Fetal and maternal outcomes after maternal biologic use during conception and pregnancy: A systematic review and meta‐analysis

O'Byrne, Laura; Alqatari, Safi; Maher, Gillian M.; O'Sullivan, Aoife; Khashan, Ali S.; Murphy, Grainne; McCarthy, Fergus P.

doi:10.1111/1471-0528.17093

Cited by 13 publications

(14 citation statements)

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“…Its unique structure may prevent fetal exposure to the drug during pregnancy ( 31 , 32 ). Both of them can be safely used in pregnancy to treat some autoimmune diseases and have recently been introduced to clinical trials on refractory recurrent spontaneous miscarriages ( 23 , 29 , 33 ). Despite little experience in applying CZP for pregnancy rescue therapy, we will further consider its use because its unique structure could avoid placental transfer, making it a better, safer choice in pregnancy.…”

Section: Discussionmentioning

confidence: 99%

Case Report: TNF-Alpha Inhibitors to Rescue Pregnancy in Women With Potential Pregnancy Loss: A Report of Ten Cases

Zhong

Wang

et al. 2022

Front. Immunol.

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Miscarriage poses a significant threat to pregnant women globally. Recurrent miscarriages or potential poor embryonic development indicated by early drops in serum human chorionic gonadotrophin (hCG) are even more catastrophic for pregnant women. However, these patients receive either individualized medical intervention supported by limited evidence or no treatment at all. In this study, we report ten patients who shared at least one episode of an early decline of hCG in the first trimester and were treated with compassionate use of tumor necrosis factor-alpha inhibitor (TNFi). They were then followed up regularly with caution. Their hCG trajectory all resumed a normal pattern within one week and the obstetric outcomes were promising. No adverse fetal, neonatal, or maternal health issues have been observed. This case series supports current safety evidence of TNFi and provides new insight into its use in pregnancy when the embryo is in danger. Further well-designed clinical trials should be carried out to consolidate the evidence.

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Section: Discussionmentioning

confidence: 99%

Case Report: TNF-Alpha Inhibitors to Rescue Pregnancy in Women With Potential Pregnancy Loss: A Report of Ten Cases

Zhong

Wang

et al. 2022

Front. Immunol.

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“…45 Finally, regarding the use of biologics in pregnancy, the evidence demonstrates no difference in pregnancy outcome, including that of fetal structural differences, in those on biologic treatment, suggesting these as a safe third-line alternative in the management of disease remission in pregnancy. 50 Anti-TNF agents including adalimumab or infliximab are commonly used in the management of sarcoidosis. Their use is nuanced by concern around neonatal immunological effects, particularly the risk of immunosuppression with avoidance of live vaccines in early life.…”

Section: Management Of Sarcoidosis In Pregnancymentioning

confidence: 99%

Sarcoidosis in pregnancy

Odendaal,

Mackie,

Tosounidou

et al. 2024

The Obstetric & Gynaecologis

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Key content: Sarcoidosis is an uncommon multi‐system disorder characterised by the presence of non‐caseating granulomas. It has a peak incidence between the ages of 20–40 years old. The pathogenesis of sarcoidosis is uncertain; however, it is known to be associated with an exaggerated T helper 1 (TH1) immune response leading to systemic inflammation and granuloma formation. Suppression in TH1 responses in pregnancy leads to disease remission in the majority of pregnancies. Nevertheless, the potential for decompensation in a subgroup remains, and consideration should be given to the pre‐pregnancy state. Sarcoidosis is associated with increased risk of maternal‐fetal morbidity, including growth restriction and pre‐eclampsia. Clinical management should focus on medication optimisation and mitigation of this increased risk. Learning objectives: To understand the clinical features, pathogenesis and diagnosis of sarcoidosis. To understand the effect of pregnancy on sarcoidosis. To understand the effect of sarcoidosis on pregnancy and the related obstetric outcomes. To understand the management of sarcoidosis in pregnancy. Ethical issues: There can be difficulties in appropriate management of medical disorders, such as sarcoidosis, with a limited obstetric evidence base. There are challenges in decision‐making regarding continuation of pregnancy in severe disease with an uncertain evidence base.

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“…Several systematic literature reviews and meta-analyses have been conducted examining exposure to biologics and pregnancy outcomes. 2,10,12 Most of these studies have concluded that prenatal exposure to biologics was not associated with either elevated or reduced risks of adverse pregnancy outcomes after controlling for disease and underlying clinical characteristics (i.e., comparing those exposed to disease-matched controls). However, comparing pregnant users to pregnant nonusers or discontinuers in an observational study design is challenging, due to confounding by disease severity.…”

Section: Potential Benefitsmentioning

confidence: 99%

“…For maternal serious infection, there is evidence of an increased risk of serious infection in pregnancy associated with biologic use. 12,17 Regarding the postpartum period specifically, a Canadian study found that the occurrence of serious postpartum infection was low and did not show any association with biologic exposure during pregnancy. 23 When assessing risk of infant infection after in utero exposure to biologics, one meta-analysis reported an increased risk of infections in newborns born to pregnant people with immune-mediated inflammatory disease exposed to TNF inhibitors compared with untreated, disease-matched controls.…”

Section: Potential Benefitsmentioning

confidence: 99%

A Benefit–Risk Conceptual Framework for Biologic Use During Pregnancy: A Mini‐Review

Bozzi,

Jacobson,

Yost

et al. 2024

Clin Pharma and Therapeutics

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Recent reports related to in utero exposure of marketed immunosuppressive biologics led to clinical recommendations to delay live vaccinations for infants due to the concern of reduced vaccine effectiveness and/or increased risk of vaccine‐related disease. These delays can increase the risk of children contracting vaccine preventable diseases, yet the alternative cessation of biologics during pregnancy may result in increased autoimmune disease activity for the pregnant person, raising complex benefit–risk (B‐R) considerations and trade‐offs. Our goal is to develop a conceptual framework for B‐R assessment based on the key benefits and risks pregnant people would consider for themselves and their children when continuing (vs. discontinuing) a biologic during pregnancy. The proposed framework defines the decision contexts, key domains and attributes for potential benefits, and risks of biologic use during pregnancy, informed by a literature review of indications for biologics and refined with key clinical stakeholders. The framework includes both the pregnant person taking the biologic and the infant potentially exposed to the biologic in utero, with potential benefit and risk domains and attributes for each participant. To advance this conceptual framework, there are considerations of potential biases and uncertainty of available data that will be imperative to address when quantifying the B‐R framework. For these reasons, we recommend the formation of a consortium to ensure development of a robust, validated framework that can be adopted in the healthcare setting.

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Fetal and maternal outcomes after maternal biologic use during conception and pregnancy: A systematic review and meta‐analysis

Cited by 13 publications

References 70 publications

Case Report: TNF-Alpha Inhibitors to Rescue Pregnancy in Women With Potential Pregnancy Loss: A Report of Ten Cases

Case Report: TNF-Alpha Inhibitors to Rescue Pregnancy in Women With Potential Pregnancy Loss: A Report of Ten Cases

Sarcoidosis in pregnancy

A Benefit–Risk Conceptual Framework for Biologic Use During Pregnancy: A Mini‐Review

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