388. Characteristics and outcomes of prospectively reported pregnancies exposed to certolizumab pegol from a safety database

Introduction Anti-tumour necrosis factor (anti-TNF) medications are effective in controlling chronic inflammatory diseases, but information about their use and safety in pregnancy is limited. Consequently, anti-TNFs are often discontinued early in gestation. Certolizumab pegol (CZP), a PEGylated, Fc-free anti-TNF approved for treatment of rheumatic diseases and/or Crohn’s disease, has no active placental transfer. Objective/Hypothesis To provide information on pregnancy outcomes in women receiving CZP, especially those with early pregnancy exposure. Methods Prospective and retrospective data on maternal CZP exposure, including timing and duration, outcomes, comorbidities, and major malformations were extracted from the UCB Pharma safety database through 6 March 2017. This analysis was limited to prospective reports to avoid bias associated with retrospective submissions. Numbers of live births, miscarriages, elective abortions, stillbirths, and major congenital malformations were ascertained. Results From a total of 1541 maternal CZP-exposed pregnancies, 1137 were reported prospectively, of which 528 pregnancies (including 10 twins) had 538 known outcomes: 459 live births (85%), 47 miscarriages (9%), 27 elective abortions (5%), and 5 stillbirths (1%). Of the 459 live births, 8 (2%) cases of major congenital malformations were reported. Of the 528 prospective pregnancies with known outcomes, 436 (83%) were exposed to CZP during the 1 st trimester, when most organogenesis occurs; 201 (45%) pregnancies were exposed during all 3 trimesters. Discussion This analysis represents the largest published cohort of pregnant women exposed to an anti-TNF for management of chronic inflammatory diseases. Analysis of pregnancy outcomes does not indicate a malformative effect of CZP compared to the EU general population (2–3%), nor an increased risk of foetal death. These data are reassuring for women of childbearing age considering treatment with CZP, however, the ongoing collection of post-marketing surveillance data, including the ongoing MotherToBaby study from the Organization of Teratology Information Specialists, will provide further important information.