No ill effects with prenatal anti-TNF-alpha exposure in young kids

Last Updated: 2018-09-28

By Anne Harding

NEW YORK (Reuters Health) - Prenatal exposure to anti-tumor necrosis factor (TNF)-alpha therapy does not appear to affect immune system function, growth or development in young children, according to a new study.

"At least up to three years it seems to be safe, but we need more long-term data," Dr. Dana Duricova of the IBD Clinical and Research Centre at ISCARE I.V.F. in Prague, Czech Republic, told Reuters Health by phone. "It's very important to follow these children for a longer time."

Inflammatory bowel disease is usually diagnosed in people of reproductive age, so many women with IBD conceive while taking biologics and other therapies, Dr. Duricova and her team note in Inflammatory Bowel Diseases, online September 14.

"There is already solid evidence of a favorable safety profile of anti-TNF-alpha preparations on pregnancy and short-term newborn outcome," they add.

The new study included 72 children born consecutively between 2007 and 2016 at three centers in the Czech Republic to mothers who received anti-TNF-alpha therapy during pregnancy. A group of 69 children consecutively born to mothers without IBD who had come for a child's mandatory checkup served as controls. The median age was 35 months for exposed children and 50 months for controls.

Children in the Czech Republic see a pediatrician starting in their first week of life, then at six weeks; three, six, 12 and 18 months; and biannually up to 18 or 19 years.

Infectious complications occurred in the first year of life in 23.9% of the exposed children and 17.4% of the unexposed children (P=0.36).

The risk of infectious complications during the entire follow-up also did not differ significantly, with a median rate of 0.016 infections per month in the exposed group and 0.031 in controls (P=0.32). Neither univariate nor multivariable linear regression models showed significant differences between the groups.

There was no significant difference in clinically apparent asthma or the risk of impaired growth or psychomotor development between exposed and unexposed children.

More than 95% of the children exposed to anti-TNF-alpha responded adequately to immunization, aside from Hib and mumps vaccines.

Dr. Duricova and her team are continuing to follow the children in the study, and are recruiting new babies exposed prenatally to anti-TNF-alpha. "We would also like to include a group of children who are exposed to other biologics," she said.

SOURCE: https://bit.ly/2zBVqkE

Inflamm Bowel Dis 2018.