TNF alpha inhibitor (Arthrogen)

The safety of biologic therapies, particularly tumor necrosis factor-alpha inhibitors (TNF-αi), during pregnancy is a critical consideration in women with autoimmune diseases, where maternal disease control must be weighed against potential fetal risks. Increasing evidence from registries, prospective cohorts, and pharmacokinetic studies indicates that TNF-α inhibitors are generally safe when used appropriately in pregnancy. IgG1 monoclonal antibodies such as infliximab and adalimumab undergo active Fc-mediated placental transfer, leading to measurable neonatal drug levels, in contrast certolizumab pegol, which lacks an Fc fragment, demonstrates minimal transfer and is often considered the safest option in late gestation. Population-based studies suggest a modestly increased risk of preterm birth, though confounding by disease activity is a major contributor. Large cohorts, including the PIANO registry, have not shown significant increases in congenital malformations, miscarriage, or neonatal complications with TNF-α inhibitors monotherapy. However, combination therapy with thiopurines increase the risk of infection in exposed infants. Professional guidelines, including those from EULAR, ACR, and BSR, support the use of TNF-α inhibitors during pregnancy when disease activity warrants, with recommendations to avoid live vaccines in exposed infants until drug is cleared. The Purpose of the review is to synthesize evidence on TNF-α inhibitor exposure in pregnancy, including registry, cohort, pharmacokinetic studies, and guidelines up to 2025. It aims to highlight placental transfer, neonatal implications, and to provide trimester-specific recommendations and prioritized research questions for clinicians managing pregnant individuals with autoimmune diseases. Overall, TNF-αi appears compatible with pregnancy, provided individualized risk assessment and multidisciplinary management are prioritized.