Biologics in Lupus Pregnancy | BIONIC Study Canada (CIHR-Funded Research)
The BIONIC Study on biologics in lupus pregnancy is a national research initiative designed to improve understanding of biologic therapy use during pregnancy for people with autoimmune diseases.
The BIONIC Study
Too often, pregnant women with immune-mediated diseases, including autoimmune diseases and severe asthma, that require targeted biologic therapy often feel they must choose between protecting their unborn child from potential treatment-related side effects and prioritizing their own health.
This decisional burden results from the limited evidence on the safety and effectiveness of biologic therapy during pregnancy since pregnant women are often not included in the trials that are often used to approve these medications. The BIONIC project will address this critical gap in evidence and will directly inform treatment decisions during pregnancy by determining whether biologics that are used to treat autoimmune diseases (including Lupus) in women of childbearing age increase the risk of adverse maternal (e.g. high blood pressure, fetal loss, and infections), infant and child-related outcomes (e.g. preterm birth, hospitalization, and development of juvenile autoimmune disorders).
The BIONIC study, led by Drs. Sonia Grandi (The Hospital for Sick Children, Toronto, ON) and Cristina Longo (University of Montreal, Montreal, QC), was launched in September, and is a 4-year, multi-center study funded by the Canadian Institutes for Health Research.
The BIONIC study uses a patient-partner centered approach and to-date has recruited 10 patient partners who have informed the study questions and are providing invaluable input and support in shaping the conduct of the study. The team looks forward to empowering patients to make informed decisions regarding the use of these medications during pregnancy.
Need More Information?
Please get in touch with the team at bionic.study@sickkids.ca