‘Reassuring’ data on certolizumab pegol use during pregnancy
medwireNews: Treatment with the tumor necrosis factor (TNF) inhibitor certolizumab pegol during pregnancy is not likely to be associated with teratogenic effects, researchers report.
“[A]nti-TNFs are often discontinued early in gestation” because “information about their use and safety in pregnancy is limited,” say Megan Clowse (Duke University Medical Center, Durham, North Carolina, USA) and study co-authors.
The team used a safety database to analyze the outcomes of 528 women with 538 pregnancies (including 10 pairs of twins), who were exposed to certolizumab pegol during gestation. Over half (57%) of the women were taking the drug for rheumatic diseases, including rheumatoid arthritis, spondyloarthritis, and juvenile idiopathic arthritis, while the other main indication was Crohn’s disease.
As reported in Arthritis & Rheumatology, the “large majority” (85.3%) of pregnancies resulted in live births. A total of 8.7% of pregnancies ended in miscarriage, and 5.0% in elective abortion. Less than 1.0% of infants were stillborn.
Furthermore, analysis of infant outcomes “did not show any patterns or clusters of events suggesting a specific safety signal in newborns,” write Clowse and team. A total of 1.7% of live birth infants had major congenital malformations, a rate they say “is similar to those reported for the general population in the US and Europe.”
The study authors also found “no discernible trends” linking congenital malformations to the timing of certolizumab pegol exposure. A total of 81.2% of women with live births took the drug during the first trimester of pregnancy, and 44.5% were exposed during all three trimesters.
The researchers caution that “no untreated control group was available for comparison”, and thus “a formal assessment of data by statistical analysis was not possible.” However, they say that their findings “represent the most comprehensive published dataset for pregnancies exposed to a single anti-TNF to date.”
And they conclude that “these data are reassuring for women of childbearing age affected by chronic inflammatory diseases who need an anti-TNF to control their condition and wish to become or are pregnant during [certolizumab pegol] treatment.”
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