Safety of Ustekinumab and Vedolizumab During Pregnancy-Pregnancy, Neonatal, and Infant Outcome: A Prospective Multicentre Study
Identifikátory výsledku
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>
Alternativní jazyky
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 > 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 > 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.
Klasifikace
Druh
J<sub>imp</sub> - Článek v periodiku v databázi Web of Science
CEP obor
—
OECD FORD obor
30219 - Gastroenterology and hepatology
Návaznosti výsledku
Projekt
—
Návaznosti
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Ostatní
Rok uplatnění
2022
Kód důvěrnosti údajů
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Údaje specifické pro druh výsledku
Název periodika
Journal of Crohn'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