Safety of first year vaccination in children born to mothers with inflammatory bowel disease and exposed <i>in utero</i> to anti‐TNFα agents: a French nationwide population‐based cohort

Luu, Maxime; Benzenine, Éric; Barkun, Alan N.; Doret, Muriel; Michiels, Christophe; Degand, Thibault; Quantin, Catherine; Bardou, Marc

doi:10.1111/apt.15504

Cited by 27 publications

(20 citation statements)

References 29 publications

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“… 153 , 171 This concern arises in part due to a fatal case of disseminated Bacillus Calmette-Guérin (BCG) infection after a BCG vaccination was administered at 3 months of age to a child exposed to 10 mg/kg infliximab monotherapy in utero . 172 There have been other reports of over 100 anti-TNF-exposed infants receiving the BCG vaccination and over 400 receiving the Measles–Mumps–Rubella vaccination without adverse effects; 167 , 173 however, significant concern regarding live vaccinations prevails. The rotavirus vaccine is not approved for administration beyond 12 months of age, primarily due to concerns about intussusception; therefore, it should be forgone rather than delayed in anti-TNF-exposed infants.…”

Section: Vaccinationsmentioning

confidence: 99%

Review of pregnancy in Crohn’s disease and ulcerative colitis

Laube

Paramsothy

Leong

2021

Therap Adv Gastroenterol

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Inflammatory bowel disease (IBD) frequently affects women of childbearing age and can have implications in pregnancy. Most women with IBD have comparable fertility with women in the general population. Fertility is reduced in women with active disease or previous ileal-pouch–anal anastomosis (IPAA) surgery and is temporarily reduced in men taking sulfasalazine. Women with IBD have an increased risk of preterm delivery, low birth weight, small-for-gestational-age infants and Cesarean section (CS) delivery, however, no increased risk of congenital abnormalities. These adverse outcomes are particularly prevalent for women with active IBD compared with those with quiescent disease. Conception should occur during disease remission to optimize maternal and fetal outcomes and reduce the risk of disease exacerbations during pregnancy. Pre-conception counseling is therefore pertinent to provide patient education, medication review for risk of teratogenicity and objective disease assessment. Most medications are safe during pregnancy and breastfeeding, with the exception of methotrexate, ciclosporin, allopurinol and tofacitinib. Delivery modality should be guided by obstetric factors in most cases; however, CS is recommended for women with active perianal disease and can be considered for women with inactive perianal disease or IPAA. In conclusion, most women with IBD have uncomplicated pregnancies. Active IBD is the predominant predictor of poor outcomes and disease exacerbations; therefore, maintenance of disease remission during and before pregnancy is crucial.

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Section: Vaccinationsmentioning

confidence: 99%

Review of pregnancy in Crohn’s disease and ulcerative colitis

Laube

Paramsothy

Leong

2021

Therap Adv Gastroenterol

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“…93 However, cohort studies of infants receiving BCG have reported no serious adverse outcomes. 74,94,95 In Canada, the only live vaccine that is routinely administered before 6 months of age is the rotavirus vaccine.…”

Section: Should Infants Exposed To Biologics Be Immunized?mentioning

confidence: 99%

The use and impact of monoclonal antibody biologics during pregnancy

Pham‐Huy

Top

Constantinescu

et al. 2021

CMAJ

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Increasingly, pregnant patients with inflammatory or autoimmune diseases use monoclonal antibody biologics before conception, during pregnancy and while breastfeeding. Anti-TNFα Infliximab Chimeric anti-TNFα IgG1 Rheumatoid arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, plaque psoriasis Adalimumab Recombinant humanized anti-TNFα IgG1 Rheumatoid arthritis, polyarticular JIA, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, hidradenitis suppurativa, plaque psoriasis, uveitis Golimumab Humanized anti-TNFα IgG1 Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, nonradiographic axial spondyloarthritis, ulcerative colitis Certolizumab pegol Recombinant, humanized antibody to the antigen-binding fragment to anti-TNFα Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis Etanercept Human recombinant TNFα receptor/IgG1-Fc fusion protein Ankylosing spondylitis, rheumatoid arthritis, polyarticular JIA, psoriatic arthritis, plaque psoriasis Anticytokine Ustekinumab Anti-IL-12 and IL-23 humanized IgG1 Plaque psoriasis, psoriatic arthritis, Crohn disease, ulcerative colitis Tocilizumab Anti-IL-6 receptor humanized IgG1 Rheumatoid arthritis, polyarticular and systemic JIA, giant cell arteritis Canakinumab Anti-IL-1β human IgG1 CAPS, TRAPS, HIDS, MKD, FMF, systemic JIA Anti-integrin Vedolizumab Humanized anti-α4β7 integrin IgG1 Ulcerative colitis, Crohn disease Natalizumab Anti-integrin α4 subunit humanized IgG4 Multiple sclerosis Anti-B cell Rituximab Anti-CD20 IgG1 Rheumatoid arthritis, non-Hodgkin lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis Belimumab Anti-B-cell activating factor human IgG1 Systemic lupus erythematosus Note: CAPS = cryopyrin-associated periodic syndromes, FMF = familial Mediterranean fever, HIDS = hyperimmunoglobulin D syndrome, Ig = immunoglobulin, IL = interleukin, JIA = juvenile idiopathic arthritis, MKD = mevalonate kinase deficiency, TNF = tumour necrosis factor, TRAPS = tumour necrosis factor receptor associated periodic syndrome. *Off-label use not listed. Box 1: Evidence used in this narrative reviewWe conducted a literature review of preclinical and clinical studies in PubMed, published from January 2005 to February 2021. We searched for articles relevant to the use of monoclonal antibody biologics during pregnancy using the following search terms: biologics, monoclonal antibody biologics, pregnancy, infliximab, adalimumab, certolizumab pegol, vedolizumab, ustekinumab, rituximab and neonatal outcomes. Given the rapid emergence of data pertaining to this topic, we also reviewed selected abstracts, published expert guidelines and case reports. In addition, we reviewed the bibliographies of articles from high-impact journals in the fields of gastroenterology, rheumatology and dermatology. Recently published articles were preferred to reflect the most upto-date evidence for this review.

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“…There is at least one reported fatality case due to disseminated tuberculosis infection in an infant who received a Bacillus Calmette-Guerin for tuberculosis (BCG) vaccination at 3 months of age and whose mother had been taking IFX 10 mg/kg every 8 weeks for Crohn's disease during all the pregnancy (Cheent et al, 2010;Heller et al, 2011). Recently a French nationwide population-based cohort on the safety of vaccinations during the first year of life in exposed children was published (Luu et al, 2019). The Authors studied 670 children exposed to anti-TNFα during pregnancy of women with IBD: among these exposed children, 88 (13%) received BCG live vaccine before 6 months of life and no adverse events were reported.…”

Section: Vaccinationsmentioning

confidence: 99%

The Influence of Treatment of Inflammatory Arthritis During Pregnancy on the Long-Term Children’s Outcome

et al. 2021

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The management of reproductive issues in women with inflammatory arthritis has greatly changed over decades. In the 1980–1990s, women with refractory forms of arthritis were either not able to get pregnant or did choose not to get pregnant because of their disabling disease. Hence, the traditional belief that pregnancy can induce a remission of arthritis. The availability of biologic agents has allowed a good control of aggressive forms of arthritis. The main topic of discussion during preconception counselling is the use of drugs during pregnancy and breastfeeding. Physicians are now supported by international recommendations released by the European League Against Rheumatism and the American College of Rheumatology, but still they must face with cultural reluctance in accepting that a pregnant woman can take medications. Patient-physician communication should be centered on the message that active maternal disease during pregnancy is detrimental to fetal health. Keeping maternal disease under control with drugs which are not harmful to the fetus is the best way to ensure the best possible outcome for both the mother and the baby. However, there might be concerns about the influence of the in utero exposure to medications on the newborn’s health conditions. Particularly, studies suggesting an increased risk of autism-spectrum-disorders in children born to women with rheumatoid arthritis has raised questions about neuropsychological impairment in the offspring of women with chronic arthritis. As a multidisciplinary group of rheumatologists and child neuropsychiatrists, we conducted a study on 16 women with chronic forms of arthritis whose diagnosis was determined before pregnancy and their 18 school-age children. The children underwent a complete neurological examination and validated tests/questionnaires. Behavioral aspects of somatization and anxiety/depression (internalizing problem) or an “adult profile” were found in nearly one third of children. Children at a high risk of neurodevelopmental problems were born to mothers with a longer history of arthritis and were breastfeed for less than 6 months of age or were not breastfeed at all. No association was found with other maternal characteristics such as autoantibody existence and disease activity during and after the pregnancy.

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Safety of first year vaccination in children born to mothers with inflammatory bowel disease and exposed in utero to anti‐TNFα agents: a French nationwide population‐based cohort

Cited by 27 publications

References 29 publications

Review of pregnancy in Crohn’s disease and ulcerative colitis

Review of pregnancy in Crohn’s disease and ulcerative colitis

The use and impact of monoclonal antibody biologics during pregnancy

The Influence of Treatment of Inflammatory Arthritis During Pregnancy on the Long-Term Children’s Outcome

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