BACKGROUND AND PURPOSE:

• Chronic inflammatory diseases (CIDs) include rheumatoid arthritis, psoriatic arthritis and inflammatory bowel disease (IBD)
• Biologic medications, particularly the TNF-α inhibitors , are used to treat CID, a subset of autoimmune diseases
  • Safety regarding use is unclear
• O’Byrne et al. (BJOG, 2022) examined pregnancy outcomes in women with CID exposed to biologics during pregnancy

METHODS:

• Systematic review and meta-analysis
• Inclusion criteria
  • Cohort | Case-control | Cross-sectional studies | Case series
  • Studies that assessed the association between biologics used for CID in  pregnancy and maternal and neonatal outcomes
• Exposures
  • Treated: women with CID prescribed biologics
  • Disease matched: women with CID without a biologic prescription
  • Disease free: women without a diagnosis of CID
• Study design
  • A meta-analysis of proportions using a random-effects model was used to pool outcomes
  • Linear regression analysis was used to compare the mean of proportions of outcomes across exposure groups using the ‘treated’ group as the reference category
  • GRADE criteria was used to assess the overall certainty of evidence
• Primary outcome
  • Pregnancy outcomes

RESULTS:

• 35 studies | 11,172 pregnancies
• There were no significant differences in outcomes between the groups
  • Congenital malformations (P=0.238)
    • Treated: pooled proportions 0.04 (95% CI, 0.03 to 0.04)
    • Disease matched: 0.04 (95% CI, 0.03 to 0.05)
  • Preterm delivery (P=0.250)
    • Treated: 0.04 (95% CI, 0.10 to 0.14)
    • Disease matched: 0.10 (95% CI, 0.09 to 0.12)
  • Severe neonatal infection (P=0.970)
    • Treated: 0.05 (95% CI, 0.03 to 0.07)
    • Disease matched: 0.05 (95% CI, 0.02 to 0.07)
  • Low birth weight (P=0.241)
    • Treated: 0.10 (95% CI, 0.07 to 0.12)
    • Disease matched: 0.08 (95% CI, 0.07 to 0.09)
  • Miscarriage (P=0.078)
    • Treated: 0.13 (95% CI, 0.10 to 0.15)
    • Disease matched: 0.08 (95% CI, 0.04 to 0.11)
  • Preeclampsia (P=0.193)
    • Treated: 0.01 (95% CI, 0.01 to 0.02)
    • Disease matched: 0.01 (95% CI, 0.00 to 0.01)
• Certainty of findings overall were low to very low

CONCLUSION:

• Women with CID in pregnancy treated with biologics did not have worse neonatal outcomes compared to untreated disease-matched controls, or disease-free controls, although certainty of findings was low
• The authors state

With over 11,172 pregnancies exposed to biologic medications, our study shows no evidence of harm for the fetus or the mother

More evidence is required to prove the likely protective effects of these medications from unwanted outcomes that disease flare may cause in CID-affected pregnancies

This is important for gastroenterologists, rheumatologists and obstetricians alike when reassuring women regarding continuation of treatment throughout pregnancy and for refractory disease during childbearing years

Learn More – Primary Sources:

Fetal and maternal outcomes after maternal biologic use during conception and pregnancy: a systematic review and meta-analysis

Related ObG Topics:

Use of Biologics in Pregnant Women with IBD: Is there an Increased Risk for Infantile Infections?

Inflammatory Bowel Disease and Biologic Therapies in Pregnancy

Can Tighter Control Improve the Course of Crohn’s Disease?