BIOlogic drug safety and effectiveness interNational pharmacoepidemiologIC study in pregnant women with autoimmune disorders and asthma and their children (BIONIC)

In Canada, the use of new biologic medications, drugs that target specific processes in the body, has been steadily rising over the last ten years. This has been mainly due to their increased effectiveness and mild side effect profile for treating chronic inflammatory diseases, which affect a large number of women of reproductive age. However, as pregnant women are typically excluded from clinical trials, the safety and effectiveness of biologics in this group is unknown. The overall goal of the BIONIC project is to evaluate whether using biologics in pregnancy is safe and effective for both mother and child. To do this, we will use international population-based data sources from a large pan-Canadian research network called the ‘CAnadian Mother-Child COhorts (CAMCCO)’ and the US (AM-PREGNANT). Using these population health data, BIONIC will compare the risk of negative outcomes in mothers (high blood pressure during pregnancy, loss of a fetus), infants (deformities, infants born small for size, infants born early) and children (hospitalization for serious infection) and to examine if biologics reduce the risk of disease flares during pregnancy in women who continue to use biologics versus women who discontinue use during pregnancy. This project brings together a diverse team of researchers at various career stages, clinicians, and patient partners with complimentary skills and lived experience. This study will provide much needed information to help guide doctors and women in their choice of drugs for use during pregnancy, which will help to reduce the number of harmful outcomes in mothers and their babies.