What biological medication is recommended for a pregnant patient with Inflammatory Bowel Disease (IBD)?

Biological Medications for Pregnant IBD Patients

Anti-TNF biologics (infliximab, adalimumab, certolizumab) are the preferred first-line biological medications for pregnant patients with IBD, as they have the most extensive safety data and can be safely continued throughout pregnancy to maintain disease remission. 1

Safety of Biological Medications During Pregnancy

Anti-TNF Agents

• Infliximab and adalimumab: Can be safely continued throughout pregnancy 1

  • Cross the placenta after 20 weeks gestation
  • Do not interfere with organogenesis
  • No increased risk of pregnancy complications
  • Associated with fewer neonatal complications by maintaining disease remission

• Certolizumab: Offers a potential advantage as it does not cross the placenta 1

  • May be preferred in situations where minimizing fetal exposure is desired

• Dosing considerations:

  • Continue based on pre-pregnancy weight
  • No need to change dosing during pregnancy 1

Vedolizumab

• Safety data is more limited but growing 1, 2
• Recent evidence from the OTIS/MotherToBaby registry shows no increased risk of major birth defects compared to other biologics 2
• Can be considered as an alternative when anti-TNF agents are not suitable 2, 3

Ustekinumab

• Limited but growing safety data during pregnancy 1
• Can be considered when anti-TNF agents are contraindicated or ineffective 1

Important Considerations

Contraindicated Biologics

• JAK inhibitors (tofacitinib, filgotinib, upadacitinib) are contraindicated during conception, pregnancy, and lactation due to serious malformations found in animal studies 1
• Ozanimod and etrasimod are also contraindicated during pregnancy 1

Vaccination Implications

• If anti-TNF medications are continued beyond 20 weeks gestation:
  • Live vaccines should be postponed for the infant for the first 6 months due to immunosuppression 1
  • Non-live vaccines can be given according to standard vaccination schedules 1

Disease Activity Management

• Active IBD during pregnancy poses greater risks than medication exposure, including:

  • Increased risk of preterm birth
  • Low birth weight
  • Spontaneous abortion
  • Poor maternal outcomes 4

• Maintaining disease remission should be the primary goal during pregnancy 1

Algorithm for Biological Selection in Pregnant IBD Patients

1. First-line: Anti-TNF agents (infliximab, adalimumab, certolizumab)

   • Continue throughout pregnancy if patient is stable
   • Consider certolizumab if minimizing placental transfer is desired

2. Second-line: Vedolizumab

   • Consider when anti-TNF agents have failed or are contraindicated
   • Growing evidence supports its safety during pregnancy

3. Third-line: Ustekinumab

   • Consider when other biologics are not suitable
   • Limited but increasing safety data

4. Contraindicated: JAK inhibitors, ozanimod, and etrasimod

Monitoring and Follow-up

• Regular assessment of disease activity throughout pregnancy
• Prompt treatment of flares is essential as active disease poses greater risks than medication exposure 1, 4
• Multidisciplinary approach involving gastroenterologists and high-risk obstetricians 1
• Consider delivery planning based on disease activity and location (particularly for perianal Crohn's disease) 1

Common Pitfalls to Avoid

• Do not discontinue effective biological therapy during pregnancy solely due to pregnancy concerns, as disease flares pose greater risks to both mother and fetus 1, 4
• Do not administer live vaccines to infants exposed to anti-TNF agents in utero until at least 6 months of age 1
• Do not initiate JAK inhibitors during pregnancy planning or pregnancy itself 1
• Do not delay treatment of active disease during pregnancy as this increases risks of adverse pregnancy outcomes 1, 4