OP0067 Pregnancy Outcomes after Exposure to Certolizumab Pegol: Updated Results from Safety Surveillance
Authors: M.E.B. Clowse, D.C. Wolf, F. Förger, J.J. Cush, A. Golembesky, L. Shaughnessy, D. De Cuyper, K. Luijtens, S. Abbas, U. Mahadevan
Journal: Annals of the Rheumatic Diseases (2014)

<h3>Background</h3> Certolizumab pegol (CZP) is a PEGylated Fc-free anti-TNF approved in 45 countries for the treatment of rheumatoid arthritis (RA) and/or Crohn9s disease (CD); it was recently approved by the EMA for psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA). Analysis of pregnancy data from the UCB Pharma global safety database through 06 March 2012 has been published previously.<sup>1</sup> <h3>Objectives</h3> To provide an updated analysis of pregnancy outcomes in rheumatic patients (pts) after CZP exposure, with a focus on RA, by including new reports and pregnancies that were still ongoing at the time of the last retrospective analysis. <h3>Methods</h3> The UCB Pharma global safety database, designed to house and report adverse events for UCB Pharma products, was searched for all medically confirmed cases of pregnancy through 28 March 2013. Reported pregnancies included women who became pregnant while participating in a clinical study and spontaneous post-marketing reports. The number of live births, spontaneous miscarriages and elective terminations for neonates exposed to CZP (maternal and paternal exposure) was examined. Congenital abnormalities, neonatal deaths and maternal demographics were also investigated. <h3>Results</h3> As of 28 March 2013, 309 CZP exposed pregnancies were reported: 285 were maternal exposure, 24 were paternal. For pregnancies with maternal exposure, although the major underlying condition was CD (190/285), RA was the underlying condition for 52 of the 285 women with the remaining 43/285 encompassing other indications, including axSpA and PsA. Pregnancy outcomes were available for 190 of these 285 pregnancies: 42 in women with RA, 124 in women with CD and 24 in women with other rheumatic indications. For the 42 pregnancies in women with RA with known outcomes, whether spontaneously reported or within a clinical trial context, 26 (61.9%) resulted in live birth, 9 (21.4%) in spontaneous miscarriage and 7 (16.7%) in elective termination. The Table presents characteristics for pregnancies in women with RA compared to those for all reported maternal exposure pregnancies. Five congenital anomalies were reported, in four neonates, among all live births with maternal CZP exposure (n=132): vesicoureteric reflux, congenital morbus hirschsprung disease and club foot, right aortic arch with aberrant left subclavian artery, and mild unilateral hydronephrosis on antenatal ultrasound (described as healthy upon birth). None of these events were considered related to CZP by the treating physicians. A single neonatal death was reported after maternal exposure in one of a set of twins delivered before 26 weeks of gestation. <h3>Conclusions</h3> Updated analysis of pregnancy outcomes after exposure to CZP supports previous reports suggesting no apparent impact of maternal CZP exposure on pregnancy outcomes. Additional prospective data are required to fully evaluate the safety and tolerability of CZP in pregnancy. <h3>References</h3> Clowse M. Arthritis Rheum 2012; 64(Suppl10):S702 <h3>Acknowledgements</h3> The authors acknowledge Costello Medical Consulting for editorial assistance which was funded by UCB Pharma <h3>Disclosure of Interest</h3> M. Clowse Consultant for: UCB Pharma, D. Wolf Grant/research support: 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, F. Förger Speakers bureau: Roche, UCB Pharma, J. Cush Grant/research support: Pfizer, Celgene, CORRONA, Amgen, NIH, Novartis, UCB Pharma, A. Golembesky Shareholder of: UCB Pharma, Employee of: UCB Pharma, L. Shaughnessy Shareholder of: UCB Pharma, Employee of: UCB Pharma, D. De Cuyper Employee of: UCB Pharma, K. Luijtens Employee of: UCB Pharma, S. Abbas Shareholder of: UCB Pharma, Employee of: UCB Pharma, U. Mahadevan Grant/research support: Prometheus, Millenium, GSK, Consultant for: Abbott, Janssen, Elan, Genetech, Shire, UCB Pharma <h3>DOI</h3> 10.1136/annrheumdis-2014-eular.1996