Exposure to Infliximab During Pregnancy: Post-Marketing Experience

Anja Geldhof (), Jennifer Slater, Michael Clark, Urmila Chandran and Danielle Coppola
Additional contact information
Anja Geldhof: Janssen Biologics B.V., Medical Affairs
Jennifer Slater: Janssen Research and Development
Michael Clark: Janssen Research and Development
Urmila Chandran: Janssen Research and Development
Danielle Coppola: Janssen Research and Development

Drug Safety, 2020, vol. 43, issue 2, No 8, 147-161

Abstract: Abstract Background Women of childbearing potential are often treated with monoclonal antibodies to control chronic and debilitating inflammatory diseases. Remicade® (innovator infliximab [IFX]) may cross the placenta after the first trimester of pregnancy. Hence, evidence is needed to optimize treatment while carefully weighing benefits and risks to the mother and child. Here, we report on birth and infant outcomes (up to 2 years) following gestational exposure to IFX based on a summary of cumulative pregnancy reports in women exposed to IFX during pregnancy from the Janssen global safety database. Methods Prospective and medically confirmed safety data on IFX-exposed pregnancies from Janssen’s global safety surveillance database since authorization in 1998 are summarized. Descriptive statistics were used to summarize pregnancy and infant outcomes overall, by disease and timing of exposure. Results As of 23 August 2018, 1850 maternally IFX-exposed pregnancies with known outcomes were identified from the safety database. Of the 1850 pregnancies (mean age 29.7 years), 1526 (82.5%) resulted in live births. When reported, most women had Crohn’s disease (67.7%) or ulcerative colitis (18.4%), and 82.8% of live births were exposed to IFX in the first trimester. Spontaneous abortion/intrauterine death/ectopic pregnancy/molar pregnancy (12.1%), preterm births (9.2%), low birth weight infants (3.6%), congenital anomalies (2.0%), and infant infections (1.2%) were documented. The type of congenital anomalies and frequency of serious infant infections observed were consistent with the general population. Frequencies of congenital anomalies and other adverse outcomes were similar in women exposed to IFX in the first trimester and those exposed in the third trimester. More preterm births (13–18.8%) and infant complications (8.7–12.5%) were reported with concomitant immunosuppressant use. Conclusions The observed prevalence of adverse pregnancy and infant outcomes including congenital anomalies following exposure to IFX did not exceed estimates reported for the general population and no unexpected patterns were observed.

Date: 2020
References: View complete reference list from CitEc
Citations:

Downloads: (external link)
http://link.springer.com/10.1007/s40264-019-00881-8 Abstract (text/html)
Access to the full text of the articles in this series is restricted.

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:spr:drugsa:v:43:y:2020:i:2:d:10.1007_s40264-019-00881-8

Ordering information: This journal article can be ordered from
http://www.springer.com/adis/journal/40264

DOI: 10.1007/s40264-019-00881-8

Access Statistics for this article

Drug Safety is currently edited by Nitin Joshi

More articles in Drug Safety from Springer
Bibliographic data for series maintained by Sonal Shukla () and Springer Nature Abstracting and Indexing ().