Registry

The German Atopic Dermatitis Registry TREATgermany is a non-interventional, disease-related, multi-centre, scientifically managed registry for long-term follow-up of patients with moderate to severe Atopic Dermatitis.

As part of the European TREAT family of registries, it provides a high-quality research platform to generate information for evidence-based decisions in routine care.

Objectives of the registry

Characterization of medical care and medication therapy of adults, adolescents and children with moderate to severe atopic dermatitis.
Evaluation of the affected person's perspective with regard to benefits, goals, quality of life, therapy sequence and change.
Exploring the comparative effectiveness, tolerability, and safety of available topical and systemic therapies for moderate to severe atopic dermatitis.
Basis and platform for further clinical, (health care) epidemiological, immunological and genetic investigations.

Browse through our publications

In this section you will find articles that have been published using data or content from the TREATgermany registry!

Where do we stand?

Since its establishment in 2016

  • about 80 dermatological clinics and practices have been recruited for participation,
  • more than 2,000 adult patients and
  • nearly 400 children and adolescents (starting 12/2020) have been enrolled,
  • 2-year follow-up is documented of about 600 adult patients,
  • biosamples of nearly 900 patients are collected.

Why a register?

Atopic dermatitis places a high burden on patients, their families and the health care system. Patients with moderate to severe atopic dermatitis often cannot be treated adequately with topical therapies, so that the use of modern systemic immunmodulactory therapies or biologic treatments becomes necessary.

Pharmaceutical treatment of patients with atopic dermatitis varies greatly in Germany and has not yet been systematically recorded.

The lack of comparative studies as well as long-term studies means that clinically relevant statements on the long-term efficacy of systemic therapies are hardly possible. The transferability of results from clinical studies to routine care has not yet been adequately investigated.

In this situation, clincial registries such as TREATgermany can provide valuable care-related data for evidence-based clinical decisions in routine care.

Inclusion criteria

Age ≥ 18 years, Age < 18 years, resp.
AD according to the UK working party diagnostic criteria
moderate to severe AD

Only one of the following criteria must apply:

Objective SCORAD > 20
Current anti-inflammatory systemic treatment for AD
Previous anti-inflammatory systemic treatment for AD

within past 24 months

Objektive SCORAD > 20
Current anti-inflammatory systemic treatment for AD
Previous anti-inflammatory systemic treatment for AD

within past 24 months

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 (every 3 to 6 months) to prospectively document patient characteristics, clinical data, patient-reported outcomes, physician’s reasons for treatment decisions, and satisfaction with treatment.

Data documentation in the registry database is done online by the physician. Patients use iPads to comlete their questionaires.

Module Bioanalytics

Content, objective and participation

Within the module “Bioanalytics”, blood and skin smears are taken from those patients who declare their consent to this. Biosamples are taken at the beginning and end of the study, as well as additional small skin biopsies before and after the initiation of a new systemic treatment.

On these samples, the genetic basis of atopic dermatitis as well as the different response to certain forms of systemic treatment and the development of the bacterial colonisation of the skin (“microbiome”) are examined in anonymised form.

The knowledge gained from this can contribute to a better understanding of the disease, to improve treatments and to develop preventive strategies. In this way, registry patients can substantially contribute to the control the disease.

Participation in this module is voluntary for recruting sites as well as for enrolled registry patients and it is based on additional informed consent.

Contact

Inken Harder, M.Sc. Biology

Quincke Research Center
Center for Inflammatory Skin Diseases
Department of Dermatology and Allergy
Rosalind-Franklin-Str. 9
24105 Kiel

Tel.: +49 (0)431 500 21346
E-Mail: TREAT-Bioanalytik-Kiel@dermatology.uni-kiel.de