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BCG vaccine safe in children exposed to anti-TNF alpha in utero
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WASHINGTON — Children exposed to anti-TNF alpha in utero do not have a higher risk for developing tuberculosis following a Bacillus Calmette-Guerin vaccination, according to research presented at Digestive Disease Week.
Maxine Luu, MD, of the Clinical Investigation Center in Dijon, France, said that physicians often do not follow current guidelines that suggest postponing vaccinating children born to mothers with inflammatory bowel disease who might have been exposed to anti-TNF in the womb until after they are six months old, but their findings suggest this practice might be safe.
“There are safety concerns about live vaccines, as there is one case of a fatal disseminated [Bacillus Calmette-Guerin] infection reported after vaccination,” Luu said in a presentation. “Whereas there were no adverse events post-BCG vaccination in a study of 15 children.”
Luu and colleagues analyzed data from the French National Health Database of children born to mothers with IBD from 2013 to 2014. They looked for all vaccines that are generally recommended to be given to children before or at 1 year old, including Bacillus Calmette-Guerin for tuberculosis (BCG).
Of the 4,741 children included in the study, 670 were exposed to anti-TNF alpha in utero (14.1%).
These children were less likely to receive the BCG vaccination (n = 88; 13.1%) compared with the non-exposed group (n = 780; 19.2%; P < .05).
Luu and colleagues found no case of disseminated BCG infection among any of the 88 children who received the vaccine. Additionally, maintenance of anti-TNF alpha during the final trimester of pregnancy had no impact of the time of BCG vaccination.
The researchers found that some physicians do postpone vaccination, but without regard for current recommendations, according to the study.
Luu and colleagues said if their findings are confirmed in further studies, physicians can consider administering the BCG vaccine in children at risk for tuberculosis infection.
“In children exposed in utero to anti-TNF, physicians do not follow current guidelines on postponing live vaccines, but we didn’t find any increased risk in BCG vaccinations prior to 6 months of age,” Luu said. - by Alex Young
Reference:
Luu M, et al. Abstract 12. Presented at: Digestive Disease Week; June 2-5, 2018; Washington, D.C.
Disclosures: Luu reports no relevant financial disclosures. Please see the DDW faculty disclosure index for a list of all other authors’ relevant financial disclosures.
Perspective
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Joel R. Rosh, MD, FAAP, FACG, AGAF
Current recommendations for children born to mothers with IBD who are on anti-TNF therapy are that vaccines should be administered as with any other child, except for live viral vaccines, and that live viral vaccines should be delayed until at least until the child reaches age 6 months. Here in this study, in addition to the live virals, another vaccine that raised concern was BCG because anti-TNF affects tuberculosis handling. So, the question was, is it safe to give BCG to infants born to moms who were anti-TNF exposed. When we drill down on the actual numbers of the study, it was small. Of the almost 4,800 children included in the study, 667 had a mother who was given an anti-TNF during pregnancy. It was evenly split between Remicade (infliximab, Janssen) and Humira (adalimumab, AbbVie), and of that, only 88 received BCG, and only 64 received BCG before 6 months. So, really, the study of interest is on those 64 children who received BCG before 6 months and were born to a mother who during pregnancy received an anti-TNF. The good news is, there were no TB-related events in those children.
Some of the other interesting points from this study were that the rate of combination therapy in pregnancy in France is very low, around 16% of the mothers who were on an anti-TNF were also on thiopurine, however there were 640 mothers who were on thiopurine alone. So, it doesn’t look like the doctors are shy about using it in pregnancy.
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