From mother to baby: antenatal exposure to monoclonal antibody biologics

Pham‐Huy, Anne; Sadarangani, Manish; Huang, Vivian; Østensen, Monika; Castillo, Eliana; Troster, Sarah M; Vaudry, Wendy; Nguyen, Geoffrey C.; Top, Karina A

doi:10.1080/1744666x.2019.1561282

Cited by 29 publications

(36 citation statements)

References 77 publications

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“…It is generally thought that little anti-TNF medication crosses the placenta in the first trimester. However, there is direct and indirect evidence of placental transfer of anti-TNF-α medications in the third trimester via measurable cord blood levels even weeks after maternal discontinuation of treatment [1]. One case report suggested that adalimumab was detectable in the cord serum of an infant delivered at 37.5 weeks gestation despite the fact that the mother discontinued treatment in gestational week 16 [22].…”

Section: Discussionmentioning

confidence: 99%

“…Adalimumab is a fully humanized monoclonal antibody with a high molecular weight and is expected to require active transport in order to cross the human placenta. For this reason, it is thought that potential exposure of the embryo via placental transfer is limited earlier in pregnancy, while transfer to the fetus later in pregnancy has been documented [1].…”

Section: Introductionmentioning

confidence: 99%

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Birth outcomes in women who have taken adalimumab in pregnancy: A prospective cohort study

Chambers

Johnson

et al. 2019

PLoS ONE

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BackgroundInformation is needed on the safety of adalimumab when used in pregnancy for the treatment of certain autoimmune diseases.Methods and findingsBetween 2004 and 2016, the Organization of Teratology Information Specialists Research Center at the University of California San Diego conducted a prospective controlled observational cohort study in 602 pregnant women who had or had not taken adalimumab. Women in the adalimumab-exposed cohort had received at least one dose of the drug in the first trimester for the treatment of rheumatoid arthritis or Crohn’s Disease (N = 257). Women in the disease comparison cohort had not used adalimumab in pregnancy (N = 120). Women in the healthy comparison cohort had no rheumatic or inflammatory bowel diseases (N = 225). Women and their infants were followed to one year postpartum with maternal interviews, medical records abstraction, and physical examinations. Study outcomes were major structural birth defects, minor defects, spontaneous abortion, preterm delivery, pre and post-natal growth deficiency, serious or opportunistic infections and malignancies. 42/602 (7.0%) of pregnancies were lost-to-follow-up. 22/221 (10.0%) in the adalimumab-exposed cohort had a live born infant with a major birth defect compared to 8/106 (7.5%) in the diseased unexposed cohort (adjusted odds ratio 1.10, 95% confidence interval [CI] 0.45 to 2.73). Women in the adalimumab-exposed cohort were more likely to deliver preterm compared to the healthy cohort (adjusted hazard ratio [aHR] 2.59, 95% CI 1.22 to 5.50), but not compared to the diseased unexposed cohort (aHR 0.82, 95% CI 0.66 to 7.20). No significant increased risks were noted with adalimumab exposure for any other study outcomes.ConclusionsAdalimumab exposure in pregnancy compared to diseased unexposed pregnancies was not associated with an increased risk for any of the adverse outcomes examined. Women with rheumatoid arthritis or Crohn’s Disease were at increased risk of preterm delivery, irrespective of adalimumab exposure.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Birth outcomes in women who have taken adalimumab in pregnancy: A prospective cohort study

Chambers

Johnson

et al. 2019

PLoS ONE

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“…The combination of tacrolimus and steroids is diabetogenic and women taking these drugs in isolation or combination should be screened for gestational diabetes. The role of intravenous immunoglobulin (IVIg) in treating immune cytopaenias is established outside of pregnancy and is safe to use in pregnancy, especially when rituximab is avoided due to the risk of neonatal B-cell depletion (see section 2) [233]. The use of IVIg is also described in case studies where infection risk precludes traditional immunosuppression [234].…”

Section: Rationale For Clinical Practice Guidelinesmentioning

confidence: 99%

Clinical practice guideline on pregnancy and renal disease

et al. 2019

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The aim of this guideline is to improve the standard of, and to reduce regional variation in, the care of women with CKD in the UK who are pregnant, planning a pregnancy or post-partum. Scope This guidance covers the care of women with CKD (including renal transplant recipients) who are planning a pregnancy, pregnant, or in the post-partum period. It also covers contraception and fertility for women with CKD. This guideline can be used in the following settings: General practice Community and hospital antenatal clinics Antenatal, labour and postnatal wards Renal outpatients Renal wards Dialysis units The target audience and intended users of this guideline are nephrologists, obstetricians, obstetric physicians, midwives, renal nurses, pharmacists, specialist trainees in both nephrology and obstetrics, and women with CKD who are pregnant or considering pregnancy. Qualitative data on the experience of pregnancy and renal disease is provided in Appendix 1. A summary of clinical responsibility for elements of the guideline is provided in Appendix 2. The clinical issues covered in this guideline are: Structure of care Medication Pre-pregnancy care 3.1.Contraception 3.2.Fertility 3.3.Pre-pregnancy counselling and optimisation for pregnancy Pregnancy care 4.1 Assessment of renal function in pregnancy 4.2 Antenatal care 4.3 Pre-eclampsia prophylaxis 4.4 Blood pressure management 4.5 Thromboembolism prophylaxis 4.6 Anaemia 4.7 Bone health 4.8 Renal biopsy 4.9 Peripartum care 4.10 Postnatal care Pregnancy Care Assessment of renal function in pregnancy Guideline 4.1.1 We recommend renal function in pregnancy is assessed using serum creatinine concentrations as estimated GFR (eGFR) is not valid for use in pregnancy (1C). Guideline 4.1.2 We recommend women with CKD have formal quantification of proteinuria in pregnancy (1D). Guideline 4.1.3 We recommend quantification of proteinuria is undertaken by protein:creatinine ratio (uPCR) or albumin:creatinine ratio (uACR). Twenty-four hour urine collection for quantification of protein is not required (1B). Antenatal care Guideline 4.2.1 We suggest pregnant women with CKD who have not had pre-pregnancy counselling by the MDT are referred to the MDT and receive the same counselling and optimisation as for women attending pre-pregnancy (2D). Guideline 4.2.2 We recommend pregnant women with CKD receive routine antenatal care, in addition to specialist input (1D). Guideline 4.2.3 We recommend pregnant women with CKD be referred for assessment by a consultant obstetrician (1D). Guideline 4.2.4 We recommend pregnant women with CKD have access to usual trisomy screening with specialist interpretation of high-risk results (1C). Guideline 4.2.5 We recommend women with CKD exposed to teratogenic drugs in the first trimester are referred to a specialist fetal medicine unit (1D). Guideline 4.1.6 We recommend pregnant women with CKD have scans to assess fetal growth and wellbeing in the third trimester (1C). Guideline 4.2.7 We recommend pregnant women taking prednisolone and/or calcineurin inhib...

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“…Im Falle einer pränatalen immunsuppressiven Medikation können und sollten Impfungen mit Totimpfstoffen zeitgerecht nach STIKO-Empfehlung erfolgen [275]. Impfungen mit Lebendimpfstoffen sollten in Abhängigkeit vom gegebenen Immunsuppressivum erst bei nachgewiesenen normwertigen Lymphozyten durchgeführt werden [ExpertInnenkonsens] [372].…”

Section: Impfen Von Säuglingen Und Kindern Nach In Utero-exposition Gunclassified