Vedolizumab Levels in Breast Milk of Nursing Mothers With Inflammatory Bowel Disease

Lahat, Adi; Shitrit, Ariella Bar-Gil; Naftali, Timna; Milgrom, Yael; Elyakim, Rami; Goldin, Eran; Levhar, Nina; Selinger, Limor; Zuker, Tzufit; Fudim, Ella; Picard, Orit; Yavzori, Miri; Ben‐Horin, Shomron

doi:10.1093/ecco-jcc/jjx120

Cited by 28 publications

(23 citation statements)

References 11 publications

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“…Vedolizumab concentrations were measured in trough blood samples obtained serially before each infusion. Vedolizumab levels were measured in St.Etienne by a commercially available ELISA (TheraDiag, France) and in Sheba by a previously described in‐house ELISA assay . Briefly, integrin alfa4‐beta7 (2 μg/mL, R&D, MN, USA) was added to pre‐plated anti‐His‐tag (4 μg/mL, R&D, MN, USA) wells of ELISA plates (Nunc, Roskilde, Denmark).…”

Section: Methodsmentioning

confidence: 99%

Safety, efficacy and pharmacokinetics of vedolizumab in patients with simultaneous exposure to an anti‐tumour necrosis factor

Ben‐Horin

Ungar

Kopylov

et al. 2018

Aliment Pharmacol Ther

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Section: Methodsmentioning

confidence: 99%

Safety, efficacy and pharmacokinetics of vedolizumab in patients with simultaneous exposure to an anti‐tumour necrosis factor

Ben‐Horin

Ungar

Kopylov

et al. 2018

Aliment Pharmacol Ther

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“…Available information indicates that maternal VDZ use appears to produce low levels in breastmilk. 45 – 47 Because VDZ is a large protein molecule (molecular weight of about 147,000), absorption is unlikely, since it is probably destroyed in the infant’s gastrointestinal tract. 6 , 48 The most recent guideline of the British Society of Gastroenterology stated that while low levels of infliximab, adalimumab, certolizumab, natalizumab, and ustekinumab can be detected in breastmilk from mothers receiving these biologics, breastfed infants of mothers receiving biologics, immunosuppressants, or combination therapy have similar risks of infection and similar milestone achievement at 12 months compared with non-breastfed infants or infants unexposed to these drugs.…”

Section: Discussionmentioning

confidence: 99%

Safety of vedolizumab in the treatment of pregnant women with inflammatory bowel disease: a targeted literature review

Terjung

Schmelz

Ehehalt

et al. 2020

Therap Adv Gastroenterol

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Background: Crohn’s disease (CD) and ulcerative colitis (UC) commonly affect women in their childbearing years. Vedolizumab (VDZ) is approved for treatment of moderate-to-severe CD and UC, but there is a knowledge gap regarding its use during pregnancy. This targeted literature review describes available evidence on safety of VDZ in pregnant patients in order to offer physicians a detailed and balanced view on persistent data during their decision-making process for an individualized treatment concept. Methods: The search included literature from the MEDLINE database and abstracts of five gastroenterological conferences published until November 2019. Publications were included if pregnancy outcomes in women receiving VDZ or neonatal outcomes in newborns of women previously exposed to VDZ were reported. Results: Out of 196 initially identified records, 18 publications reporting results of five different studies were identified. In total, for 213 of 284 VDZ-exposed documented pregnancies the following pregnancy outcomes were reported: 167 live births (172 infants due to twin births), 1 stillbirth, 35 miscarriages, 10 elective terminations (1 due to detected Down syndrome). Furthermore, during pregnancy, the following complications were observed: seven cases of (pre) eclampsia, three cases of premature rupture of membranes and one case each of placenta previa, chorioamnionitis, pneumonia, first-trimester bleeding, cholestasis, sepsis, or neonatal intraventricular hemorrhage. Based on 172 infants, 30 preterm deliveries (17.4%), 9 cases of low birth weight (5.2%), 5 infections (2.9%), and 6 cases (3.8%) with congenital anomalies were reported. Conclusion: There was no evidence for safety concerns regarding pregnancy outcomes associated with VDZ therapy. Due to the limited scope of included records, further research is needed to understand the safety profile regarding the use of VDZ during pregnancy.

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“…In most studies, the concentrations of biological agents found in milk are minimal (< 1% of serum concentration) as the drug is degraded in the stomach of the child and no harm from breastfeeding on biologic therapies has been described [120]. Data for anti-interleukin 12-23 and anti-integrin are very limited but due to limited transfer detectable and their monoclonal antibody molecular structures it is presumed that they are compatible with lactation [121,122]. Women on tofacitinib are advised not to breastfeed due to the lack of data on this molecule during the lactation period.…”

Section: Postpartummentioning

confidence: 99%

Update on the Management of Inflammatory Bowel Disease during Pregnancy and Breastfeeding

et al. 2020

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Inflammatory bowel disease (IBD) affects patients during their peak reproductive years. This raises important questions, in both patients and healthcare providers, regarding conception, pregnancy, and breastfeeding. Lack of information and insufficient communication among healthcare providers can leave patients with limited information and even contradictory advice. Given the fact that pregnant and/or breastfeeding IBD patients are excluded from clinical studies the evidence on many questions related to pregnancy and postpartum period is limited. However, there exists increasing data from case series and cohort studies that allows to provide clinical guidance. The overarching concept is that optimizing the mother's health is critical for optimizing the health of the unborn child and benefit of continuing medical therapy in IBD during pregnancy outweighs possible risks in most instances. This paper provides an up-to-date systematic review of the literature on IBD in pregnancy and proposes guidance to questions frequently encountered by healthcare professionals.

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Vedolizumab Levels in Breast Milk of Nursing Mothers With Inflammatory Bowel Disease

Abstract: 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.

Cited by 28 publications

References 11 publications

Safety, efficacy and pharmacokinetics of vedolizumab in patients with simultaneous exposure to an anti‐tumour necrosis factor

Safety, efficacy and pharmacokinetics of vedolizumab in patients with simultaneous exposure to an anti‐tumour necrosis factor

Safety of vedolizumab in the treatment of pregnant women with inflammatory bowel disease: a targeted literature review

Update on the Management of Inflammatory Bowel Disease during Pregnancy and Breastfeeding

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