Background/Purpose: Data on the impact of anti-TNF medications on pregnancy outcomes are
limited. Certolizumab pegol (CZP) is a PEGylated
Fc-free anti-TNF approved in more than 50 countries for the treatment of
rheumatoid arthritis (RA) and/or Crohn’s disease, psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA). The objective of
this project is to provide information on pregnancy outcomes in women receiving
CZP.

Methods: The
UCB Pharma safety database was searched for CZP-exposed pregnancies through 1
February 2015. Maternal and paternal CZP exposure, prospective and
retrospective reports were included. This abstract focuses on maternal exposure
pregnancies that are prospectively reported to reduce bias in outcome reporting
rates. Available data on CZP exposure, pregnancy dating, pregnancy outcomes,
comorbidities and infant events were independently extracted by 2 internal
reviewers. The number of live births, miscarriages, induced abortions and
stillbirths for CZP-exposed pregnancies were examined.

Results: There
were a total of 723 CZP exposed pregnancy reports, of which 572 were prospectively
reported. 540 pregnancies were maternally exposed (256 with known pregnancy
outcomes, 47.4%) and 32 were paternally exposed (18 with known outcomes,
56.3%). Of the 256 maternally exposed pregnancies with known outcome, there
were 207 live births (80.9%), 26 miscarriages (10.2%), 22 induced abortions
(8.6%), and 1 stillbirth (0.4%) (Figure). The majority of pregnancies were reported
through routine surveillance (65.9%); clinical trials accounted for 9.1% of
pregnancy reports. Indications for CZP use included rheumatic disease (n=100,
39.1%) and Crohn’s disease (n=140, 54.7%). The mean maternal age at estimated
delivery date was 31.3 (SD 5.4) years. Many pregnancies (n=70, 44.6%) were
exposed only during the first trimester, when the majority of fetal organ and
organ system development takes place; 52 were exposed to CZP in all 3
trimesters (Table). 9 cases of congenital malformations were prospectively
reported among 210 infants (including 3 sets of twins) with no discernable
pattern in the reported malformations.

Conclusion: The
analysis represents a uniquely large number of pregnancies exposed to a single
anti-TNF. The majority of pregnancies had first trimester CZP exposure, and up
to a third of prospectively-collected pregnancies continued treatment into the
second and/or third trimesters. A limitation of this study is that the majority
of the data originated from spontaneous post-marketing reports, which can be
affected by bias and inherent limitations due to the passive and voluntary
nature of the reporting systems. The data collectively suggests that CZP
exposure in utero does not adversely affect pregnancy outcome.