Grant: DRA: Canada Impact+ Research Training Awards - Doctoral

"The goal of the BIOlogic drug safety and effectiveness interNational pharmacoepidemiologIC (BIONIC) study is to examine the maternal and child health impacts of biologic exposure during pregnancy in women with chronic inflammatory autoimmune disorders (AD) or moderate-to-severe asthma who were prescribed biologics before their pregnancy. The specific aims of BIONIC are to: 1) compare the risks of: (a) adverse pregnancy outcomes (such as miscarriage or stillbirth) and maternal outcomes (such as pre-eclampsia, eclampsia, diabetes, and hospitalizations for serious infections) and (b) exacerbations of AD or asthma in women who either continue using biologics in pregnancy or stop using them; and 2) to compare the risks of continuing vs stopping use of biologics during pregnancy. We will compare the rates of adverse outcomes in infants (such as preterm birth, birth defects, neonatal ICU (NICU) admissions) and in children (number of serious infections by 5 years of age, juvenile AD, type 1 diabetes, asthma onset, atopic dermatitis) born to women who continue vs. discontinue use of biologics during their pregnancy. Safety and effectiveness outcomes in mothers as well as their babies and children will be compared for those who continue vs. discontinue use of biologics in pregnancy will be compared using a technique that emulates a series of nested trials regarding the decision to continue or discontinue treatment at each gestational week. This work is important as pregnancy is a major exclusion criteria for most clinical trials for medications like biologics, and as such there is not high quality evidence to support families and physicians caring for pregnant women in their decision-making regarding managing chronic ADs or asthma during pregnancy. "