Is it safe to continue Humira (adalimumab) during pregnancy?

Safety of Humira (Adalimumab) During Pregnancy

For patients with active disease or high risk of relapse, adalimumab (Humira) can be safely continued throughout pregnancy, while for those with inactive disease who wish to discontinue therapy, it may be reasonable to stop at the start of the third trimester. 1, 2

Benefits vs. Risks Assessment

• Disease activity considerations: Active inflammatory disease during pregnancy poses greater risks to both mother and fetus than continuing adalimumab therapy 1, 2
• Maternal outcomes: Untreated active disease is associated with increased risk of preterm birth (OR 2.64) and low birth weight (OR 2.05) 1
• Fetal exposure: Adalimumab crosses the placenta significantly during the third trimester, resulting in detectable drug levels in the neonate 2, 3

Recommendations Based on Disease Status

For Patients with Active Disease or High Risk of Relapse:

• Continue adalimumab throughout pregnancy 1, 2
• Benefits of disease control outweigh potential risks of medication exposure
• Discontinuation may lead to disease flare and worse pregnancy outcomes 1

For Patients with Well-Controlled Disease:

• Consider discontinuing at the start of the third trimester to minimize fetal exposure 1
• This timing balances maternal disease control with minimizing drug levels in the newborn

Post-Delivery Considerations

• Breastfeeding: Adalimumab is considered compatible with breastfeeding 2
• Vaccination schedule: If adalimumab is continued beyond 24 weeks gestation:
  • Postpone live vaccines (including BCG) for the infant until drug levels are undetectable 1, 2
  • This may require waiting up to 6-12 months after birth
  • Non-live vaccinations can proceed according to standard schedule 1

Special Considerations

• Monitoring: No special laboratory monitoring is required during pregnancy beyond routine care 1
• Alternative TNF inhibitors: If planning pregnancy and concerned about fetal exposure, certolizumab may be considered as it has minimal placental transfer 2

Potential Risks

• Maternal complications: Slightly higher risk of overall maternal complications (adjusted OR 1.49) and infections (adjusted OR 1.31) 1
• However, long-term studies show no increased risk of adverse health outcomes, adverse reactions to vaccination, or infection rates in children exposed to anti-TNF therapy in utero 1

The most recent evidence strongly supports continuing adalimumab during pregnancy when clinically indicated, with the primary consideration being control of maternal disease activity to ensure optimal outcomes for both mother and baby.