Pregnancy outcomes in subjects exposed to certolizumab pegol

Megan E.B. Clowse, Douglas C. Wolf, Frauke Förger, John J. Cush, Amanda Golembesky, Laura Shaughnessy, Dirk De Cuyper, Uma Mahadevan

Research output: Contribution to journalArticle

37 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)2270-2278
Number of pages9
JournalJournal of Rheumatology
Volume42
Issue number12
DOIs
StatePublished - Dec 2015
Externally publishedYes

Keywords

  • Certolizumab pegol
  • Congenital malformations
  • Miscarriage
  • Pregnancy

ASJC Scopus subject areas

  • Rheumatology
  • Immunology and Allergy
  • Immunology

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  • Cite this

    Clowse, M. E. B., Wolf, D. C., Förger, F., Cush, J. J., Golembesky, A., Shaughnessy, L., De Cuyper, D., & Mahadevan, U. (2015). Pregnancy outcomes in subjects exposed to certolizumab pegol. Journal of Rheumatology, 42(12), 2270-2278. https://doi.org/10.3899/jrheum.140189