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

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Dermatitis atopic
• Additional medical condition(s):
  Adverse Pregnancy Outcomes

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  3930

Study design details

• Main study objective:
  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.
• Outcomes:
  • Incidence of major congenital malformations, • Incidence of spontaneous abortion or miscarriage • Incidence of stillbirth • Incidence of small for gestational age
• Data analysis plan:
  The analysis aims to characterize and quantify the occurrence of pregnancy outcomes. Descriptive statistics will be reported for the dupilumab exposed group and 1:2 matched comparator groups. Adjusted risk ratios will be estimated for dupilumab exposure groups compared to unexposed groups for the study outcomes.