Adverse Pregnancy Outcomes, Atopic Dermatitis
Conditions
Brief 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.
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.
Sponsors
Sanofi
Regeneron Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of MCMs | Up to 21 months | Initially identified through the presence of corresponding codes on the insurance claims, confirmed through medical record review for infant outcomes: 01 April 2017 through December 2024 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of spontaneous abortion or miscarriage | Up to 9 months | Identified through the presence of corresponding codes on the insurance claims for pregnancy outcomes: 01April 2017 through 31 March 2024 |
| Incidence of stillbirth | Up to 9 months | Identified through the presence of corresponding codes on the insurance claims for pregnancy outcomes: 01April 2017 through 31 March 2024 |
| Incidence of SGA | Up to 21 months | Identified through the presence of corresponding codes on the insurance claims for infant outcomes: 01 April 2017 through December 2024 |
Countries
United States
Contacts
Primary ContactClinical Trials Administrator
Outcome results
None listed