Dupilumab and Pregnancy Outcomes A Retrospective Cohort Study Using Administrative Healthcare Databases

What this Trial Is About

This research aims to describe and compare the occurrence of adverse pregnancy outcomes, such as miscarriage and stillbirth, and the prevalence of adverse infant outcomes, including major birth defects and small size for gestational age, in women with atopic dermatitis. The study focuses on women treated with dupilumab during pregnancy compared to those with atopic dermatitis who are not treated with dupilumab. It is an observational retrospective cohort study using healthcare databases to gather information. The study groups include women exposed to dupilumab during the first trimester and pregnancy, those exposed to other systemic medications or phototherapy during the same periods, and a group not exposed to systemic medications or phototherapy but who received topical prescription therapy or had multiple diagnoses for atopic dermatitis. No study drug is administered as part of this study since it is based on retrospective data analysis from medical and prescription claims and medical records. Participants' medical and pharmacy benefit coverage will be reviewed for at least six months before and through pregnancy. Researchers will assess outcomes such as major congenital malformations up to 21 months after birth, and spontaneous abortion, miscarriage, stillbirth, and small for gestational age incidence up to nine months or 21 months as applicable. The study will use existing healthcare data without additional interventions, focusing on long-term pregnancy and infant outcomes in women with atopic dermatitis treated or not treated with dupilumab.

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