BACKGROUND AND PURPOSE:

• Studies on safety and outcomes with the use of biologics during pregnancy in women with inflammatory bowel disease (IBD) are limited
• Nielsen et al. (Clinical Gastroenterology and Hepatology, 2020) estimated the prevalence of adverse pregnancy outcomes in women with IBD who are using biologic therapies

METHODS:

• Systematic review and meta-analysis
• Data sources
  • Major databases through June 2020
• Inclusion criteria
  • At least one treatment group where biologics were used
  • Estimates available regarding the prevalence of adverse pregnancy outcomes when using biologics
• Study design
  • Biologics: Anti-TNF | Anti-integrins | Anti-cytokines
  • Prevalence and relative risk (RR) were pooled using a random effects model
  • Authors assessed impact of disease activity and stratifying by type of biologic administered when possible

RESULTS:

• 48 studies | 6,963 patients
• Biologic therapy in IBD pregnancies was associated with the following pooled prevalences
  • Early pregnancy loss: 8% (95% CI, 6 to 10%)
  • Preterm birth: 9% (95% CI, 7 to 11%)
  • Still birth: 0% (95% CI, 0 to 0%)
  • Low birth weight: 8% (95% CI, 5 to 10%)
  • Congenital malformations: 1% (95% CI, 1 to 2%)
• Overall, above prevalence rates comparable to general populations
• In subgroup analyses of a small number of studies, the prevalence of early pregnancy loss and preterm birth were higher in vedolizumab (an anti-integrin) vs anti-TNF users
• Continued TNF inhibitor use during the third trimester was not associated with risk for the following
  • Preterm birth: RR 1.41 (95% CI, 0.77 to 2.60)
  • Low birth weight: RR 1.32 (95% CI, 0.80 to 2.18)
  • Congenital malformations: RR 1.28 (95% CI, 0.47 to 3.49)

CONCLUSION:

• Women with IBD who use biologics during pregnancy experience adverse pregnancy outcomes similar to the general population
  • Results included no evidence of increased prevalence for early pregnancy loss or stillbirth rates which were comparable to those seen in women with IBD and the general population
• The authors conclude that

…prevalence of adverse pregnancy outcomes in pregnant women with

IBD exposed to TNF inhibitors is not greater than the general population while larger studies are needed to better evaluate the newest biologics, vedolizumab and ustekinumab

Our data also suggests that continued biologic therapy throughout the third trimester of pregnancy is not associated with increased risk of adverse pregnancy outcomes as compared to discontinuing biologics earlier on

Learn More – Primary Sources:

Biologics for Inflammatory Bowel Disease and their Safety in Pregnancy: A Systematic Review and Meta-analysis

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