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Anti-TNF use by pregnant women with IBD does not appear to increase infection risk in children
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Children exposed to anti-tumor necrosis factor alpha drugs in utero did not experience increased short- or long-term risk for severe infection, according to results from the TEDDY study published in the American Journal of Gastroenterology.
Javier P. Gisbert, MD, PhD, of the department of gastroenterology at La Princesa University Hospital in Madrid, Spain, and colleagues wrote that previous studies have shown anti-TNF alpha drugs to be safe in the short term, but use of the drugs during pregnancy by women with inflammatory bowel diseases is often cautioned due to a lack of data on the long-term impact.
“Most patients with inflammatory bowel disease (IBD) are affected during their peak reproductive years, when many female patients affected by Crohn’s disease or ulcerative colitis want to have children,” the study investigators wrote. “[Anti-TNF alpha] drugs have been increasingly used for the treatment of IBD. Therefore, many women wishing to become pregnant may be exposed to these drugs.”
Gisbert and colleagues conducted a retrospective cohort study to analyze the safety of anti-TNF alpha drugs in children exposed in utero (n = 388) vs. unexposed children (n = 453).
Follow-up was a median 47 months in the exposed group and 68 months in the non-exposed group.
The analysis showed that the incidence rate of severe infections was similar in the non-exposed and exposed groups (1.6% to 2.8% per person-year; HR = 1.2; 95% CI, 0.8–1.8). Ninety children developed severe infection during the follow-up period, including 46 children in the exposed cohort and 44 in the non-exposed cohort (12% vs 9.7%; P = .3).
Gisbert and colleagues found that risk for infection was higher in children born preterm (2.5%; 1.5–4.3).
“The results of the present study show that exposure to anti-TNF [alpha] drugs in utero does not increase the risk of severe infections in children born to mothers with IBD,” the investigators concluded. – by Alex Young
Disclosures : Gisbert reports serving as a speaker, a consultant and an advisory member for or has received research funding from MSD, AbbVie, Hospira, Pfizer, Kern Pharma, Biogen, Takeda, Janssen, Roche, Ferring, Faes Farma, Shire Pharmaceuticals, Dr. Falk Pharma, Tillotts Pharma, Chiesi, Casen Fleet, Gebro Pharma, Otsuka Pharmaceutical, and Vifor Pharma. Please see the full study for all other authors’ relevant financial disclosures.
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