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

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.