One-Year Insights into the GLOBOSTAD Multinational Prospective Observational Study of Patients Receiving Dupilumab for Atopic Dermatitis

Calzavara-Pinton P. Chu C.-Y. Lapeere H. Rossi M. Ferrucci S.M. Chung W.-H. Fougerousse A.-C. Fomina D.S. Holzer G. Čelakovská J. Al-Ahmad M. Tzellos T. Wu J. Ardeleanu M. Bosman K.
February 2025 Adis

Advances in Therapy
2025 #42 Issue 2 720 - 733 pp.

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 , Dupilumab , Long-term treatment , Real-world

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Dermatology Department, University of Brescia, Brescia, Italy
Department of Dermatology, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan
University College of Medicine, Taipei, Taiwan
Department of Dermatology, Ghent University Hospital, Ghent, Belgium
Unit of Dermatology, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy
Drug Hypersensitivity Clinical and Research Center, Chang Gung Memorial Hospital, Taipei, Taiwan
Bégin Military Teaching Hospital, Saint Mandé, France
ResoEczéma, Paris, France
Moscow Clinical and Research Center of Allergology and Immunology, City Clinical Hospital No 52, Moscow, Russian Federation
I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation, Moscow, Russian Federation
Department of Pulmonology, Astana Medical University, Astana, Kazakhstan
Medical University of Vienna, Vienna, Austria
Sozialmedizinisches Zentrum Ost – Donauspital, Vienna, Austria
Department of Dermatology and Venereology, Faculty Hospital and Medical Faculty of Charles University, Hradec Králové, Czech Republic
Microbiology Department, College of Medicine, Kuwait University, Kuwait City, Kuwait
Institute of Clinical Medicine, Arctic University of Norway, Tromsø, Norway
Sanofi, Bridgewater, NJ, United States
Regeneron Pharmaceuticals Inc., Tarrytown, NY, United States
Sanofi, Amsterdam, Netherlands

Dermatology Department
Department of Dermatology
University College of Medicine
Department of Dermatology
Unit of Dermatology
Drug Hypersensitivity Clinical and Research Center
Bégin Military Teaching Hospital
ResoEczéma
Moscow Clinical and Research Center of Allergology and Immunology
I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation
Department of Pulmonology
Medical University of Vienna
Sozialmedizinisches Zentrum Ost – Donauspital
Department of Dermatology and Venereology
Microbiology Department
Institute of Clinical Medicine
Sanofi
Regeneron Pharmaceuticals Inc.
Sanofi

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