TREATgermany: German National Clinical Registry for Patients With Moderate-to-severe Atopic Dermatitis

Condition(s) studied

Investigational drug(s) / intervention(s)

Study summary

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

Eligibility

Primary outcome measure(s)

• Score of Atopic Dermatitis (oSCORAD) — Change from Baseline oSCORAD at 2 years
  Severity scoring of atopic dermatitis: the SCORAD index. Consensus Report of the European Task Force on Atopic Dermatitis: Dermatology 1993;186:23-31

Trial sites (3)

More Technische Universität Dresden trials in Germany

Other trials for the same condition