A registry-based non-interventional post-authorization safety study to evaluate the long-term safety of dupilumab in children aged ≥6 months to <6 years with moderate-to-severe atopic dermatitis using the PEDISTAD registry: a cohort design

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000149
• EU PAS number:
  EUPAS1000000149
• Study ID:
  1000000149
• Official title and acronym:
  A registry-based non-interventional post-authorization safety study to evaluate the long-term safety of dupilumab in children aged ≥6 months to <6 years with moderate-to-severe atopic dermatitis using the PEDISTAD registry: a cohort design
• DARWIN EU® study:
  No
• Study countries:
  Argentina

  Australia

  Belgium

  Brazil

  Canada

  China

  Colombia

  Denmark

  France

  Greece

  Israel

  Italy

  Japan

  Korea, Republic of

  Mexico

  Netherlands

  Norway

  Portugal

  Russian Federation

  Spain

  United States
• Study description:
  This registry-based PASS aims to evaluate the long-term safety of dupilumab in children who initiate dupilumab at age ≥6 months to <6years old, using data from the PEDISTAD disease registry of pediatric patients with moderate-to-severe atopic dermatitis (AD). ; It is expected that most pediatric patients will have prior exposure to other therapies for AD before initiation of dupilumab or may have overlapping usage with other AD therapies at dupilumab initiation. ; For this reason, the cohort of dupilumab initiators will be referred to as the DUPI-All cohort, to communicate that the safety profile of dupilumab initiators may be confounded by prior therapies. ; A sub-cohort of dupilumab initiators, restricted to those who only have prior use of systemic corticosteroids or high potency topical corticosteroids will be referred to as the DUPI-Steroid cohort. ; The rationale is to have a sub-cohort of dupilumab initiators that is less confounded by use of prior non-steroid immunosuppressant therapies. A sub-cohort of dupilumab initiators that is naïve to all other AD therapies listed in this protocol will also be created, referred to as the Pure-DUPI cohort. ; This sub-cohort will reflect the least confounded cohort. The numbers included will depend on real-world drug utilization patterns. To provide context for the long-term safety of dupilumab, safety data will also be described for a cohort of children enrolled in the PEDISTAD disease registry who initiate systemic corticosteroids, UV therapy, immunosuppressants (cyclosporine, methotrexate, mycophenolate and azathioprine), JAK inhibitors (abrocitinib, upadacitinib, tofacitinib, baricitinib), other systemic biologic treatments for moderate-to-severe AD (e.g., tralokinumab) or high potency TCS at age ≥6 months to <6 years old (referred to throughout as the Other AD Therapies cohort).
• Study status:
  Ongoing

Research institutions and networks

Institutions

Sanofi Winthrop Industrie

IQVIA

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 15/12/2022

Actual: 15/12/2022

Study start date

Planned: 30/09/2024

Actual: 25/04/2024

Data analysis start date

Planned: 30/09/2024

Actual: 20/08/2024

Date of final study report

Planned: 30/09/2032

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sanofi Winthrop Industrie

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)