Use of biologics during pregnancy and risk of serious infections in the mother and baby: a Canadian population-based cohort study.

OBJECTIVES: To investigate the association between exposure to biologics during pregnancy and serious infections in mothers and infants. DESIGN: Retrospective cohort study. SETTING: Population-based. PARTICIPANTS: Women with one or more autoimmune diseases identified by International Classification of Diseases 9th/10th revision codes in healthcare administrative databases in British Columbia, Canada, who had pregnancies ending in a live or stillbirth between 1 January 2002 and 31 December 2012. Women were defined as exposed if they had at least one biologic prescription during pregnancy, and infants born to these women were considered exposed in utero. Disease-matched women with no biologics prescriptions during pregnancy, and their infants, comprised the unexposed groups. PRIMARY OUTCOME MEASURES: Serious infections requiring hospitalisation. RESULTS: Over the 10-year study period, there were 6218 women (8607 pregnancies) who had an autoimmune disease diagnosis, of which 90 women were exposed to biologics during pregnancy, with 100 babies born to these women. Among women exposed to biologics during pregnancy, occurrence of serious postpartum infections were low, ranging from 0% to 5%, depending on concomitant exposures to immunosuppressants. In multivariable models using logistic regression, the OR for the association of biologics exposure with serious maternal postpartum infections was 0.79 (95% CI 0.24 to 2.54). In infants exposed to biologics in utero, occurrence of serious infections during the first year of life ranged from 0% to 7%, depending on concomitant exposures to immunosuppressants in utero. Multivariable models showed no association between biologics exposure in utero and serious infant infections (OR 0.56, 95% CI 0.17 to 1.81). CONCLUSIONS: These population-based data suggest that the use of biologics by women with autoimmune diseases during pregnancy is not associated with an increased risk of serious infections in mothers, during post partum or in infants during the first year of life.