Vyepti Pregnancy Registry: A prospective, comparative cohort study of maternal, fetal and infant safety in pregnant women exposed to eptinezumab 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:
  Primary data collection

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 or other 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)
  • Adolescents (12 to < 18 years)
  • 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:
  844

Study design details

• Study design:
  National, prospective cohort study in pregnant women with migraine exposed to eptinezumab or non-CGRP targeting preventive migraine medications, during pregnancy or up to 5 drug half-lives prior to the estimated conception date.
• Main study objective:
  To estimate and compare the frequency (prevalence) of major congenital malformations (MCM) in women with migraine exposed to eptinezumab during pregnancy; and women with migraine exposed to non-CGRP targeting preventive migraine medications during pregnancy
• Setting:
  The study will include migraine patients exposed to eptinezumab or non-CGRP targeting preventive migraine medications during pregnancy. The study will include prospectively and retrospectively reported pregnancies. The main analysis will be conducted based on prospectively reported pregnancies.
• Comparators:
  Non-CGRP targeting preventive migraine medications
• Outcomes:
  Primary outcome: major congenital malformations (MCM); Secondary outcomes: adverse pregnancy outcomes (e.g., spontaneous abortions, stillbirths); pregnancy complications; adverse fetal/neonatal/infant outcomes (e.g., during postnatal growth and development);
• Data analysis plan:
  The ratio of the MCM prevalences will be used to estimate the relative risk of MCM. In addition to the estimation of unadjusted relative risks with corresponding 95% CIs, propensity score based methods are planned to conduct adjusted analyses.