Post-Authorization Safety Study to Monitor Pregnancy and Infant Outcomes Following Administration of Dupilumab During Planned or Unexpected Pregnancy in North America

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

  Asthma

Population studied

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

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  500

Study design details

• Main study objective:
  The objective is to evaluate the potential effect of exposure to dupilumab in pregnancy compared to the primary comparison group of disease-matched pregnant women who are not exposed to dupilumab, and the secondary comparison group of healthy pregnant women.
• Outcomes:
  • Rate of major structural defects, • Incidence of spontaneous abortion or miscarriage and stillbirth • Incidence of elective termination/abortion • Incidence of premature delivery • Incidence of small for gestational age • Incidence of a pattern of 3 or more minor structural defects • Postnatal growth deficiency • Incidence of postnatal serious or opportunistic infections and hosptializations in live born children
• Data analysis plan:
  The analyses in this study aim to characterize and quantify outcomes of interest. Following descriptive analyses of the study groups, frequencies of outcomes by group and adjusted risk ratios will be calculated to compare dupilumab exposed groups to the non-exposed groups.