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Observational Study
. 2025 Feb;42(2):720-733.
doi: 10.1007/s12325-024-03049-8. Epub 2024 Dec 2.

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

Piergiacomo Calzavara-Pinton  1 , Chia-Yu Chu  2   3 , Hilde Lapeere  4 , Mariateresa Rossi  5 , Silvia M Ferrucci  6 , Wen-Hung Chung  7 , Anne-Claire Fougerousse  8   9 , Daria S Fomina  10   11   12 , Gregor Holzer  13   14 , Jarmila Čelakovská  15 , Mona Al-Ahmad  16 , Thrasyvoulos Tzellos  17 , Jiangming Wu  18 , Marius Ardeleanu  19 , Kwinten Bosman  20
Affiliations
Observational Study

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

Piergiacomo Calzavara-Pinton et al. Adv Ther. 2025 Feb.

Abstract

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.

Keywords: Atopic dermatitis; Dupilumab; Long-term treatment; Real-world.

Plain language summary

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.

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Conflict of interest statement

Declarations. Conflict of Interest: P. Calzavara-Pinton is an advisory board member for AbbVie, Almirall, Galderma, LEO Pharma, Meda, and Sanofi. C-Y. Chu is an investigator for AbbVie, Dermira, Eli Lilly, Novartis, Oneness Biotech, Pfizer, Regeneron Pharmaceuticals Inc., Roche, and Sanofi; a consultant for AbbVie, Eli Lilly, Novartis, Pfizer, Roche, and Sanofi; a speaker for AbbVie, Eli Lilly, Mylan, Novartis, Pfizer, Roche, Sanofi, and Viatris; and an advisory board member for Mylan, Pfizer, Roche, and Sanofi. Hilde Lapeere is on the advisory boards of AbbVie, LEO Pharma, Eli Lilly, Pfizer, and Sanofi. M. Rossi is a speaker for AbbVie, Galderma, La Roche-Posay, LEO Pharma, Pfizer, and Sanofi. S.M. Ferrucci is an advisory board member for AbbVie, Eli Lilly, and Sanofi; a principal Investigator for Almirall, Menarini, and Pfizer; and reports honoraria for lectures and research grants from Novartis. W-H. Chung has nothing to disclose. A-C. Fougerousse is a consultant for AbbVie, Galderma, LEO Pharma, Lilly, and Sanofi; and a consultant for AbbVie, Eli Lilly, and Sanofi. D.S. Fomina reports honoraria from CSL Behring, Novartis, Sanofi, and Shire. G. Holzer is an advisory board member for AbbVie, Almirall, Eli Lilly, Galderma, LEO Pharma, and Sanofi. J. Čelakovská has nothing to disclose. M. Al-Ahmad is an advisory board member and speaker for AstraZeneca, GSK, and Novartis. T. Tzellos has received honoraria from and is an advisory board member and speaker for AbbVie; and has received honoraria from and is an advisory board member for Boehringer Ingelheim and Sanofi. J. Wu is an employee of Sanofi, and may hold stock and/or stock options in the company. M. Ardeleanu is an employee and shareholder of Regeneron Pharmaceuticals Inc. K. Bosman is an employee and shareholder of Sanofi. Ethical Approval: The study was conducted in accordance with the Declaration of Helsinki, the International Conference on Harmonisation Good Clinical Practice guideline and applicable regulatory requirements. The local institutional review board or ethics committee at each study center oversaw trial conduct and documentation. All patients, or their parents/guardians, provided written informed consent before participating in the trial. Pediatric patients provided assent according to the ethics committee (institutional review board/independent ethics committee)-approved standard practice for pediatric patients at each participating center.

Figures

Fig. 1
Fig. 1
Mean (SE) clinician- and patient-reported outcomes over time in the follow-up population: a EASI, b SCORAD, c BSA affected, d POEM, e DLQI, f CDLQI, g pruritus NRS. BSA body surface area; CDLQ Children’s Dermatology Life Quality Index; DLQI Dermatology Life Quality Index; EASI Eczema Area and Severity Index; NRS Numerical Rating Scale; POEM Patient-Oriented Eczema Measure; SCORAD SCORing Atopic Dermatitis; SE standard error
Fig. 2
Fig. 2
a Kaplan–Meier curve for time to first temporary dupilumab interruption (follow-up population); b Kaplan–Meier curve for time to permanent discontinuation of dupilumab (follow-up population)
Fig. 3
Fig. 3
a Proportion of patients reporting hospitalization or visits to the emergency room/urgent care center due to eczema in the 3 months prior to visit month after initiating dupilumab treatment (follow-up population); b reasons for visit to the emergency room/urgent care center due to eczema in the 3 months prior to visit month after initiating dupilumab treatment (follow-up population)
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References

    1. Birdi G, Cooke R, Knibb RC. Impact of atopic dermatitis on quality of life in adults: a systematic review and meta-analysis. Int J Dermatol. 2020;59(4):e75–91. - PubMed
    1. Chiesa Fuxench ZC, Block JK, Boguniewicz M, et al. Atopic dermatitis in America study: a cross-sectional study examining the prevalence and disease burden of atopic dermatitis in the US adult population. J Invest Dermatol. 2019;139(3):583–90. - PubMed
    1. Eckert L, Gupta S, Amand C, Gadkari A, Mahajan P, Gelfand JM. Impact of atopic dermatitis on health–related quality of life and productivity in adults in the United States: an analysis using the National Health and Wellness Survey. J Am Acad Dermatol. 2017;77(2):274-9.e3. - PubMed
    1. Abuabara K, Yu AM, Okhovat JP, Allen IE, Langan SM. The prevalence of atopic dermatitis beyond childhood: a systematic review and meta–analysis of longitudinal studies. Allergy. 2018;73(3):696–704. - PMC - PubMed
    1. Garmhausen D, Hagemann T, Bieber T, et al. Characterization of different courses of atopic dermatitis in adolescent and adult patients. Allergy. 2013;68(4):498–506. - PMC - PubMed

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