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

Amy S. Paller; Jonathan I. Silverberg; Eric L. Simpson; Michael J. Cork; Peter D. Arkwright; Zhen Chen; Ashish Bansal; Randy Prescilla; Zhixiao Wang; Ainara R. Marco

doi:10.1016/j.jaad.2024.09.039

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

Amy S. Paller^*, Jonathan I. Silverberg, Eric L. Simpson, Michael J. Cork, Peter D. Arkwright, Zhen Chen, Ashish Bansal, Randy Prescilla, Zhixiao Wang, Ainara R. Marco

^*Corresponding author for this work

Dermatology

Research output: Contribution to journal › Article › peer-review

1 Scopus citations

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.

Original language	English (US)
Pages (from-to)	116-126
Number of pages	11
Journal	Journal of the American Academy of Dermatology
Volume	92
Issue number	1
DOIs	https://doi.org/10.1016/j.jaad.2024.09.039
State	Published - Jan 2025

Funding

Medical writing and editorial assistance were provided by Liselotte van Delden of Excerpta Medica, funded by Sanofi and Regeneron Pharmaceuticals Inc , according to the Good Publication Practice guidelines. National Institute for Health and Care Research provided support to The Manchester Clinical Research Facility at Royal Manchester Children's Hospital. 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.Medical writing and editorial assistance were provided by Liselotte van Delden of Excerpta Medica, funded by Sanofi and Regeneron Pharmaceuticals Inc, according to the Good Publication Practice guidelines. The National Institute for Health and Care Research provided support to the Manchester Clinical Research Facility at Royal Manchester Children's Hospital.

Keywords

atopic dermatitis
burden of disease
caregivers
children
dupilumab
itch
quality of life
sleep

ASJC Scopus subject areas

Dermatology

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10.1016/j.jaad.2024.09.039

Cite this

Paller, A. S., Silverberg, J. I., Simpson, E. L., Cork, M. J., Arkwright, P. D., Chen, Z., Bansal, A., Prescilla, R., Wang, Z., & Marco, A. R. (2025). 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. Journal of the American Academy of Dermatology, 92(1), 116-126. https://doi.org/10.1016/j.jaad.2024.09.039

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title = "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",

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.",

keywords = "atopic dermatitis, burden of disease, caregivers, children, dupilumab, itch, quality of life, sleep",

author = "Paller, {Amy S.} and Silverberg, {Jonathan I.} and Simpson, {Eric L.} and Cork, {Michael J.} and Arkwright, {Peter D.} and Zhen Chen and Ashish Bansal and Randy Prescilla and Zhixiao Wang and Marco, {Ainara R.}",

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year = "2025",

month = jan,

doi = "10.1016/j.jaad.2024.09.039",

language = "English (US)",

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Paller, AS, Silverberg, JI, Simpson, EL, Cork, MJ, Arkwright, PD, Chen, Z, Bansal, A, Prescilla, R, Wang, Z & Marco, AR 2025, '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', Journal of the American Academy of Dermatology, vol. 92, no. 1, pp. 116-126. https://doi.org/10.1016/j.jaad.2024.09.039

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. / Paller, Amy S.; Silverberg, Jonathan I.; Simpson, Eric L. et al.
In: Journal of the American Academy of Dermatology, Vol. 92, No. 1, 01.2025, p. 116-126.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - The effect of dupilumab on caregiver- and patient-reported outcomes in young children with moderate-to-severe atopic dermatitis

T2 - Results from a placebo-controlled, phase 3 study

AU - Paller, Amy S.

AU - Silverberg, Jonathan I.

AU - Simpson, Eric L.

AU - Cork, Michael J.

AU - Arkwright, Peter D.

AU - Chen, Zhen

AU - Bansal, Ashish

AU - Prescilla, Randy

AU - Wang, Zhixiao

AU - Marco, Ainara R.

PY - 2025/1

Y1 - 2025/1

N2 - 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.

AB - 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.

KW - atopic dermatitis

KW - burden of disease

KW - caregivers

KW - children

KW - dupilumab

KW - itch

KW - quality of life

KW - sleep

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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

Abstract

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