Pregnancy Safety with Infliximab
Yes, pregnancy is safe for women receiving infliximab therapy, and the medication should be continued throughout pregnancy to maintain disease remission. 1, 2
Primary Recommendation: Continue Treatment Throughout Pregnancy
The most recent high-quality guidelines strongly recommend continuation of infliximab throughout all trimesters of pregnancy. 1, 2 The 2024 AGA Clinical Practice Update explicitly states that anti-TNF medications like infliximab do not increase the risk of pregnancy complications and have been found to lead to fewer neonatal complications, supporting the need for maintaining remission during pregnancy. 1
Key Safety Evidence
The evidence supporting continuation is robust:
- No increased risk of congenital malformations compared to the general population or unexposed IBD patients 1, 2, 3
- No increased risk of spontaneous abortions across multiple systematic reviews of over 50 studies 1, 2
- No increased risk of preterm birth or low birth weight when adjusted for disease severity 2
- No increased risk of infections in offspring according to systematic reviews 1, 2
- Post-marketing surveillance of 1,850 pregnancies showed congenital anomaly rates (2.0%) consistent with the general population 3
Why Continuation is Critical
Maintaining disease remission is more important than minimizing drug exposure. 1, 2 The data clearly demonstrate that:
- Discontinuing infliximab risks disease flare during pregnancy, with a 32% relapse rate in the first 3 weeks postpartum when therapy is stopped 1, 2
- Active inflammatory disease poses its own significant risks including preterm birth and intrauterine growth restriction 4
- Women who continued anti-TNF therapy throughout pregnancy had lower rates of unfavorable pregnancy outcomes (25% vs 69%) compared to those who discontinued 1
Dosing During Pregnancy
The dose of infliximab does not change with pregnancy and should be continued based on prepregnancy weight to maintain remission. 1 Do not reduce or modify the dosing schedule during pregnancy. 1
Understanding Placental Transfer
Infliximab crosses the placenta after 20 weeks of gestation and does not interfere with organogenesis. 1 Key pharmacokinetic facts:
- Active placental transfer begins around week 13 and increases progressively through the second and third trimesters 2
- Cord blood levels can be up to 4-fold higher than maternal blood levels at delivery 1, 2
- Infliximab remains detectable in infant serum for up to 6-7 months after birth 2, 5
This placental transfer is not a reason to discontinue therapy, as the benefits of disease control outweigh these pharmacokinetic considerations. 1, 2
Alternative Strategy: Selective Discontinuation (Only in Exceptional Cases)
If a patient has compelling reasons to minimize fetal exposure AND meets very strict low-risk criteria, the last infliximab dose may be given at 22-24 weeks gestation. 1, 2 However, this is a conditional recommendation based on very low-quality evidence and should only be considered when ALL of the following criteria are met: 1, 2
- Sustained symptomatic remission for 12 months before conception 1, 2
- No active disease on endoscopy or imaging during preconception period 1, 2
- No prior secondary loss of response to infliximab or dose escalation 1, 2
- Demonstrated therapeutic drug levels 1, 2
- No prior intestinal resections 1, 2
- No hospitalizations in past 36 months 1, 2
This strategy is NOT recommended for most patients because there is no strong evidence supporting the need for discontinuation, and it carries significant risk of disease relapse. 1
Critical Postpartum Considerations
Vaccination Restrictions
Live vaccines must be delayed for at least 6 months after birth in infants exposed to infliximab in utero. 1, 2, 6 This includes:
This restriction exists because infants may have immunosuppression from transplacentally transferred medication. 1 A fatal case of disseminated mycobacterial infection has been reported in an infant who received BCG vaccine at 3 months after in utero infliximab exposure. 5
Non-live vaccines can be administered on the normal schedule. 2
Newborn Monitoring
- Consider checking complete blood count in newborns, as case reports describe transient anemia and rare agranulocytosis 2, 6
- Monitor for infections, though systematic reviews show no increased infection risk in the first year of life 2
Breastfeeding Compatibility
Infliximab is compatible with breastfeeding. 2, 7 The medication is present in breast milk in only miniscule amounts with unlikely toxicity. 2, 7 The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for continued therapy. 6
Common Pitfalls to Avoid
Do not discontinue infliximab based on outdated concerns about teratogenicity - the most recent 2024 guidelines clearly support continuation 1
Do not modify dosing schedules in the third trimester - there is little evidence this strategy minimizes transplacental transfer, and it may lead to loss of remission 1
Do not confuse infliximab with methotrexate - methotrexate is contraindicated and must be stopped at least 6 months before conception 1
Do not allow patients to receive live vaccines postpartum if they continued infliximab after 20 weeks - ensure the 6-month waiting period is observed 1, 6
Addressing Contradictory Evidence
While older 2009 guidelines from the British Association of Dermatologists cited FDA database reports of 61 congenital anomalies in 41 children exposed to TNF antagonists 1, the most recent and highest quality evidence from 2024 clearly refutes these concerns. 1 The 2024 AGA guidelines, based on meta-analyses and the Pregnancy in IBD and Neonatal Outcomes registry, show no increased risk of congenital anomalies. 1 Post-marketing surveillance of 1,850 pregnancies confirms congenital anomaly rates consistent with the general population. 3
When faced with this contradiction, prioritize the 2024 guideline evidence over the 2009 data, as it represents larger sample sizes, more rigorous methodology, and 15 additional years of safety data. 1, 3