SAN DIEGO — The use of biologic therapy for rheumatoid arthritis during pregnancy did not significantly increase risk for developing serious or opportunistic infections among infants, according to findings presented at the American College of Rheumatology Annual Meeting.
“The question we are attempting to address with this analysis is whether or not patients who take one of the biologic medications during pregnancy are at increased risk of having an infant with a serious or opportunistic infection in the first year of life,” Christina Chambers, PhD, MPH, co-director of the Center for Better Beginnings and director of the University of California – San Diego ACTRI Center for Life Course Research, said during her presentation.
“While the theoretical concern is that if an immunosuppressant medication is taken during pregnancy, could they potentially impact the infant’s immune function? However, more specifically with biologics, there is concern that perhaps exposure to these medications in the third trimester might be of more concern in terms of immune response in the infant.”
During a press conference at the American College of Rheumatology Annual Meeting, Christina Chambers, PhD, MPH, noted that while her findings did not rule out low risks for serious infections among infants, these results can reassure clinicians and patients who need to be treated with a biologic during their pregnancy.
To determine whether the use of biologic therapies for RA in pregnancy could inhibit postnatal immune function among infants and increase their risk for infection, Chambers and colleagues analyzed data from a prospective observational cohort study of pregnant women from the U.S. and Canada (n = 1,184). These women included patients with RA who were treated with a biologic (n = 502), those with RA who did not receive treatment during pregnancy (n = 231) and those with no chronic diseases (n = 423).
Researchers collected data regarding the initiation and discontinuation of biologics during pregnancy from medical records from the delivery hospital and obstetric and specialty providers, as well as through a series of three to four telephone interviews with the patients. The researchers also acquired follow-up data from the infants’ pediatricians regarding serious and/or opportunistic infections rates through 1 year of age.
“We defined serious or opportunistic infections a priori as a list of 16 potential infections including X-ray proven pneumonia, sepsis, pneumocystis and Legionnaire’s disease, as well as any infection that may not have been specified but landed the child in the hospital,” Chambers said.
According to study results, among pregnant women with RA who used biologics, 43.2% received their final dose in the first or second trimester, and 56.8% received their last dose in the third trimester. However, serious or opportunistic infections were reported in only 4% of infants born to women with RA who were treated with a biologic, compared with 2.6% of infants born to women with RA not treated with a biologic (RR = 0.71; 95% CI 0.3-1.71) and 2.1% of infants whose mothers had no chronic diseases (RR = 1.09; 95% CI 0.43-2.72).
In addition, the researchers compared infection rates among infants born to mothers whose final biologic dose was after 24 weeks gestation vs. mothers who received a final dose after 32 weeks gestation. Among women who received the final biologic dose after 24 weeks gestation, 3.5% reported infant infections, comparable to the rate among women with RA who abstained from biologics; similarly, 2.7% of women who received the final biologic dose after 32 weeks gestation reported infant infections, a risk nearly identical to those with RA who did not use biologics.
“Our overall conclusions were that, at least preliminarily, these data provide some reassurance for clinicians who are concerned that their patients need to be treated with a biologic late in pregnancy rather than taking them off the drug during that period of time. However, the limitations are that we did not address risk for less serious infections and certainly that may be of interest to parents and clinicians as well.”– by Bob Stott
Chambers CD, et al. Abstract 1785. Presented at: American College of Rheumatology Annual Meeting; Nov. 4-8, 2017; San Diego.
Disclosures: Chambers reports no relevant financial disclosures. Please see the full study for a complete list of all other authors’ relevant financial disclosures.