S1671 Comparative Safety of Ustekinumab vs Anti-TNF Therapy During Pregnancy in Patients With Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis

Introduction: Inflammatory bowel disease (IBD) frequently affects women of reproductive age. While the safety of anti-tumor necrosis factor (anti-TNF) agents during pregnancy is well established, data on the safety of ustekinumab remain limited. We aimed to compare the safety of ustekinumab vs anti-TNF therapy in pregnant patients with IBD in terms of pregnancy and neonatal outcomes. Methods: We systematically searched PubMed, Embase, and Cochrane databases through November 2024. Studies comparing ustekinumab and anti-TNF agents in pregnant patients with IBD and reporting key pregnancy or neonatal outcomes were included. Odds ratio (OR) was used as the effect measure. Pooled analyses were performed using random-effects models. Results: Four studies, encompassing 3,308 pregnancies (592 ustekinumab, 2,716 anti-TNF) were included. The majority of patients (2,914; 88.2%) had Crohn’s disease, and median disease duration ranged from 6.5 to 14 years. There was no significant difference between ustekinumab and anti-TNF therapy in live birth rates (67.2% vs 67.7%; OR 0.73, 95% 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: No significant differences in major pregnancy and neonatal outcomes were found between ustekinumab-exposed and anti-TNF-exposed pregnancies. These findings suggest the use of ustekinumab during pregnancy is comparable with anti-TNF therapy and can be considered safe. Nevertheless, it should be acknowledged that the data are still limited, and further studies are needed.