INTRODUCTION: Insights into real-world treatment of atopic dermatitis (AD) are relevant to clinical decision making. The aim of this analysis was to characterize patients who receive dupilumab for AD in a real-world setting. METHODS: The GLOBOSTAD registry is an ongoing, longitudinal, prospective, observational study of patients with AD who receive dupilumab according to country-specific prescribing information. We report baseline characteristics, comorbidities and treatment patterns for patients enrolled from July 11, 2019 to March 31, 2022. Analyses are descriptive; no formal statistical comparisons were performed. RESULTS: Nine hundred fifty-two adults and adolescents were enrolled in GLOBOSTAD. Patients had a high disease burden before starting dupilumab: (mean [standard deviation]) percent body surface area affected (44.8 [24.42]), Eczema Area and Severity Index total score (24.8 [12.95]), SCORing Atopic Dermatitis total score (60.5 [16.34]), Patient-Oriented Eczema Measure total score (19.7 [6.37]) and Dermatology Life Quality Index total score (13.7 [7.02]). Overall, 741 (77.8%) patients reported ≥ 1 type 2 inflammatory comorbidities, most frequently allergic rhinitis (492 [51.7%]), asthma (323 [33.9%]), food allergy (294 [30.9%]) or another allergy (274 [28.8%]). In the previous 12 months, 310 (32.6%) patients had received systemic non-steroidal immunosuppressants and 169 (17.8%) systemic corticosteroids; 449 (47.2%) had received topical corticosteroids, most commonly potent topical corticosteroids; 141 (14.8%) had received topical calcineurin inhibitors and 32 (3.4%) ultraviolet therapy. Most (713 [74.9%]) patients started dupilumab because of prior treatment failure. CONCLUSION: Patients enrolled in GLOBOSTAD demonstrated considerable multidimensional burden of disease across AD signs, symptoms and quality of life despite previous use of systemic and non-systemic AD treatments. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT03992417. Video Abstract.

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

Chang Gung Memorial Hospital Linkou and Taipei Taiwan

City Clinical Hospital No 52 Moscow Russian Federation

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 Dermatology Osaka Habikino Medical Center Osaka Japan

Dermatology Department University of Brescia Brescia Italy

Institute of Clinical Medicine Arctic University of Norway Tromsø Norway

Microbiology Department College of Medicine Kuwait University Kuwait City Kuwait

Military Teaching Hospital Begin Saint Mandé Paris France

Regeneron Pharmaceuticals Inc Tarrytown NY USA

ResoEczema Paris France

Sanofi Bridgewater NJ USA

Sanofi Cambridge MA USA

Sozialmedizinisches Zentrum Ost Donauspital Vienna Austria

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

Zobrazit více v PubMed

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–e91. doi: 10.1111/ijd.14763. PubMed DOI

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. doi: 10.1016/j.jaad.2017.04.019. PubMed DOI

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. doi: 10.1111/all.13320. PubMed DOI PMC

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. doi: 10.1111/all.12112. PubMed DOI PMC

Bylund S, Kobyletzki LB, Svalstedt M, Svensson Å. Prevalence and incidence of atopic dermatitis: a systematic review. Acta Derm Venereol. 2020;100(12):adv00160. doi: 10.2340/00015555-3510. PubMed DOI PMC

Silverberg JI, Kantor R. The role of interleukins 4 and/or 13 in the pathophysiology and treatment of atopic dermatitis. Dermatol Clin. 2017;35(3):327–334. doi: 10.1016/j.det.2017.02.005. PubMed DOI

Moyle M, Cevikbas F, Harden JL, Guttman-Yassky E. Understanding the immune landscape in atopic dermatitis: The era of biologics and emerging therapeutic approaches. Exp Dermatol. 2019;28(7):756–768. doi: 10.1111/exd.13911. PubMed DOI PMC

Gandhi NA, Pirozzi G, Graham NMH. Commonality of the IL-4/IL-13 pathway in atopic diseases. Expert Rev Clin Immunol. 2017;13(5):425–437. doi: 10.1080/1744666X.2017.1298443. PubMed DOI

Shrestha S, Miao R, Wang L, Chao J, Yuce H, Wei W. Burden of atopic dermatitis in the United States: analysis of healthcare claims data in the commercial, Medicare, and medical databases. Adv Ther. 2017;34(8):1989–2006. doi: 10.1007/s12325-017-0582-z. PubMed DOI PMC

de Bruin-Weller M, Gadkari A, Auziere S, et al. The patient-reported disease burden in adults with atopic dermatitis: a cross-sectional study in Europe and Canada. J Eur Acad Dermatol Venereol. 2020;34(5):1026–1036. doi: 10.1111/jdv.16003. PubMed DOI PMC

Macdonald LE, Karow M, Stevens S, et al. Precise and in situ genetic humanization of 6 Mb of mouse immunoglobulin genes. Proc Natl Acad Sci U S A. 2014;111(14):5147–5152. doi: 10.1073/pnas.1323896111. PubMed DOI PMC

Murphy AJ, Macdonald LE, Stevens S, et al. Mice with megabase humanization of their immunoglobulin genes generate antibodies as efficiently as normal mice. Proc Natl Acad Sci U S A. 2014;111(14):5153–5158. doi: 10.1073/pnas.1324022111. PubMed DOI PMC

Dupilumab Prescribing Information. https://www.regeneron.com/downloads/dupixent_fpi.pdf. Accessed 13 Nov 2022.

Dupixent Summary of Product Characteristics. https://www.ema.europa.eu/en/documents/product-information/dupixent-epar-product-information_en.pdf. Accessed 13 Nov 2022.

Blauvelt A, de Bruin-Weller M, Gooderham M, et al. Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial. Lancet. 2017;389(10086):2287–2303. doi: 10.1016/S0140-6736(17)31191-1. PubMed DOI

de Bruin-Weller M, Thaçi D, Smith CH, et al. Dupilumab with concomitant topical corticosteroid treatment in adults with atopic dermatitis with an inadequate response or intolerance to ciclosporin A or when this treatment is medically inadvisable: a placebo-controlled, randomized phase III clinical trial (LIBERTY AD CAFÉ) Br J Dermatol. 2018;178(5):1083–1101. doi: 10.1111/bjd.16156. PubMed DOI

Simpson EL, Bieber T, Guttman-Yassky E, et al. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med. 2016;375(24):2335–2348. doi: 10.1056/NEJMoa1610020. PubMed DOI

de Bruin-Weller M, Pink AE, Patrizi A, et al. Disease burden and treatment history among adults with atopic dermatitis receiving systemic therapy: baseline characteristics of participants on the EUROSTAD prospective observational study. J Dermatolog Treat. 2021;32(2):164–173. doi: 10.1080/09546634.2020.1866741. PubMed DOI

Hanifin JM, Thurston M, Omoto M, Cherill R, Tofte SJ, Graeber M. The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. EASI Evaluator Group Exp Dermatol. 2001;10(1):11–18. doi: 10.1034/j.1600-0625.2001.100102.x. PubMed DOI

Kunz B, Oranje AP, Labrèze L, Stalder JF, Ring J, Taïeb A. Clinical validation and guidelines for the SCORAD index: consensus report of the European Task Force on Atopic Dermatitis. Dermatology. 1997;195(1):10–19. doi: 10.1159/000245677. PubMed DOI

Charman CR, Venn AJ, Williams HC. The patient-oriented eczema measure: development and initial validation of a new tool for measuring atopic eczema severity from the patients' perspective. Arch Dermatol. 2004;140(12):1513–1519. doi: 10.1001/archderm.140.12.1513. PubMed DOI

Badia X, Mascaró JM, Lozano R. Measuring health-related quality of life in patients with mild to moderate eczema and psoriasis: clinical validity, reliability and sensitivity to change of the DLQI. The Cavide Research Group. Br J Dermatol. 1999;141(4):698–702. doi: 10.1046/j.1365-2133.1999.03112.x. PubMed DOI

Chopra R, Vakharia PP, Sacotte R, et al. Severity strata for Eczema Area and Severity Index (EASI), modified EASI, Scoring Atopic Dermatitis (SCORAD), objective SCORAD, Atopic Dermatitis Severity Index and body surface area in adolescents and adults with atopic dermatitis. Br J Dermatol. 2017;177(5):1316–1321. doi: 10.1111/bjd.15641. PubMed DOI

Leshem YA, Hajar T, Hanifin JM, Simpson EL. What the Eczema Area and Severity Index score tells us about the severity of atopic dermatitis: an interpretability study. Br J Dermatol. 2015;172(5):1353–1357. doi: 10.1111/bjd.13662. PubMed DOI

Vakharia PP, Chopra R, Sacotte R, et al. Severity strata for five patient-reported outcomes in adults with atopic dermatitis. Br J Dermatol. 2018;178(4):925–930. doi: 10.1111/bjd.16078. PubMed DOI PMC

Silverberg JI, Gelfand JM, Margolis DJ, et al. Severity strata for POEM, PO-SCORAD, and DLQI in US adults with atopic dermatitis. Ann Allergy Asthma Immunol. 2018;121(4):464–68.e3. doi: 10.1016/j.anai.2018.07.004. PubMed DOI

Charman CR, Venn AJ, Ravenscroft JC, Williams HC. Translating Patient-Oriented Eczema Measure (POEM) scores into clinical practice by suggesting severity strata derived using anchor-based methods. Br J Dermatol. 2013;169(6):1326–1332. doi: 10.1111/bjd.12590. PubMed DOI PMC

Bagel J, Nguyen TQ, Lima H, et al. Baseline demographics and severity and burden of atopic dermatitis in adult patients initiating dupilumab treatment in a real-world registry (PROSE) Dermatol Ther (Heidelb) 2022;12(6):1417–1430. doi: 10.1007/s13555-022-00742-w. PubMed DOI PMC

Bosma AL, de Wijs LEM, Hof MH, et al. Long-term effectiveness and safety of treatment with dupilumab in patients with atopic dermatitis: Results of the TREAT NL (TREatment of ATopic eczema, the Netherlands) registry. J Am Acad Dermatol. 2020;83(5):1375–1384. doi: 10.1016/j.jaad.2020.05.128. PubMed DOI

Katoh N, Saeki H, Kataoka Y, et al. Atopic dermatitis disease registry in Japanese adult patients with moderate to severe atopic dermatitis (ADDRESS-J): Baseline characteristics, treatment history and disease burden. J Dermatol. 2019;46(4):290–300. doi: 10.1111/1346-8138.14787. PubMed DOI PMC

Siegels D, Haufe E, Heinrich L, Werfel T, Weidinger S, Schmitt J, TREATgermany Study Group Status report on the atopic dermatitis registry TREATgermany. Allergol Select. 2021;5:274–286. doi: 10.5414/ALX02262E. PubMed DOI PMC

Spekhorst LS, Ariëns LFM, van der Schaft, et al. Two-year drug survival of dupilumab in a large cohort of difficult-to-treat adult atopic dermatitis patients compared to cyclosporine A and methotrexate: Results from the BioDay registry. Allergy. 2020;75(9):2376–2379. doi: 10.1111/all.14324. PubMed DOI PMC

Thaçi D, Bauer A, von Kiedrowski R, et al. Dupilumab treatment of atopic dermatitis in routine clinical care: baseline characteristics of patients in the PROLEAD prospective, observational study. Dermatol Ther (Heidelb) 2022;12(9):2145–2160. doi: 10.1007/s13555-022-00791-1. PubMed DOI PMC

Boguniewicz M, Beck LA, Sher L, et al. Dupilumab improves asthma and sinonasal outcomes in adults with moderate to severe atopic dermatitis. J Allergy Clin Immunol Pract. 2021;9(3):1212–23.e6. doi: 10.1016/j.jaip.2020.12.059. PubMed DOI

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

Zobrazit více v PubMed

ClinicalTrials.gov
NCT03992417