Assessing the Drug Exposure Risk of Infants Breastfed by Women With Inflammatory Bowel Disease

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The inflammatory bowel disease (IBD) shows the highest incidence among people of childbearing age. Indeed, it is not uncommon that pregnant or lactating women with IBD require drug therapy, including monoclonal antibodies against Tumor Necrosis Factor-alpha (TNF?). However, these patients face chall...

The inflammatory bowel disease (IBD) shows the highest incidence among people of childbearing age. Indeed, it is not uncommon that pregnant or lactating women with IBD require drug therapy, including monoclonal antibodies against Tumor Necrosis Factor-alpha (TNF?). However, these patients face challenges, because information on pregnancy and breastfeeding safety of these new medications is lacking due to exclusion of pregnant and breastfeeding women from drug development processes. Whereas the data necessary for fetal safety assessment is accumulating gradually, significant gaps in the research efforts and the understanding on excretion of TNF? inhibitors into milk remain. Experts generally consider it acceptable to use the TNF? inhibitors during breastfeeding, because the previous studies found relatively low levels of these drugs in milk. However, the existing data on milk levels of these drugs are highly inconsistent, probably because previous reports gave no consideration to potential interference from high levels of endogenous TNF? in milk. As a result, a comprehensive picture of TNF? inhibitors in breast milk remains obscure. Moreover, in a recent mouse study, transfer of TNF?-dependent chemokines through milk has been shown to play a role in shaping the postnatal programming of brain development, implying that altered disposition of endogenous TNF? and other chemokines in milk during anti-TNF? therapy has an impact on brain development of the offspring. This is an observational cohort study with comparison group, which describes the first step to address the issue by uncovering the TNF?-dependent 'lactocrine' pathway and disposition of TNF? inhibitors in milk. The study will also investigate the pharmacokinetics of TNF? inhibitors in breast milk (as a sub-study), using the population pharmacokinetic (popPK) approach.

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