INTRODUCTION: Currently, limited data are available on long-term use of dupilumab to treat atopic dermatitis (AD) in a multinational real-world setting. The aim of this analysis was to report the interim 1-year data for patients with AD enrolled in the GLOBOSTAD registry, including treatment patterns, dupilumab effectiveness and safety, and healthcare burden. METHODS: GLOBOSTAD is an ongoing, 5-year, multinational, prospective, observational study of adult/adolescent (aged ≥ 12 years at baseline) patients with AD who initiated dupilumab in real-world settings according to their local country-specific prescribing guidelines. Outcomes were evaluated at baseline and at 3, 6 and 12 months and included Eczema Area and Severity Index (EASI) total score, SCORing Atopic Dermatitis (SCORAD) total score, percent body surface area (BSA) affected, Patient-Oriented Eczema Measure (POEM), Dermatology Life Quality Index (DLQI) total score for adults or Children's Dermatology Life Quality Index (CDLQI) total score for adolescents and pruritus Numeric Rating Scale (NRS) total score. RESULTS: At the interim 1-year cut-off (March 2023), 955 patients were enrolled in GLOBOSTAD, and follow-up data were obtained from 903 patients. After dupilumab initiation, mean improvements in effectiveness outcome measures from baseline to month 3 were EASI from 25.1 to 6.1, SCORAD 59.3 to 25.3, POEM 19.7 to 8.7, DLQI 13.7 to 5.3, CDLQI 12.2 to 2.7 and pruritus NRS 6.3 to 2.5, with each measure exceeding the minimal clinically important difference. These positive changes in effectiveness outcomes were maintained or further improved through 12 months since treatment initiation. AD-related hospitalizations and emergency room or urgent care facility visits decreased from 11.1% to 1.7% from baseline to month 12. CONCLUSIONS: In a multinational real-world setting, dupilumab demonstrated rapid, robust and sustained effectiveness in patients with moderate-to-severe AD across multiple disease domains, including AD signs, symptoms, quality of life and emergency/urgent care visits. Safety was consistent with the known dupilumab safety profile. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03992417.

Atopic dermatitis (AD) is a chronic relapsing skin disease that can have a negative effect on the quality of patients’ lives. In clinical trials, when patients with AD were treated with a drug called dupilumab, there were improvements in their AD signs and symptoms and quality of life. More information is needed about how well dupilumab works when patients are prescribed the drug by their doctors in the real world over a long period. In total, almost 1000 adults and adolescents with AD joined a prospective observational study called GLOBOSTAD. GLOBOSTAD aims to follow them for up to 5 years after their first dupilumab treatment. This study looked at the effects of dupilumab in about 900 patients during their first year of treatment. At 3 months after starting dupilumab, there were improvements in each of the measures that show how effective a treatment is. These included measures that doctors use to judge how serious AD is. They also included measures that patients use to report how serious they feel their AD is and how AD affects their quality of life. After 1 year, those changes had either stayed or improved further. After 1 year, there was also an improvement in how often patients had to visit the hospital because of their AD. Safety was consistent with the known dupilumab safety information.

1 M Sechenov 1st Moscow State Medical University of the Ministry of Health of the Russian Federation Moscow Russian Federation

Bégin Military Teaching Hospital Saint Mandé France

Department of Dermatology and Venereology Faculty Hospital and Medical Faculty of Charles University Hradec Králové Czech Republic

Department of Dermatology Ghent University Hospital Ghent Belgium

Department of Dermatology National Taiwan University Hospital and National Taiwan University College of Medicine Taipei Taiwan

Department of Pulmonology Astana Medical University Astana Kazakhstan

Dermatology Department University of Brescia Brescia Italy

Drug Hypersensitivity Clinical and Research Center Chang Gung Memorial Hospital Taipei Taiwan

Institute of Clinical Medicine Arctic University of Norway Tromsø Norway

Medical University of Vienna Vienna Austria

Microbiology Department College of Medicine Kuwait University Kuwait City Kuwait

Moscow Clinical and Research Center of Allergology and Immunology City Clinical Hospital No 52 Moscow Russian Federation

Regeneron Pharmaceuticals Inc Tarrytown NY USA

ResoEczéma Paris France

Sanofi Amsterdam the Netherlands

Sanofi Bridgewater NJ USA

Sozialmedizinisches Zentrum Ost Donauspital Vienna Austria

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

University College of Medicine Taipei Taiwan

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NCT03992417