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Safety of Ustekinumab and Vedolizumab During Pregnancy-Pregnancy, Neonatal, and Infant Outcome: A Prospective Multicentre Study
K. Mitrova, B. Pipek, M. Bortlik, L. Bouchner, J. Brezina, T. Douda, T. Drasar, P. Klvana, P. Kohout, V. Leksa, P. Minarikova, A. Novotny, P. Svoboda, J. Skorpik, J. Ulbrych, M. Veinfurt, B. Zborilova, M. Lukas, D. Duricova, Czech IBD Working Group
Jazyk angličtina Země Anglie, Velká Británie
Typ dokumentu pozorovací studie, multicentrická studie, časopisecké články
PubMed
35708729
DOI
10.1093/ecco-jcc/jjac086
Knihovny.cz E-zdroje
- MeSH
- gastrointestinální látky škodlivé účinky terapeutické užití MeSH
- humanizované monoklonální protilátky * škodlivé účinky terapeutické užití MeSH
- idiopatické střevní záněty * farmakoterapie MeSH
- inhibitory TNF škodlivé účinky terapeutické užití MeSH
- kojenec MeSH
- lidé MeSH
- matka - expozice noxám MeSH
- novorozenec MeSH
- placenta MeSH
- prospektivní studie MeSH
- těhotenství MeSH
- ustekinumab * škodlivé účinky terapeutické užití MeSH
- výsledek těhotenství MeSH
- výsledek terapie MeSH
- Check Tag
- kojenec MeSH
- lidé MeSH
- novorozenec MeSH
- těhotenství MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- pozorovací studie MeSH
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, multicentre, 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 with the anti-tumour necrosis factor [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 the vedolizumab or the 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 and it was 0.59 in vedolizumab. CONCLUSIONS: Use of ustekinumab and vedolizumab in pregnancy seems to be safe, with favuorable 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 with anti-TNF preparations.
2nd Department of Internal Medicine St Anne's University Hospital Brno Brno Czech Republic
4th Internal Clinic General University Hospital Charles University Prague Czech Republic
Beskydy Gastrocentre Hospital Frydek Mistek Frýdek místek Czech Republic
Department of Gastroenterology Hospital Ceske Budejovice Ceske Budejovice Czech Republic
Department of Gastroenterology Hospital Jihlava Jihlava Czech Republic
Department of Gastroenterology Hospital Karlovy Vary Karlov Vary Czech Republic
Department of Internal Medicine Faculty of Medicine University of Ostrava Ostrava Czech Republic
Digestive Diseases Centre Hospital AGEL Vitkovice Ostrava Czech Republic
Endoscopy Internal Department Pardubice Hospital Pardubice Czech Republic
IBD centre Turnov Liberec Regional Hospital Liberec Czech Republic
Institute of Pharmacology 1st Faculty of Medicine Charles University Prague Prague Czech Republic
Citace poskytuje Crossref.org
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- $a 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, multicentre, 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 with the anti-tumour necrosis factor [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 the vedolizumab or the 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 and it was 0.59 in vedolizumab. CONCLUSIONS: Use of ustekinumab and vedolizumab in pregnancy seems to be safe, with favuorable 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 with anti-TNF preparations.
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