INTRODUCTION: Atopic dermatitis (AD) is a chronic, relapsing, heterogeneous skin disease affecting 2%-7% of adults, with roughly 30% having moderate-to-severe disease. AD symptoms, like intense itching and skin pain, carry a substantial disease burden that negatively impacts patients' quality of life (QoL) and psychosocial well-being. Lebrikizumab is a novel, high-affinity monoclonal antibody that selectively binds to and neutralises interleukin-13 with high potency. Three clinical trials with lebrikizumab (ADvocate 1 and 2; ADhere) demonstrated significant clinical benefit in patients with AD, while the 3-year long-term extension study of lebrikizumab (ADjoin) further demonstrated long-term efficacy and safety in patients with AD. The ADTrust study will evaluate patient well-being, their relationship with their skin, long-term effectiveness, and safety of lebrikizumab, treatment satisfaction, and long-term effect of lebrikizumab treatment on different aspects of patients' lives, including itch, pain, sleep, fatigue, work impairment and overall QoL among adult patients with moderate-to-severe AD in a real-world setting. METHODS AND ANALYSIS: This non-interventional, prospective, observational, real-world evidence study will involve approximately 150 sites across Europe and approximately 1200 adults with moderate-to-severe AD treated with lebrikizumab for 2 years. The primary endpoint is patient well-being assessed by the 5-item WHO Well-Being Index (WHO-5) questionnaire. Key secondary endpoints include clinical effectiveness (Eczema Area and Severity Index and Investigator's Global Assessment Scale), disease symptomatology and control (Patient-Oriented Eczema Measure, 24-hour peak pruritus, skin pain, fatigue and sleep quality Numerical Rating Scale, and safety and tolerability. Other validated endpoints will evaluate physician-reported and patient-reported QoL and treatment satisfaction (Dermatology Life Quality Index, Treatment Satisfaction Questionnaire-9), patients' work productivity and impairment (Work Productivity and Activity Impairment (WPAI)-AD) and disease control (AD Control Tool). Novel experimental endpoints will also be evaluated with the aim to assess patients' relationship with their skin (SkinLove questionnaire), disease control (intensity and frequency of flares) and an Effectiveness Diary+© (a brief monthly survey on a voluntary basis with the aim to assess the long-term impact of lebrikizumab on three fundamental aspects of the patients' life: the well-being (WHO-5), the itch intensity (24 hours peak pruritus) and the frequency and intensity of flares). Statistical analyses will be descriptive and explorative and based on observed cases. Missing data imputation may be used to handle missing data for primary endpoints and secondary effectiveness endpoints. ETHICS AND DISSEMINATION: This study will be conducted according to the protocol, which has ethics committee approval (Hamburg Ethic Committee in Germany: 2024-101358-BO-ff), and all applicable laws and regulatory requirements for each participating country. The results will be disseminated through scientific publications and congress presentations. TRIAL REGISTRATION NUMBER: NCT06815380 (Pre-results).

Abteilung für Dermatologie und Venerologie Medizinische Universität Graz Graz Austria

Almirall S A Barcelona Spain

Avant Health LLC Bethesda Maryland USA

Christine Kühne Center for Allergy Research and Education Davos Switzerland

Department of Dermato Venereology 4th Military Hospital Faculty of Medicine University of Science and Technology Wroclaw Poland

Department of Dermatology Aarhus University Hospital Aarhus Denmark

Department of Dermatology and Allergology National Expertise Center for Atopic Dermatitis University Medical Center Utrecht Utrecht Netherlands

Department of Dermatology and Allergy Hannover Medical School Hannover Germany

Department of Dermatology and Venereology Karolinska University Hospital Stockholm Sweden

Department of Dermatology CAC ICBAS CHP Porto Portugal

Department of Dermatology EpiDermE Henri Mondor Hospital Université Paris Est Créteil Créteil France

Department of Dermatology Ghent University Hospital Ghent Belgium

Department of Dermatology Oslo University Hospital Oslo Norway

Department of Dermatology Université Paris Est Créteil Val de Marne Université Paris Créteil France

Department of Dermatology University Hospital Zurich Zürich Switzerland

Department of Dermatology Vrije Universiteit Brussel Universitair Ziekenhuis Brussels Jette Belgium

Department of Dermatovenereology 3rd Faculty of Medicine Charles University and Kralovske Vinohrady University Hospital Prague Czech Republic

Department of Dermatovenerology University Hospital Luis Pasteur Košice Slovakia

Dermatology Department Hospital Universitario La Paz Madrid Spain

Dermatology Unit Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan Italy

Division of Dermatology and Venereology Department of Medicine Solna Karolinska Institute Stockholm Sweden

Faculty of Medicine Institute of Clinical Medicine University of Oslo Oslo Norway

Institute for Health Services Research in Dermatology and Nursing University Medical Center Hamburg Eppendorf Hamburg Germany

Royal London Hospital Whitechapel London UK

Unit for Multidisciplinary Research in Biomedicine Instituto de Ciências Biomédicas Abel Salazar University of Porto Porto Portugal

University of Zurich Zürich Switzerland

Whipps Cross University Hospital Whitechapel London UK

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NCT06815380