Vedolizumab levels in breast milk of nursing mothers with inflammatory bowel disease

Lahat A1, Shitrit AB2, Naftali T3, Milgrom Y2, Elyakim R1, Goldin E2, Levhar N1, Selinger L1, Zuker T2, Fudim E1, Picard O1, Yavzori M1, Ben-Horin S1. J Crohns Colitis. 2017 Aug 31. doi: 10.1093/ecco-jcc/jjx120. [Epub ahead of print]
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1 Department of Gastroenterology, Sheba Medical Center, Tel Hashomer, Israel, affiliated with Sackler School of Medicine, Tel Aviv University, Israel. 2 Digestive Diseases Institute, Shaare Zedek Medical Center, Affiliated with the Hebrew University School of Medicine, Jerusalem, Israel. 3 Gastroenterology institute, Meir Medical Center, Kfar Saba, affiliated with Sackler School of Medicine, Tel Aviv University, Israel.


INTRODUCTION: There are no data on the transfer of vedolizumab in breast milk of nursing mothers. We aimed to assess the presence of vedolizumab in breast milk of nursing inflammatory bowel disease (IBD) patients.

METHODS: This was a prospective observational study of vedolizumab-treated breast-feeding patients with IBD. Serum and breast milk samples were obtained at pre-defined time-points. The in-house developed ELISA assay for measuring vedolizumab in blood was adapted and validated for measurement of drug in breast milk. The level of vedolizumab was also measured in breast milk of a control group of nursing healthy mothers.

RESULTS: Vedolizumab was undetectable in breast milk in IBD patients prior to the first infusion of vedolizumab (n=3) and in all of the healthy controls (n=5). Vedolizumab was measurable in all lactating women who received vedolizumab (n=5). However, on serial measurements in breast milk after an infusion, drug levels did not surpass 480ng/ml, which was roughly 1/100 than the comparable serum levels.

CONCLUSIONS: Vedolizumab can be detected in the breast milk of nursing mothers. Although more data are imperative, the concentrations of vedolizumab in breast milk are minute and are therefore unlikely to result in systemic or gastro-intestinal immune-suppression of the infant.

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