Risk of congenital anomalies in infants born to women with autoimmune disease using biologics before or during pregnancy: a population-based cohort study.

OBJECTIVES

To determine the association between perinatal biologic use and congenital anomalies in women with autoimmune disease.

METHODS

We linked population-based administrative health data including information on all medications with a perinatal registry in British Columbia, Canada. Women with one or more autoimmune diseases who had pregnancies between January 1st, 2002 and December 31st, 2012 were included. Exposure to biologics was defined as having at least one biologic prescription 3 months before conception or during the first trimester of pregnancy. Each exposed pregnancy was matched with five unexposed pregnancies using high dimensional propensity scores (HDPS). Logistic regression modelling was used to evaluate the association between biologics use and congenital anomalies.

RESULTS

The HDPS-matched cohort included 117 pregnancies (107 women) exposed to biologics, and 585 pregnancies (562 women) that were not exposed to biologics during the period of interest; 6% of newborns had ≥1 congenital anomalies at birth, in the exposed and unexposed groups. There were no obvious patterns with regards to the congenital anomalies observed in the biologics exposed group. In primary analysis, the OR for the association between biologic exposure and congenital anomalies was 1.06 (95%CI 0.46-2.47). Secondary and sensitivity analyses did not change the results appreciably.

CONCLUSIONS

These population-based data suggest that the use of biologics before and during pregnancy is not associated with an increased risk of congenital anomalies.