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The effect of dupilumab on caregiver- and patient-reported outcomes in young children with moderate-to-severe atopic dermatitis: Results from a placebo-controlled, phase 3 study - 18/12/24

Doi : 10.1016/j.jaad.2024.09.039 
Amy S. Paller, MD a, b, , Jonathan I. Silverberg, MD, PhD c, Eric L. Simpson, MD d, Michael J. Cork, MB, PhD e, f, Peter D. Arkwright, MD, PhD g, Zhen Chen, PhD h, Ashish Bansal, MD, MBA h, Randy Prescilla, MD i, Zhixiao Wang, PhD h, Ainara R. Marco, MD j
a Department of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, Illinois 
b Division of Dermatology, Ann & Robert H. Lurie Children's Hospital, Chicago, Illinois 
c Department of Dermatology, The George Washington University School of Medicine and Health Sciences, Washington, District of Columbia 
d Department of Dermatology, Oregon Health & Science University, Portland, Oregon 
e Sheffield Children's Hospital, Sheffield, UK 
f Department of Infection, Immunity and Cardiovascular Disease, Sheffield Dermatology Research, University of Sheffield, Sheffield, UK 
g Lydia Becker Institute of Immunology & Inflammation, University of Manchester, Manchester, UK 
h Regeneron Pharmaceuticals Inc., Tarrytown, New York 
i Sanofi, Cambridge, Massachusetts 
j Sanofi, Madrid, Spain 

Correspondence to: Amy S. Paller, MD, Department of Dermatology, Northwestern University Feinberg School of Medicine, 676 N. St. Clair, Suite 1600, Chicago, IL 60611.Department of DermatologyNorthwestern University Feinberg School of Medicine676 N. St. ClairSuite 1600ChicagoIL60611

Abstract

Background

Moderate-to-severe atopic dermatitis (AD) greatly impacts children/caregivers.

Objective

Evaluate the impact of treatment with dupilumab on caregiver- and patient-reported AD symptoms and quality of life (QoL) in young children.

Methods

In the LIBERTY AD PRESCHOOL (randomized, placebo-controlled) study, children aged 6 months to 5 years with moderate-to-severe AD received dupilumab or placebo plus low-potency topical corticosteroids for 16 weeks. This posthoc analysis assessed the change from baseline to week 16 in caregiver-reported outcome measures of AD symptoms (eg, itch and sleep) and QoL of patients and their caregivers/families.

Results

Dupilumab (n = 83) vs placebo (n = 79) provided significant improvements in caregiver-reported AD symptoms and QoL. Significant improvements were seen as early as week 4 and sustained through the end of the study. Additionally, dupilumab vs placebo provided rapid and significant improvement in QoL measures for the patients' caregivers/families.

Limitations

Few patients aged <2 years; significance only reported for prespecified endpoints; Infant's Dermatitis QoL Index severity strata adopted from Children's Dermatology Life Quality Index.

Conclusion

Dupilumab improved AD symptoms and QoL in patients and their caregivers/families.

Le texte complet de cet article est disponible en PDF.

Key words : atopic dermatitis, burden of disease, caregivers, children, dupilumab, itch, quality of life, sleep

Abbreviations used : AD, CDLQI, CI, DFI, EASI, IDQoL, IGA, LS, NRS, POEM, q4w, QoL, SD, TCS, WOCF, WSI-NRS


Plan


 Funding sources: This research was sponsored by Sanofi and Regeneron Pharmaceuticals Inc. The journal's rapid service fees were funded by Sanofi and Regeneron Pharmaceuticals Inc.
 Patient consent: Written informed consent was obtained from participants' parent(s) or legal guardian(s).
 IRB approval status: Approved.
 Data sharing statement: Qualified researchers may request access to study documents (including the clinical study report, study protocol with any amendments, blank case report form, and statistical analysis plan) that support the methods and findings reported in this manuscript. Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification. Submit requests to vivli.org/.


© 2024  American Academy of Dermatology, Inc.. Publié par Elsevier Masson SAS. Tous droits réservés.
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Vol 92 - N° 1

P. 116-126 - janvier 2025 Retour au numéro
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