An Observational Case Series to Describe Women Exposed to Repatha During Pregnancy and Infant Outcomes During the First Year of Life (20200408)

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:
  Other
• Non-interventional study design, other:
  Case-series

Study drug and medical condition

• Name of medicine:
  REPATHA
• Study drug International non-proprietary name (INN) or common name:
  EVOLOCUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (C10AX13) evolocumab

  evolocumab

Population studied

• Short description of the study population:
  The study population includes women worldwide exposed to Repatha during pregnancy that consented for pregnancy and infant follow-up.
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  40

Study design details

• Main study objective:
  Among women exposed to Repatha during pregnancy, the main objective of this study is to estimate the proportion of: pregnancy and maternal complications, adverse events in the developing fetus and neonate, and among their infants, adverse events for the first year of life.
• Outcomes:
  Pregnancy Outcomes: Number of cases reporting live full-term births, spontaneous abortion, elective abortion, stillbirth, and premature delivery. ; Infant Outcomes: Number of cases reporting adverse events including complications, medical problems or congenital anomalies at birth. Number of cases reporting adverse events at 6 and 12 months.
• Data analysis plan:
  All analyses will be descriptive. Collection of exposure and outcome information in this group provides additional evidence on the safety of Repatha use during pregnancy. The denominator is the number of pregnant women exposed to Repatha during pregnancy and the numerator is the number with the outcome. To assess events in the developing fetus and neonate in women exposed to Repatha during pregnancy, the proportion of pregnancies resulting in spontaneous abortions, elective abortions, fetal death/ stillbirths and premature delivery will be presented, along with corresponding 95% confidence. The proportion of infants with adverse events at 6 and 12 months of age including complications, medical problems or congenital anomalies at birth will be assessed in infants of women exposed to Repatha during pregnancy with corresponding 95% confidence intervals.