TREAT NL (TREatment of ATopic Eczema, the Netherlands) Registry: Dutch National Registry for Patients With Moderate-to-severe Atopic Eczema on Photo- or Systemic Therapies

Study Overview
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Brief Summary
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The TREAT NL (TREatment of ATopic eczema, the Netherlands) registry is a national registry for children and adults with moderate-to-severe atopic eczema aiming to gather data on their prescribed photo- and systemic immunomodulating therapies. Atopic eczema is a common, chronic, itchy, inflammatory skin disease that can have a major impact on the quality of life of patients and their immediate surroundings. Serious atopic eczema patients are treated by means of photo- or systemic immunomodulating therapy. Of these mostly off-label applied therapies, there is insufficient evidence on the short and long term for their effectiveness, safety and cost-effectiveness. Moreover, good comparative research and real-life data are lacking. With the arrival of new expensive treatments it is crucial to get insight into these treatments in order to improve quality of care. By means of a prospective registry these data can be collected and help to obtain information for clinical practice, for answering research questions, for reducing costs and implementing the results by guidelines and decision aids.

Official Title
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TREAT NL (TREatment of ATopic Eczema, the Netherlands) Registry

Conditions
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Moderate-to-severe Atopic Eczema

Intervention / Treatment
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* Other: No study-specific intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has a diagnosis of atopic eczema, based on the U.K. working party's diagnostic criteria; Starts with any type of phototherapy (e.g. UVB) or systemic immunomodulating therapy (e.g. cyclosporin, systemic glucocorticosteroids, azathioprine, methotrexate, mycophenolic acid, dupilumab); Has voluntarily signed and dated an informed consent prior to any study related procedure or has a legal representative to do so and is willing to comply with the requirements of this study protocol. Exclusion Criteria: Patient uses only (systemic) antibiotics or antihistamines; Patient starts with systemic immunomodulating therapy for another indication than atopic eczema; Insufficient understanding of the study by the patient or parent/legal representative.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with moderate-to-severe atopic eczema<br>Adult and pediatric patients that start treatment with phototherapy or systemic immunomodulating therapy for their atopic eczema | Other: No study-specific intervention<br>* Treatment of atopic eczema with phototherapy or systemic immunomodulating therapy according to usual clinical practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in EASI (Eczema Area and Severity Index) score | Investigator-assessed outcome measure for disease severity at physical examination | 5 years | 
| Mean change in IGA (Investigator's Global Assessment) score | Investigator-assessed outcome measure for global disease severity | 5 years | 
| Mean change in POEM (Patient-Oriented Eczema Measure) score | Patient-reported outcome measure for symptoms of atopic eczema | 5 years | 
| Mean change in PGA (Patient's Global Assessment) score | Patient-reported outcome measure for global disease severity | 5 years | 
| Mean change in DLQI (Dermatology Life Quality Index) score | Patient-reported outcome measure for skin-related quality of life | 5 years | 
| Mean time to reach a change in EASI (Eczema Area and Severity Index) score of 50% | Investigator-assessed outcome measure for disease severity at physical examination | 5 years | 
| The occurrence of severe adverse events | Any undesirable experience of severe nature occurring to a subject is reported | 5 years | 
| Drug survival of the therapies | Assessment of the duration until discontinuation of a drug together with the reason thereof | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic Eczema, Atopic Dermatitis, Registries, Systemic therapies, Off-label use, Phototherapy, Child, Adult