634 - Patient-reported outcomes and safety in adolescent and adult atopic dermatitis patients treated with dupilumab: real-world insights one year into the GLOBOSTAD multinational prospective observational study

Abstract Introduction The GLOBOSTAD study aims to capture long-term dupilumab effectiveness in real-world atopic dermatitis (AD) treatment. Objective To present patient-reported outcomes, that complement clinical AD assessments and guide healthcare decision-making, and a summary of adverse events one year after dupilumab initiation. Methods The GLOBOSTAD five-year, multinational, prospective, observational study (NCT03992417) enrolled patients aged ≥12 years with moderate-to-severe AD. Patients received dupilumab based on country-specific prescribing information. Assessments were performed at baseline, 3 months (M; ±1M), 6M (±2M), and 12M (±2M). Data are reported as observed for enrollment/safety (N = 955; data cutoff: March 2023) and follow-up (N = 903) populations. Results 758/863/705 patients completed ≥1 follow-up assessment at 3M/6M/12M, respectively. During the study, patients reported rapid improvements in mean (SD) patient-oriented eczema measure from 19.7 (6.4) at baseline to 8.7 (6.6) at 3M to 7.1 (5.8) at end of observation period (12M); pruritus numerical rating scale from 6.3 (2.2) to 2.5 (2.4) to 1.7 (2.0); scoring of atopic dermatitis sleep loss score from 5.6 (3.0) to 1.7 (2.3) to 1.0 (1.8); dermatology life quality index (DLQI) from 13.7 (7.1) to 5.3 (5.1) to 3.9 (4.2); and children’s DLQI from 12.2 (6.2) to 2.7 (2.9) to 4.8 (4.8). Adverse events considered related to dupilumab by the investigator were reported in 187 (19.6%) patients. Adverse events leading to permanent dupilumab discontinuation were reported in 23 (2.4%) patients. Conclusion On initiating dupilumab treatment, patients reported rapid improvements in skin lesions, itch, sleep, and overall quality of life, from severe/very large effect scores to mild/small effect scores, which were sustained for up to one year. Safety data were consistent with previous studies.

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Journal
British Journal of Dermatology
Published
2024-08-01
DOI
https://doi.org/10.1093/bjd/ljae266.016
Primary Topic
Dermatology and Skin Diseases
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article
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article

634 - Patient-reported outcomes and safety in adolescent and adult atopic dermatitis patients treated with dupilumab: real-world insights one year into the GLOBOSTAD multinational prospective observational study

Dedee Frances Murrell, Kwinten Bosman, Hilde Lapeere, Marius Ardeleanu et al.
British Journal of Dermatology
Dermatology and Skin Diseases
article

634 - Patient-reported outcomes and safety in adolescent and adult atopic dermatitis patients treated with dupilumab: real-world insights one year into the GLOBOSTAD multinational prospective observational study

Dedee Frances Murrell, Kwinten Bosman, Hilde Lapeere, Marius Ardeleanu, Anne‐Claire Fougerousse, Piergiacomo Calzavara‐Pinton, Caterina Foti, Silvia Mariel Ferrucci, Jiangming Wu, Bibiana Pérez‐García
article en

Abstract

Abstract Introduction The GLOBOSTAD study aims to capture long-term dupilumab effectiveness in real-world atopic dermatitis (AD) treatment. Objective To present patient-reported outcomes, that complement clinical AD assessments and guide healthcare decision-making, and a summary of adverse events one year after dupilumab initiation. Methods The GLOBOSTAD five-year, multinational, prospective, observational study (NCT03992417) enrolled patients aged ≥12 years with moderate-to-severe AD. Patients received dupilumab based on country-specific prescribing information. Assessments were performed at baseline, 3 months (M; ±1M), 6M (±2M), and 12M (±2M). Data are reported as observed for enrollment/safety (N = 955; data cutoff: March 2023) and follow-up (N = 903) populations. Results 758/863/705 patients completed ≥1 follow-up assessment at 3M/6M/12M, respectively. During the study, patients reported rapid improvements in mean (SD) patient-oriented eczema measure from 19.7 (6.4) at baseline to 8.7 (6.6) at 3M to 7.1 (5.8) at end of observation period (12M); pruritus numerical rating scale from 6.3 (2.2) to 2.5 (2.4) to 1.7 (2.0); scoring of atopic dermatitis sleep loss score from 5.6 (3.0) to 1.7 (2.3) to 1.0 (1.8); dermatology life quality index (DLQI) from 13.7 (7.1) to 5.3 (5.1) to 3.9 (4.2); and children’s DLQI from 12.2 (6.2) to 2.7 (2.9) to 4.8 (4.8). Adverse events considered related to dupilumab by the investigator were reported in 187 (19.6%) patients. Adverse events leading to permanent dupilumab discontinuation were reported in 23 (2.4%) patients. Conclusion On initiating dupilumab treatment, patients reported rapid improvements in skin lesions, itch, sleep, and overall quality of life, from severe/very large effect scores to mild/small effect scores, which were sustained for up to one year. Safety data were consistent with previous studies.

British Journal of DermatologyVol. 191(Supplement_2)
Arkema (France) (FR), Regeneron (United States) (US), Instituto Cajal (ES), Ghent University Hospital (BE), Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IT), UNSW Sydney (AU), Sanofi (Netherlands) (NL), Sanofi (United States) (US), St George Hospital (AU), Hôpital d'Instruction des Armées Bégin (FR), University of Bari Aldo Moro (IT), University of Brescia (IT)
Openalex Percentile: Top 74%
Dermatology and Skin Diseases
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