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Purpose <p>Biologic therapies, including tumor necrosis factor (TNF) blockers, vedolizumab (VDZ), and ustekinumab (UST), are generally considered safe during pregnancy in patients with inflammatory bowel disease (IBD), though comparative data remain limited. This meta-analysis examines their safety and effectiveness.</p> Methods <p>A systematic search of MEDLINE, EMBASE, CINAHL, Cochrane, and Web of Science was conducted through July 2025. Eligible studies reported maternal or neonatal outcomes in pregnant IBD patients treated with biologics. Studies were pooled using a random-effects model to calculate risk ratios (RRs) with 95% confidence intervals. Heterogeneity was assessed using I<sup>2</sup>. Primary outcomes were preterm birth and disease activity; secondary outcomes included pregnancy and neonatal outcomes.</p> Results <p>Nine observational studies (<i>n</i> = 6,054) were included. Compared to TNF blockers, VDZ was associated with a higher risk of preterm delivery (RR = 1.35, 95% CI 1.04–1.75, I<sup>2</sup> = 0%) and active disease (RR = 1.55, 95% CI 1.01–2.40, I<sup>2</sup> = 50%). UST was associated with a higher risk of active disease (RR = 1.30, 95% CI 1.06–1.60, I<sup>2</sup> = 0%) and congenital anomalies (RR = 2.08, 95% CI 1.30–3.32, I<sup>2</sup> = 0%) compared to TNF blockers. Compared to UST, VDZ was linked to increased risks of preterm birth (RR = 2.60, 95% CI 1.03–6.57, I<sup>2</sup> = 0%) and low birth weight (RR = 2.38, 95% CI 1.01–5.60, I<sup>2</sup> = 0%). No significant differences were observed for live births, abortions, hospitalizations, or neonatal infections.</p> Conclusion <p>TNF blockers showed a favorable safety and effectiveness profile, VDZ and UST performed broadly similar, and all three biological classes appeared compatible with safe use in pregnancy to maintain effective disease control. Observed differences reflect that VDZ and UST cohorts likely had longer disease duration, prior biologic exposure, and more active disease. The results of this meta-analysis support the continuation of biologic therapy for disease control in pregnant patients with IBD. Treatment decisions should be individualized and tailored to each patient’s clinical context.</p>

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Pairwise Comparative Safety and Effectiveness of Anti-TNF Blockers, Vedolizumab, and Ustekinumab During Pregnancy: A Systematic Review and Meta-Analysis

  • 期刊论文

  • 发表日期：

    2026年5月25日

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  • Omotayo Segun-Omosehin,
  • Natalie E. Bourdakos,
  • Kosta G. Tzanis,
  • Marie Michele Macaron,
  • Fares Jamal,
  • Lisa Marks,
  • Abdullah Hamad,
  • Talha A. Malik

摘要

Purpose

Biologic therapies, including tumor necrosis factor (TNF) blockers, vedolizumab (VDZ), and ustekinumab (UST), are generally considered safe during pregnancy in patients with inflammatory bowel disease (IBD), though comparative data remain limited. This meta-analysis examines their safety and effectiveness.

Methods

A systematic search of MEDLINE, EMBASE, CINAHL, Cochrane, and Web of Science was conducted through July 2025. Eligible studies reported maternal or neonatal outcomes in pregnant IBD patients treated with biologics. Studies were pooled using a random-effects model to calculate risk ratios (RRs) with 95% confidence intervals. Heterogeneity was assessed using I2. Primary outcomes were preterm birth and disease activity; secondary outcomes included pregnancy and neonatal outcomes.

Results

Nine observational studies (n = 6,054) were included. Compared to TNF blockers, VDZ was associated with a higher risk of preterm delivery (RR = 1.35, 95% CI 1.04–1.75, I2 = 0%) and active disease (RR = 1.55, 95% CI 1.01–2.40, I2 = 50%). UST was associated with a higher risk of active disease (RR = 1.30, 95% CI 1.06–1.60, I2 = 0%) and congenital anomalies (RR = 2.08, 95% CI 1.30–3.32, I2 = 0%) compared to TNF blockers. Compared to UST, VDZ was linked to increased risks of preterm birth (RR = 2.60, 95% CI 1.03–6.57, I2 = 0%) and low birth weight (RR = 2.38, 95% CI 1.01–5.60, I2 = 0%). No significant differences were observed for live births, abortions, hospitalizations, or neonatal infections.

Conclusion

TNF blockers showed a favorable safety and effectiveness profile, VDZ and UST performed broadly similar, and all three biological classes appeared compatible with safe use in pregnancy to maintain effective disease control. Observed differences reflect that VDZ and UST cohorts likely had longer disease duration, prior biologic exposure, and more active disease. The results of this meta-analysis support the continuation of biologic therapy for disease control in pregnant patients with IBD. Treatment decisions should be individualized and tailored to each patient’s clinical context.