Table 1.

Summary of available data on biologic agents in pregnancy

Biologic Agent	FDA Approval	Mechanism of Action	Structure	Studies
Certolizumab Cimzia	PsA	TNF-alpha inhibition	PEGylated Fab′ IgG fragment of humanized monoclonal antibody	Limited data: - Multiple studies (cohorts, case control, case reports/series) of more than 300 pregnancies show no increased risk of miscarriage or congenital malformation; however, no studies with control group available (Götestam Skorpen et al., 2016). - Low levels in cord blood, suggesting minimal active transplacental transport (Förger et al., 2016)
Secukinumab Cosentyx	PsO PsA	IL-17 inhibition	IgG1κ monoclonal antibody	Extremely limited data: - No human studies - Studies in mice and monkeys show no embryofetal toxicity
Etanercept Enbrel	PsO PsA	TNF-alpha inhibition	Fc Fragment of human IgG fusion protein	Limited data: - Multiple studies (cohorts, case controls, registry data, case reports/series) of more than 300 exposed pregnancies show no difference in miscarriage or congenital malformations compared with controls (Götestam Skorpen et al., 2016).
Adalimumab Humira	PsO PsA	TNF-alpha inhibition	IgG1 Fully human monoclonal antibody	Limited data: - Multiple studies (cohorts, case controls, registry data, case reports/series) of more than 500 exposed pregnancies show no difference in miscarriage or congenital malformations compared with controls (Götestam Skorpen et al., 2016).
Infliximab Remicade	PsO PsA	TNF-alpha inhibition	IgG1 Mouse-human chimeric monoclonal antibody	Limited data: - Multiple studies (cohorts, case controls, registry data, case reports/series) of more than 1000 exposed pregnancies show no difference in miscarriage or congenital malformations compared with controls (Götestam Skorpen et al., 2016).
Ustekinumab Stelara	PsO PsA	IL-12/23 inhibition	IgG1κ monoclonal antibody	Very limited data: - Few case reports/case series and limited registry data (Götestam Skorpen et al., 2016). - No increased risk of congenital defects or miscarriages (Götestam Skorpen et al., 2016). - One case report of spontaneous abortion is reported for a patient with other risk factors (Fotiadou et al., 2012).
Ixekizumab Taltz	PsO	IL-17A inhibition	Humanized IgG4 monoclonal antibody	Extremely limited data: - No human studies - One study in monkeys shows no harmful effect on the fetus when the medication was administered during the first 20 weeks of gestation. Medication administration from week 20 to birth showed an increase in neonatal deaths. No effects on the infants’ immune system development or maturation were noted at 6 months of age (Clarke et al., 2015).

Fab, antigen-binding fragment antibody; FDA, U.S. Food and Drug Administration; IgG, Immunoglobin G; IL, interleukin; PsA, psoriatic arthritis; PsO, psoriasis