Birth Defects Not Up Significantly With Anti-TNFs in Pregnancy
Based on data from health registers, risk of birth defects up slightly, but not significantly
MONDAY, Feb. 22, 2016 (HealthDay News) -- Birth defects are not significantly more prevalent among women receiving anti-tumor necrosis factor (TNF) agents during pregnancy, according to a study published in the February issue of Clinical Gastroenterology and Hepatology.
Gabriella Bröms, M.D., from the Karolinska Institutet in Stockholm, and colleagues collected data on 1,272,424 live-born infants identified from the Danish and Swedish population-based health registers. They examined the prevalence of birth defects among infants born to women with chronic inflammatory disease (683 treated with and 21,549 without anti-TNF agents during early pregnancy) and in the general population.
The researchers found that the prevalence of birth defects was higher among infants born to women with chronic inflammatory disease than in the general population (4.8 versus 4.2 percent), irrespective of anti-TNF treatment status. Birth defects occurred in 6.3 percent of infants born to women who received anti-TNF treatment versus 4.7 percent of infants born to women with chronic inflammatory disease who received no treatment. In women receiving anti-TNF treatment, the odds ratios were 1.32 (95 percent confidence interval [CI], 0.93 to 1.82) for any defect; 1.60 (95 percent CI, 0.93 to 2.58) for a cardiovascular defect; and 2.22 (95 percent CI, 0.86 to 4.71) for a urinary defect.
"Women who received anti-TNF agents during pregnancy had a slightly (but not significantly) higher risk of having children with birth defects," the authors write.
The authors' institutions have received financial support from pharmaceutical companies. The study was developed independently from a post-authorization safety study commissioned via Janssen Biotech.