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Safety of perinatal biologic use in autoimmune diseases : population-based studies of maternal and infant outcomes

University of British Columbia

Objectives: To examine biologic use before or during pregnancy among women with autoimmune inflammatory disease by: 1) Describing the patterns of use, discontinuation, and 10-year secular trends; 2) Evaluating the association between biologic exposure before or during pregnancy and adverse maternal and infant outcomes including: preterm deliveries, small-for-gestational-age (SGA) births, congenital anomalies, and serious infections; and 3) Reviewing existing literature and meta-analyzing my findings with published results. Methods: Using provincial population-based administrative health data linked with the perinatal registry and prescription dispensations database, a cohort of women with autoimmune inflammatory disease who had at least one pregnancy during 2002-2012 was identified. Descriptive statistics, multivariable modeling, and high-dimensional propensity score (HDPS) methods were used to describe the patterns of perinatal biologic prescriptions and assess associations with outcomes of interest. Results were meta-analyzed with findings from existing literature. Findings: 1) Perinatal biologic use has increased significantly over 10 years, comprising 5.7% of all pregnancies in this population by 2012. Most often women discontinued their biologic in the first (31%), or second (38%) trimesters, while 98% of those on treatment during the second trimester continued through to delivery. Only disease type was associated with discontinuation. 2) After applying HDPS matching, there were no associations observed between biologic use before or during pregnancy and risk of preterm deliveries (OR 1.13, 95% CI 0.67 to 1.90); SGA (OR 0.91, 95% CI 0.46 to 1.78); or congenital anomalies (OR 1.06, 95% CI 0.46 to 2.47). The theoretical concern of serious infections due to immunomodulatory effects of biologics was not observed. 3) Meta-analysis of unadjusted risk estimates showed significantly increased risks of congenital anomalies, preterm deliveries, and low birth weight babies associated with biologic exposure. However, pooled adjusted risk estimates showed no significant associations. Conclusions: Using novel methods to address potential confounding and pooling existing evidence, the findings from this thesis demonstrated that treatment with biologics before or during pregnancy are not associated with a number of important perinatal outcomes. These findings help patients and clinicians weigh risks and benefits of treatment options in pregnancy, and support difficult decision making around using biologics in a vulnerable population.

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2020-08-31

Attribution-NonCommercial-NoDerivatives 4.0 International

http://hdl.handle.net/2429/66761

Pharmaceutical Sciences

University of British Columbia

UBCV

http://creativecommons.org/licenses/by-nc-nd/4.0/