Are Biologic Therapies Safe for Pregnant Women with Rheumatic Diseases?

Many chronic inflammatory diseases, such as rheumatoid arthritis and inflammatory bowel disease (IBD), can develop in women at peak reproductive age. During pregnancy, disease activity can be associated with pregnancy complications and adverse fetal outcomes. Tumor necrosis factor (TNF) inhibitors are used to treat pregnant women who have inflammatory diseases, but risk associated with these agents remains unclear. Certolizumab pegol (CZP; Cimzia) — which is FDA-approved for rheumatoid arthritis, ankylosing spondylitis, psoriasis, and Crohn disease — is unique, because it is pegylated and unlikely to cross the placenta.

In this industry-sponsored study, researchers used the manufacturer's safety database to examine outcomes in 528 pregnancie…