Favorable Certolizumab Safety Profile in Pregnancy Save

Clowse and colleagues have published an extensive review of the certolizumab pegol (CZP) in pregnancy database, and found no evidence that CZP has a teratogenic effect or contributes to fetal harm when compared to the general population. 

CZP is a PEGylated, Fc‐free anti‐TNF approved for use in Crohn's disease, rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis.  Studies have shown little to no active placental transfer of CZP from the mother to fetus in utero.  Recent studies have also shown no or miniscule levels of CZP in the breast milk of women during lactation.

This report analyzes prospective and retrospective data on maternal CZP exposure from the UCB safety database through March 2017. Analysis was limited to prospective reports to avoid potential bias. 

Of the 1137 maternal CZP‐exposed prospective pregnancies, 528 (including 10 twin pregnancies) had 538 known outcomes: 459 live births (85.3%), 47 miscarriages (8.7%), 27 elective abortions (5.0%), and 5 stillbirths (0.9%).

A total of 8 major congenital malformations (1.7%) were seen in 459 infants.

The vast majority of these exposures were from patients with RA (n=235) or Crohn's disease (n=195) and during the first trimester (81.2%). Nearly half (44.5%) had CZP exposure during all 3 trimesters of pregnancy.

These findings are reassuring for women of childbearing age who are considering treatment with CZP.