Background Biological drugs used for IBD are detected in breast milk at a concentration below 10% of the maternal serum concentration and have therefore been considered as permitted drugs. However, warnings have recently been published regarding vaccination with live agents in children whose mothers receive infliximab during breastfeeding. Aim To assess the risk of serious adverse events related to the administration of live vaccines in children exposed to biological drugs in utero or whose mothers were receiving biological agents during breastfeeding. Methods Children born to IBD mothers from DUMBO registry of GETECCU were included. DUMBO is a prospective, observational and multicentre registry, which enrolls pregnant women with IBD over 5 years in 70 centres in Spain. Data on treatment during gestation, type of lactation, breastfeeding, end-date of breastfeeding, maternal treatments during breastfeeding and serious adverse events in children from birth are being prospectively included contacting with the mothers every-3-months. Following the Spanish immunization calendar, rotavirus vaccine is (voluntarily) administered at 2, 4 and 6 (3rd dose only with Rotateq®) months; measles, mumps and rubella (MMR) at 12 months and 3-4 years of age; and varicella at 15 months and 3-4 years of age. Results 526 newborns were included in the registry at the time of data analysis. A total of 205 (39%) had been exposed to biologics during pregnancy or breastfeeding (table 1): 80 (42%) during pregnancy, 7 (2%) during breastfeeding, and 109 (57%) during both. Newborn’s demographics and exposure to drugs during breastfeeding are summarized in table 2. Mean follow-up was 12 months; proportion of children breastfed during follow-up is shown in table 3a. The percentage of children who had been vaccinated according to the recommended schedule was above 95% at all visits (table 3b). Live vaccines administered to children exposed in utero to biologics during the 3rd trimester of gestation are shown in table 4a. From birth, 71% of infants were breastfed (52% exclusively breastfed). Live vaccines administered to children breastfed at least until month 6, until month 12 and until month 15 are summarized in table 4b. No serious adverse event related to live vaccine was reported in our cohort. Conclusion Administration of live virus vaccines from 12 months of age in children born to IBD mothers and exposed to biological drugs in utero or during breastfeeding seems safe and should not be recommended against vaccination or breastfeeding. Rotavirus vaccine (under 6 months of age) appears to be equally safe in these children.

In some areas of Spain, toxic nodular goitre continues to be the most frequent cause of thyrotoxicosis. It is necessary to insist on implementation and monitoring of iodine supplementation programs.

Background Prospective registries are necessary to evaluate the safety of inflammatory bowel disease (IBD) treatment during pregnancy and in children in the long term. Aims The overall aim of DUMBO registry is to know the risk of serious adverse events (SAEs) during pregnancy and in children up to 4 years of age exposed during pregnancy to drugs for IBD (mainly focused on biologics), compared to unexposed children. In this analysis we aim to evaluate the risk of SAEs during pregnancy and the predictive factors of it (mainly focused on IBD drugs). Methods Prospective, observational and multicentre registry, which enrols pregnant women with IBD (Crohn’s disease, ulcerative colitis, IBD-unclassified) over 5 years in 70 centres in Spain. The registry was kicked off in September 2019. SAE was defined based on “Clinical Safety Data Management: Definitions and Standards for Expedited Reporting by European Medicines Agency”. Study protocol is summarized in figure 1. Results 433 women have been included so far; 241 got pregnant at least 9 months before this interim analysis (table 1). Mean age was 34 years, and 17% of women had active disease at any time during pregnancy. 23% of pregnancies were exposed to immumodulators (thiopurines), 25% to biologics and 10% to combo therapy (biologics and immunomodulators). 85 pregnancies (35%) were exposed to biologics (60 anti-TNF, 17 ustekinumab, and 8 vedolizumab) either in combo or in monotherapy. There were 237 newborns (227 singleton and 5 pair of twins), 9 miscarriages and 1 abortion. 72% of patients had vaginal delivery and 28% C-sections (18% due to perianal CD or active disease). A total of 59 pregnancies (24.5%) reported at least one SAE: 32% in exposed to biologics and 20.5% in non-exposed group (p>0.05) (figure 2). Four out of 17 pregnancies exposed to ustekinumab and 3 out of 8 exposed to vedolizumab had SAEs (non-related with the drug). In the multivariate analysis, adjusted by disease activity, in comparison with no immunosuppressive treatment, neither immunosuppressants [Odds ratio (OR)=1.1, 95% confidence interval (CI)=0.3–4.3] nor biologics in monotherapy or in combo (OR=0.8; 95%CI=0.2–3) were associated with higher risk of SAEs. 40 patients (17%) were hospitalised due to complications during pregnancy or delivery (figure 3). Two patients underwent surgery during pregnancy due to IBD complications Conclusion IBD treatment (either immunomodulators or biologics) does not increase the risk of SAEs during pregnancy. Nevertheless, one-quarter of IBD women suffer SAEs during pregnancy and about 20% need hospitalisation, which should be taken into account when managing IBD during pregnancy.