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ORLANDO -- Use of anti-tumor necrosis factor-alpha (TNF-α) therapy during the third trimester was not associated with adverse birth outcomes in women with moderate to severe inflammatory bowel disease (IBD), according to researchers here.
Results from a Danish cohort of 219 women found that for those who experienced IBD activity during pregnancy, the adjusted odds ratio was 2.23 (95% CI 0.80-6.20) for preterm birth and 1.16 (95% CI 0.26-5.23) for low birth weight among those treated with anti-TNF-α therapy, reported , Odense University Hospital and University of Southern Denmark, and colleagues.
Action Points
- Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.
In comparison, for women without disease activity during pregnancy, the aOR for preterm birth and low birth weight was 3.36 (95% CI 0.31-36.46) and 0.86 (95% CI 0.05-14.95), respectively, among those treated with anti-TNF-α therapy during third trimester, they said in a presentation at the Advances in Inflammatory Bowel Diseases meeting.
"Our results confirm the previously published results that treatment with anti-TNF-α therapy during third trimester was not associated with an increased risk of preterm birth or LBW," they concluded, calling the results "reassuring."
They reviewed medical records from a nationwide unselected cohort of Danish women with IBD. All women had been treated with anti-TNF-α therapy at some time during pregnancy (n=144) or 3 months before conception (n= 75) from 2005 to 2014.
The researchers also retrospectively collected data on disease activity indices, demographics, and clinical details.
Using logistic regression analyses -- with adjustment for confounders such as parity, mother's age, medications other than anti-TNF-α therapy, Charlson comorbidity score, and smoking -- the group examined the drug's effect on low birth weight (birthweight ≤2500 g) and preterm birth (<37 weeks of gestation).
After comparing the birth outcomes of children whose mothers received anti-TNF-α treatment during the third trimester with birth outcomes of children whose mothers discontinued anti-TNF-α therapy before the third trimester, the researchers found no increased risk for low birth weight or preterm birth.
Primary Source
Advances in Inflammatory Bowel Diseases 2016
Kammerlander H, et al "Anti-TNF-α therapy in late pregnancy and the risk of adverse birth outcomes in women with inflammatory bowel disease" AIBD 2016; Abstract P-038.