Observational Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Erenumab-aooe During Pregnancy (20180172)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  AIMOVIG
• Study drug International non-proprietary name (INN) or common name:
  ERENUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (N02CD01) erenumab

  erenumab
• Medical condition to be studied:
  Migraine

Population studied

• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  1500

Study design details

• Main study objective:
  To estimate and compare the proportion of live-born infants with major congenital malformations among women with migraine directly exposed to erenumab-aooe prior to and during pregnancy, women with migraine exposed to other preventive migraine medications prior to or during pregnancy, and women with migraine not exposed to any preventive migraine medications prior to or during pregnancy.
• Outcomes:
  To estimate and compare the proportion of live-born infants with major congenital malformations. To estimate and compare the proportion of pregnancies ending in spontaneous abortions, and, separately, stillbirths. To estimate and compare the proportion of live-born infants who are small-for gestational age. To describe baseline characteristics and medication treatment patterns during pregnancy.
• Data analysis plan:
  Discrete variables will be summarized using frequencies and proportions, and continuous variables will be summarized using means and standard deviation or medians and interquartile range, as appropriate. Demographic and other baseline characteristics will be summarized by cohort of exposure. Each of the primary and secondary outcomes will be described using frequencies, proportions and corresponding 95% confidence intervals (CI). If there is sufficient sample size, formal comparisons to estimate risk (odds ratios and corresponding 95% CIs) will be undertaken, using standardized mortality ratio weights to account for confounding.