Safety of Ustekinumab and Vedolizumab During Pregnancy-Pregnancy, Neonatal, and Infant Outcome: A Prospective Multicentre Study

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00669806%3A_____%2F22%3A10444554" target="_blank" >RIV/00669806:_____/22:10444554 - isvavai.cz</a>

Alternative codes found

RIV/00159816:_____/22:00076306 RIV/00023001:_____/22:00083835 RIV/00098892:_____/22:10157482 RIV/00064165:_____/22:10444554 and 6 more

Result on the web

<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=UJ8IUWrXxR" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=UJ8IUWrXxR</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1093/ecco-jcc/jjac086" target="_blank" >10.1093/ecco-jcc/jjac086</a>

Result language

angličtina

Original language name

Safety of Ustekinumab and Vedolizumab During Pregnancy-Pregnancy, Neonatal, and Infant Outcome: A Prospective Multicentre Study

Original language description

BACKGROUND AND AIMS: Evidence on the safety of newer biologics during pregnancy is limited. We aimed to assess the safety of ustekinumab and vedolizumab treatment during gestation on pregnancy and infant outcome. Furthermore, we evaluated the placental transfer of these agents. METHODS: We performed a prospective multicenter observational study in consecutive women with inflammatory bowel disease exposed to ustekinumab or vedolizumab 2 months prior to conception or during pregnancy. Pregnancy, neonatal, and infant outcomes were evaluated and compared to the anti-TNF exposed control group. Drug levels were assessed in maternal and cord blood at delivery. RESULTS: We included 54 and 39 pregnancies exposed to ustekinumab and vedolizumab, respectively. In the ustekinumab group, 43 (79.9%) resulted in live births, and 11 (20.4%) led to spontaneous abortion. Thirty-five (89.7%) pregnancies on vedolizumab ended in a live birth, two (5.1%) in spontaneous, and two (5.1%) in therapeutic abortion. No significant difference in pregnancy outcome between either vedolizumab or ustekinumab group and controls was observed (p &gt; 0.05). Similarly, there was no negative safety signal in the postnatal outcome of exposed children regarding growth, psychomotor development, and risk of allergy/atopy or infectious complications. The median infant-to-maternal ratio of ustekinumab levels was 1.67, while it was 0.59 in vedolizumab. CONCLUSION: Use of ustekinumab and vedolizumab in pregnancy seems to be safe, with favorable pregnancy and postnatal infant outcomes. Placental transfer differed between these two drugs, with ustekinumab having similar and vedolizumab having inverse infant-to-maternal ratio of drug levels compared to anti-TNF preparations.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

—

OECD FORD branch

30219 - Gastroenterology and hepatology

Project

—

Continuities

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2022

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Journal of Crohn&apos;s and Colitis

ISSN

1873-9946

e-ISSN

1876-4479

Volume of the periodical

16

Issue of the periodical within the volume

12

Country of publishing house

NL - THE KINGDOM OF THE NETHERLANDS

Number of pages

8

Pages from-to

1808-1815

UT code for WoS article

000821168100001

EID of the result in the Scopus database

2-s2.0-85143551817