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

Kód výsledku v 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>

Nalezeny alternativní kódy

RIV/00159816:_____/22:00076306 RIV/00023001:_____/22:00083835 RIV/00098892:_____/22:10157482 RIV/00064165:_____/22:10444554 a 6 dalších

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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.

Název v anglickém jazyce

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

Popis výsledku anglicky

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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30219 - Gastroenterology and hepatology

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2022

Kód důvěrnosti údajů

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

Název periodika

Journal of Crohn&apos;s and Colitis

ISSN

1873-9946

e-ISSN

1876-4479

Svazek periodika

16

Číslo periodika v rámci svazku

12

Stát vydavatele periodika

NL - Nizozemsko

Počet stran výsledku

8

Strana od-do

1808-1815

Kód UT WoS článku

000821168100001

EID výsledku v databázi Scopus

2-s2.0-85143551817