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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 &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.

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&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