Benralizumab Pregnancy Exposure Study
Benralizumab Pregnancy Exposure Study
This is a prospective, observational, exposure cohort study of pregnancy and infant outcomes
 in women with asthma exposed to benralizumab anytime during pregnancy, or within 8 weeks
 prior to the first day of the last menstrual period (LMP).

 The objective of the study is to monitor planned or unplanned pregnancies to evaluate
 potential teratogenic effect (birth defect) when exposed to benralizumab compared to two
 unexposed comparator groups.

 The primary outcome is major structural birth defects (abnormalities in development of
 structures of the body) and the secondary outcomes are preterm delivery (premature baby),
 small for gestational age infants (small for weight, length, and/or head circumference),
 spontaneous abortion (miscarriage), stillbirth (baby born without signs of life), elective
 termination (voluntary abortion) and small for age postnatal growth to one year of age (small
 for weight, length and/or head circumference). The birth prevalence or incidence of outcomes
 in women exposed to benralizumab, and their infants, will be compared to those observed in
 two unexposed comparator groups: a disease-matched comparison group of women who have not
 used benralizumab during pregnancy or within 8 weeks of their last menstrual period (LMP),
 but who have used other anti-asthmatic medications (treated disease comparison group), and a
 comparison group of healthy women who do not have a diagnosis of asthma, have not had
 exposure to a known human teratogen (substance that causes birth defect), and have not taken
 benralizumab in pregnancy (healthy comparison group).
Participants will be recruited into the three cohorts concurrently, on the basis of the
 following inclusion/exclusion criteria:

 Cohort 1: Benralizumab-Exposed

 Inclusion Criteria:

 -  Currently pregnant women diagnosed with asthma who contact the OTIS Research Center
 and who have been exposed to benralizumab for any number of days, at any dose, and at
 any time from 8 weeks before the first day of LMP up to and including the end of
 pregnancy.

 -  Eligible participants will be currently pregnant women who agree to the conditions and
 requirements of the study including the interview schedule and release of medical
 records.

 Exclusion Criteria:

 -  Women who have had exposure to another biologic, used for any indication, anytime
 during pregnancy or within 8 weeks of LMP.

 -  Women will not be eligible for Cohort 1 if they first contact the OTIS Research Center
 after prenatal diagnosis of a major structural birth defect.

 -  Restrospective cases (outcome of pregnancy known prior to enrollment).

 -  Women who have enrolled in the current study with a previous pregnancy.

 Cohort 2: Treated Diseased Comparison

 Inclusion Criteria:

 -  Currently pregnant women diagnosed with asthma and exposed to asthma medications for
 any number of days, at any dose, and at any time from LMP up to the date of
 enrollment, who contact the OTIS Research Center but who were not exposed to
 benralizumab during pregnancy or within 8 weeks prior to LMP.

 -  Eligible participants will be currently pregnant women who agree to the conditions and
 requirements of the study including the interview schedule and release of medical
 records.

 Exclusion Criteria:

 -  Women with exposure to benralizumab any time during pregnancy or within 8 weeks prior
 to LMP.

 -  Women will not be eligible for Cohort 2 if they first come in contact with the OTIS
 Research Center after prenatal diagnosis of a major structural birth defect.

 -  Retrospective cases (outcome of pregnancy known prior to enrollment).

 -  Women who have enrolled in the current study with a previous pregnancy.

 Cohort 3: Non-Asthmatic Comparison

 Inclusion Criteria:

 -  Currently pregnant women who contact the OTIS Research Center.

 -  Eligible women may potentially have been exposed to non-teratogenic agents during this
 pregnancy.

 -  Women who agree to the conditions and requirements of the study including the
 interview schedule and release of medical records.

 Exclusion Criteria:

 -  Women who have been exposed to any known teratogenic agents as determined by the OTIS
 Research Center (list in Annex 1) for any number of days, at any dose, from the first
 day of the last menstrual period up to and including the end of pregnancy.

 -  Women with a self-reported diagnosis of asthma, current or previous.

 -  Women will not be eligible for Cohort 3 if they come in contact with the OTIS Research
 Center after prenatal diagnosis of a major structural birth defect.

 -  Retrospective cases (outcome of pregnancy known prior to enrollment).

 -  Women who have enrolled in the current study with a previous pregnancy.