Comparative safety of ustekinumab versus anti-TNF therapy during pregnancy in patients with inflammatory bowel disease: A systematic review and meta-analysis

Bardak A. E., Saeed H., Teker G., Friedman S., Alsakarneh S., Mitev S.

Medicine, vol.104, no.37, 2025 (SCI-Expanded) identifier identifier identifier

  • Publication Type: Article / Article
  • Volume: 104 Issue: 37
  • Publication Date: 2025
  • Doi Number: 10.1097/md.0000000000044393
  • Journal Name: Medicine
  • Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus, BIOSIS, CAB Abstracts, CINAHL, Veterinary Science Database, Directory of Open Access Journals
  • Keywords: anti-TNF, Crohn disease, inflammatory bowel disease, pregnancy outcomes, ulcerative colitis, ustekinumab
  • Istanbul University Affiliated: Yes

Abstract

BACKGROUND: Inflammatory bowel disease (IBD) frequently affects women of reproductive age. While the safety of anti-tumor necrosis factor (TNF) agents during pregnancy is well established, data on the safety of ustekinumab remain limited. We aimed to compare the safety of ustekinumab versus anti-TNF therapy in pregnant patients with IBD in terms of pregnancy outcomes. METHODS: We systematically searched PubMed, Embase, and Cochrane databases. Studies comparing ustekinumab and anti-TNF agents and reporting key pregnancy outcomes were included. Pooled analyses were performed using random-effects models. RESULTS: Four studies, encompassing 3308 pregnancies (592 ustekinumab, 2716 anti-TNF) were included. The majority of patients (2914; 88.2%) had Crohn disease, and the median disease duration ranged from 6.5 to 14 years. There was no significant difference between ustekinumab and anti-TNF therapy in major pregnancy outcomes, including live birth rates (67.2% vs 67.7%; odds ratio [OR] = 0.73, 95% confidence interval [CI] = 0.39-1.37), spontaneous abortion rates (5.9% vs 4.2%; OR = 1.51, 95% CI = 0.74-3.36), preterm delivery rates (6.6% vs 7.4%; OR = 0.50, 95% CI = 0.15-1.61), low birth weight rates (4.6% vs 7.1%; OR = 0.68, 95% CI = 0.23-1.98), and cesarean section rates (30.0% vs 30.1%; OR = 1.11, 95% CI = 0.85-1.45). CONCLUSION: Ustekinumab appears comparable to anti-TNF agents regarding major pregnancy outcomes in pregnant patients with IBD, suggesting its potential safety during pregnancy.