{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T02:32:09Z","timestamp":1790217129581,"version":"4.1.0"},"reference-count":44,"publisher":"MDPI AG","issue":"23","license":[{"start":{"date-parts":[[2023,12,4]],"date-time":"2023-12-04T00:00:00Z","timestamp":1701648000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Data on the real long-term influences of in utero drug exposure in pregnant women on childhood development are scarce and remain not well determined and depend on the duration of in utero drug exposure and maternal drug levels. Therapeutic drug monitoring (TDM) during pregnancy may help limit fetal drug exposure while maintaining an effective dose for the treatment of the underlying inflammatory bowel disease (IBD) in women. Most antibody therapies used in patients with IBD are IgG molecules which are actively transported across the placenta, especially during the third trimester of the pregnancy. Here, we propose an up-to-date clinical review to summarize the available findings of serum drug levels in maternal blood during pregnancy, in the cord blood, infants at delivery and in breast milk of patients with IBD treated with biologics. Conversely, in comparison to adalimumab (ADA) levels, which are relatively stable during pregnancy, infliximab (IFX) drug clearance decreased significantly during the last two trimesters of the pregnancy, leading to increasing drug concentrations in the blood of the pregnant women. As most guidelines recommend using live vaccines in infants at the age of one or earlier in case of negative serum drug levels in newborns, statistical models could help clinicians in making a decision to adjust the last dose of the biologic during pregnancy and to determine the optimal date to vaccinate. Altogether, data from the literature offers strong reassurance in terms of safety for anti-TNF\u03b1 therapies during pregnancy not only for IBD patients who intend to conceive, but also for pregnant women and for the physicians taking care of these patients. ADA and IFX levels in breast milk are detectable, but at very low levels, and therefore, it is recommended to pursue breast feeding under anti-TNF\u03b1 therapy. Our knowledge on ustekinumab or vedolizumab levels in pregnant women remains unclear and scarce. These drugs are currently not recommended for patients with IBD in clinical practice. Therefore, TDM and proactive dose adjustment are not necessary during pregnancy since its impact on making a clinical decision have not yet been clearly demonstrated in routine practice. Overall, drug concentrations in the cord blood, an infant at birth and postpartum serum concentrations in infants, due to active placental drug transfer, may have a greater impact than the limited drug transfer in breast milk during lactation on the risk of infection and developmental outcomes. Ustekinumab and vedolizumab exposure during pregnancy and lactation are both considered low risk by the recent ECCO guidelines despite the limited data that are currently available.<\/jats:p>","DOI":"10.3390\/jcm12237495","type":"journal-article","created":{"date-parts":[[2023,12,4]],"date-time":"2023-12-04T05:28:21Z","timestamp":1701667701000},"page":"7495","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["What Should We Know about Drug Levels and Therapeutic Drug Monitoring during Pregnancy and Breastfeeding in Inflammatory Bowel Disease under Biologic Therapy?"],"prefix":"10.3390","volume":"12","author":[{"given":"Mathilde","family":"Barrau","sequence":"first","affiliation":[{"name":"Department of Gastroenterology, University Hospital of Saint-Etienne, 42000 Saint-Etienne, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xavier","family":"Roblin","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, University Hospital of Saint-Etienne, 42000 Saint-Etienne, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leslie","family":"Andromaque","sequence":"additional","affiliation":[{"name":"CIRI\u2014Centre International de Recherche en Infectiologie, University Lyon, Inserm U1111, University Claude Bernard Lyon 1, CNRS, UMR5308, ENS de Lyon, 69007 Lyon, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aurore","family":"Rozieres","sequence":"additional","affiliation":[{"name":"CIRI\u2014Centre International de Recherche en Infectiologie, University Lyon, Inserm U1111, University Claude Bernard Lyon 1, CNRS, UMR5308, ENS de Lyon, 69007 Lyon, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mathias","family":"Faure","sequence":"additional","affiliation":[{"name":"CIRI\u2014Centre International de Recherche en Infectiologie, University Lyon, Inserm U1111, University Claude Bernard Lyon 1, CNRS, UMR5308, ENS de Lyon, 69007 Lyon, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8830-4273","authenticated-orcid":false,"given":"St\u00e9phane","family":"Paul","sequence":"additional","affiliation":[{"name":"Department of Immunology, CIC1408, GIMAP EA3064, University Hospital of Saint-Etienne, 42055 Saint-Etienne, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"St\u00e9phane","family":"Nancey","sequence":"additional","affiliation":[{"name":"CIRI\u2014Centre International de Recherche en Infectiologie, University Lyon, Inserm U1111, University Claude Bernard Lyon 1, CNRS, UMR5308, ENS de Lyon, 69007 Lyon, France"},{"name":"Department of Gastroenterology, Lyon Sud Hospital, Hospices Civils de Lyon, University Claude Bernard Lyon 1, 69003 Lyon, France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2023,12,4]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"228","DOI":"10.1038\/ajg.2008.71","article-title":"Placental transport of immunoglobulins: A clinical review for gastroenterologists who prescribe therapeutic monoclonal antibodies to women during conception and pregnancy","volume":"104","author":"Kane","year":"2009","journal-title":"Am. 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Crohn\u2019s Colitis"}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/12\/23\/7495\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T21:37:30Z","timestamp":1760132250000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/12\/23\/7495"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,12,4]]},"references-count":44,"journal-issue":{"issue":"23","published-online":{"date-parts":[[2023,12]]}},"alternative-id":["jcm12237495"],"URL":"https:\/\/doi.org\/10.3390\/jcm12237495","relation":{},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,12,4]]}}}