Paller Amy S, Marcoux Danielle, Ramien Michele, Baselga Eulalia, Carvalho Vania Oliveira, Ardusso Ledit R F, de Graaf Marlies, Pasmans Suzanne, Toledo-Bahena Mirna, Rubin Cory, Joyce Joel C, Lee Lara Wine, Gupta Rajan, Adams Bryan, Ardeleanu Marius, Zhang Annie
Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Ann and Robert H. Lurie Children's Hospital, Chicago, IL, USA.
Am J Clin Dermatol. 2025 Sep 19. doi: 10.1007/s40257-025-00962-8.
Atopic dermatitis (AD), a chronic systemic disease, can cause intense skin itching and negatively impact sleep, mood, and quality of life (QoL) for patients and families.
PEDISTAD is an ongoing, 10-year, observational registry describing disease characteristics, atopic comorbidities, and treatment patterns in pediatric patients (aged <12 years at enrollment) with moderate-to-severe AD. This 3-year interim analysis evaluates clinician-reported and caregiver-reported/patient-reported outcomes (Eczema Area and Severity Index [EASI], percent body surface area affected, worst itching/scratching, Children's Dermatology Life Quality Index, and Dermatitis Family Impact) in children treated with dupilumab, methotrexate, and/or cyclosporine. Outcomes were assessed as change from therapy start to last observation (either data cutoff date or treatment discontinuation).
Mean (±SE) EASI scores at the time of the last 3-year interim observation were consistent with mild disease in the dupilumab cohort and moderate disease in the methotrexate and cyclosporine cohorts. Improvements in pruritus were numerically greater in the dupilumab cohort relative to the methotrexate and cyclosporine cohorts, while improvements in QoL were similar in the dupilumab and methotrexate cohorts, with no significant change in the cyclosporine cohort. Rates of AD exacerbation were numerically lower with dupilumab treatment relative to methotrexate treatment which were numerically lower than cyclosporine treatment. Dupilumab discontinuation rates were numerically lower relative to methotrexate which were numerically lower than cyclosporine.
This PEDISTAD 3-year interim analysis of dupilumab, methotrexate, and cyclosporine treatment in children with AD demonstrates numerically greater improvements in AD signs, symptoms and QoL with dupilumab treatment relative to methotrexate and cyclosporine [Video abstract and graphical abstract available].
NCT03687359. Supplementary file1 (MP4 58163 KB).
特应性皮炎（AD）是一种慢性全身性疾病，可导致剧烈的皮肤瘙痒，并对患者及其家人的睡眠、情绪和生活质量（QoL）产生负面影响。
PEDISTAD是一项正在进行的为期10年的观察性登记研究，描述中度至重度AD的儿科患者（入组时年龄<12岁）的疾病特征、特应性合并症和治疗模式。这项为期3年的中期分析评估了使用度普利尤单抗、甲氨蝶呤和/或环孢素治疗的儿童中临床医生报告的以及照顾者报告/患者报告的结局（湿疹面积和严重程度指数 [EASI]、受影响的体表面积百分比、最严重的瘙痒/抓挠、儿童皮肤病生活质量指数和皮炎家庭影响）。结局评估为从治疗开始到最后一次观察（数据截止日期或治疗中断）的变化。
在最后一次为期3年的中期观察时，度普利尤单抗队列的平均（±SE）EASI评分与轻度疾病一致，甲氨蝶呤和环孢素队列的平均（±SE）EASI评分与中度疾病一致。相对于甲氨蝶呤和环孢素队列，度普利尤单抗队列的瘙痒改善在数值上更大，而度普利尤单抗和甲氨蝶呤队列的生活质量改善相似，环孢素队列无显著变化。与甲氨蝶呤治疗相比，度普利尤单抗治疗的AD加重率在数值上更低，而甲氨蝶呤治疗的AD加重率在数值上低于环孢素治疗。度普利尤单抗的停药率在数值上低于甲氨蝶呤，而甲氨蝶呤的停药率在数值上低于环孢素。
这项PEDISTAD对AD儿童使用度普利尤单抗、甲氨蝶呤和环孢素治疗的3年中期分析表明，相对于甲氨蝶呤和环孢素，度普利尤单抗治疗在AD体征、症状和生活质量方面的改善在数值上更大[可获取视频摘要和图形摘要]。
NCT03687359。补充文件1（MP4，58163 KB）。
