title: Pregnancy Outcomes in Subjects Exposed to Certolizumab Pegol.
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.
  
  
  CONCLUSIONS
  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.affiliation: 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.
authors.forename: Megan E B
authors.initials: ME
authors.lastname: Clowse
authors.affiliation: 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.
authors.forename: Douglas C
authors.initials: DC
authors.lastname: Wolf
authors.affiliation: 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.
authors.forename: Frauke
authors.initials: F
authors.lastname: Förger
authors.affiliation: 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.
authors.forename: John J
authors.initials: JJ
authors.lastname: Cush
authors.affiliation: 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.
authors.forename: Amanda
authors.initials: A
authors.lastname: Golembesky
authors.affiliation: 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.
authors.forename: Laura
authors.initials: L
authors.lastname: Shaughnessy
authors.affiliation: 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.
authors.forename: Dirk
authors.initials: D
authors.lastname: De Cuyper
authors.affiliation: 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.
authors.forename: Uma
authors.initials: U
authors.lastname: Mahadevan
mesh_terms: D000022:Abortion, Spontaneous / Q000139:chemically induced / Q000453:epidemiology; D000328:Adult; D018501:Antirheumatic Agents / Q000009:adverse effects / Q000627:therapeutic use; D001172:Arthritis, Rheumatoid / Q000175:diagnosis / Q000188:drug therapy*; D000068582:Certolizumab Pegol / Q000009:adverse effects* / Q000627:therapeutic use; D000013:Congenital Abnormalities / Q000453:epidemiology / Q000209:etiology; D016208:Databases, Factual; D005260:Female; D005865:Gestational Age; D006801:Humans; D007231:Infant, Newborn; D011247:Pregnancy; D011248:Pregnancy Complications / Q000139:chemically induced* / Q000453:epidemiology / Q000503:physiopathology; D011256:Pregnancy Outcome; D018566:Pregnancy, High-Risk; D012016:Reference Values; D012189:Retrospective Studies; D018570:Risk Assessment
chemical_list: D018501:Antirheumatic Agents; D000068582:Certolizumab Pegol
keywords: CERTOLIZUMAB PEGOL; CONGENITAL MALFORMATIONS; MISCARRIAGE; PREGNANCY