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
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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 post-hoc analysis assessed the change from baseline to week 16 in caregiver-reported outcome measures of AD symptoms (e.g., 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 pre-specified 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.
背景：中度至重度特应性皮炎（AD中度至重度特应性皮炎（AD）对儿童/照护者的影响很大：评估使用杜度单抗治疗对护理者和患者报告的幼儿特应性皮炎症状和生活质量（QoL）的影响：在LIBERTY AD PRESCHOOL（随机、安慰剂对照）研究中，6个月至5岁的中重度AD患儿接受了为期16周的dupilumab或安慰剂加低效局部皮质类固醇治疗。这项事后分析评估了从基线到第16周期间，由护理人员报告的AD症状（如瘙痒和睡眠）和患者及其护理人员/家属的QoL结果的变化：结果：杜匹单抗（83例）与安慰剂（79例）相比，能显著改善护理人员报告的AD症状和QoL。早在第 4 周就出现了明显改善，并一直持续到研究结束。此外，dupilumab与安慰剂相比，能迅速显著地改善患者照顾者/家属的QoL指标：局限性：少数患者年龄偏大杜匹单抗可改善AD患者及其照顾者/家属的症状和QoL。
期刊介绍：
The Journal of the American Academy of Dermatology (JAAD) is the official scientific publication of the American Academy of Dermatology (AAD). Its primary goal is to cater to the educational requirements of the dermatology community. Being the top journal in the field, JAAD publishes original articles that have undergone peer review. These articles primarily focus on clinical, investigative, and population-based studies related to dermatology. Another key area of emphasis is research on healthcare delivery and quality of care. JAAD also highlights high-quality, cost-effective, and innovative treatments within the field. In addition to this, the journal covers new diagnostic techniques and various other topics relevant to the prevention, diagnosis, and treatment of skin, hair, and nail disorders.
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