Vedolizumab clearance in neonates, susceptibility to infections and developmental milestones: a prospective multicentre population‐based cohort study
Summary Background Little is known about the consequences of intrauterine exposure to, and the post‐natal clearance of, vedolizumab. Aims To investigate the levels of vedolizumab in umbilical cord blood of newborns and rates of clearance after birth, as well as how these correlated with maternal dru...
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| Veröffentlicht in: | Alimentary pharmacology & therapeutics 2021-11, Vol.54 (10), p.1320-1329 |
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| creator | Julsgaard, Mette Baumgart, Daniel C. Baunwall, Simon M. D. Hansen, Mette M. Grosen, Anne Bibby, Bo M. Uldbjerg, Niels Kjeldsen, Jens Sørensen, Heidi G. Larsen, Lone Wildt, Signe Weimers, Petra Haderslev, Kent V. Vind, Ida Svenningsen, Lise Brynskov, Jørn Lyhne, Søren Vestergaard, Thea Hvas, Christian L. Kelsen, Jens |
| description | Summary
Background
Little is known about the consequences of intrauterine exposure to, and the post‐natal clearance of, vedolizumab.
Aims
To investigate the levels of vedolizumab in umbilical cord blood of newborns and rates of clearance after birth, as well as how these correlated with maternal drug levels, risk of infection and developmental milestones during the first year of life
Methods
Vedolizumab‐treated pregnant women with inflammatory bowel disease were prospectively recruited from 12 hospitals in Denmark and Canada in 2016‐2020. Demographics were collected from medical records. Infant developmental milestones were evaluated by the Ages and Stages Questionnaire (ASQ‐3). Vedolizumab levels were measured at delivery and, in infants, every third month until clearance. Non‐linear regression analysis was applied to estimate clearance.
Results
In 50 vedolizumab‐exposed pregnancies, we observed 43 (86%) live births, seven (14%) miscarriages, no congenital malformations and low risk of adverse pregnancy outcomes. Median infant:mother vedolizumab ratio at birth was 0.44 (95% confidence interval [CI], 0.32‐0.56). The mean time to vedolizumab clearance in infants was 3.8 months (95% CI, 3.1‐4.4). No infant had detectable levels of vedolizumab at 6 months of age. Developmental milestones at 12 months were normal or above average. Neither vedolizumab exposure in the third trimester (RR 0.54, 95% CI, 0.28‐1.03) nor combination therapy with thiopurines (RR 1.29, 95% CI, 0.60‐2.77) seemed to increase the risk of infections in the offspring.
Conclusions
Neonatal vedolizumab clearance following intrauterine exposure is rapid. Infant vedolizumab levels did not correlate with the risk of infections during the first year of life. Continuation of vedolizumab throughout pregnancy is safe.
Vedolizumab clearance in neonates, susceptibility to infections and developmental milestones. |
| doi_str_mv | 10.1111/apt.16593 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2568598303</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2585782113</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3653-4ba34934787385bbd30bc9d2184b5a568649058ab1523d0b160b09908ac931bd3</originalsourceid><addsrcrecordid>eNp1kbFuFDEQhi0EEkeg4A0s0YDEJvZ6vWfTRREBpEhQBNrV2DsnHHntZe1NdFQ8Al3ejydhjqNCYhoX8_nX_8_P2HMpTiXNGcz1VPbaqgdsI1Wvm1ao_iHbiLa3TWukesyelHIjhOi3ot2w-y845hi-rxM47iPCAskjD4knzAkqlte8rMXjXIMLMdQ9r5nWO_Q15FQ4pJGPeIsxzxOmCpFPIWKpOWF5w4HPSy7zAb5FPq2xBk_UgnzO8xrhoPHrx08HBUfu89e8VF7qOu6fskc7iAWf_X1P2OfLt9cX75urj-8-XJxfNZ7CqaZzoDqruq3ZKqOdG5Vw3o6tNJ3ToHvTd1ZoA07qVo3CyV44Ya0w4K2ShJ-wl0dd8vltJd_DFChtjED51zK0pKGtUUIR-uIf9CavSyJ3RBm9Na2UB-rVkfIUvCy4G-YlTLDsBymGQ0UDVTT8qYjYsyN7Ryfb_x8czj9dH3_8BkOQltw</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2585782113</pqid></control><display><type>article</type><title>Vedolizumab clearance in neonates, susceptibility to infections and developmental milestones: a prospective multicentre population‐based cohort study</title><source>Wiley Online Library Journals Frontfile Complete</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>Wiley Free Content</source><creator>Julsgaard, Mette ; Baumgart, Daniel C. ; Baunwall, Simon M. D. ; Hansen, Mette M. ; Grosen, Anne ; Bibby, Bo M. ; Uldbjerg, Niels ; Kjeldsen, Jens ; Sørensen, Heidi G. ; Larsen, Lone ; Wildt, Signe ; Weimers, Petra ; Haderslev, Kent V. ; Vind, Ida ; Svenningsen, Lise ; Brynskov, Jørn ; Lyhne, Søren ; Vestergaard, Thea ; Hvas, Christian L. ; Kelsen, Jens</creator><creatorcontrib>Julsgaard, Mette ; Baumgart, Daniel C. ; Baunwall, Simon M. D. ; Hansen, Mette M. ; Grosen, Anne ; Bibby, Bo M. ; Uldbjerg, Niels ; Kjeldsen, Jens ; Sørensen, Heidi G. ; Larsen, Lone ; Wildt, Signe ; Weimers, Petra ; Haderslev, Kent V. ; Vind, Ida ; Svenningsen, Lise ; Brynskov, Jørn ; Lyhne, Søren ; Vestergaard, Thea ; Hvas, Christian L. ; Kelsen, Jens ; for the NOVA Study Group</creatorcontrib><description>Summary
Background
Little is known about the consequences of intrauterine exposure to, and the post‐natal clearance of, vedolizumab.
Aims
To investigate the levels of vedolizumab in umbilical cord blood of newborns and rates of clearance after birth, as well as how these correlated with maternal drug levels, risk of infection and developmental milestones during the first year of life
Methods
Vedolizumab‐treated pregnant women with inflammatory bowel disease were prospectively recruited from 12 hospitals in Denmark and Canada in 2016‐2020. Demographics were collected from medical records. Infant developmental milestones were evaluated by the Ages and Stages Questionnaire (ASQ‐3). Vedolizumab levels were measured at delivery and, in infants, every third month until clearance. Non‐linear regression analysis was applied to estimate clearance.
Results
In 50 vedolizumab‐exposed pregnancies, we observed 43 (86%) live births, seven (14%) miscarriages, no congenital malformations and low risk of adverse pregnancy outcomes. Median infant:mother vedolizumab ratio at birth was 0.44 (95% confidence interval [CI], 0.32‐0.56). The mean time to vedolizumab clearance in infants was 3.8 months (95% CI, 3.1‐4.4). No infant had detectable levels of vedolizumab at 6 months of age. Developmental milestones at 12 months were normal or above average. Neither vedolizumab exposure in the third trimester (RR 0.54, 95% CI, 0.28‐1.03) nor combination therapy with thiopurines (RR 1.29, 95% CI, 0.60‐2.77) seemed to increase the risk of infections in the offspring.
Conclusions
Neonatal vedolizumab clearance following intrauterine exposure is rapid. Infant vedolizumab levels did not correlate with the risk of infections during the first year of life. Continuation of vedolizumab throughout pregnancy is safe.
Vedolizumab clearance in neonates, susceptibility to infections and developmental milestones.</description><identifier>ISSN: 0269-2813</identifier><identifier>EISSN: 1365-2036</identifier><identifier>DOI: 10.1111/apt.16593</identifier><language>eng</language><publisher>Chichester: Wiley Subscription Services, Inc</publisher><subject>Babies ; Birth ; Cohort analysis ; Congenital defects ; Cord blood ; Demography ; Infants ; Infections ; Inflammatory bowel diseases ; Intrauterine exposure ; Medical records ; Neonates ; Population studies ; Population-based studies ; Pregnancy ; Umbilical cord</subject><ispartof>Alimentary pharmacology & therapeutics, 2021-11, Vol.54 (10), p.1320-1329</ispartof><rights>2021 John Wiley & Sons Ltd.</rights><rights>Copyright © 2021 John Wiley & Sons Ltd</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3653-4ba34934787385bbd30bc9d2184b5a568649058ab1523d0b160b09908ac931bd3</citedby><cites>FETCH-LOGICAL-c3653-4ba34934787385bbd30bc9d2184b5a568649058ab1523d0b160b09908ac931bd3</cites><orcidid>0000-0001-6391-1782 ; 0000-0003-3070-8950 ; 0000-0002-5135-7435 ; 0000-0001-5158-4112 ; 0000-0003-4067-2381</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fapt.16593$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fapt.16593$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,778,782,1414,1430,27911,27912,45561,45562,46396,46820</link.rule.ids></links><search><creatorcontrib>Julsgaard, Mette</creatorcontrib><creatorcontrib>Baumgart, Daniel C.</creatorcontrib><creatorcontrib>Baunwall, Simon M. D.</creatorcontrib><creatorcontrib>Hansen, Mette M.</creatorcontrib><creatorcontrib>Grosen, Anne</creatorcontrib><creatorcontrib>Bibby, Bo M.</creatorcontrib><creatorcontrib>Uldbjerg, Niels</creatorcontrib><creatorcontrib>Kjeldsen, Jens</creatorcontrib><creatorcontrib>Sørensen, Heidi G.</creatorcontrib><creatorcontrib>Larsen, Lone</creatorcontrib><creatorcontrib>Wildt, Signe</creatorcontrib><creatorcontrib>Weimers, Petra</creatorcontrib><creatorcontrib>Haderslev, Kent V.</creatorcontrib><creatorcontrib>Vind, Ida</creatorcontrib><creatorcontrib>Svenningsen, Lise</creatorcontrib><creatorcontrib>Brynskov, Jørn</creatorcontrib><creatorcontrib>Lyhne, Søren</creatorcontrib><creatorcontrib>Vestergaard, Thea</creatorcontrib><creatorcontrib>Hvas, Christian L.</creatorcontrib><creatorcontrib>Kelsen, Jens</creatorcontrib><creatorcontrib>for the NOVA Study Group</creatorcontrib><title>Vedolizumab clearance in neonates, susceptibility to infections and developmental milestones: a prospective multicentre population‐based cohort study</title><title>Alimentary pharmacology & therapeutics</title><description>Summary
Background
Little is known about the consequences of intrauterine exposure to, and the post‐natal clearance of, vedolizumab.
Aims
To investigate the levels of vedolizumab in umbilical cord blood of newborns and rates of clearance after birth, as well as how these correlated with maternal drug levels, risk of infection and developmental milestones during the first year of life
Methods
Vedolizumab‐treated pregnant women with inflammatory bowel disease were prospectively recruited from 12 hospitals in Denmark and Canada in 2016‐2020. Demographics were collected from medical records. Infant developmental milestones were evaluated by the Ages and Stages Questionnaire (ASQ‐3). Vedolizumab levels were measured at delivery and, in infants, every third month until clearance. Non‐linear regression analysis was applied to estimate clearance.
Results
In 50 vedolizumab‐exposed pregnancies, we observed 43 (86%) live births, seven (14%) miscarriages, no congenital malformations and low risk of adverse pregnancy outcomes. Median infant:mother vedolizumab ratio at birth was 0.44 (95% confidence interval [CI], 0.32‐0.56). The mean time to vedolizumab clearance in infants was 3.8 months (95% CI, 3.1‐4.4). No infant had detectable levels of vedolizumab at 6 months of age. Developmental milestones at 12 months were normal or above average. Neither vedolizumab exposure in the third trimester (RR 0.54, 95% CI, 0.28‐1.03) nor combination therapy with thiopurines (RR 1.29, 95% CI, 0.60‐2.77) seemed to increase the risk of infections in the offspring.
Conclusions
Neonatal vedolizumab clearance following intrauterine exposure is rapid. Infant vedolizumab levels did not correlate with the risk of infections during the first year of life. Continuation of vedolizumab throughout pregnancy is safe.
Vedolizumab clearance in neonates, susceptibility to infections and developmental milestones.</description><subject>Babies</subject><subject>Birth</subject><subject>Cohort analysis</subject><subject>Congenital defects</subject><subject>Cord blood</subject><subject>Demography</subject><subject>Infants</subject><subject>Infections</subject><subject>Inflammatory bowel diseases</subject><subject>Intrauterine exposure</subject><subject>Medical records</subject><subject>Neonates</subject><subject>Population studies</subject><subject>Population-based studies</subject><subject>Pregnancy</subject><subject>Umbilical cord</subject><issn>0269-2813</issn><issn>1365-2036</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><recordid>eNp1kbFuFDEQhi0EEkeg4A0s0YDEJvZ6vWfTRREBpEhQBNrV2DsnHHntZe1NdFQ8Al3ejydhjqNCYhoX8_nX_8_P2HMpTiXNGcz1VPbaqgdsI1Wvm1ao_iHbiLa3TWukesyelHIjhOi3ot2w-y845hi-rxM47iPCAskjD4knzAkqlte8rMXjXIMLMdQ9r5nWO_Q15FQ4pJGPeIsxzxOmCpFPIWKpOWF5w4HPSy7zAb5FPq2xBk_UgnzO8xrhoPHrx08HBUfu89e8VF7qOu6fskc7iAWf_X1P2OfLt9cX75urj-8-XJxfNZ7CqaZzoDqruq3ZKqOdG5Vw3o6tNJ3ToHvTd1ZoA07qVo3CyV44Ya0w4K2ShJ-wl0dd8vltJd_DFChtjED51zK0pKGtUUIR-uIf9CavSyJ3RBm9Na2UB-rVkfIUvCy4G-YlTLDsBymGQ0UDVTT8qYjYsyN7Ryfb_x8czj9dH3_8BkOQltw</recordid><startdate>202111</startdate><enddate>202111</enddate><creator>Julsgaard, Mette</creator><creator>Baumgart, Daniel C.</creator><creator>Baunwall, Simon M. D.</creator><creator>Hansen, Mette M.</creator><creator>Grosen, Anne</creator><creator>Bibby, Bo M.</creator><creator>Uldbjerg, Niels</creator><creator>Kjeldsen, Jens</creator><creator>Sørensen, Heidi G.</creator><creator>Larsen, Lone</creator><creator>Wildt, Signe</creator><creator>Weimers, Petra</creator><creator>Haderslev, Kent V.</creator><creator>Vind, Ida</creator><creator>Svenningsen, Lise</creator><creator>Brynskov, Jørn</creator><creator>Lyhne, Søren</creator><creator>Vestergaard, Thea</creator><creator>Hvas, Christian L.</creator><creator>Kelsen, Jens</creator><general>Wiley Subscription Services, Inc</general><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>7TK</scope><scope>7U9</scope><scope>H94</scope><scope>M7N</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0001-6391-1782</orcidid><orcidid>https://orcid.org/0000-0003-3070-8950</orcidid><orcidid>https://orcid.org/0000-0002-5135-7435</orcidid><orcidid>https://orcid.org/0000-0001-5158-4112</orcidid><orcidid>https://orcid.org/0000-0003-4067-2381</orcidid></search><sort><creationdate>202111</creationdate><title>Vedolizumab clearance in neonates, susceptibility to infections and developmental milestones: a prospective multicentre population‐based cohort study</title><author>Julsgaard, Mette ; Baumgart, Daniel C. ; Baunwall, Simon M. D. ; Hansen, Mette M. ; Grosen, Anne ; Bibby, Bo M. ; Uldbjerg, Niels ; Kjeldsen, Jens ; Sørensen, Heidi G. ; Larsen, Lone ; Wildt, Signe ; Weimers, Petra ; Haderslev, Kent V. ; Vind, Ida ; Svenningsen, Lise ; Brynskov, Jørn ; Lyhne, Søren ; Vestergaard, Thea ; Hvas, Christian L. ; Kelsen, Jens</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3653-4ba34934787385bbd30bc9d2184b5a568649058ab1523d0b160b09908ac931bd3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Babies</topic><topic>Birth</topic><topic>Cohort analysis</topic><topic>Congenital defects</topic><topic>Cord blood</topic><topic>Demography</topic><topic>Infants</topic><topic>Infections</topic><topic>Inflammatory bowel diseases</topic><topic>Intrauterine exposure</topic><topic>Medical records</topic><topic>Neonates</topic><topic>Population studies</topic><topic>Population-based studies</topic><topic>Pregnancy</topic><topic>Umbilical cord</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Julsgaard, Mette</creatorcontrib><creatorcontrib>Baumgart, Daniel C.</creatorcontrib><creatorcontrib>Baunwall, Simon M. D.</creatorcontrib><creatorcontrib>Hansen, Mette M.</creatorcontrib><creatorcontrib>Grosen, Anne</creatorcontrib><creatorcontrib>Bibby, Bo M.</creatorcontrib><creatorcontrib>Uldbjerg, Niels</creatorcontrib><creatorcontrib>Kjeldsen, Jens</creatorcontrib><creatorcontrib>Sørensen, Heidi G.</creatorcontrib><creatorcontrib>Larsen, Lone</creatorcontrib><creatorcontrib>Wildt, Signe</creatorcontrib><creatorcontrib>Weimers, Petra</creatorcontrib><creatorcontrib>Haderslev, Kent V.</creatorcontrib><creatorcontrib>Vind, Ida</creatorcontrib><creatorcontrib>Svenningsen, Lise</creatorcontrib><creatorcontrib>Brynskov, Jørn</creatorcontrib><creatorcontrib>Lyhne, Søren</creatorcontrib><creatorcontrib>Vestergaard, Thea</creatorcontrib><creatorcontrib>Hvas, Christian L.</creatorcontrib><creatorcontrib>Kelsen, Jens</creatorcontrib><creatorcontrib>for the NOVA Study Group</creatorcontrib><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>MEDLINE - Academic</collection><jtitle>Alimentary pharmacology & therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Julsgaard, Mette</au><au>Baumgart, Daniel C.</au><au>Baunwall, Simon M. D.</au><au>Hansen, Mette M.</au><au>Grosen, Anne</au><au>Bibby, Bo M.</au><au>Uldbjerg, Niels</au><au>Kjeldsen, Jens</au><au>Sørensen, Heidi G.</au><au>Larsen, Lone</au><au>Wildt, Signe</au><au>Weimers, Petra</au><au>Haderslev, Kent V.</au><au>Vind, Ida</au><au>Svenningsen, Lise</au><au>Brynskov, Jørn</au><au>Lyhne, Søren</au><au>Vestergaard, Thea</au><au>Hvas, Christian L.</au><au>Kelsen, Jens</au><aucorp>for the NOVA Study Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Vedolizumab clearance in neonates, susceptibility to infections and developmental milestones: a prospective multicentre population‐based cohort study</atitle><jtitle>Alimentary pharmacology & therapeutics</jtitle><date>2021-11</date><risdate>2021</risdate><volume>54</volume><issue>10</issue><spage>1320</spage><epage>1329</epage><pages>1320-1329</pages><issn>0269-2813</issn><eissn>1365-2036</eissn><abstract>Summary
Background
Little is known about the consequences of intrauterine exposure to, and the post‐natal clearance of, vedolizumab.
Aims
To investigate the levels of vedolizumab in umbilical cord blood of newborns and rates of clearance after birth, as well as how these correlated with maternal drug levels, risk of infection and developmental milestones during the first year of life
Methods
Vedolizumab‐treated pregnant women with inflammatory bowel disease were prospectively recruited from 12 hospitals in Denmark and Canada in 2016‐2020. Demographics were collected from medical records. Infant developmental milestones were evaluated by the Ages and Stages Questionnaire (ASQ‐3). Vedolizumab levels were measured at delivery and, in infants, every third month until clearance. Non‐linear regression analysis was applied to estimate clearance.
Results
In 50 vedolizumab‐exposed pregnancies, we observed 43 (86%) live births, seven (14%) miscarriages, no congenital malformations and low risk of adverse pregnancy outcomes. Median infant:mother vedolizumab ratio at birth was 0.44 (95% confidence interval [CI], 0.32‐0.56). The mean time to vedolizumab clearance in infants was 3.8 months (95% CI, 3.1‐4.4). No infant had detectable levels of vedolizumab at 6 months of age. Developmental milestones at 12 months were normal or above average. Neither vedolizumab exposure in the third trimester (RR 0.54, 95% CI, 0.28‐1.03) nor combination therapy with thiopurines (RR 1.29, 95% CI, 0.60‐2.77) seemed to increase the risk of infections in the offspring.
Conclusions
Neonatal vedolizumab clearance following intrauterine exposure is rapid. Infant vedolizumab levels did not correlate with the risk of infections during the first year of life. Continuation of vedolizumab throughout pregnancy is safe.
Vedolizumab clearance in neonates, susceptibility to infections and developmental milestones.</abstract><cop>Chichester</cop><pub>Wiley Subscription Services, Inc</pub><doi>10.1111/apt.16593</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0001-6391-1782</orcidid><orcidid>https://orcid.org/0000-0003-3070-8950</orcidid><orcidid>https://orcid.org/0000-0002-5135-7435</orcidid><orcidid>https://orcid.org/0000-0001-5158-4112</orcidid><orcidid>https://orcid.org/0000-0003-4067-2381</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0269-2813 |
| ispartof | Alimentary pharmacology & therapeutics, 2021-11, Vol.54 (10), p.1320-1329 |
| issn | 0269-2813 1365-2036 |
| language | eng |
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| source | Wiley Online Library Journals Frontfile Complete; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Wiley Free Content |
| subjects | Babies Birth Cohort analysis Congenital defects Cord blood Demography Infants Infections Inflammatory bowel diseases Intrauterine exposure Medical records Neonates Population studies Population-based studies Pregnancy Umbilical cord |
| title | Vedolizumab clearance in neonates, susceptibility to infections and developmental milestones: a prospective multicentre population‐based cohort study |
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