Table 5
Consensus on statements and expert opinion on use of biologic drugs in clinical practice in pregnant and lactating patients
| Pregnancy | Breast feeding | |||||
|---|---|---|---|---|---|---|
| Drug | Statement on compatibility of drug with pregnancy based on evidence | Percentage of agreement with statement | Expert opinion on use of drug in clinical practice (%)* | Statement on compatibility of drug with breast feeding based on evidence | Percentage of agreement with statement | Expert opinion on breast feeding and medication (%)† |
| Infliximab | Current evidence indicates no increased rate of congenital malformations; infliximab can be continued up to gestational week 20; if indicated, it can be used throughout pregnancy | 100 |  | Infliximab is compatible with breast feeding | 100 |  |
| Adalimumab | Current evidence indicates no increased rate of congenital malformations; adalimumab can be continued up to gestational week 20; if indicated, it can be used throughout pregnancy | 100 |  | Adalimumab is compatible with breast feeding | 100 |  |
| Golimumab | Current evidence does not indicate an increased rate of congenital malformations; because of limited evidence, alternative medications should be considered for treatment throughout pregnancy | 100 |  | Golimumab is compatible with breast feeding | 94 |  |
| Etanercept | Current 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 pregnancy | 100 |  | Etanercept is compatible with breast feeding | 100 |  |
| Certolizumab | Current evidence indicates no increased rate of congenital malformations; certolizumab can be continued throughout pregnancy | 100 |  | Certolizumab is compatible with breast feeding | 94 |  |
| Rituximab | Current 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 neonate | 100 |  | No data exist regarding rituximab in breast milk, therefore rituximab should be avoided in breast feeding | 80 |  |
| Anakinra | Current 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 treatment | 100 |  | No data exist regarding anakinra in breast milk, therefore anakinra should be avoided in breast feeding | 88 |  |
| Ustekinumab | Current evidence does not indicate an increased rate of congenital malformations; because of limited evidence, alternative medications should be considered for treatment throughout pregnancy | 100 |  | No data exist regarding ustekinumab in breast milk, therefore ustekinumab should be avoided in breast feeding | 75 |  |
| Tocilizumab | No statement can be made in regard to safety during pregnancy due to scarce documentation; treatment with tocilizumab is therefore best avoided | 100 |  | No data exist regarding tocilizumab in breast milk, therefore tocilizumab should be avoided in breast feeding | 69 |  |
| Abatacept | No statement can be made in regard to safety during pregnancy due to scarce documentation; treatment with abatacept is therefore best avoided | 94 |  | No data exist regarding abatacept in breast milk, therefore abatacept should be avoided in breast feeding | 75 |  |
| Belimumab | Current evidence does not indicate an increased rate of congenital malformations; because of limited evidence, alternative medications should be considered for treatment throughout pregnancy | 100 |  | No data exist regarding belimumab in breast milk, therefore belimumab should be avoided in breast feeding | 82 |  |
*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.