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
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. |
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Patient consent: Written informed consent was obtained from participants' parent(s) or legal guardian(s). |
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IRB approval status: Approved. |
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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/. |
Vol 92 - N° 1
P. 116-126 - janvier 2025 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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