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

Autor: Mitrova K; Clinical and Research Centre for Inflammatory Bowel Disease, ISCARE a.s., Charles University in Prague, Prague, Czech Republic.; Department of Paediatrics, 2nd Faculty of Medicine, Charles University in Prague and Motol University Hospital, Prague, Czech Republic., Pipek B; Digestive Diseases Centre, Hospital AGEL Vitkovice, Ostrava, Czech Republic.; 2nd Department of Internal Medicine-Gastroenterology and Geriatrics, Faculty of Medicine and Dentistry, Palacky University and University Hospital Olomouc, Czech Republic.; Department of Internal Medicine, Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic., Bortlik M; Department of Gastroenterology, Hospital Ceske Budejovice, Ceske Budejovice, Czech Republic.; Institute of Pharmacology, 1st Faculty of Medicine, Charles University in Prague, Prague, Czech Republic.; Department of Internal Medicine, 1st Faculty of Medicine and Central Military Hospital, Prague, Czech Republic., Bouchner L; Department of Internal Medicine, Faculty of Medicine in Pilsen, Charles University in Prague, Czech Republic., Brezina J; Department of hepatogastroenterology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic., Douda T; 2nd Department of Gastroenterology, University Hospital Hradec Kralove, Charles University-Faculty of Medicine in Hradec Kralove, Hradec Kralove, Czech Republic., Drasar T; IBD centre Turnov, Liberec Regional Hospital, Liberec, Czech Republic., Klvana P; Beskydy Gastrocentre, Hospital Frydek-Mistek, Frýdek-místek, Czech Republic., Kohout P; Endoscopy, Internal Department, Pardubice Hospital, Pardubice, Czech Republic., Leksa V; Department of Medicine 1st Faculty of Medicine Charles University and Military University Hospital, Prague, Czech Republic., Minarikova P; Department of Internal Medicine, 1st Faculty of Medicine and Central Military Hospital, Prague, Czech Republic., Novotny A; 4th Internal Clinic, General University Hospital, Charles University, Prague, Czech Republic., Svoboda P; Department of Internal Medicine, Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic., Skorpik J; Department of Gastroenterology, Hospital Jihlava, Jihlava, Czech Republic., Ulbrych J; 2nd Department of Internal Medicine, St. Anne's University Hospital Brno, Brno, Czech Republic.; SurGal Clinic, Brno, Czech Republic., Veinfurt M; Department of Gastroenterology, Hospital Karlovy Vary, Karlov Vary, Czech Republic., Zborilova B; Department of Gastroenterology, Hospital Karlovy Vary, Karlov Vary, Czech Republic., Lukas M; Clinical and Research Centre for Inflammatory Bowel Disease, ISCARE a.s., Charles University in Prague, Prague, Czech Republic., Duricova D; Clinical and Research Centre for Inflammatory Bowel Disease, ISCARE a.s., Charles University in Prague, Prague, Czech Republic.; Institute of Pharmacology, 1st Faculty of Medicine, Charles University in Prague, Prague, Czech Republic.
Jazyk: angličtina
Zdroj: Journal of Crohn's & colitis [J Crohns Colitis] 2022 Dec 05; Vol. 16 (12), pp. 1808-1815.
DOI: 10.1093/ecco-jcc/jjac086
Abstrakt: 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.
(© The Author(s) 2022. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
Databáze: MEDLINE
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