Pharmacovigilance Pregnancy Data in a Population of Japanese Patients With Chronic Inflammatory Disease Exposed to Certolizumab Pegol

Aim: Uncontrolled chronic inflammatory diseases (CIDs) before, during, and after pregnancy, as well as some CID medications, can increase the risk of impaired fertility in addition to adverse maternal/pregnancy outcomes in women of childbearing age. We report pregnancy outcomes from prospectively reported pregnancies in Japanese women treated with certolizumab pegol (CZP). Methods: Data from July 2001 to November 2020 on CZP-exposed pregnancies from the CZP Pharmacovigilance safety database were reviewed. Pregnancy outcomes analyzed included live birth, ectopic pregnancy, abortion (miscarriage or medically indicated/elective), and stillbirth. Congenital anomalies (major and minor), preterm delivery, and low birth weight were also examined. Results: Among 149 prospective pregnancies with maternal CZP exposure and known outcomes identified in Japanese women, 111/149 (74.5%) involved at least first-trimester exposure and 53/149 (35.6%) were exposed in all trimesters; 135/149 (90.6%) live births, 12/149 (8.1%) abortions (11 miscarriages, one elective termination), 2/149 (1.3%) stillbirths, no ectopic pregnancies reported. One (0.7%) infant, whose mother had first-trimester exposure, manifested a minor congenital anomaly (accessory auricle). There were no major congenital anomalies. Among live births, 3/135 (2.2%) were preterm and 10/135 (7.4%) had low birth weight. Conclusion: The safety profile of CZP in pregnant Japanese women was consistent with published global data.