- Title
- Timing of Live Attenuated Vaccination in Infants Exposed to Infliximab or Adalimumab in Utero: A Prospective Cohort Study in 107 Children
- Creator
- Liu, Zheng; Julsgaard, Mette; Rosella, Ourania; Grosen, Anne; Toong, Catherine; Flanagan, Emma; Wieringa, Jantien W.; van der Woude, C. Janneke; Bell, Sally J.; The CARINA Study Group,; Zhu, Xiao; Martin, Jennifer; Barclay, Murray L.; Cranswick, Noel; Gibson, Peter R.; Gearry, Richard B.; van der Giessen, Janine; Connor, Susan J.
- Relation
- Journal of Crohn's and Colitis Vol. 16, Issue 12, p. 1835-1844
- Publisher Link
- http://dx.doi.org/10.1093/ecco-jcc/jjac093
- Publisher
- Oxford University Press
- Resource Type
- journal article
- Date
- 2022
- Description
- Background and Aims: For infants exposed in utero to anti-tumour necrosis factor-α [TNF] medications, it is advised that live-attenuated vaccinations be postponed until the drug is cleared, but little is known about time to clearance. To minimize delays before live-attenuated vaccination can be given, we aimed to develop a pharmacokinetic model to predict time-to-clearance in infants exposed during pregnancy. Methods: We prospectively followed in utero infliximab/adalimumab-exposed infants of mothers with inflammatory bowel disease across four countries between 2011 and 2018. Infants with a detectable anti-TNF umbilical-cord level and at least one other blood sample during the first year of life were included. RESULTS: Overall, 107 infants were enrolled, including 166 blood samples from 71 infliximab-exposed infants and 77 samples from 36 adalimumab-exposed infants. Anti-TNF was detectable in 23% [n = 25] of infants at 6 months. At 12 months, adalimumab was not detected but 4% [n = 3] had detectable infliximab. A Bayesian forecasting method was developed using a one-compartment pharmacokinetic model. Model validation showed that the predicted clearing time was in accordance with the measured observations. A clinician-friendly online calculator was developed for calculating full anti-TNF clearing time: https://xiaozhu.shinyapps.io/antiTNFcalculator2/. Conclusions: Almost one-quarter of infants born to mothers receiving anti-TNF during pregnancy have detectable anti-TNF at 6 months. To limit the time to live-attenuated vaccination in infants of mothers receiving anti-TNF during pregnancy, the results of a cord drug level at birth and a second sample ≥ 1 month thereafter can be used to estimate the time for full anti-TNF clearance in these children.
- Subject
- anti-tumour necrosis factor alpha; clearance; inflammatory bowel disease; pharmacokinetics; pregnancy; pregnancy outcome
- Identifier
- http://hdl.handle.net/1959.13/1490469
- Identifier
- uon:52914
- Identifier
- ISSN:1873-9946
- Language
- eng
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