Etanercept concentrations in maternal serum, umbilical cord serum, breast milk and child serum during breastfeeding

Berthelsen, Birgitte; Fjeldsøe-Nielsen, Hans; Nielsen, Christoffer Tandrup; Hellmuth, Ellinor

doi:10.1093/rheumatology/keq185

Cited by 108 publications

(71 citation statements)

References 4 publications

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“…It is to be noted that levels in the cord blood were undetectable in 4 out of 12 infants; this minimal transplacental transfer is probably due to a passive diffusion, even if the mechanism is not currently understood (62). Case reports on etanercept have also found drug levels in the newborns, although they were lower than the levels in the mother's blood stream, in fact the concentration ratio of the cord/mother blood ranged from 3.6 to 7% (5,6). A study of macaque monkeys treated with golimumab during pregnancy and lactation showed that foetuses were exposed to high concentrations of golimumab from the end of the second quarter, and the neonates had high levels of golimumab after birth.…”

Section: N Biological Therapies In the Pregnant Patientmentioning

confidence: 99%

Are biological drugs safe in pregnancy?

et al. 2015

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The introduction of biological therapies has significantly improved the outcome of inflammatory rheumatic diseases. As most of these diseases affect women and men in childbearing age, some concerns have been voiced as to the safety of these drugs in relation to reproduction and pregnancy. Data from many hundreds of pregnancies in patients affected by inflammatory bowel disease and inflammatory arthritis have suggested that exposure to anti-TNF therapies at conception and/or during pregnancy is not associated with adverse pregnancy outcomes or any increase in congenital abnormalities. However, the exposure to anti-TNFα agents, particularly to monoclonal antibodies, in late pregnancy is associated with high drug levels in the newborn and their long-term effects on children remain unknown. Therefore, limiting the use of anti-TNFα to the first 30 weeks of pregnancy is recommended to reduce fetal exposure. Live-virus vaccines should be given only when levels of anti-TNFα drugs are undetectable in the serum of infants. Studies suggest that many of these drugs do enter breast milk in small amounts, but the extent to which the infant absorbs them is less clear. Limited reports have not suggested adverse pregnancy outcomes in women whose partners were exposed to anti-TNF therapies at the time of conception. Pregnancy data for rituximab, abatacept, anakinra, tocilizumab and belimumab are limited and their use in pregnancy cannot currently be recommended.

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Section: N Biological Therapies In the Pregnant Patientmentioning

confidence: 99%

Are biological drugs safe in pregnancy?

et al. 2015

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“…Serum levels only gradually reduce over time, and they can still be detected in the newborn 6 months after birth [99]. The limited data suggest that placental transport might not be a major concern for etanercept [100,101]. For golimumab, no data are available.…”

Section: Tnf Inhibitors and Pregnancymentioning

confidence: 99%

Pregnancy and rheumatoid arthritis

Ince-Askan

Dolhain

2015

Best Practice & Research Clinical Rheumatology

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“…Placental transfer of etanercept has been quantified through the measurement of etanercept concentrations in maternal serum, cord blood, and neonatal serum. 44 It was found that cord blood concentrations were significantly lower than maternal serum concentrations during the second and third trimesters of pregnancy and that they decreased progressively in the child's serum after birth, indicating that etanercept placental transfer does occur but results in much lower concentrations than those seen in the mother.…”

Section: Etanerceptmentioning

confidence: 97%

“…Minimal concentrations were still, however, detectable in the mother's milk, suggesting that the drug might be transmitted through the placenta but not breast milk. Berthelsen et al 49 described the case of a 34-year-old patient with ankylosing spondylitis treated with etanercept 25 mg twice weekly throughout pregnancy and breastfeeding. Very low drug concentrations were detected in breast milk and the levels present in the infant's serum decreased rapidly, supporting the theory that the drug is not passed through breast milk.…”

Section: Breastfeeding and Biologic Therapymentioning

confidence: 99%

Psoriasis In Pregnancy: A Review (II)

Ruiz

Manubens

Puig

2014

Actas Dermo-Sifiliográficas (English Edition)

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Scarce scientific evidence is available to define the precise effects that certain drugs might have on embryonic and fetal development if taken by pregnant women with psoriasis, given the ethical concerns that preclude enrolling such women in clinical trials. The little information on the use of biologics during gestation that has been published is based on retrospective and observational studies, and experience with these drugs in this context in psoriasis is still very limited. The literature seems to suggest that biologic therapy is safe during pregnancy, but there is no certainty. This detailed review of accumulated experience with biologic therapy during pregnancy relies mainly on descriptions of the management of other types of rheumatic disease, although the use of these agents in psoriasis is growing steadily.

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Etanercept concentrations in maternal serum, umbilical cord serum, breast milk and child serum during breastfeeding

Cited by 108 publications

References 4 publications

Are biological drugs safe in pregnancy?

Are biological drugs safe in pregnancy?

Pregnancy and rheumatoid arthritis

Psoriasis In Pregnancy: A Review (II)

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