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Risk for birth defects low with anti-TNF agents
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In an analysis of health registries data in Denmark and Sweden, researchers found a slightly higher, but not significantly higher, risk for birth defects when pregnant women with chronic inflammatory disease were prescribed anti-tumor necrosis factor agents in early pregnancy. Furthermore, there was no common etiology found with the birth defects that were observed.
“The possibility of an almost doubled risk, however, likely is of low importance when weighed against the possible detrimental effects of abstaining from effective treatment during pregnancy,” the researchers wrote.
Researchers used health registries to examine data on 1,272,424 live-born infants. Population-based data from Denmark included data from 2004 to 2012 and from Sweden from 2006 to 2012.
The incidence of birth defects in children born to women with chronic inflammatory disease was calculated from the data. Women were considered if they had inflammatory bowel disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis or psoriasis. The prevalence of birth defects was then compared in women who were treated with anti-TNF treatment during pregnancy to those who were not treated, as well as to the general population.
In the group that was prescribed anti-TNF treatment during pregnancy, there were 683 women, and in the group that did not receive treatment, there were 21,549 women. When determining risks, the researchers adjusted for the following: the mother’s age, parity, smoking, BMI, multiple gestation, country and type of chronic inflammatory disease diagnosis.
Infants had more birth defects when the mother had a chronic inflammatory disease with or without treatment compared to the general population (4.8% vs 4.2%). Birth defects also occurred 6.3% of the time in women with a chronic disease who were prescribed treatment, compared to 4.7% in women who were not prescribed treatment. The odds ratio for all birth defects in children born to women receiving anti-TNF treatment was 1.32 (95% CI, 0.93-1.82); for a cardiovascular defect, 1.6 (95% CI, 0.93–2.58); and, for a urinary defect, 2.22 (95% CI, 0.86-4.71).
“We report a slightly, but not significantly, increased risk of birth defects for infants born to women treated with anti-TNF with an upper boundary of the confidence interval at 1.82,” the researchers wrote.
“The previous studies reporting risks of birth defects in association with exposure to anti-TNF treatment during pregnancy were hampered by the limited numbers of exposed women and of reported birth defects. … Strengths of this study included its large size, encompassing all infants born to women exposed to anti-TNF treatment in Denmark and Sweden,” they wrote.
Disclosures: The researchers report no relevant financial disclosures.
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