Dupilumab and Pregnancy Outcomes: A Retrospective Cohort Study Using Administrative Healthcare Databases (Dupi PODS)
Regeneron Pharmaceuticals
Summary
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.
Eligibility
- Age range
- 18–49 years
- Sex
- Female
- Healthy volunteers
- No
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
Interventions
- Drugdupilumab
No study drug will be administered. This study is based on an analysis of automated medical and prescription claims, supplemented by information abstracted from the medical record.
Location
- Regeneron Research SiteBoston, Massachusetts