Pregnancy and neonatal outcomes in women with immune mediated inflammatory diseases exposed to anti-tumor necrosis factor-α during pregnancy: A systemic review and meta-analysis

Barenbrug, Liana; Groen, Maarten te; Hoentjen, Frank; Drongelen, J. van; Reek, J.M.P.A. van den; Joosten, Irma; Jong, E.M.G.J. de; Molen, Renate G. van der

doi:10.1016/j.jaut.2021.102676

Cited by 25 publications

(18 citation statements)

References 74 publications

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“…Most of the current studies on the impact of such immunomodulators during pregnancy have focused on birth-related outcomes and the risk of postnatal infection 16 ; however, their impact on the shaping/ontogeny of the exposed-newborn immune system is still unknown. There is evidence of an effect of the use of immunomodulators through pregnancy on selected fetal immune components (Tables 1 and 2; Figure 4).…”

Section: Ta B L Ementioning

confidence: 99%

Expected impact of immunomodulatory agents during pregnancy: A newborn's perspective

Luo

Acevedo

Baños

et al. 2023

Pediatric Allergy Immunology

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The neonatal immune ontogeny begins during pregnancy to ensure that the neonate is well-suited for perinatal life. It prioritizes Th2/M2 and regulatory responses over Th/M1 activity to avoid excessive inflammatory responses and to ensure immune tolerance and homeostasis. Newborns also present increased Th17/Th22 responses providing effective anti-fungal immunity and mucosal protection. Intrauterine exposure to immune modulatory drugs with the placental transfer may influence the natural course of the fetal immune development. The vertical transfer of both biological How to cite this article: Luo Y, Acevedo D, Baños N, et al. Expected impact of immunomodulatory agents during pregnancy: A newborn's perspective.

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Section: Ta B L Ementioning

confidence: 99%

Expected impact of immunomodulatory agents during pregnancy: A newborn's perspective

Luo

Acevedo

Baños

et al. 2023

Pediatric Allergy Immunology

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“…Another meta-analysis from 2021 revealed that exposure to anti-TNF-α agents during pregnancy increased the risk of preterm birth, low birth weight, and infections in the newborns of women with IMIDs compared to disease-matched controls. 40 On the other hand, a 2020 systematic review 39 considered the results of each biologic individually in pregnant women with IMIDs, reporting rates of miscarriages and congenital malformations comparable to the general population. Similarly, a meta-analysis of observational studies with adjusted ORs did not reveal an increase in congenital malformations in pregnant women with IMIDs taking versus not taking biologics, suggesting that disease activity or other confounders are behind the adverse events, not the biologic therapy.…”

Section: Discussionmentioning

confidence: 99%

“…To our knowledge, this is the first meta‐analysis that specifically studies such effects. The literature has only a few systematic reviews 38–41 that synthesize pregnancy outcomes in women taking biologics for various conditions, but these are not limited to psoriasis. However, including women with different pathologies could limit the extrapolation of results to women with psoriasis, since many biologics used in rheumatic or gastroenterological IMIDs (e.g., golimumab, abatacept, or rituximab) are not authorized for psoriasis or are used with different protocols for each indication 4,42–46 .…”

Section: Discussionmentioning

confidence: 99%

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Exposure to biologic therapy before and during pregnancy in patients with psoriasis: Systematic review and meta‐analysis

Sánchez‐García,

Hernández‐Quiles,

de‐Miguel‐Balsa

et al. 2023

Acad Dermatol Venereol

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Biologicals have transformed the management of severe disease phenotypes in psoriasis and are often prescribed in women of childbearing age. However, information on safety of biologicals in pregnancy are lacking. We conducted a systematic review and meta‐analysis aimed to describe the characteristics and pregnancy outcomes in women with psoriasis exposed to biologics within 3 months before or during pregnancy, and to estimate the pooled prevalence of spontaneous, elective and total abortions, and congenital malformations in their newborns. Bibliographic searches were performed in the PubMed, Embase, Scopus and Web of Science databases up to 14 April 2022. No restrictions on sample size or publication date were applied. Review performance complied with PRISMA guidelines, and two reviewers assessed randomized controlled trials and nonrandomized studies reporting pregnancy outcomes in women exposed to biologics indicated for psoriasis during the pre‐gestational and/or gestational period. Studies focusing on rheumatologic or gastroenterological immune‐mediated inflammatory diseases were excluded. Regardless of data heterogeneity, a random‐effects model was used to pool prevalence estimates. We included 51 observational studies, involving 739 pregnancies exposed to approved biologics for psoriasis. Administration was mostly (70.4%) limited to the first trimester, and the most common drug was ustekinumab (36.0%). The estimated prevalence of miscarriage was 15.3% (95% confidence interval [CI] 12.7–18.0) and elective abortions, 10.8% (95% CI 7.7–14.3). Congenital malformations occurred in about 3.0% (95% CI 1.6–4.8) of live births exposed to biologics during pregnancy. Altogether, exposure to biologics for psoriasis during pregnancy and/or conception does not seem to be associated with an increased risk of miscarriage/abortion or congenital malformations, showing similar rates to the general population. These results suggest that biologic drugs are safe and pose an acceptable risk to the foetuses/neonates.

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“…Meta-analyses support the safety of infliximab, adalimumab and certolizumab during pregnancy 88–90. Certolizumab does not cross the placenta owing to pegylation.…”

Section: Appropriate Statementsmentioning

confidence: 92%

Australian inflammatory bowel disease consensus statements for preconception, pregnancy and breast feeding

Laube

Selinger

Seow

et al. 2023

Gut

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ObjectiveBecause pregnancy outcomes tend to be worse in women with inflammatory bowel disease (IBD) than in those without, we aimed to update consensus statements that guide the clinical management of pregnancy in patients with IBD.DesignA multidisciplinary working group was established to formulate these consensus statements. A modified RAND/UCLA appropriateness method was used, consisting of a literature review, online voting, discussion meeting and a second round of voting. The overall agreement among the delegates and appropriateness of the statement are reported.ResultsAgreement was reached for 38/39 statements which provide guidance on management of pregnancy in patients with IBD. Most medications can and should be continued throughout pregnancy, except for methotrexate, allopurinol and new small molecules, such as tofacitinib. Due to limited data, no conclusion was reached on the use of tioguanine during pregnancy. Achieving and maintaining IBD remission before conception and throughout pregnancy is crucial to optimise maternofetal outcomes. This requires a multidisciplinary approach to engage patients, allay anxieties and maximise adherence tomedication. Intestinal ultrasound can be used for disease monitoring during pregnancy, and flexible sigmoidoscopy or MRI where clinically necessary.ConclusionThese consensus statements provide up-to-date, comprehensive recommendations for the management of pregnancy in patients with IBD. This will enable a high standard of care for patients with IBD across all clinical settings.

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Pregnancy and neonatal outcomes in women with immune mediated inflammatory diseases exposed to anti-tumor necrosis factor-α during pregnancy: A systemic review and meta-analysis

Cited by 25 publications

References 74 publications

Expected impact of immunomodulatory agents during pregnancy: A newborn's perspective

Expected impact of immunomodulatory agents during pregnancy: A newborn's perspective

Exposure to biologic therapy before and during pregnancy in patients with psoriasis: Systematic review and meta‐analysis

Australian inflammatory bowel disease consensus statements for preconception, pregnancy and breast feeding

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