{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,29]],"date-time":"2026-06-29T23:16:03Z","timestamp":1782774963414,"version":"3.54.5"},"reference-count":54,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2020,1,23]],"date-time":"2020-01-23T00:00:00Z","timestamp":1579737600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100002998","name":"College ter Beoordeling van Geneesmiddelen","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100002998","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brit J Clinical Pharma"],"published-print":{"date-parts":[[2020,3]]},"abstract":"<jats:sec><jats:title>Aims<\/jats:title><jats:p>The effects of biologics on reproduction\/lactation are mostly unknown although many patients that receive biologics are women of reproductive age. The first objective of this study was to investigate the publicly available data on pregnancy\/lactation before and after marketing authorization in Europe of biologics for the indications of rheumatologic inflammatory autoimmune diseases and inflammatory bowel disease. Secondary objectives included the assessment of the clinical relevance of the provided data and comparison of initial and post\u2010authorization data.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Initial and post\u2010authorization data were extracted from the European Public Assessment Reports and the latest versions of Summary of Product Characteristics using publicly available documents on the European Medicines Agency's website. Four sections were categorized regarding pregnancy outcomes: pre\u2010clinical\/animal studies, human female fertility, pregnancy\u2010related outcomes and congenital malformations in the human fetus. Three sections were categorized regarding lactation outcomes: pre\u2010clinical\/animal studies, excretion in human breast milk and absorption in children through breastfeeding. The clinical applicability of each category was scored by specified criteria, based on scientific literature, and further as defined by the authors.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>For the 16 included biologics, post\u2010authorization data were delivered only for adalimumab, certolizumab pegol, etanercept and infliximab. For the 12 remaining biologics limited data on pregnancy and lactation during the post\u2010marketing period of 2\u201321 years were available.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>In this article several suggestions are provided for improving a multidisciplinary approach to these issues. The initiation of suitable registries by marketing authorization holders and data transparency for clinicians and academics are highly endorsed.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bcp.14145","type":"journal-article","created":{"date-parts":[[2019,10,21]],"date-time":"2019-10-21T14:44:06Z","timestamp":1571669046000},"page":"580-590","source":"Crossref","is-referenced-by-count":21,"title":["The pre\u2010 and post\u2010authorisation data published by the European medicines agency on the use of biologics during pregnancy and lactation"],"prefix":"10.1111","volume":"86","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7130-2749","authenticated-orcid":false,"given":"N.","family":"Ghalandari","sequence":"first","affiliation":[{"name":"Department of Rheumatology Erasmus University Medical Center  Rotterdam The Netherlands"},{"name":"Medicines Evaluation Board (MEB)  Graadt van Roggenweg 500, 3531, AH Utrecht The Netherlands"},{"name":"Academic Center of Inflammunity Erasmus University Medical Center  Rotterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R.J.E.M.","family":"Dolhain","sequence":"additional","affiliation":[{"name":"Department of Rheumatology Erasmus University Medical Center  Rotterdam The Netherlands"},{"name":"Academic Center of Inflammunity Erasmus University Medical Center  Rotterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.M.W.","family":"Hazes","sequence":"additional","affiliation":[{"name":"Department of Rheumatology Erasmus University Medical Center  Rotterdam The Netherlands"},{"name":"Medicines Evaluation Board (MEB)  Graadt van Roggenweg 500, 3531, AH Utrecht The Netherlands"},{"name":"Academic Center of Inflammunity Erasmus University Medical Center  Rotterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C.L.E.","family":"Siezen","sequence":"additional","affiliation":[{"name":"Medicines Evaluation Board (MEB)  Graadt van Roggenweg 500, 3531, AH Utrecht The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.W.","family":"van der Laan","sequence":"additional","affiliation":[{"name":"Medicines Evaluation Board (MEB)  Graadt van Roggenweg 500, 3531, AH Utrecht The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H.J.M.J.","family":"Crijns","sequence":"additional","affiliation":[{"name":"Medicines Evaluation Board (MEB)  Graadt van Roggenweg 500, 3531, AH Utrecht The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E.P.","family":"van Puijenbroek","sequence":"additional","affiliation":[{"name":"Netherlands Pharmacovigilance Centre Lareb, \u2018s Hertogenbosch  The Netherlands"},{"name":"Unit of Pharmacotherapy, Epidemiology &amp; Economics; Faculty of Science and Engineering University of Groningen  Groningen The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C.J.","family":"van der Woude","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology Erasmus University Medical Center  Rotterdam The Netherlands"},{"name":"Academic Center of Inflammunity Erasmus University Medical Center  Rotterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,1,23]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrrheum.2009.103"},{"key":"e_1_2_10_3_1","first-page":"143","article-title":"ICH S6 regulatory reproduction toxicity studies to support the use of monoclonal antibodies","author":"Laan J","year":"2011","journal-title":"Future Trends in Primate Toxicology and Biotechnology"},{"key":"e_1_2_10_4_1","unstructured":"(ICH) I.C.o.H. 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