Ustekinumab During Pregnancy in Patients With Inflammatory Bowel Disease

A Prospective Multicentre Cohort Study

Irit Avni-Biron; Tali Mishael; Eran Zittan; Moran Livne-Margolin; Adar Zinger; Roie Tzadok; Rosie Goldenberg; Uri Kopylov; Yulia Ron; Eran Hadar; Sarit Helman; Sorina Grisaru Granovsky; Jacob E. Ollech; Ayelet Arazi; Rivka Farkash; Maor H. Pauker; Henit Yanai; Iris Dotan; Ariella Bar-Gil Shitrit


Aliment Pharmacol Ther. 2022;56(9):1361-1369. 

In This Article

Abstract and Introduction


Background: Women with inflammatory bowel diseases (IBD) often receive biologics to maintain remission during pregnancy.

Aims: To assess maternal and neonatal outcomes in patients with IBD treated with ustekinumab (UST) during pregnancy

Methods: In a multicentre, prospective cohort study, we recruited women with IBD treated with UST during pregnancy between 2019 and 2021. Outcomes were compared among patients treated with UST, anti-tumour necrosis factor α, (anti-TNF) and non-UST, non-anti-TNF therapies. UST-treated patients were matched 1:2 to controls according to age, body mass index and parity. Newborns were followed up to 12 months.

Results: We recruited 129 pregnant patients: UST 27; anti-TNF 52; non-UST, non-anti-TNF 50 (thiopurine or mesalazine 30, no therapy 20); Crohn's disease 25 (96.9%). Overall, pregnancy, neonatal and newborn outcomes were satisfactory, with no significant differences among patients treated with UST, anti-TNF and non-UST non-anti-TNF agents for obstetrical maternal complications [UST 3 (11.5%), anti TNF 12 (23.1%), non UST, non-anti-TNF 4 (8.2%), p = 0.095], pre-term delivery [1 (4.3%), 9 (18.4%), 4 (5.7%), p = 0.133], low birth weight [1 (4.2%), 5 (10.2%), 4 (8.3%), p = 0.679], or first year newborn hospitalisation [2 (9.1%), 4 (8.2%), 3 (6.1%), p = 0.885].

Conclusion: Pregnant patients with IBD treated with UST demonstrated favourable pregnancy and neonatal outcomes that were comparable with those in patients treated with anti-TNF or other therapy. Data are reassuring for patients with IBD and their physicians when considering UST during pregnancy.


The prevalence of inflammatory bowel disease (IBD) is high in women of childbearing age.[1] Preserving remission from conception to delivery is key, as active disease is associated with a higher risk of pregnancy-related complications such as spontaneous abortions, premature birth and low birth weight.[2] Continuation of medical therapy is thus required during conception and pregnancy to induce or maintain remission.[3,4] The risk associated with fetal exposure to IBD medications such as mesalazine, thiopurines, anti-TNF and vedolizumab is considered to be low.[2,5,6]

Ustekinumab (UST), a monoclonal antibody against the P40 subunit common to interleukin (IL)-12 and IL-23 effective in moderate-to-severe Crohn's disease (CD) and ulcerative colitis (UC), is increasingly used, especially in patients refractory to conventional therapies and anti-TNF agents.[7,8] Similar to anti-TNF, UST is an immunoglobulin G1 antibody that transfers across the placenta during pregnancy.[9] UST has been detected in umbilical cord blood and in infant's blood several months after birth.[10–12] Data on pregnancy outcomes in patients treated with UST are limited.

This study aimed to assess outcomes in patients treated with UST during pregnancy and their neonates, and to compare these outcomes with those of patients and neonates exposed to anti-TNF and conventional therapy during pregnancy.