Megan E B Clowse1, Douglas C Wolf2, Frauke Förger2, John J Cush2, Amanda Golembesky2, Laura Shaughnessy2, Dirk De Cuyper2, Uma Mahadevan2. 1. From Duke University Medical Center, Durham; Union Chimique Belge (UCB) Pharma, Raleigh, North Carolina; Atlanta Gastroenterology Associates, Atlanta, Georgia; Baylor Research Institute and Baylor University Medical Center, Dallas, Texas; University of California San Francisco (UCSF) Center for Colitis and Crohn's Disease, San Francisco, California, USA; Department of Rheumatology, Immunology and Allergology, Inselspital, University of Bern, Bern, Switzerland; UCB Pharma, Brussels, Belgium.M.E. Clowse, MD, Duke University Medical Center; D.C. Wolf, MD, Atlanta Gastroenterology Associates; F. Förger, MD, Department of Rheumatology and Immunology and Allergology, Inselspital, University of Bern; J.J. Cush, MD, Baylor Research Institute and Baylor University Medical Center; A. Golembesky, PhD, UCB Pharma; L. Shaughnessy, PhD, UCB Pharma; D. De Cuyper, MD, UCB Pharma; U. Mahadevan, MD, UCSF Center for Colitis and Crohn's Disease. megan.clowse@duke.edu. 2. From Duke University Medical Center, Durham; Union Chimique Belge (UCB) Pharma, Raleigh, North Carolina; Atlanta Gastroenterology Associates, Atlanta, Georgia; Baylor Research Institute and Baylor University Medical Center, Dallas, Texas; University of California San Francisco (UCSF) Center for Colitis and Crohn's Disease, San Francisco, California, USA; Department of Rheumatology, Immunology and Allergology, Inselspital, University of Bern, Bern, Switzerland; UCB Pharma, Brussels, Belgium.M.E. Clowse, MD, Duke University Medical Center; D.C. Wolf, MD, Atlanta Gastroenterology Associates; F. Förger, MD, Department of Rheumatology and Immunology and Allergology, Inselspital, University of Bern; J.J. Cush, MD, Baylor Research Institute and Baylor University Medical Center; A. Golembesky, PhD, UCB Pharma; L. Shaughnessy, PhD, UCB Pharma; D. De Cuyper, MD, UCB Pharma; U. Mahadevan, MD, UCSF Center for Colitis and Crohn's Disease.
Abstract
OBJECTIVE: To provide information on pregnancy outcomes in women receiving certolizumab pegol (CZP). METHODS: The UCB Pharma safety database was searched for pregnancies through to September 1, 2014. Reports for maternal and paternal CZP exposure were included and outcomes examined, and data on CZP exposure, pregnancy, comorbidities, and infant events were extracted by 2 independent reviewers. Concomitant medications and disease activity were reviewed for clinical trial patients. RESULTS: Of 625 reported pregnancies, 372 (59.5%) had known outcomes. Paternal exposure pregnancies (n = 33) reported 27 live births, 4 miscarriages, 1 induced abortion, and 1 stillbirth. Maternal exposure pregnancies (n = 339) reported 254 live births, 52 miscarriages, 32 induced abortions, and 1 stillbirth. Almost all reported pregnancies had exposure to CZP in the first trimester, when organogenesis takes place, and a third of them continued the drug into the second and/or third trimesters. The most frequent indications for maternal CZP use were Crohn disease (192/339) and rheumatic diseases (118/339). Twelve cases of congenital malformation and a single neonatal death were reported. CONCLUSION: Analysis of pregnancy outcomes after exposure to CZP supports previous reports, suggesting a lack of harmful effect of maternal CZP exposure on pregnancy outcomes. However, additional data from a larger number of outcomes after exposure and studies including an unexposed comparison group are required to fully evaluate CZP safety and tolerability in pregnancy.
OBJECTIVE: To provide information on pregnancy outcomes in women receiving certolizumab pegol (CZP). METHODS: The UCB Pharma safety database was searched for pregnancies through to September 1, 2014. Reports for maternal and paternal CZP exposure were included and outcomes examined, and data on CZP exposure, pregnancy, comorbidities, and infant events were extracted by 2 independent reviewers. Concomitant medications and disease activity were reviewed for clinical trial patients. RESULTS: Of 625 reported pregnancies, 372 (59.5%) had known outcomes. Paternal exposure pregnancies (n = 33) reported 27 live births, 4 miscarriages, 1 induced abortion, and 1 stillbirth. Maternal exposure pregnancies (n = 339) reported 254 live births, 52 miscarriages, 32 induced abortions, and 1 stillbirth. Almost all reported pregnancies had exposure to CZP in the first trimester, when organogenesis takes place, and a third of them continued the drug into the second and/or third trimesters. The most frequent indications for maternal CZP use were Crohn disease (192/339) and rheumatic diseases (118/339). Twelve cases of congenital malformation and a single neonatal death were reported. CONCLUSION: Analysis of pregnancy outcomes after exposure to CZP supports previous reports, suggesting a lack of harmful effect of maternal CZP exposure on pregnancy outcomes. However, additional data from a larger number of outcomes after exposure and studies including an unexposed comparison group are required to fully evaluate CZP safety and tolerability in pregnancy.
Authors: Jamil M Kazma; John van den Anker; Karel Allegaert; André Dallmann; Homa K Ahmadzia Journal: J Pharmacokinet Pharmacodyn Date: 2020-02-06 Impact factor: 2.745