The Benralizumab Pregnancy Exposure Study: A VAMPSS Post-Marketing Surveillance 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:
  Other
• Non-interventional study design, other:
  This is a prospective, observational, exposure cohort study of pregnancy outcomes in pregnant women with asthma exposed to benralizumab and comparison women

Study drug and medical condition

• Name of medicine, other:
  FasenraTM
• Medical condition to be studied:
  Asthma

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)

  Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  800

Study design details

• Main study objective:
  To monitor planned and unplanned pregnancies exposed to benralizumab and evaluate the potential teratogenic effect of this medication relative to the primary pregnancy outcome of major structural birth defects and the secondary pregnancy outcomes of preterm delivery, small for gestational age infants, spontaneous abortion, stillbirth, elective termination and postnatal growth to one year of age.
• Outcomes:
  Major structural birth defects, - Spontaneous abortion/miscarriage - Stillbirth - Elective termination/abortion - Preterm delivery - Small for gestational age infants - Small for age postnatal growth of live born children to 1 year of age
• Data analysis plan:
  Descriptive tables will be prepared for characteristics of each of the cohorts in each interim and final report displaying n, means, standard deviations, minimums and maximums or proportions and percentages. For the primary endpoint and for the secondary endpoints un-adjusted relative risk estimates will be presented together with exact two-sided 95% and 80% confidence intervals. For the secondary endpoints survival methods will be used (Kaplan Meier) to estimate crude rates and confidence intervals accounting for gestational timing of enrollment in the study. Adjusted analyses producing relative risks and 95% and 80% confidence intervals or hazard ratios and 95% and 80% confidence intervals, where numbers permit, will be conducted. Confounders will be considered for each adjusted analysis separately, using several methods including the method of change in estimate of the effect of exposure to benralizumab by 10% or more.

Documents

Study report

2019 FINAL OTIS BENRALIZUMAB ANNUAL INTERIM REPORT_03Dec2019

2020 OTIS Benralizumab Pregnancy Registry Annual Report_10Nov2020

2021 FINAL OTIS Fasenra Annual Interim Report_08Feb2022

Study, other information

2020 OTIS Benralizumab Pregnancy Registry Annual Report_10Nov2020.pdf

2021 FINAL OTIS Fasenra Annual Interim Report_08Feb2022.pdf