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.
Study Type
OBSERVATIONAL
Enrollment
3,930
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.
Regeneron Research Site
Boston, Massachusetts, United States
RECRUITINGPrevalence of MCMs
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
Time frame: Up to 21 months
Incidence of spontaneous abortion or miscarriage
Identified through the presence of corresponding codes on the insurance claims for pregnancy outcomes: 01April 2017 through 31 March 2024
Time frame: Up to 9 months
Incidence of stillbirth
Identified through the presence of corresponding codes on the insurance claims for pregnancy outcomes: 01April 2017 through 31 March 2024
Time frame: Up to 9 months
Incidence of SGA
Identified through the presence of corresponding codes on the insurance claims for infant outcomes: 01 April 2017 through December 2024
Time frame: Up to 21 months
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