Use of biologics while breastfeeding

Nov 6, 2018 - Uncategorized

Issue 19

Clinical Question

Do biologics used during breastfeeding cross into breast milk and increase the risk of infection or affect child development?

Editor’s Bottom Line

The use of biologic drugs for inflammatory bowel disease (IBD) while breastfeeding appears to be safe.

Reference

Matro R, Martin CF, Wolf D, et al. Exposure Concentrations of Infants Breastfed by Women Receiving Biologic Therapies for Inflammatory Bowel Diseases and Effects of Breastfeeding on Infections and Development. Gastroenterol. 2018;155(3):696–704. https://www.gastrojournal.org/article/S0016-5085(18)34573-6/fulltext

Synopsis

In this prospective multicenter study, researchers examined overall child development and infection rates up to 12 months in the offspring of 620 breastfeeding women who either received or did not receive biologic drugs for IBD and 204 similar women who did not breastfeed. Child health and development information were obtained from mothers and paediatricians and were linked with data on maternal medication exposure, IBD history and activity, pregnancy, and postpartum complications. Fifty-eight percent of women had Crohn’s disease, 40% had ulcerative colitis and 2% had unclassified IBD. The investigators also analyzed breast milk drug concentrations at a number of time-points between one and 168 hours following a dose of biologics in a subset of 72 patients who received postpartum biologic monotherapy or combination therapy.

At 12 months, children who were vs. were not breastfeed had similar rates of infection (39% in both groups) and achieved similar developmental milestones. Use of biologics, immunomodulators, or combination therapy during breastfeeding did not increase the likelihood of infection or change developmental milestones, compared to use of mesalamine, corticosteroids or no medication during breastfeeding.

Infliximab was detected in breast milk samples from 19 of 29 women treated with this agent (maximum: 0.74 μg/mL), adalimumab was found in samples from two of 21 women receiving this drug (maximum: 0.71 μg/mL), certolizumab was detected in samples from three of 13 women treated with this agent (maximum: 0.29 μg/mL), natalizumab was found in samples from one of two treated women (maximum: 0.46 μg/mL), and ustekinumab was detected in samples from four of six women treated with this agent (maximum: 1.57 μg/mL). Golimumab was not detected in the breast milk of the one woman receiving that drug.

Details

Study Design: Prospective, observational
Funding: The Crohn’s and Colitis Foundation provided a research grant. Prometheus Laboratories provided breast milk sample testing at no cost
Allocation: Not applicable
Setting: Multicenter registry
Level of Evidence: 2b (Oxford Levels of Evidence)