Effects of Certolizumab Pegol Exposure on Pregnancy Outcomes in Women With Rheumatic Disease

Researchers sought to provide information on pregnancy outcomes, including major congenital malformations and other maternal and fetal adverse outcomes, in women treated with certolizumab pegol.

An analysis of pregnancy outcomes among women treated with the anti-tumor necrosis factor (TNF) certolizumab pegol (CZP) did not show a teratogenic effect of CZP compared with the general population, nor an increased risk for fetal death, according to an analysis of findings from a pharmacovigilance safety database published in Arthritis & Rheumatism.

Prospective and retrospective data on maternal CZP exposure were obtained from the UCB Pharma safety database through March 6, 2017. Information was compiled on pregnancy outcomes among CZP-treated women, particularly those with early pregnancy exposure. Researchers collected information on numbers of live births, miscarriages, elective abortions, stillbirths, and major congenital malformations.

Of 1137 maternal CZP-exposed prospective pregnancies, 528, including 10 twin pregnancies, had 538 known outcomes: 85.3% were live births, 8.7% were miscarriages, 5.0% were elective abortions, and 0.9% were stillbirths. Eight major congenital malformations were reported among the 459 infants. First-trimester CZP exposure occurred in 81.2% of pregnancies, which resulted in 459 live births. CZP exposure during all 3 trimesters occurred for 44.5% of pregnancies.

Common indications among women exposed to CZP with known pregnancy outcomes were Crohn disease (n=195) and rheumatic diseases (n=301), including rheumatoid arthritis (n=235), ankylosing spondylitis/axial spondyloarthritis (n=45), psoriatic arthritis (n=18), and juvenile idiopathic arthritis (n=5). The investigators noted that 11 patients were counted 2 times because of multiple reported indications.

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The current analysis is the largest cohort of pregnant women to date exposed to a single anti-TNF for the management of chronic inflammatory disease. The investigators concluded that these data are encouraging for women of childbearing age who are considering treatment with CZP. The study findings confirm the safety of CZP exposure during pregnancy.

Please refer to original study text for a full list of disclosures.


Clowse MEB, Scheuerle AE, Chambers C, et al. Pregnancy outcomes after exposure to certolizumab pegol: updated results from a pharmacovigilance safety database [published online April 5, 2018].  Arthritis Rheumatol. doi: 10.1002/art.40508