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Abstract

Allergologie select, Vol. 5/2021 (265-273)

A new era has begun: Treatment of atopic dermatitis with biologics

Dora Stölzl, Stephan Weidinger, and Katharina Drerup

Department of Dermatology, Venereology and Allergology, UKSH, Campus Kiel
The era of biologics for the treatment of moderate-to-severe atopic dermatitis (AD) began in 2017 with the approval of dupilumab, a monoclonal antibody that binds to the α-subunit of the interleukin IL-4 receptor. Until then, only conventional immunosuppressants were available for systemic treatment, of which only cyclosporine is approved for the treatment of severe AD. In the meantime, the therapeutic landscape of AD has been changing rapidly, and additional biologics have been developed which target IL-13, the IL-31 receptor, OX40, and OX40L, among others. Many of these substances have already shown promising results in phase 1, 2, and in some cases also phase 3 trials. In June 2021, tralokinumab, an IL-13 antibody, has been approved in Europe for the treatment of moderate-to-severe AD in adults. In addition to antibody-based therapies, “small molecules” that, e.g., inhibit Janus kinases enrich the armamentarium of systemic AD therapies. With all these agents, not only will many more targeted therapies become available, but also will the complex and heterogeneous pathophysiological processes of this disease be better understood.Correspondence to:
Dr. med. Univ. Dora Stölzl, Klinik für Dermatologie, Venerologie und Allergologie, UKSH, Campus Kiel, Arnold-Heller-Straße 3, 24105 Kiel, Germany
Email: [email protected]

Abstract

Allergologie select, Vol. 5/2021 (274-286)

Status report on the atopic dermatitis registry TREATgermany

Doreen Siegels¹, Eva Haufe¹, Luise Heinrich¹, Thomas Werfel², Stephan Weidinger³, Jochen Schmitt¹; and the TREATgermany Study Group

¹Center for Evidence-Based Healthcare, University Hospital Carl Gustav Carus and Carl Gustav Carus Faculty of Medicine, Technische Universität Dresden, ²Department of Immunodermatology and Experimental Allergology, Department of Dermatology, Allergology and Venereology, Hannover Medical School, Hannover, and ³Department of Dermatology, Venereology and Allergology, Schleswig-Holstein University Hospital, Kiel Campus, Kiel, Germany
Background: The TREATgermany registry collects data from children, adolescents, and adults with moderate-to-severe atopic dermatitis (AD) in Germany. For this purpose, clinical and patient-reported outcomes, the course of the disease, and applied therapies are observed. Methods: TREATgermany recruits patients with moderate-to-severe AD according to the diagnostic criteria of the UK Working Party, an “Objective Scoring for Atopic Dermatitis” (oSCORAD) > 20 and/or currently antiinflammatory systemic treatment for AD or previous anti-inflammatory systemic treatment for AD within past 24 months before inclusion. No study related interventions will be performed. Currently, 59 dermatological practices, clinics, and university hospitals are participating in TREATgermany (as of May 2021). Based on the interim analysis of October 13, 2020, patient characteristics were described from 4,373 documented visits of adult participants (n = 1,025). Results: The mean age at inclusion in TREATgermany was 42 years, 57.7% of patients were men (n = 591) and 42.3% were women (n = 434). According to oSCORAD, 85.8% of those included suffered from moderate-to-severe AD. At baseline visit, 744 patients had already received one or more systemic treatments for AD (glucocorticosteroids n = 600, ciclosporin A (CSA) n = 307, dupilumab n = 98). 597 patients received dupilumab during their participation in TREATgermany, 134 patients received CSA. Conclusion: With the increasing number of recruitment centers (October 2020: 38 centers; May 2021: 59 centers), TREATgermany can continue to make an important contribution to health services research for patients with moderate-to-severe AD. The registry fulfills the methodological requirements of IQWiG for the collection and processing of healthcare-related data. With the successful and expected approval of further systemic treatments, these can be compared in terms of efficacy and safety in the future. In addition, with the recruitment of children and adolescents started in 2021, this patient group can also be observed.Correspondence to:
Prof. Dr. med. Jochen Schmitt, Center for Evidence-Based Healthcare, University Hospital Carl Gustav Carus and Carl Gustav Carus Faculty of Medicine, Technische Universität Dresden, Fetscherstr. 74, 01307 Dresden
Email: [email protected]

Abstract

Allergologie select, Vol. 9/2025 (40-46)

The importance of registries in clinical practice: Insights from the national atopic dermatitis registry TREATgermany

Tatjana Honstein¹, Barbara Kind², Dora Stölzl³, Inken Harder³, Sigrid Müller², Thomas Birkner², Luise Heinrich², Sascha Fischer¹, Nicole Sander³, Annice Heratizadeh¹, Jochen Schmitt², Stephan Weidinger³, and Thomas Werfel¹

¹Division of Immunodermatology and Allergy Research, Department of Dermatology and Allergy, Hannover Medical School, Hannover,, ²Center for Evidence-Based Healthcare, University Hospital Carl Gustav Carus and Carl Gustav Carus Faculty of Medicine, Technische Universität Dresden, Dresden, and ³Department of Dermatology, Venereology and Allergology, Schleswig-Holstein University Hospital, Kiel Campus, Kiel, Germany
Atopic dermatitis (AD) is an inflammatory, multifactorial skin disease characterized by eczematous skin lesions, severe itching, and serious limitations in quality of life. Since 2016, TREATgermany has been a national clinical registry for patients with moderate to severe AD with around 2,550 participating patients, enabling the collection of physical, patient-reported social and psychological data as well as the collection of biosamples in routine care. TREATgermany is one of the largest academically managed AD registries in the world. This current review summarizes a selection of published analyses from registry data from TREATgermany, which retrospectively identified important correlations with regard to treatment response and safety, and investigated quality of life, performance, and mental health under everyday conditions. In addition, initial molecular signatures were identified from the blood and skin samples obtained from the patients included in the registry, which may be useful as prognostic markers.Correspondence to:
Tatjana Honstein, Hannover Medical School, OE6600, Carl-Neuberg-Str. 1, 30625 Hannover, Germany
Email: [email protected]

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