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While there are several reports detailing uncontrolled, observational results of biologic use during pregnancy, most are hampered by low numbers, incomplete data and too small a sample to make reliable judgments regarding the teratogenicity. A company-sponsored claims data analysis has shown that etanercept exposure during pregnancy was not associated with an increase in major congenital malformations (MCMs).
Investigators used claims data to quantify prevalence estimates of pregnancy and infant outcomes including by etanercept (ETN) exposure among infants born to women with chronic inflammatory arthritis (cIA) or psoriasis (PsO). These findings were compared to general population (GP) estimates from the same dataset.
Prevalence estimates for at least one MCM were 6.1% (ETN exposed), 5.5% (unexposed), and 5.7% (GP cohort) for the cIA cohort. Lower numbers were seen among PsO cohort; MCM estimates were 2.0% (ETN exposed), 4.2% (unexposed), and 4.7% ((GP cohort).
The risk of MCM during ETN-exposure was not increased (OR 1.03; 95%CI 0.51-2.10) in inflammatory arthritis patients, nor in infants of PsO mothers (OR 0.39; 95%CI 0.05-2.98).
Overall, this study did not identify any new safety concerns associated with the use of etanercept during pregnancy. Etanercept, along with the other TNFis, remains a treatment without well-controlled clinical trials in pregnant women. Patients should continue to consult their doctor regarding benefit risk decisions of TNFi therapy during pregnancy.