Tofacitinib in Pregnancy: Assessing Pregnancy and Infant Outcomes, Cord Blood, and Breast Milk Concentrations

Katarina Mitrova; Mette Julsgaard; Patrick Augustijns; Karin Cerna; Uma Mahadevan; Dana Duricova; Pregnancy Study Group

doi:10.1016/j.cgh.2024.01.019

Tofacitinib in Pregnancy: Assessing Pregnancy and Infant Outcomes, Cord Blood, and Breast Milk Concentrations

Clin Gastroenterol Hepatol. 2024 Feb 1:S1542-3565(24)00096-X. doi: 10.1016/j.cgh.2024.01.019. Online ahead of print.

Authors

Katarina Mitrova¹, Mette Julsgaard², Patrick Augustijns³, Karin Cerna⁴, Uma Mahadevan⁵, Dana Duricova⁶; Pregnancy Study Group

Collaborators

Pregnancy Study Group:
Raf Mols³, Kristyna Zdychyncova⁷, Michal Konecny⁸, Philip O Anderson⁹, Milan Lukas⁷

Affiliations

¹ IBD Clinical and Research Centre, ISCARE a.s., Prague, Czech Republic; Department of Paediatrics, 2nd Faculty of Medicine, Motol University Hospital, Charles University in Prague, Prague, Czech Republic.
² Department of Hepatology and Gastroenterology, Aarhus University Hospital, Aarhus, Denmark; Center for Molecular Prediction of Inflammatory Bowel Disease, Department of Clinical Medicine, Aalborg University, Copenhagen, Denmark.
³ Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
⁴ Immunology Department, IBD Clinical and Research Centre, ISCARE a.s., Prague, Czech Republic; GENNET s.r.o., Prague, Czech Republic.
⁵ Division of Gastroenterology, Department of Medicine, University of California, San Francisco, San Francisco, California.
⁶ IBD Clinical and Research Centre, ISCARE a.s., Prague, Czech Republic; Department of Pharmacology, 1st Faculty of Medicine, Charles University in Prague, Czech Republic.
⁷ IBD Clinical and Research Centre, ISCARE a.s., Prague, Czech Republic.
⁸ 2nd Department of Internal Medicine Gastroenterology and Geriatrics, Faculty of Medicine and Dentistry, Palacky University and University Hospital Olomouc, Czech Republic.
⁹ UC San Diego Skaggs School of Pharmacy and Pharmaceutical Sciences, La Jolla, California.

PMID: 38309493
DOI: 10.1016/j.cgh.2024.01.019

Abstract

Janus kinase (JAK) inhibitors are effective anti-inflammatory agents for treatment of ulcerative colitis (UC).¹ According to drug regulatory agencies and international guidelines, JAK inhibitors should be avoided during pregnancy and lactation.^2-4 The existing evidence on safety of JAK inhibitors during pregnancy is scarce and almost exclusively limited to tofacitinib.^4-7.