Pregnancy outcomes in women exposed to adalimumab or infliximab: The experience of the Berlin Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy

Weber-Schoendorfer, Corinna; Fritzsche, Juliane; Schaefer, Christof

doi:10.1016/j.reprotox.2010.12.052

Cited by 10 publications

(5 citation statements)

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“…This data also reported evidence of placental transfer and a presence of higher concentration of ADA in the infant compared to the mother [88].…”

Section: Adalimumabsupporting

confidence: 69%

“…Several case reports and case series of ADA use exist in the published literature [52,58,61,[84][85][86][87][88][89]. A recent comparative analysis by Schnitzler et al reported seven pregnancies in six women treated for refractory luminal CD during the first (7/7) and second (4/7) trimesters [52].…”

Section: Adalimumabmentioning

confidence: 99%

“…Twentyeight of these patients were taking ADA, and within this group, there were two miscarriages and two voluntary abortions. Of the 24 live births, four were delivered prematurely [88]. Five infants were reported to have been followed up and no evidence of developmental delay or abnormality was found.…”

Section: Adalimumabmentioning

confidence: 99%

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Safety of anti-TNF therapy in inflammatory bowel disease during pregnancy

Khan

Asim

Lichtenstein³

2014

Expert Opinion on Drug Safety

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“…This data also reported evidence of placental transfer and a presence of higher concentration of ADA in the infant compared to the mother [88].…”

Section: Adalimumabsupporting

confidence: 69%

Section: Adalimumabmentioning

confidence: 99%

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Safety of anti-TNF therapy in inflammatory bowel disease during pregnancy

Khan

Asim

Lichtenstein³

2014

Expert Opinion on Drug Safety

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“…Given primarily to the lack of controlled studies, the current manufacturers' guidelines in Italy (2) recommend that all licensed biological therapies be discontinued prior to conception for variable time intervals (Table I). Besides registry data, some case reports and small case series (38)(39)(40)(41)(42)(43)(44)(45)(46)(47)(48)(49)(50)(51)(52)(53) have been published reporting exposure to biologics and pregnancy outcomes. However, large population-based studies are limited, and there is a lack of prospective data in pregnant women.…”

Section: N Introductionmentioning

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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“… 65 ). They can induce SA and preterm birth in three different trimesters of gestation as the medicine of RA (Refs 61 , 62 , 66 ).…”

Section: Effect Of Anti-tnf- α Drugs On Adverse Pr...mentioning

confidence: 99%

TNF-α/anti-TNF-αdrugs and its effect on pregnancy outcomes

Dai

Zhang

et al. 2022

Expert Rev. Mol. Med.

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Pregnancy is a complex biological process. The establishment and maintenance of foetal–maternal interface are pivotal events. Decidual immune cells and inflammatory cytokines play indispensable roles in the foetal–maternal interface. The disfunction of decidual immune cells leads to adverse pregnancy outcome. Tumour necrosis factor (TNF)-α, a common inflammatory cytokine, has critical roles in different stages of normal pregnancy process. However, the relationship between the disorder of TNF-α and adverse pregnancy outcomes, including preeclampsia (PE), intrauterine growth restriction (IUGR), spontaneous abortion (SA), preterm birth and so on, is still indefinite. In this review, we thoroughly reviewed the effect of TNF-α disorder on pathological conditions. Moreover, we summarized the reports about the adverse pregnancy outcomes (PE, IUGR, SA and preterm birth) of using anti-TNF-α drugs (infliximab, etanercept and adalimumab, certolizumab and golimumab) currently in the clinical studies. Overall, IUGR, SA and preterm birth are the most common adverse pregnancy outcomes of anti-TNF-α drugs. Our review may provide insight for the immunological treatment of pregnancy-related complication, and help practitioners make informed decisions based on the current evidences.

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Pregnancy outcomes in women exposed to adalimumab or infliximab: The experience of the Berlin Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy

Cited by 10 publications

References 0 publications

Safety of anti-TNF therapy in inflammatory bowel disease during pregnancy

Safety of anti-TNF therapy in inflammatory bowel disease during pregnancy

Are biological drugs safe in pregnancy?

TNF-α/anti-TNF-αdrugs and its effect on pregnancy outcomes

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