Adalimumab Use During Pregnancy
Adalimumab should be continued throughout pregnancy to maintain disease remission, as the benefits of disease control outweigh theoretical fetal risks, with discontinuation only considered in select low-risk patients at 22-24 weeks gestation if there is compelling patient preference. 1
Primary Recommendation for Continuation
The Toronto Consensus strongly recommends continuing adalimumab therapy throughout pregnancy because maintaining disease remission is critical, and the short-term benefits outweigh potential fetal risks. 1
The American College of Rheumatology conditionally recommends continuing adalimumab prior to and during pregnancy for rheumatic diseases. 1
Available FDA data from the OTIS/MotherToBaby registry showed a 10% rate of major birth defects with first-trimester adalimumab exposure compared to 7.5% in disease-matched controls, with no pattern of specific malformations identified. 2
A prospective cohort study of 221 adalimumab-exposed pregnancies found no increased risk of major birth defects (adjusted OR 1.10,95% CI 0.45-2.73) compared to diseased unexposed controls. 3
Rationale: Disease Activity Poses Greater Risk
Uncontrolled inflammatory disease during pregnancy carries documented risks including preterm delivery, low birth weight, and small-for-gestational-age infants. 2
Discontinuing adalimumab risks disease relapse during pregnancy and postpartum, and may lead to low trough levels that promote anti-drug antibody development and subsequent loss of response. 1
Optional Discontinuation Strategy (Conditional)
If discontinuation is pursued, it should only occur in highly selected low-risk patients:
Administer the last adalimumab dose at 22-24 weeks gestation (or alternatively at week 34-36 per common practice patterns). 1
This strategy is only appropriate for patients meeting ALL of the following criteria:
Important caveat: There is no strong evidence that early discontinuation provides benefit, as there is no evidence of increased infection risk or developmental delay with continued therapy. 1
Placental Transfer and Timing
Adalimumab contains an Fc IgG1 construct that does not cross the placenta in significant concentrations until the second trimester. 1
Active transplacental transfer occurs during the third trimester, resulting in detectable and potentially high neonatal drug levels. 2
Adalimumab drug levels remain stable throughout pregnancy (unlike infliximab, which increases). 4
Neonatal Considerations
Live vaccines must be avoided in exposed infants until drug levels are undetectable, which may require 6-12 months after birth. 5
Case reports document severe neonatal neutropenia and one fatal disseminated BCG infection in an infant vaccinated at 3 months whose mother received anti-TNF therapy throughout pregnancy. 1, 5
Risks and benefits should be carefully weighed before administering live or live-attenuated vaccines to infants with in-utero adalimumab exposure. 2
Breastfeeding
- The American College of Rheumatology conditionally recommends adalimumab as compatible with breastfeeding, as large monoclonal antibodies have minimal transfer into breast milk and poor oral bioavailability. 6
Common Pitfalls to Avoid
Do not routinely discontinue adalimumab based solely on pregnancy without assessing individual disease risk, as this may precipitate flares that harm both mother and fetus. 1
Do not assume that third-trimester dose timing modifications (such as giving the last dose at weeks 30-32) meaningfully reduce placental transfer—there is little evidence supporting this practice. 1
Do not overlook neonatal vaccine planning—coordinate with pediatrics to delay live vaccines in exposed infants. 2, 5