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Exposure Concentrations of Infants Breastfed by Women Receiving Biologic Therapies for Inflammatory Bowel Diseases and Effects of Breastfeeding on Infections and Development.

Gastroenterology; 2018 May 29.
Artigo em Inglês | MEDLINE | ID: mdl-29857090
BACKGROUND & AIMS: Exposure to biologic and immunosuppressant agents during breastfeeding is controversial and there are limited data on safety. We investigated whether biologics are detectable in breast milk from women receiving treatment for inflammatory bowel diseases (IBD) and whether breastfeeding while on treatment is associated with infections or developmental delays.


We performed a multi-center prospective study of women with IBD and their infants, collecting breast milk samples (n=72) from patients receiving biologic therapy from October 2013 to November 2015. Drug concentrations were measured in all breast milk samples at several time points within 48 hrs of collection and within 168 hrs for some samples. Child development was assessed using the Ages and Stages Questionnaire 3 (ASQ3), completed by 824 women with IBD (treated or untreated) during pregnancy RESULTS: We detected infliximab in breast milk samples from 19 of 29 treated women (max 0.74 µg/mL), adalimumab in 2 of 21 treated women (max 0.71 µg/mL), certolizumab in 3 of 13 treated women (max 0.29 µg/mL), natalizumab in 1 of 2 treated women (max 0.46 µg/mL), and ustekinumab in 4 of 6 treated women (max 1.57 µg/mL); we did not detect golimumab in breast milk from the 1 woman receiving this drug. Rates of infection and developmental milestones at 12 months were similar in breastfed vs non-breastfed i CONCLUSIONS: In a study of women receiving treatment for IBD and their infants, we detected low concentrations of infliximab, adalimumab, certolizumab, natalizumab, and ustekinumab in breast milk samples. We found breastfed infants of mothers on biologics, immunomodulators, or combination therapies to have similar risks of infection and rate of milestone achievement compared to non-breastfed or infants unexposed to these drugs. Maternal use of biologic therapy appears compatible with breastfeeding. Clinicalt