Assessment of pregnancy outcomes in patients treated with Ajovy (fremanezumab): pregnancy database 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

• Name of medicine:
  AJOVY
• Medical condition to be studied:
  Migraine

Population studied

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

  Infants and toddlers (28 days – 23 months)

  Adults (18 to < 46 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  to assess major congenital malformations, spontaneous abortions, stillbirths, preeclampsia, eclampsia, preterm delivery, low birth weight, and small-for-gestational age births in women exposed to AJOVY during pregnancy compared to comparison groups unexposed to AJOVY.
• Outcomes:
  major congenital anomalies, spontaneous abortions, stillbirths, preeclampsia, eclampsia, preterm delivery, low birth weight, and small-for-gestational age births.
• Data analysis plan:
  Study data will be summarized using descriptive statistics. The prevalence of major congenital malformations and secondary endpoints will be calculated as the proportion of events identified in the database of all live births or of pregnancies, as applicable. Analyses of the primary and secondary endpoints between the AJOVY group and Comparison Groups I and II are the primary comparisons of interest. Analyses using Comparison Groups III and IV are considered supportive. Analyses will be performed to compare the rates of major congenital malformations between the AJOVY group and each of Comparison Groups I and II, using a generalized linear model, adjusting for mother’s age as a continuous covariate, and stratified by gestational timing of exposure.