Vedolizumab clearance in neonates, susceptibility to infections and developmental milestones: a prospective multicentre population‐based cohort study

Julsgaard, Mette; Baumgart, Daniel C.; Baunwall, Simon Mark Dahl; Hansen, Mette; Grosen, Anne; Bibby, Bo Martin; Uldbjerg, Niels; Kjeldsen, Jens; Sørensen, Heidi G.; Larsen, Lone; Wildt, Signe; Weimers, Petra; Haderslev, Kent V.; Vind, Ida; Svenningsen, Lise; Brynskov, Jørn; Lyhne, Søren; Vestergaard, Thea; Hvas, Christian Lodberg; Kelsen, Jens

doi:10.1111/apt.16593

Cited by 25 publications

(27 citation statements)

References 28 publications

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“…Regarding the use of biologics, we found the usage twice as high in women with CD compared to women with UC, which is in line with previous studies 20,27–29 . When solely considering women with disease activity, the usage was even three times higher among women with CD as in women with UC.…”

Section: Discussionsupporting

confidence: 91%

“…A noteworthy finding in this study was a prevalence of malformations of 9.0% and 7.4% in UC and CD, respectively, that exceeds those of previous studies 20,28–31 . The congenital malformations were equally distributed between minor and major, and were categorised in different ICD classes.…”

Section: Discussioncontrasting

confidence: 61%

“…Regarding the use of biologics, we found the usage twice as high in women with CD compared to women with UC, which is in line with previous studies. 20,[27][28][29] When solely considering women with disease activity, the usage was even three times higher among women with CD as in women with UC. This may reflect the fact that we continue to hold fewer remedies, that is, topical treatment, in CD as opposed to UC, and that the degree of chronicity and systemic inflammatory nature of CD may lead to more widespread use of biologics.…”

Section: Discussionmentioning

confidence: 98%

“…When assessing the presence of disease activity, we employed the Physician's Global Assessment (PGA) to define dichotomously whether or not a woman experienced disease activity. The PGA is an arbitrarily designed, multicomponent measure of disease activity that is often used in prospective studies 14,18–20 . The PGA was based on the attending gastroenterologist's assessment incorporating escalation in medical treatment, patient completion of validated disease activity indices (Harvey Bradshaw or Simple Clinical Colitis Activity Index) and if available biomarker of inflammation (C‐reactive protein [CRP] and faecal calprotectin [FC]).…”

Section: Methodsmentioning

confidence: 99%

“…The PGA is an arbitrarily designed, multicomponent measure of disease activity that is often used in prospective studies. 14,[18][19][20] The PGA was based on the attending gastroenterologist's assessment incorporating escalation in medical treatment, patient completion of validated disease activity indices (Harvey Bradshaw or Simple Clinical Colitis Activity Index) and if available biomarker of inflammation (C-reactive protein [CRP] and faecal calprotectin [FC]). The PGA was performed by only one gastroenterologist to ensure consistency in all assessments, and was applied during the pre-conception period (6 months), at conception and in each trimester of pregnancy.…”

Section: Collection Of Data Through Review Of Medical Recordsmentioning

confidence: 99%

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Predictors of disease activity during pregnancy in women with inflammatory bowel disease—a Danish cohort study

Vestergaard

Julsgaard

Røsok

et al. 2022

Aliment Pharmacol Ther

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Summary Background and Aims Inflammatory bowel disease (IBD) activity during pregnancy is associated with adverse pregnancy outcomes. We aimed to identify key clinical characteristics that predict disease activity during pregnancy. Methods Between January 2008 through 2021, we identified all singleton pregnancies among women with IBD recorded in patient and birth registries at a tertiary IBD centre in Denmark. Maternal and infant data were retrieved from medical records. Demographics, Physicians Global Assessment (PGA) of disease activity 6 months prior to pregnancy and in all three trimesters of pregnancy and pregnancy outcomes were recorded. Results In 609 pregnancies, we observed 603 (99.0%) live births. Disease activity in one or more trimesters was seen in 283 women (46.5%). UC phenotype was associated with an increase in risk of disease activity (adjusted OR = 2.6 [1.8–3.9]; p < 0.001). Disease activity within 6 months prior to conceiving (169 women [27.7%]) was associated with an increased risk of continuous disease activity during pregnancy (adjusted OR of 5.3 [3.5–8.2]; p < 0.001). Disease activity during a previous pregnancy was associated with an increased risk of flares in subsequent pregnancies (adjusted OR of 3.2 [1.5–6.6]; p = 0.002). Sustained clinical remission throughout pregnancy was associated with an increased probability of normal birth term, birthweight and low risk of fetal growth restriction (FGR) and stillbirth. Conclusion Predictors for disease activity include disease activity in a previous pregnancy and/or prior to conception, as well as UC phenotype. Reassuringly, women with IBD in remission are not at increased risk of adverse pregnancy outcomes.

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Section: Discussionsupporting

confidence: 91%

Section: Discussioncontrasting

confidence: 61%

Section: Discussionmentioning

confidence: 98%

Section: Methodsmentioning

confidence: 99%

Section: Collection Of Data Through Review Of Medical Recordsmentioning

confidence: 99%

See 3 more Smart Citations

Predictors of disease activity during pregnancy in women with inflammatory bowel disease—a Danish cohort study

Vestergaard

Julsgaard

Røsok

et al. 2022

Aliment Pharmacol Ther

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Serological responses to vaccination in children exposed in utero to ustekinumab or vedolizumab: cross-sectional analysis of a prospective multicentre cohort

Mitrova,

Cerna,

Zdychyncova

et al. 2024

Eur J Pediatr

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Evidence on serological responses to vaccination in children exposed to ustekinumab (UST) or vedolizumab (VDZ) in utero is lacking. This multicentre prospective study aimed to assess the impact of prenatal exposure to UST or VDZ due to maternal inflammatory bowel disease (IBD) on serological responses to vaccination and other immunological parameters in exposed children. Children aged ≥ 1 year who were exposed in utero to UST or VDZ and completed at least 1-year of mandatory vaccination were included. We assessed the serological response to vaccination (non-live: tetanus, diphtheria, and Haemophilus influenzae B; live: mumps, rubella, and measles), whole blood count, and immunoglobulin levels. The control group comprised unexposed children born to mothers without IBD. A total of 23 children (median age, 25 months) exposed to UST (n = 13) or VDZ (n = 10) and 10 controls (median age, 37 months) were included. The serological response to vaccination was comparable between the UST and VDZ groups and controls, with an adequate serological response rate of ≥ 80%. Only children exposed to UST showed a slightly reduced serological response to mumps (67% vs. 86% in controls), whereas all children exposed to VDZ showed an adequate response. The majority of the exposed children had normal levels of individual immunoglobulin classes, similar to the controls. No severe pathology was observed in any of the children.Conclusion: Despite the limited sample size, our findings suggest that in utero exposure to VDZ or UST does not significantly impair the vaccine response or broader immunological parameters in exposed children. What is known:• Treatment with anti-TNF inhibitors during pregnancy does not appear to affect serologic response to vaccination in exposed children.• Evidence on the efficacy of vaccination in children exposed to ustekinumab or vedolizumab in utero is almost lacking.What is new:• Our findings suggest that in utero exposure to ustekinumab or vedolizumab does not significantly affect the serological responses to common childhood non-live (tetanus, Haemophilus influenzae B, diphtheria) and live vaccines (measles, mumps, rubella).• No major adverse effects on overall immunological health were observed in children exposed in utero to ustekinumab or vedolizumab.

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Common teratogenic medication exposures—a population-based study of pregnancies in the United States

Wang,

Smolinski,

Thai

et al. 2024

American Journal of Obstetrics & Gynecology MFM

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Vedolizumab clearance in neonates, susceptibility to infections and developmental milestones: a prospective multicentre population‐based cohort study

Cited by 25 publications

References 28 publications

Predictors of disease activity during pregnancy in women with inflammatory bowel disease—a Danish cohort study

Predictors of disease activity during pregnancy in women with inflammatory bowel disease—a Danish cohort study

Serological responses to vaccination in children exposed in utero to ustekinumab or vedolizumab: cross-sectional analysis of a prospective multicentre cohort

Common teratogenic medication exposures—a population-based study of pregnancies in the United States

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