An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)

Regeneron Pharmaceuticals

Status: Enrolling

Conditions: Atopic Dermatitis; Adverse Pregnancy Outcomes

Treatments: Drug: dupilumab

Study type: Observational

Funder types: Industry

Identifiers

NCT03936335

R668-AD-1760

43838 (Registry Identifier)

Details and patient eligibility

About

The objective of this study is to describe and compare the incidence of adverse pregnancy outcomes (spontaneous abortion/miscarriage, stillbirth) and prevalence of adverse infant outcomes (major congenital malformations [MCMs], small for gestational age [SGA]) in women with AD who are treated with dupilumab during pregnancy relative to women with AD who are not treated with dupilumab during pregnancy.

Enrollment: 3,930 estimated patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Continuous medical and pharmacy benefit coverage for at minimum 6 months prior to and including the estimated LMP
• Diagnosis code indicative of AD in the period from up to 1 year prior to the estimated LMP through the end of the pregnancy

Note: Other Protocol Defined Inclusion / Exclusion Criteria Apply

Trial design

3,930 participants in 3 patient groups

Dupilumab cohort

Description:

Exposed to dupilumab during the relevant exposure window: * First trimester * Pregnancy

Treatment:

Drug: dupilumab

Other systemic therapy or phototherapy cohort

Description:

Exposed to systemic medications other than dupilumab or to phototherapy during the relevant exposure window: * First trimester * Pregnancy

Unexposed cohort

Description:

* Not exposed to systemic medications (including dupilumab) or phototherapy; and * Received topical prescription therapy, or a second diagnosis for AD on a date that differs from the base population qualifying AD diagnosis date during the relevant exposure window: * First trimester * Pregnancy