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.
Authors
- Dedee Frances Murrell (ORCID: https://orcid.org/0000-0003-2971-0199)
- Kwinten Bosman
- Hilde Lapeere (ORCID: https://orcid.org/0000-0003-4319-4776)
- Marius Ardeleanu (ORCID: https://orcid.org/0000-0002-7712-6862)
- Anne‐Claire Fougerousse
- Piergiacomo Calzavara‐Pinton (ORCID: https://orcid.org/0000-0002-0935-7204)
- Caterina Foti (ORCID: https://orcid.org/0000-0001-6196-9788)
- Silvia Mariel Ferrucci (ORCID: https://orcid.org/0000-0002-6734-1366)
- Jiangming Wu
- Bibiana Pérez‐García
Institutions
- 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)
Publication Details
- Journal
- British Journal of Dermatology
- Published
- 2024-08-01
- DOI
- https://doi.org/10.1093/bjd/ljae266.016
- Primary Topic
- Dermatology and Skin Diseases
- Type
- article
- Field-Weighted Citation Impact
- 0.00