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

Study Overview
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Brief Summary
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The objective of this study is to describe and compare the incidence of adverse pregnancy outcomes (spontaneous abortion/miscarriage, stillbirth) and prevalence of 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.

Official Title
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Dupilumab and Pregnancy Outcomes: A Retrospective Cohort Study Using Administrative Healthcare Databases (Dupi PODS)

Conditions
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Adverse Pregnancy Outcomes, Atopic Dermatitis

Intervention / Treatment
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* Drug: dupilumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dupilumab cohort<br>Exposed to dupilumab during the relevant exposure window: First trimester Pregnancy | Drug: dupilumab<br>* 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.<br>* Other names: SAR23189;|
| Other systemic therapy or phototherapy cohort<br>Exposed to systemic medications other than dupilumab or to phototherapy during the relevant exposure window: First trimester Pregnancy | |
| Unexposed cohort<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of major congenital malformations | Initially identified through the presence of corresponding codes on the insurance claims, confirmed through medical record review for infant outcomes: 01 April 2017 through 31 July 2023 | Up to 21 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Up to 9 months | 
| Incidence of small for gestational age | Identified through the presence of corresponding codes on the insurance claims for infant outcomes: 01 April 2017 through 31 July 2023 | Up to 21 months |