New research led by Rebecca Matro, M.D., assistant professor of gastroenterology in the OHSU School of Medicine, has confirmed that biologic therapies pose no health risks to infants of nursing mothers.
As part of the PIANO (Pregnancy in IBD and Neonatal Outcomes) Registry, the multicenter study collected breast milk samples from 72 mothers using biologics for inflammatory bowel disease. Drug concentrations of the biologics — including infliximab, adalimumab, certolizumab, natalizumab, ustekinumab and golimumab — were measured in all samples at several time points within 48 hours of collection.
Study results indicate minimal drug concentration of biologics in breast milk:
• adalimumab in two of 21 treated women (max 0.71 μg/mL)
• certolizumab in three of 13 treated women (max 0.29 μg/mL)
• golimumab in one woman (no trace)
• infliximab in 19 of 29 treated women (max 0.74 μg/mL)
• natalizumab in one of two treated women (max 0.46 μg/mL)
• ustekinumab in four of six treated women (max 1.57 μg/mL)
The results, which are published in the September 2018 issue of the journal Gastroenterology, indicate minimal rates of drug transfer within the breast milk. Further, survey data — provided by 824 women with IBD during pregnancy — indicates no association of biologics with developmental milestone achievement or rate of infant infection in breastfed infants exposed and unexposed to biologics and non-breastfed infants at 12 months of age.
These findings indicate that maternal biologic therapy is safely compatible with lactation, and can provide reassurance to physicians and mothers living with IBD.
This study was completed in collaboration with research teams at the University of North Carolina at Chapel Hill, Atlanta Gastroenterology Associates, Warren Alpert School of Medicine at Brown University, and the University of California San Francisco.
Funding was provided by the Crohn’s and Colitis Foundation.