Table 5

Consensus on statements and expert opinion on use of biologic drugs in clinical practice in pregnant and lactating patients

PregnancyBreast feeding
DrugStatement on compatibility of drug with pregnancy based on evidencePercentage of agreement with statementExpert opinion on use of drug in clinical practice (%)*Statement on compatibility of drug with breast feeding based on evidencePercentage of agreement with statementExpert opinion on breast feeding and medication (%)†
InfliximabCurrent evidence indicates no increased rate of congenital malformations; infliximab can be continued up to gestational week 20; if indicated, it can be used throughout pregnancy100Embedded ImageInfliximab is compatible with breast feeding100Embedded Image
AdalimumabCurrent evidence indicates no increased rate of congenital malformations; adalimumab can be continued up to gestational week 20; if indicated, it can be used throughout pregnancy100Embedded ImageAdalimumab is compatible with breast feeding100Embedded Image
GolimumabCurrent evidence does not indicate an increased rate of congenital malformations; because of limited evidence, alternative medications should be considered for treatment throughout pregnancy100Embedded ImageGolimumab is compatible with breast feeding94Embedded Image
EtanerceptCurrent evidence indicates no increased rate of congenital malformations; etanercept can be continued up to gestational week 30–32; if indicated, it can be used throughout pregnancy100Embedded ImageEtanercept is compatible with breast feeding100Embedded Image
CertolizumabCurrent evidence indicates no increased rate of congenital malformations; certolizumab can be continued throughout pregnancy100Embedded ImageCertolizumab is compatible with breast feeding94Embedded Image
RituximabCurrent evidence indicates no increased rate of congenital malformations; in exceptional cases it can be used early in gestation; with use at later stages of pregnancy clinicians should be aware of the risk of B cell depletion and other cytopenias in the neonate100Embedded ImageNo data exist regarding rituximab in breast milk, therefore rituximab should be avoided in breast feeding80Embedded Image
AnakinraCurrent evidence does not indicate an increased rate of congenital malformations; anakinra can be used before and during pregnancy when there are no other well studied options available for treatment100Embedded ImageNo data exist regarding anakinra in breast milk, therefore anakinra should be avoided in breast feeding88Embedded Image
UstekinumabCurrent evidence does not indicate an increased rate of congenital malformations; because of limited evidence, alternative medications should be considered for treatment throughout pregnancy100Embedded ImageNo data exist regarding ustekinumab in breast milk, therefore ustekinumab should be avoided in breast feeding75Embedded Image
TocilizumabNo statement can be made in regard to safety during pregnancy due to scarce documentation; treatment with tocilizumab is therefore best avoided100Embedded ImageNo data exist regarding tocilizumab in breast milk, therefore tocilizumab should be avoided in breast feeding69Embedded Image
AbataceptNo statement can be made in regard to safety during pregnancy due to scarce documentation; treatment with abatacept is therefore best avoided94Embedded ImageNo data exist regarding abatacept in breast milk, therefore abatacept should be avoided in breast feeding75Embedded Image
BelimumabCurrent evidence does not indicate an increased rate of congenital malformations; because of limited evidence, alternative medications should be considered for treatment throughout pregnancy100Embedded ImageNo data exist regarding belimumab in breast milk, therefore belimumab should be avoided in breast feeding82Embedded Image
  • *As an expert in the field.

  • I would recommend the drug in the same way as if the patient was not pregnant.

  • I would only recommend the drug if I feared at least moderate disease activity in its absence.

  • I would only recommend the drug if I feared at least severe disease activity in its absence.

  • I would never recommend the drug in pregnancy.

  • †As an expert in the field.

  • I would recommend the drug in the same way as if the patient did not breastfeed.

  • I would only recommend the drug if I feared at least moderate disease activity in its absence.

  • I would only recommend the drug if I feared at least severe disease activity in its absence.

  • I would never recommend the drug while the woman was breast feeding.