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Biologic Use During Pregnancy May Not Increase Infection Risks in Infants

ACE has carefully monitored the research on biologic use during pregnancy in response to the many ACE members who are thinking of starting a family and have concerns about continuing their medications.

We have previously reported on the study by Dr. Mary De Vera, Assistant Professor at the University of British Columbia’s Faculty of Pharmaceutical Sciences, and her team on “Patterns of medication use before, during, and after pregnancy among women with systemic lupus erythematosus: A population-based study”.

picture of pregnant womanDr. De Vera’s team assessed the use of medications in pregnant women with lupus in British Columbia. Most pregnancy trimesters in the study were exposed to hydroxychloroquine and/or chloroquine (41 to 45% of exposed pregnancy trimesters). The research observed an increase in glucocorticosteroid (like prednisone) exposures during pregnancy, as well as post-delivery. Findings emphasized the importance of counseling women regarding childbearing decisions as well as the need for evaluation of the risk-benefit profiles of medications in pregnancy.

At this year’s 2017 ACR/ARHP Annual Meeting in San Diego, researchers presented new findings that using a biologic therapy to manage rheumatoid arthritis (RA) during pregnancy may not significantly increase an infant’s risk for developing infections like pneumonia, meningitis, and tuberculosis.

RA is a chronic disease that causes pain, stiffness, swelling, and limitation in the motion and function of multiple joints. Though joints are the principal body parts affected by RA, inflammation can develop in other organs as well. An estimated 300,000 Canadians have RA, and the disease typically affects women twice as often as men. Researchers at the University of California wanted to gauge the serious infection risk for infants whose mothers used biologics during pregnancy. Because biologic drugs suppress the immune system, there has been a concern that infants prenatally exposed to these medications in pregnancy could be at increased risk for infection.

“I think this issue has been an important concern for clinicians and patients with respect to risk for infection in these infants,” said Christina Chambers, PhD, MPH, Co-Director of the Center for Better Beginnings and Professor, University of California, San Diego. “This is true especially with later pregnancy exposure, when placental transfer is increased.”

In this study, the researchers included data on pregnant women in the United States or Canada, including those with and without RA, and those who used biologics and other therapies. Among the pregnant mothers with RA who used biologics, 43.2 % took their last dose in the first or second trimester, and 56.8 % took their last dose in the third trimester. Serious infections occurred in 4 % of the infants born to these mothers. However, serious or opportunistic infections occurred in 2.6 % of the infants who were born to mothers with RA who did not use biologics during pregnancy and in 2.1% of the infants born to mothers with no chronic diseases.

The researchers also examined the infection rates among infants potentially exposed in the third trimester when most experts believe placental transfer of these medications is increased. Among infants born to mothers whose last biologic dose was after 24 weeks of gestation, 3.5 % reported infant infections, similar to the rate among women with RA who did not use biologics. They then looked at women with RA whose last biologic dose was after 32 weeks of gestation, and found that 2.7% reported these infections in their infants, approximately the same risk of those with RA who did not use any biologic during pregnancy.

“While this study cannot rule out low risks for serious infections, and we did not examine risks for milder infections,” said Dr. Chambers. “However, these results should be reassuring for women with RA who need to be treated throughout pregnancy with a biologic.”