TREATgermany: German National Clinical Registry for Patients With Moderate-to-severe Atopic Dermatitis
TREATgermany: German National Clinical Registry for Patients With Moderate-to-severe Atopic Dermatitis
About 60% of all patients with AD are adults. However, the prevalence and incidence is
 significantly higher in childhood and adolescence.

 Some children, adolescents and adults with moderate-to-severe AD cannot be sufficiently
 controlled with topical treatments alone and require intermittent or continuous treatment
 with systemic immunomodulating agents or UV-therapy.

 Systematic reviews indicate that although several different interventions for
 moderate-to-severe AD have been studied in clinical trials, strong recommendations are only
 possible for Dupilumab in adults and the short-term use of cyclosporin A (CSA).

 Pharmaceutical treatment of patients suffering from AE is diverse and frequently not in line
 with the current guidelines (for example S2-guideline in Germany).

 Large head-to-head trials are missing so that long-term effectiveness of systemic
 interventions for moderate-to-severe AD is speculative.

 In this situation, clinical registries can provide valuable information for evidence-based
 clinical decision making.

 Extension of TREATgermany to children and adolescents is necessary as

 -  moderate-to-severe AD is frequent in this age group, but the effectiveness of existing
 topical and systemic agents in the routine care setting on clinical severity,
 patient-reported outcomes, and the course of AD and associated atopic and non-atopic
 comorbidities over time is still poorly understood

 -  it is unclear how many children and adolescents cannot be effectively controlled with
 the avoidance of trigger factors, patient education, and topical anti-inflammatory
 treatment alone

 -  innovative agents will become available for these age groups within the next years and
 reference data will be necessary to evaluate their effectiveness and indication criteria

 -  adequate evidence regarding patient needs in children and adolescents with
 moderate-to-severe AD is urgently needed to provide value-based healthcare for this
 vulnerable patient group

 -  Best-practice models of transition from adolescent to adult care of patients with
 moderate-to-severe AD do not exist yet, but constitute a prerequisite for the
 establishment of efficient patient care
Study procedures:

 No study related intervention will be performed. Included patients will be prospectively
 followed for at least 24 months. A maximum duration of follow-up is not intended.

 During the observation period standardized study visits are performed to prospectively
 document patient characteristics, clinical data, patient-reported outcomes, physician's
 reasons for treatment decisions, and satisfaction with treatment.

 The first study visit is scheduled at patient inclusion (baseline-visit; V1). The second and
 third study visits are scheduled 3 and 6 months after baseline, respectively. (V2 after 3
 months, V3 after 6 months). Thereafter, study visits are scheduled after 3 months (if a new
 systemic treatment was initiated) or after 6 months (in case no new systemic treatment was
 prescribed).

 In a subset of patients biosamples for molecular analyses including blood, swabs and stool
 will be taken at baseline and at V6, as well as skin biopsies prior to and 3 months after
 systemic therapy initiation. This optional module requires separate patient information and
 informed consent.

 Data assessment:

 Prospective electronic documentation of disease course and severity, medical care and
 pharmaceutical treatment of AD.

 Pseudomized data will be stored at the registry center (Center for Evidence-based Healthcare,
 Dresden).

 Study assessments include:

 1. A short physician report form to document patient history and clinical parameters such
 as the objective severity of clinical signs, affected body regions, physician's global
 assessment of disease severity, course of disease and medical treatment of AD including
 adverse events.

 2. A patient report form to assess important subjective parameters, patient reported
 outcomes such as symptoms, quality of life, treatment satisfaction, patient's assessment
 of global disease severity, totally/partial well-controlled weeks.
Inclusion Criteria:

 -  AD according to the United Kingdom (UK) working party diagnostic criteria

 -  Moderate to severe AD

 -  Objective SCORAD > 20 or Currently anti-inflammatory systemic treatment for AD or
 Previous anti-inflammatory systemic treatment for AD within past 24 months

 Exclusion Criteria:

 -