Systemic Treatments in Moderate-to-Severe Atopic Dermatitis in Pediatric Patients up to 12 Years of Age: Real-World Treatment Outcomes from the PEDISTAD Registry.

IF 8.8 1区 医学 Q1 DERMATOLOGY
Amy S Paller, Danielle Marcoux, Michele Ramien, Eulalia Baselga, Vania Oliveira Carvalho, Ledit R F Ardusso, Marlies de Graaf, Suzanne Pasmans, Mirna Toledo-Bahena, Cory Rubin, Joel C Joyce, Lara Wine Lee, Rajan Gupta, Bryan Adams, Marius Ardeleanu, Annie Zhang
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Abstract

Background: 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.

Methods: 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).

Results: 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.

Conclusions: 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].

Clinical trial registration: NCT03687359. Supplementary file1 (MP4 58163 KB).

12岁以下儿童患者中重度特应性皮炎的全身治疗:来自PEDISTAD注册的真实世界治疗结果
背景:特应性皮炎(AD)是一种慢性全身性疾病,可引起强烈的皮肤瘙痒,并对患者和家属的睡眠、情绪和生活质量(QoL)产生负面影响。方法:PEDISTAD是一项持续10年的观察性注册研究,描述了儿童患者的疾病特征、特应性合并症和治疗模式(老年)。结果:在最近3年的中期观察中,EASI评分的平均值(±SE)与杜比单抗组的轻度疾病和甲氨蝶呤和环孢素组的中度疾病一致。与甲氨蝶呤和环孢素组相比,杜匹单抗组瘙痒症状的改善在数值上更大,而杜匹单抗组和环孢素组生活质量的改善相似,环孢素组无显著变化。与甲氨蝶呤治疗相比,dupilumab治疗的AD加重率在数值上较低,而甲氨蝶呤治疗的数值低于环孢素治疗。杜匹单抗停药率在数值上低于甲氨蝶呤,甲氨蝶呤在数值上低于环孢素。结论:PEDISTAD对dupilumab、甲氨蝶呤和环孢素治疗AD儿童的3年中期分析显示,与甲氨蝶呤和环孢素相比,dupilumab治疗在AD体征、症状和生活质量方面有更大的改善。临床试验注册:NCT03687359。补充文件1 (MP4 58163kb)。
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来源期刊
CiteScore
15.20
自引率
2.70%
发文量
84
审稿时长
>12 weeks
期刊介绍: The American Journal of Clinical Dermatology is dedicated to evidence-based therapy and effective patient management in dermatology. It publishes critical review articles and clinically focused original research covering comprehensive aspects of dermatological conditions. The journal enhances visibility and educational value through features like Key Points summaries, plain language summaries, and various digital elements, ensuring accessibility and depth for a diverse readership.
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