J Crohns Colitis. 2022 Dec 5;16(12):1808-1815.doi: 10.1093/ecco-jcc/jjac086.

Katarina Mitrova ^1 2, Barbora Pipek ^3 4 5, Martin Bortlik ^6 7 8, Ludek Bouchner ⁹, Jan Brezina ¹⁰, Tomas Douda ¹¹, Tomas Drasar ¹², Pavel Klvana ¹³, Pavel Kohout ¹⁴, Vaclav Leksa ¹⁵, Petra Minarikova ⁸, Ales Novotny ¹⁶, Pavel Svoboda ⁵, Jan Skorpik ¹⁷, Jan Ulbrych ^18 19, Marek Veinfurt ²⁰, Blanka Zborilova ²⁰, Milan Lukas ¹, Dana Duricova ^1 7; Czech IBD Working Group

Author information

¹Clinical and Research Centre for Inflammatory Bowel Disease, ISCARE a.s., Charles University in Prague, Prague, Czech Republic.

²Department of Paediatrics, 2nd Faculty of Medicine, Charles University in Prague and Motol University Hospital, Prague, Czech Republic.

³Digestive Diseases Centre, Hospital AGEL Vitkovice, Ostrava, Czech Republic.

⁴2nd Department of Internal Medicine-Gastroenterology and Geriatrics, Faculty of Medicine and Dentistry, Palacky University and University Hospital Olomouc, Czech Republic.

⁵Department of Internal Medicine, Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic.

⁶Department of Gastroenterology, Hospital Ceske Budejovice, Ceske Budejovice, Czech Republic.

⁷Institute of Pharmacology, 1st Faculty of Medicine, Charles University in Prague, Prague, Czech Republic.

⁸Department of Internal Medicine, 1st Faculty of Medicine and Central Military Hospital, Prague, Czech Republic.

⁹Department of Internal Medicine, Faculty of Medicine in Pilsen, Charles University in Prague, Czech Republic.

¹⁰Department of hepatogastroenterology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic.

¹¹2nd Department of Gastroenterology, University Hospital Hradec Kralove, Charles University-Faculty of Medicine in Hradec Kralove, Hradec Kralove, Czech Republic.

¹²IBD centre Turnov, Liberec Regional Hospital, Liberec, Czech Republic.

¹³Beskydy Gastrocentre, Hospital Frydek-Mistek, Frýdek-místek, Czech Republic.

¹⁴Endoscopy, Internal Department, Pardubice Hospital, Pardubice, Czech Republic.

¹⁵Department of Medicine 1st Faculty of Medicine Charles University and Military University Hospital, Prague, Czech Republic.

¹⁶4th Internal Clinic, General University Hospital, Charles University, Prague, Czech Republic.

¹⁷Department of Gastroenterology, Hospital Jihlava, Jihlava, Czech Republic.

¹⁸2nd Department of Internal Medicine, St. Anne's University Hospital Brno, Brno, Czech Republic.

¹⁹SurGal Clinic, Brno, Czech Republic.

²⁰Department of Gastroenterology, Hospital Karlovy Vary, Karlov Vary, Czech Republic.

Abstract

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.