FRI0141 Vaccination decisions and incidence of neonatal infections in mothers exposed to biologicals during pregnancy

Abstract

BackgroundRheumatologic diseases commonly affect women of childbearing age(.1, 2 There is currently limited data available regarding the safety of vaccinations in infants after in utero exposure to biologics.ObjectivesTo determine the vaccination decisions of mothers with rheumatologic diseases exposed to biologics during pregnancy and the incidence of serious neonatal infections after third trimester exposure.MethodsAll Australian women with inflammatory arthritis, exposed to biologics during the preconception, antenatal and/or postpartum periods, were invited to participate in the Pregnancy Exposed to Biological (PEB) study from May 2009 – . Jan 2018 Recruitment was via direct invitation from patients treating rheumatologists, community groups, and via social media. Following self-referral to the study, retrospective data was collected, including biological exposure, vaccination history and the incidence of serious neonatal infections, defined as infection requiring hospitalisation.ResultsPreliminary data is available regarding 35 offspring from 28 mothers. 34 of 35 offspring were vaccinated. 29 received vaccinations in accordance with the Australian National Immunisation Program Schedule. 1 mother declined to immunise her infant due to personal preference.13 infants were exposed to a tumour necrosis factor inhibitor (TNFi) during the third trimester. Of these, 4 had Rotavirus vaccine delayed from 2 to 4 months and 1 infant until 6 months. 1 infant did not receive the Rotavirus vaccine at 2 months due to exposure to a TNFi while breastfeeding. There were no incidences of serious neonatal infections.ConclusionsCurrent guidelines recommend deferring live vaccines, such as rotavirus, until after 6 months if exposed to a biologic in the third trimesterr.(2–5 Compliance with these recommendations was only observed in one infant in our study. One infant received delayed Rotavirus vaccination due to concern about TNFi exposure during breastfeeding; this is not in keeping with current guidelines. Of the 12 infants exposed to a biologic during the third trimester who did not delay live vaccination until after 6 months, there were no incidents of serious neonatal infections, in keeping with the findings of current published case series.References[1] Brouwer J, Hazes JM, Laven JS, Dolhain RJ. Fertility in women with rheumatoid arthritis: influence of disease activity and medication. Ann Rheum Dis. 2015;74(10):1836–41.[2] Gotestam Skorpen C, Hoeltzenbein M, Tincani A, Fischer-Betz R, Elefant E, Chambers C, et al. The EULAR points to consider for use of antirheumatic drugs before pregnancy, and during pregnancy and lactation. Ann Rheum Dis. 2016;75(5):795–810.[3] Flint J, Panchal S, Hurrell A, van de Venne M, Gayed M, Schreiber K, et al. BSR and BHPR guideline on prescribing drugs in pregnancy and breastfeeding-Part I: standard and biologic disease modifying anti-rheumatic drugs and corticosteroids. Rheumatology (Oxford). 2016;55(9):1693–7.[4] Health AGDo. 3.3 Groups with special vaccination requirements2017.[5] Ostensen M. ...

Intrauterine Exposure to Biologics in Inflammatory Autoimmune Diseases: A Systematic Review

“…In some of the included publications the type of biologic used was not specified for the outcomes. In general, these studies did not show any abnormal outcomes in children exposed to biologics during pregnancy/lactation [155][156][157][158][159][160][161][162][163][164][165][166][167].…”

The Risks and Benefits of Monoclonal Antibody Therapy During Pregnancy and Postpartum: Maternal, Obstetric, and Neonatal Considerations

“…Cohort studies and case series have described safe vaccination without serious complications in infants who received rotavirus vaccine after in utero exposure to mAbs, 55 including those who were exposed during the third trimester. 56 A systematic review of live vaccine outcomes before 12 months for 276 in utero exposures found that administration of the MMR and rotavirus vaccines were not associated with harmful adverse reactions; however, the BCG vaccine was and should be cautioned against due to increased risk of fatal disseminated BCG infection after vaccination. 57 Current guidelines recommend that all infants exposed to mAbs in utero receive inactivated immunizations according to routine schedule.…”

The use and impact of monoclonal antibody biologics during pregnancy

“…Case series 65,82 and more recently, cohort studies 59,76,96 have described exposed infants who received this vaccine without serious complications, such as vaccine-associated rotavirus disease. 83,[97][98][99] Rotavirus infection from the live-attenuated vaccine has been limited primarily to patients with severe combined immune deficiency, [100][101][102] suggesting that this adverse event is mostly observed in children with severe T-and B-cell immunodeficiency and not with other immune defects or mild immunosuppression. [103][104][105] Specialist assessment of immune function is recommended before considering administration of rotavirus vaccination, with careful review of the specific drug exposure.…”