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* = Presenting author

P255 Life virus vaccines in infants with intrauterine exposure to biologics

B. Truta*, J. Canner, J. Efron, B. Safar

Johns Hopkins University, Baltimore, United States

Background

High levels of anti-TNFs (infliximab, adalimumab) were detected in the blood of newborn infants from mothers treated with biologics during pregnancy. This exposure was associated with deadly cases of tuberculosis in infants vaccinated for tuberculosis. Therefore, current guidelines limit the use of life virus vaccines in the first 6 months of life.

Aim: to evaluate the immunisation schedule for live-virus vaccines in newborns with intrauterine exposure to anti-TNFs.

Methods

This was a retrospective study of all newborns registered with the Truven Health Analytics MarketScan database from January 2010 to December 2012. Study patients were all the infants with intrauterine exposure to anti-TNF. Controls were infants without intrauterine exposure to anti-TNFs. We collected all information regarding age of the infant at immunisation, type and timing of vaccination. Statistical analysis using Chi-square tests were used to compare the rate of infection between infants with and those without intrauterine exposure to anti-TNFs.

Results

There were 305 study patients and 398.482 controls: 39% were exposed to infliximab, 47% were exposed to adalimumab, 14% were exposed to certolizumab; and the newborns were followed-up to a mean of 371 days with a range of 0–720 days. There was similar number of infants immunised against rotavirus (43.6% vs 39%, p = NS) and against MMR infections (18.12% vs 16.8%, p = NS) in both groups, during the time of follow-up. The mean age at the time of vaccination against rotavirus was 80 ± 55 days for infants exposed to biologics and 71 ± 42.5 for those non-exposed; interestingly, in both groups, 95% infants were vaccinated in the first 6 months of life. The mean age at the time of vaccination against MMR infections was 410 ± 69 days for infants exposed to biologics and 392 ± 71 for those non-exposed, most of them been immunised in the second year of life (76% and 83%, respectively). Similar findings were for found for all 3 biologics with no difference in immunisation schedule between the biologics able to cross the placenta (infliximab and adalimumab) and those who not (certolizumab).

Conclusion

In the community, the use of live-virus vaccines does not differ between infants with or without intrauterine exposure to anti-TNFs.