Background: Anti-tumor necrosis factor (anti-TNF) medications are effective in controlling chronic inflammatory diseases, but information about pregnancy outcomes is still limited. Certolizumab pegol (CZP), a PEGylated, Fc-free anti-TNF approved for treatment of Crohn’s disease (CD) and/or rheumatic diseases (RD), has no active placental transfer. This project provides information on pregnancy exposure and outcomes in women receiving CZP. Methods: Data on maternal CZP exposure, including timing, outcomes and malformations were extracted from the UCB Pharma safety database through 6Mar2017. Analysis focused on prospective data to reduce bias associated with retrospective reporting. Numbers of live births, miscarriages, induced abortions, stillbirths, and major congenital malformations were ascertained. Results: 1137/1541 maternal CZP-exposed pregnancies were reported prospectively, 528 had 538 known outcomes (10 twin sets). Mothers’ indications included CD (195/528) and RD (301/528). Most pregnancies resulted in live birth; numbers of miscarriages, induced abortions and stillbirths were low (Figure 1). Trimesters of exposure were known for 444/452 pregnancies resulting in live birth; 367/452 (81%) were exposed during at least the 1st trimester, more women with CD than RD were exposed during all 3 trimesters (Figure 2). 8/459 (2%) infants had major congenital malformations; 3 of those were of mothers with CD. 43% CD patients had a caesarian section. Early delivery (<37 weeks) and low birth weight were reported for 12% and 13% infants of mothers with CD, respectively. Conclusion: This analysis represents the largest published cohort of pregnant women exposed to an anti-TNF for management of chronic inflammatory diseases. There is no observed increased risk of major congenital malformations for CZP, compared to the US general population (3%), nor an increased risk of fetal death. These results are reassuring for women of childbearing age considering treatment with CZP.
