severity Index) = 6 at screening and baseline (corresponding with moderate-to-severe disease) - IGA (Investigators Global Assessment) = 3 at screening and baseline (corresponding with moderate-to-severe disease)
Exclusion criteria
Exclusion criteria: - children under the age of 2 years (due to the prescribe conditions of CsA) and patients older than 18 years - contraindication for CsA or dupilumab - use of topical corticosteroids (TCS) or topical calcineurine inhibitors (TCI) 2 weeks before randomization (during the washout period) - use of systemic anti-inflammatory medication 4 weeks before randomization - patient (or one of the parents/guardians) not willing to be randomized - children with a history of any known primary immunodeficiency disorder - children with a history of cancer - EASI < 6 at screening or at baseline - IGA <3 at screening or at baseline
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Relative reduction in EASI (Eczema Area and Severity Index, EASI) at t = 6 months -Proportion of patients that achieved EASI75 (relative reduction of 75% from baseline EASI) without the use of rescue medication, at t = 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| - Relative and absolute reduction in EASI from baseline at t = 1, 2, 3 and 6 months - Relative and absolute reduction in SCORAD (Scoring Atopic Dermatitis) from baseline at t = 1, 2, 3 and 6 months - Proportion of patients that achieved IGA 0 or IGA 1 (Investigator’s Global Assessment) without the use of rescue medication at t = 1, 2, 3 and 6 months - Absolute reduction and proportion of patients that achieved a reduction =4 points on the NRS-11 for itch intensity (Numeric Rating Scale) at t = 1, 2, 3 and 6 months - Relative and absolute reduction in POEM (Patient-Oriented Eczema Measure) from baseline at t = 1, 2, 3 and 6 months - Emollients and steroid use in frequency and tubes used (per patient) over the course of 6 months - Quality of life by patients (aged 16-18 years DLQI (Dermatolgy Life Quality Index); 4-15 years CDLQI (Children’s Dermatology Life Quality Index); <4 years IDQoL (Infants’ Dermatitis Quality of Life Index)) and by parents (EQ-5D-Y (Parents’ Dermatitis Family Impact Questionnaire)) at t = 0, 6 and 12 months - Healthcare costs related to the treatment of AD (medical specialist care, hospitalization, and costs directly associated with complications and recurrence). | — |
Contacts
Public ContactSuzanne Pasmans
ErasmusMC
Outcome results
None listed