The Mepolizumab Pregnancy Exposure Study: a VAMPSS post marketing surveillance study of Mepolizumab safety in pregnancy (200870 NPSS (Nucala Pregnancy Surveillance Study))

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

• Study drug International non-proprietary name (INN) or common name:
  MEPOLIZUMAB
• Medical condition to be studied:
  Pregnancy

Population studied

• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  800

Study design details

• Main study objective:
  The objectives of the study are to assess mepolizumab exposure in pregnancy with respect to major birth defects, spontaneous abortion, stillbirth, preterm delivery, and small for gestational age infants.
• Outcomes:
  The primary analysis will be a comparison of the prevalence rate of major structural defects in live born infants between the mepolizumab-exposed cohort and the treated disease cohort. Multivariable analyses will be conducted as numbers permit. The secondary analyses will be comparisons of the prevalence rates of the following outcomes, small for gestational age, preterm delivery, spontaneous abortion and stillbirth between the mepolizumab-exposed cohort and the treated disease cohort. Multivariable analyses will be conducted as numbers permit.
• Data analysis plan:
  For the primary endpoint of major structural defects and for the secondary endpoint of small for gestational age infants, crude comparisons will be made using exact methods to develop relative risk estimates and their 95% confidence intervals. For the secondary endpoints of preterm delivery, spontaneous abortion, and stillbirth, survival methods will be used (Kaplan Meier) to estimate crude rates and confidence intervals accounting for gestational timing of enrollment in the study. Adjusted analyses producing rates and 95% confidence intervals, where numbers permit, will be conducted for major birth defects and small for gestational age infants using logistic regression. Adjusted analyses producing rates and 95% confidence intervals, for preterm delivery, spontaneous abortion and stillbirth, if numbers permit, will be conducted using Cox Proportional Hazards.