Pregnancy, fetal and infant outcomes of pregnancies exposed to eptinezumab compared to two migraine control cohorts unexposed to eptinezumab: a claims database study in the United States

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  VYEPTI
• Study drug International non-proprietary name (INN) or common name:
  EPTINEZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (N02CD05) eptinezumab

  eptinezumab
• Medical condition to be studied:
  Migraine

  Pregnancy

Population studied

• Short description of the study population:
  Pregnant patients with migraine, exposed to eptinezumab, other preventive migraine medications, or without exposure to preventive migraine medications
• Age groups:
  • In utero
  • Neonate

    • Preterm newborn infants (0 – 27 days)
    • Term newborn infants (0 – 27 days)
  • Infants and toddlers (28 days – 23 months)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 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:
  4004

Study design details

• Study design:
  Pregnant women with migraine and their newborns are identified in healthcare databases. Study cohorts will be followed up throughout the pregnancy. Linked infants will be followed up for 12 months after birth.
• Main study objective:
  To assess pregnancy, fetal and infant outcomes of women with migraine exposed to eptinezumab during pregnancy compared to two unexposed control populations
• Setting:
  The study population will consist of pregnant women with migraine and their newborns in the US. The study will include women with pregnancy exposure to (1) eptinezumab; (2) other, non-CGRP-targeting, preventive migraine medications; or (3) without preventive migraine treatment.
• Comparators:
  Non-CGRP targeting preventive migraine medications
• Outcomes:
  Primary outcome: major congenital malformations. Secondary outcomes: pregnancy outcomes (spontaneous abortion; elective abortions; stillbirth; live birth); pre-eclampsia; eclampsia; infant outcomes (small-for-gestational-age, low birth weight, developmental delays during infancy, growth delays during infancy)
• Data analysis plan:
  Frequencies (prevalences) of outcomes will be presented as counts and percentages with 95% confidence intervals. When feasible, comparative analyses will be conducted based on the ratios of prevalences. Potential confounding will be controlled for by using propensity score based methods.