Risk of disseminated tuberculosis and other infections after neonatal Bacillus Calmette-Guérin vaccination in infants with in-utero exposure to tumor necrosis factor-α inhibitors.

INTRODUCTION

Infants born to mothers with autoimmune rheumatic diseases, including rheumatoid arthritis, spondyloarthropathy, and inflammatory bowel disease, may be exposed antenatally to tumor necrosis factor-alpha (TNF-α) inhibitors. Recent guidelines recommend deferring live attenuated vaccines, such as Bacillus Calmette-Guérin (BCG), until after 6-12 months of age in this population, owing to conflicting safety data. This study aimed to evaluate the safety of administering BCG vaccination at birth in infants exposed to TNF-α inhibitors in utero.

METHOD: We retrospectively screened the electronic health records of women with autoimmune rheumatic diseases treated with TNF-α inhibitors during pregnancy. Only children with complete health records from infancy were included in the analysis. Data were obtained from the largest health system in Qatar. Information on obstetric history, type and duration of TNF-α inhibitor therapy during pregnancy, age at BCG vaccine administration, adverse reactions to the vaccine, and any infections and hospitalizations documented during infancy was collected. Descriptive statistics and univariate analyses were used to assess factors associated with infection and hospitalization using SPSS (version 27.0).

RESULTS

We identified 63 infants exposed to TNF-α inhibitors in utero, 49 (77.8%) of whom received BCG vaccination within the first year of life, including 27 infants (42.8%) who were vaccinated at birth. Most infants vaccinated at birth (20/27) were exposed to TNF-α inhibitors during the third trimester. Certolizumab was the most frequently prescribed agent. Over half of the children in this cohort experienced at least three infections during infancy; however, none developed disseminated tuberculosis. Exposure to TNF-α inhibitors did not demonstrate an increased risk of infection or hospitalization during the first year of life.

CONCLUSION

BCG vaccination at birth did not result in disseminated tuberculosis, even among infants exposed to TNF-α inhibitors during the third trimester.