RT Journal Article
SR Electronic
T1 Pregnancy Outcomes in Subjects Exposed to Certolizumab Pegol
JF The Journal of Rheumatology
JO J Rheumatol
FD The Journal of Rheumatology
SP 2270
OP 2278
DO 10.3899/jrheum.140189
VO 42
IS 12
A1 Megan E.B. Clowse
A1 Douglas C. Wolf
A1 Frauke Förger
A1 John J. Cush
A1 Amanda Golembesky
A1 Laura Shaughnessy
A1 Dirk De Cuyper
A1 Uma Mahadevan
YR 2015
UL http://www.jrheum.org/content/42/12/2270.abstract
AB 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.