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Background <p>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.</p> Methods <p>PEDISTAD is an ongoing, 10-year, observational registry describing disease characteristics, atopic comorbidities, and treatment patterns in pediatric patients (aged &lt;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).</p> Results <p>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.</p> Conclusions <p>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].</p> Clinical Trial Registration <p>NCT03687359.</p> Graphical abstract <p></p> Video abstract <p><MediaObject ID="MOESM1"> <VideoObject FileRef="MediaObjects/40257_2025_962_MOESM1_ESM.mp4" VideoID="4iMF7SCrL7A95zKhLr7mU4"> <Caption Language="En" xml:lang="en"> <CaptionContent> <p>Supplementary file1 (MP4 58163 KB)</p> </CaptionContent> </Caption> </VideoObject> </MediaObject></p>

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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

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年9月19日

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  • 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

摘要

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.

Graphical abstract

Video abstract

Supplementary file1 (MP4 58163 KB)