Timing of Live Attenuated Vaccination in Infants Exposed to Infliximab or Adalimumab in Utero: A Prospective Cohort Study in 107 Children
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 develo...
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Veröffentlicht in: | Journal of Crohn's and colitis 2022-12, Vol.16 (12), p.1835-1844 |
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creator | Liu, Zheng Julsgaard, Mette Zhu, Xiao Martin, Jennifer Barclay, Murray L Cranswick, Noel Gibson, Peter R Gearry, Richard B van der Giessen, Janine Connor, Susan J Rosella, Ourania Grosen, Anne Toong, Catherine Flanagan, Emma Wieringa, Jantien W Janneke van der Woude, C Bell, Sally J |
description | 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.
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.
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/.
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. |
doi_str_mv | 10.1093/ecco-jcc/jjac093 |
format | Article |
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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.
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/.
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.</description><identifier>ISSN: 1873-9946</identifier><identifier>EISSN: 1876-4479</identifier><identifier>DOI: 10.1093/ecco-jcc/jjac093</identifier><identifier>PMID: 35779236</identifier><language>eng</language><publisher>England</publisher><subject>Adalimumab - therapeutic use ; Bayes Theorem ; Child ; Female ; Humans ; Infant ; Infant, Newborn ; Inflammatory Bowel Diseases - drug therapy ; Infliximab - therapeutic use ; Maternal Exposure ; Pregnancy ; Prospective Studies ; Tumor Necrosis Factor Inhibitors - therapeutic use ; Vaccination ; Vaccines, Attenuated - administration & dosage</subject><ispartof>Journal of Crohn's and colitis, 2022-12, Vol.16 (12), p.1835-1844</ispartof><rights>The Author(s) 2022. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: journals.permissions@oup.com.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c299t-758dd50426a797c90363eea4f1c25fdf1b6593bf84e956c9d934e5e43a2398bd3</citedby><cites>FETCH-LOGICAL-c299t-758dd50426a797c90363eea4f1c25fdf1b6593bf84e956c9d934e5e43a2398bd3</cites><orcidid>0000-0003-3295-619X ; 0000-0002-3911-4780 ; 0000-0001-5606-0270 ; 0000-0003-3070-8950</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27923,27924</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/35779236$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Liu, Zheng</creatorcontrib><creatorcontrib>Julsgaard, Mette</creatorcontrib><creatorcontrib>Zhu, Xiao</creatorcontrib><creatorcontrib>Martin, Jennifer</creatorcontrib><creatorcontrib>Barclay, Murray L</creatorcontrib><creatorcontrib>Cranswick, Noel</creatorcontrib><creatorcontrib>Gibson, Peter R</creatorcontrib><creatorcontrib>Gearry, Richard B</creatorcontrib><creatorcontrib>van der Giessen, Janine</creatorcontrib><creatorcontrib>Connor, Susan J</creatorcontrib><creatorcontrib>Rosella, Ourania</creatorcontrib><creatorcontrib>Grosen, Anne</creatorcontrib><creatorcontrib>Toong, Catherine</creatorcontrib><creatorcontrib>Flanagan, Emma</creatorcontrib><creatorcontrib>Wieringa, Jantien W</creatorcontrib><creatorcontrib>Janneke van der Woude, C</creatorcontrib><creatorcontrib>Bell, Sally J</creatorcontrib><creatorcontrib>CARINA Study Group</creatorcontrib><creatorcontrib>The CARINA Study Group</creatorcontrib><title>Timing of Live Attenuated Vaccination in Infants Exposed to Infliximab or Adalimumab in Utero: A Prospective Cohort Study in 107 Children</title><title>Journal of Crohn's and colitis</title><addtitle>J Crohns Colitis</addtitle><description>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.
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.
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/.
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.</description><subject>Adalimumab - therapeutic use</subject><subject>Bayes Theorem</subject><subject>Child</subject><subject>Female</subject><subject>Humans</subject><subject>Infant</subject><subject>Infant, Newborn</subject><subject>Inflammatory Bowel Diseases - drug therapy</subject><subject>Infliximab - therapeutic use</subject><subject>Maternal Exposure</subject><subject>Pregnancy</subject><subject>Prospective Studies</subject><subject>Tumor Necrosis Factor Inhibitors - therapeutic use</subject><subject>Vaccination</subject><subject>Vaccines, Attenuated - administration & dosage</subject><issn>1873-9946</issn><issn>1876-4479</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2022</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNo9kF1PgzAUhhujcXN675XpH8AVSin1jpCpS5Zo4uYtKf1wJdASKGb7Cf5rwalX5_N9c84DwG2I7kPE8FIJ4YJKiGVVcTE2zsA8TGkSxDFl5z85DhiLkxm46vsKIcIITS_BDBNKWYSTOfjamsbYD-g03JhPBTPvlR24VxK-cyGM5d44C42Fa6u59T1cHVrXj2PvplZtDqbhJXQdzCSvTTNM1bi-86pzDzCDr53rWyX85J67ves8fPODPE5LIaIw35tadspegwvN617d_MYF2D2utvlzsHl5WufZJhARYz6gJJWSoDhKOGVUMIQTrBSPdSgioqUOy4QwXOo0VowkgkmGY0VUjHmEWVpKvADo5CvGw_pO6aLtxhe6YxGiYqJaTFSLkWrxS3WU3J0k7VA2Sv4L_jDib1bWd14</recordid><startdate>20221205</startdate><enddate>20221205</enddate><creator>Liu, Zheng</creator><creator>Julsgaard, Mette</creator><creator>Zhu, Xiao</creator><creator>Martin, Jennifer</creator><creator>Barclay, Murray L</creator><creator>Cranswick, Noel</creator><creator>Gibson, Peter R</creator><creator>Gearry, Richard B</creator><creator>van der Giessen, Janine</creator><creator>Connor, Susan J</creator><creator>Rosella, Ourania</creator><creator>Grosen, Anne</creator><creator>Toong, Catherine</creator><creator>Flanagan, Emma</creator><creator>Wieringa, Jantien W</creator><creator>Janneke van der Woude, C</creator><creator>Bell, Sally J</creator><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><orcidid>https://orcid.org/0000-0003-3295-619X</orcidid><orcidid>https://orcid.org/0000-0002-3911-4780</orcidid><orcidid>https://orcid.org/0000-0001-5606-0270</orcidid><orcidid>https://orcid.org/0000-0003-3070-8950</orcidid></search><sort><creationdate>20221205</creationdate><title>Timing of Live Attenuated Vaccination in Infants Exposed to Infliximab or Adalimumab in Utero: A Prospective Cohort Study in 107 Children</title><author>Liu, Zheng ; Julsgaard, Mette ; Zhu, Xiao ; Martin, Jennifer ; Barclay, Murray L ; Cranswick, Noel ; Gibson, Peter R ; Gearry, Richard B ; van der Giessen, Janine ; Connor, Susan J ; Rosella, Ourania ; Grosen, Anne ; Toong, Catherine ; Flanagan, Emma ; Wieringa, Jantien W ; Janneke van der Woude, C ; Bell, Sally J</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c299t-758dd50426a797c90363eea4f1c25fdf1b6593bf84e956c9d934e5e43a2398bd3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2022</creationdate><topic>Adalimumab - therapeutic use</topic><topic>Bayes Theorem</topic><topic>Child</topic><topic>Female</topic><topic>Humans</topic><topic>Infant</topic><topic>Infant, Newborn</topic><topic>Inflammatory Bowel Diseases - drug therapy</topic><topic>Infliximab - therapeutic use</topic><topic>Maternal Exposure</topic><topic>Pregnancy</topic><topic>Prospective Studies</topic><topic>Tumor Necrosis Factor Inhibitors - therapeutic use</topic><topic>Vaccination</topic><topic>Vaccines, Attenuated - administration & dosage</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Liu, Zheng</creatorcontrib><creatorcontrib>Julsgaard, Mette</creatorcontrib><creatorcontrib>Zhu, Xiao</creatorcontrib><creatorcontrib>Martin, Jennifer</creatorcontrib><creatorcontrib>Barclay, Murray L</creatorcontrib><creatorcontrib>Cranswick, Noel</creatorcontrib><creatorcontrib>Gibson, Peter R</creatorcontrib><creatorcontrib>Gearry, Richard B</creatorcontrib><creatorcontrib>van der Giessen, Janine</creatorcontrib><creatorcontrib>Connor, Susan J</creatorcontrib><creatorcontrib>Rosella, Ourania</creatorcontrib><creatorcontrib>Grosen, Anne</creatorcontrib><creatorcontrib>Toong, Catherine</creatorcontrib><creatorcontrib>Flanagan, Emma</creatorcontrib><creatorcontrib>Wieringa, Jantien W</creatorcontrib><creatorcontrib>Janneke van der Woude, C</creatorcontrib><creatorcontrib>Bell, Sally J</creatorcontrib><creatorcontrib>CARINA Study Group</creatorcontrib><creatorcontrib>The CARINA Study Group</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><jtitle>Journal of Crohn's and colitis</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Liu, Zheng</au><au>Julsgaard, Mette</au><au>Zhu, Xiao</au><au>Martin, Jennifer</au><au>Barclay, Murray L</au><au>Cranswick, Noel</au><au>Gibson, Peter R</au><au>Gearry, Richard B</au><au>van der Giessen, Janine</au><au>Connor, Susan J</au><au>Rosella, Ourania</au><au>Grosen, Anne</au><au>Toong, Catherine</au><au>Flanagan, Emma</au><au>Wieringa, Jantien W</au><au>Janneke van der Woude, C</au><au>Bell, Sally J</au><aucorp>CARINA Study Group</aucorp><aucorp>The CARINA Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Timing of Live Attenuated Vaccination in Infants Exposed to Infliximab or Adalimumab in Utero: A Prospective Cohort Study in 107 Children</atitle><jtitle>Journal of Crohn's and colitis</jtitle><addtitle>J Crohns Colitis</addtitle><date>2022-12-05</date><risdate>2022</risdate><volume>16</volume><issue>12</issue><spage>1835</spage><epage>1844</epage><pages>1835-1844</pages><issn>1873-9946</issn><eissn>1876-4479</eissn><abstract>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.
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.
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/.
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.</abstract><cop>England</cop><pmid>35779236</pmid><doi>10.1093/ecco-jcc/jjac093</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0003-3295-619X</orcidid><orcidid>https://orcid.org/0000-0002-3911-4780</orcidid><orcidid>https://orcid.org/0000-0001-5606-0270</orcidid><orcidid>https://orcid.org/0000-0003-3070-8950</orcidid></addata></record> |
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source | MEDLINE; Oxford University Press Journals All Titles (1996-Current); Alma/SFX Local Collection |
subjects | Adalimumab - therapeutic use Bayes Theorem Child Female Humans Infant Infant, Newborn Inflammatory Bowel Diseases - drug therapy Infliximab - therapeutic use Maternal Exposure Pregnancy Prospective Studies Tumor Necrosis Factor Inhibitors - therapeutic use Vaccination Vaccines, Attenuated - administration & dosage |
title | Timing of Live Attenuated Vaccination in Infants Exposed to Infliximab or Adalimumab in Utero: A Prospective Cohort Study in 107 Children |
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