Real-world treatment outcomes of systemic treatments for moderate-to-severe atopic dermatitis in children aged less than 12 years: 2-year results from PEDIatric STudy in Atopic Dermatitis - 30/10/24

Doi : 10.1016/j.jaad.2024.09.046

Amy S. Paller, MD ^a, Marjolein de Bruin-Weller, MD ^b, Danielle Marcoux, MD ^c, Eulalia Baselga, MD ^d, Vania Oliveira de Carvalho, MD ^e, Ledit R.F. Ardusso, MD ^f, Suzanne G.M.A. Pasmans, MD ^g, Mirna Toledo-Bahena, MD, MSc ^h, Cory Rubin, MD ⁱ, Joel C. Joyce, MD ^j, Lara Wine Lee, MD, PhD ^k, Bryan Adams, PhD ^l, Rajan Gupta, PhD ^l, Marius Ardeleanu, MD ^m, Annie Zhang, MD ^n,^⁎
^a Departments of Dermatology and Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, Illinois
^b National Expertise Center for Atopic Dermatitis, Department of Dermatology and Allergology, University Medical Center Utrecht, Utrecht, The Netherlands
^c Division of Dermatology, Department of Pediatrics, University of Montreal and CHU Sainte-Justine University Hospital Center, Montreal, Quebec, Canada
^d Department of Dermatology, Hospital Sant Joan de Deu, Barcelona, Spain
^e Division of Pediatric Dermatology, Department of Pediatrics, Federal University of Paraná, Curitiba, Brazil
^f Pulmonology, Allergy and Immunology Department, School of Medicine, National University of Rosario, Rosario, Argentina
^g Center of Pediatric Dermatology, Department of Dermatology, Sophia Children's Hospital, Erasmus MC University Medical Center, Rotterdam, The Netherlands
^h Dermatology Department, Children's Hospital of Mexico Federico Gómez, Mexico City, Mexico
ⁱ Michigan Dermatology Institute, Waterford, Michigan
^j Division of Dermatology, Department of Medicine, NorthShore University Health System, Skokie, Illinois
^k Department of Dermatology and Pediatrics, Medical University of South Carolina, Charleston, South Carolina
^l Department of Biostatistics, Sanofi, Cambridge, Massachusetts
^m Department of Medical Affairs, Regeneron Pharmaceuticals Inc, Tarrytown, New York
ⁿ Department of Medical Affairs, Sanofi, Cambridge, Massachusetts

^∗Correspondence to: Annie Zhang, MD, Department of Medical Affairs, Immunology & Dermatology, 450 Water St, Cambridge, MA 02142.450 Water StCambridgeMA02142

En prensa. Pruebas corregidas por el autor. Disponible en línea desde el Wednesday 30 October 2024

Abstract

Background

The arrival of biologics and small-molecule therapies (eg Janus kinase inhibitors) changed atopic dermatitis treatment, but older systemic treatments continue to be prescribed.

Objective

To provide real-world effectiveness, safety, and adherence data for dupilumab, cyclosporine, and methotrexate.

Methods

PEDIatric STudy in Atopic Dermatitis (NCT03687359) is a real-world, prospective, observational, 10-year study of children (<12 years) with inadequately controlled moderate-to-severe atopic dermatitis. We report 2-year interim results.

Results

Median treatment durations were 8.1, 13.0, and 10.7 months for dupilumab (n = 144), methotrexate (n = 114), and cyclosporine (n = 121), respectively. Dupilumab had numerically greater within-group improvements than methotrexate and cyclosporine in Eczema Area and Severity Index (−12.4∗ vs −5.7∗ and −3.3); body surface area affected (−19.9%∗ vs −11.8%∗ and −8.8%∗); itching (night-time: −2.1∗ vs −0.4 and + 0.1; daytime: −1.5∗ vs +0.1 and + 0.2; ≥6 years); itching/scratching (−3.6∗ vs −1.4∗ and −0.2; <6 years); and Patient-Oriented Eczema Measure (−7.0∗ vs −4.7∗ and −1.5) (∗P < .05 within-group improvements from baseline). Dupilumab had less discontinuations (8.3% vs 28.9% and 43.0%) and adverse event(s) (18.1% vs 29.8% and 31.4%).

Limitations

No randomization, placebo, or specified dosages.

Conclusion

Dupilumab was associated with numerically greater outcomes and higher adherence than cyclosporine or methotrexate.

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Key words : atopic dermatitis, cyclosporine, dupilumab, methotrexate, moderate-to-severe, pediatric, real-world, systemic

Abbreviations used : AD, AE, BSA, CDLQI, DFI, EASI, IDQOL, MedDRA, PEDISTAD, POEM, PT, RCT, TEAE

Esquema

Baseline characteristics

Treatment durations and doses

Outcomes

Treatment persistence

Safety

Discussion

	Funding sources: This study was sponsored by Sanofi and Regeneron Pharmaceuticals Inc.
	Patient consent: Not applicable.
	IRB approval status: This study is being conducted in accordance with the principles established by the 18th World Medical Assembly and all subsequent amendments and in accordance with the guidelines for Good Epidemiology Practice. Each participating country has ensured that all the necessary local regulations are met. Ethics approval from an Institutional Review Board/Institutional Ethics Committee has been obtained in all countries currently participating in PEDIatric STudy in Atopic Dermatitis (PEDISTAD).