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OP0018 Pregnancy Outcomes with Trimesters of Maternal Exposure to Certolizumab Pegol: Prospective and Retrospective Reports from Safety Surveillance
  1. M.E. Clowse1,
  2. F. Förger2,
  3. J. Cush3,
  4. D. Wolf4,
  5. A. Golembesky5,
  6. L. Shaughnessy5,
  7. D. De Cuyper6,
  8. U. Mahadevan7
  1. 1Duke University Medical Center, Durham, United States
  2. 2Inselspital, University of Bern, Bern, Switzerland
  3. 3Baylor Research Institute and Baylor University Medical Center, Dallas
  4. 4Atlanta Gastroenterology Associates, Atlanta
  5. 5UCB Pharma, Raleigh, United States
  6. 6UCB Pharma, Brussels, Belgium
  7. 7UCSF Center for Colitis and Crohn's Disease, San Francisco, United States

Abstract

Background Data on the impact of anti-TNF medications on pregnancy outcomes are limited. Certolizumab pegol (CZP) is a PEGylated Fc-free anti-TNF approved in more than 50 countries for the treatment of rheumatoid arthritis (RA) and/or Crohn's disease (CD), psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA). Analysis of pregnancy data from the UCB Pharma safety database through 28th March 2013 has been published.1

Objectives To provide information on pregnancy outcomes in women receiving CZP.

Methods The UCB Pharma safety database was searched for medically confirmed pregnancies through 1st September 2014. Maternal and paternal CZP exposure, prospective and retrospective reports were included. Data on CZP exposure, pregnancy dating when reported, pregnancy outcomes, comorbidities and infant events were extracted by 2 independent reviewers. The number of live births, miscarriages, induced abortions and stillbirths for CZP-exposed pregnancies was examined. Exposure to concomitant medications and disease activity for pregnancies reported from clinical trial patients was reviewed.

Results The 1st September 2014 datacut included 625 CZP-exposed pregnancies; 372 (60%) had known outcomes. 579 were maternal and 46 were paternal exposure, of which 339 and 33 had known pregnancy outcomes, respectively. 226/339 (67%) maternal cases were prospective, 113/339 (33%) retrospective (Figure). Most pregnancies were exposed during the 1st trimester, when the majority of fetal organ and organ system development takes place. For the prospective pregnancies, 63 women stopped CZP in the 1st trimester (of which 34 had live births, 16 a miscarriage and 13 an induced abortion), 41 continued CZP in all 3 trimesters (Table). For pregnancies with maternal exposure and known outcomes, the major underlying conditions were rheumatic diseases (118/339; 35%) and CD (192/339; 57%). Of the 118 women with rheumatic diseases, 83 (70%) had live births, 17 (14%) spontaneous miscarriage, 17 (14%) induced abortion and 1 (0.8%) a stillbirth. Congenital anomalies were reported for 12 babies from 254 live births following maternal CZP exposure: 1 had 22q11.2 deletion syndrome, unilateral right kidney, hypospadias and inguinal hernia; 1 had congenital morbus hirschsprung disease and club foot. 10 were born with one of the following: anal fistula, left-sided vesico-ureteric reflux, pyloric stenosis, cleft palate, club foot, polydactyly, right aortic arch with aberrant left subclavian artery, renal cyst (no treatment required), posterior ankyloglossia and diaphragmatic hernia.

Conclusions Data regarding pregnancy outcomes after CZP exposure are encouraging and suggest that CZP exposure in utero, including 1st trimester exposure, does not adversely affect pregnancy outcome. The analysis represents a uniquely large number of pregnancies exposed to a single anti-TNF, and further prospective data with increased numbers of pregnant women exposed to CZP continue to be collected to assess CZP safety and tolerability in pregnancy.

References

  1. Clowse M. Arthritis Rheum 2014;66(S11):621

Acknowledgements The authors acknowledge Costello Medical Consulting for writing and editorial assistance, which was funded by UCB Pharma.

Disclosure of Interest M. Clowse Consultant for: UCB Pharma, F. Förger Consultant for: UCB Pharma and Roche, Speakers bureau: UCB Pharma and Roche, J. Cush Grant/research support from: Pfizer, Celgene, CORRONA, Amgen, NIH, Novartis, UCB Pharma, D. Wolf Grant/research support from: Abbott, Bristol-Myers Squibb, Genentech, GIVEN Imaging, Janssen Biotech Inc., Millennium Research Group, Prometheus Laboratories, UCB Pharma, Consultant for: Abbott, Genetech, GIVEN Imaging, Janssen Biotech Inc., Millennium Research Group, Prometheus Laboratories, Salix Pharmaceuticals, UCB Pharma, Speakers bureau: Abbott, Janssen Biotech Inc., Prometheus, Salix, UCB Pharma, Warner Chilcott, A. Golembesky Shareholder of: UCB Pharma, Employee of: UCB Pharma, L. Shaughnessy Employee of: UCB Pharma, D. De Cuyper Employee of: UCB Pharma, U. Mahadevan Grant/research support from: Prometheus, Millenium and GSK, Consultant for: Abbvie, Janssen, Genentech, Takeda, UCB Pharma

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