Pregnancy and infant outcomes including major congenital malformations among women with chronic inflammatory arthritis or psoriasis, with and without etanercept use.

PURPOSE: Objectives were to quantify prevalence estimates of pregnancy and infant outcomes including major congenital malformations (MCMs) by etanercept (ETN) exposure among infants born to women with chronic inflammatory arthritis (cIA) or psoriasis (PsO).

METHODS: Claims-based data delineated pregnancy exposures and outcomes of live or nonlive births among women with cIA and PsO (ETN exposed, unexposed) and general population (GP) comparators. Infant outcomes were determined for live-born infants covered by the mother's insurer. Medical records were obtained from all accessible mother-infant pairs with claims for MCMs and a random sample of mothers. Multivariable logistic regression estimated the odds ratios (ORs) of having at least one algorithm-defined MCM in the ETN-exposed cohorts versus unexposed comparators.

RESULTS: Prevalence estimates for pregnancy outcomes were comparable across cIA and PsO cohorts. Algorithm-defined prevalence estimates of having at least one MCM were 6.1% (ETN exposed), 5.5% (unexposed), and 5.7% (GP cohort) for the cIA cohort; PsO cohort estimates were 2.0%, 4.2%, and 4.7%, respectively. The ETN-exposure ORs for having at least one algorithm-defined MCM among infants of cIA mothers was 1.03 (95%CI: 0.51-2.10) and 0.39 (95%CI: 0.05-2.98) among infants of PsO mothers. Logistic regression with inverse probability of treatment weighting that included disease state resulted in an OR of 0.65 (0.24, 1.72).

CONCLUSIONS: 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.