Pregnancy Outcomes in Subjects Exposed to Certolizumab Pegol.

Clowse, Megan E B; Wolf, Douglas C; Förger, Frauke; Cush, John J; Golembesky, Amanda; Shaughnessy, Laura; De Cuyper, Dirk; Mahadevan, Uma (2015). Pregnancy Outcomes in Subjects Exposed to Certolizumab Pegol. Journal of rheumatology, 42(12), pp. 2270-2278. Journal of Rheumatology Pub. Co. 10.3899/jrheum.140189

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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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Dermatology, Urology, Rheumatology, Nephrology, Osteoporosis (DURN) > Clinic of Rheumatology and Immunology

UniBE Contributor:

Förger, Frauke

Subjects:

600 Technology > 610 Medicine & health

ISSN:

0315-162X

Publisher:

Journal of Rheumatology Pub. Co.

Language:

English

Submitter:

Stefan Kuchen

Date Deposited:

13 Apr 2016 13:23

Last Modified:

05 Dec 2022 14:55

Publisher DOI:

10.3899/jrheum.140189

PubMed ID:

26523031

Uncontrolled Keywords:

CERTOLIZUMAB PEGOL; CONGENITAL MALFORMATIONS; MISCARRIAGE; PREGNANCY

BORIS DOI:

10.7892/boris.80948

URI:

https://boris.unibe.ch/id/eprint/80948

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