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Protocol for a prospective, observational, longitudinal study in paediatric patients with moderate-to-severe atopic
Amy S Paller1, Emma Guttman-Yassky2, Alan D Irvine3,4
1Department of Dermatology, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA APaller@nm.org.
Insights
This observational study tracks children with moderate-to-severe atopic dermatitis (AD) over five years to understand disease progression and treatment patterns. The Pediatric Study in Atopic Dermatitis (PEDISTAD) aims to fill gaps in long-term data for pediatric AD management.
Area of Science:
- Dermatology
- Pediatrics
- Epidemiology
Background:
- Atopic dermatitis (AD) is a chronic inflammatory skin condition impacting children and families.
- Limited longitudinal data exists on moderate-to-severe pediatric AD, affecting treatment strategies.
- Understanding disease characteristics and clinical practice in pediatric AD is crucial.
Purpose of the Study:
- To evaluate AD characteristics and progression in pediatric patients with moderate-to-severe AD.
- To gather long-term data on disease course and treatment in children with AD.
- To inform clinical practice and future research in pediatric atopic dermatitis.
Main Methods:
- Prospective, observational, longitudinal study (PEDISTAD).
- Enrollment of 1300 children across 100-150 sites globally, followed for 5 years.
- Data collection includes disease characteristics, comorbidities, therapies, patient-reported outcomes, and safety biomarkers.
Main Results:
- Pre-results data available; study ongoing.
- Data collection focuses on disease progression and treatment patterns.
- Analysis will provide insights into real-world management of pediatric AD.
Conclusions:
- The PEDISTAD study will provide essential long-term data on moderate-to-severe pediatric atopic dermatitis.
- Findings will enhance understanding of disease trajectory and treatment effectiveness.
- This research aims to improve clinical care for children with AD.
Introduction:
Atopic dermatitis (AD) is a chronic inflammatory skin disease often associated with atopic comorbidities and has significant impact on children and their families. There is a lack of robust and longitudinal long-term data on disease characteristics and typical clinical practice with currently available treatments in children with moderate-to-severe AD. Hence, an observational study is needed to evaluate AD characteristics and progression in paediatric patients with moderate-to-severe AD.
Methods And Analysis:
Pediatric Study in Atopic Dermatitis (PEDISTAD) is a prospective, observational, longitudinal study in paediatric patients with moderate-to-severe AD who are currently receiving systemic or topical treatment and whose disease is not adequately controlled by topical prescription therapies or for whom those therapies are not medically advisable. 1300 children at 100-150 sites in approximately 20 countries worldwide will be enrolled and followed for 5 years. AD therapy is at the discretion of the investigator. Data collected will include: AD disease characteristics and comorbidities; current therapy for AD and initiation of new treatments/changes in current treatment; patient-reported/caregiver-reported outcomes; days missed from school/work for the patient/caregiver; healthcare professional visits; safety and biomarkers.
Ethics And Dissemination:
This study is conducted in accordance with the principles established by the 18th World Medical Assembly and all subsequent amendments and the guidelines for Good Epidemiology Practice. Each individual country assures that ethics approval has been received and local regulatory requirements are met. Ethics approval has been obtained in all countries currently participating in PEDISTAD. Study data will be disseminated in manuscripts submitted to peer-reviewed medical journals as well as in abstracts submitted to congresses and in the resulting posters and presentations.
Trial Registration Number:
NCT03687359; pre-results.
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