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For this reason, physicians are focused on approaches to controlling disease activity prior to and during pregnancy. The safety profile of many therapies used for these conditions has been relatively well established, though evidence on newer therapies is lacking. Ustekinumab is a relatively new interleukin\u201012\/23 inhibitor approved for IBD, psoriasis, and psoriatic arthritis, whose safety in pregnancy is not yet fully understood. In this comprehensive review, we critically assess the available evidence on ustekinumab in pregnancy across animal studies and human case reports, case series, observational studies, and clinical practice guidelines. We show that, to date, studies have not identified an excess risk of adverse pregnancy outcomes among women exposed to ustekinumab in pregnancy, with few exposed pregnancies and potential for some bias. Clinical guidelines are conflicted regarding whether they recommend continuing or discontinuing ustekinumab, highlighting the paucity of data and need for more research on this issue.<\/jats:bold><\/jats:p>","DOI":"10.1002\/acr.24813","type":"journal-article","created":{"date-parts":[[2021,11,8]],"date-time":"2021-11-08T08:52:50Z","timestamp":1636361570000},"page":"930-935","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Ustekinumab Safety in Pregnancy: A Comprehensive Review"],"prefix":"10.1002","volume":"75","author":[{"given":"Jonah H.","family":"Gorodensky","sequence":"first","affiliation":[{"name":"McGill University, Montreal, Quebec, Canada, and Research Institute of the McGill University Health Center, McGill University  Montreal Quebec Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sasha","family":"Bernatsky","sequence":"additional","affiliation":[{"name":"McGill University, Montreal, Quebec, Canada, and Research Institute of the McGill University Health Center, McGill University  Montreal Quebec Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Waqqas","family":"Afif","sequence":"additional","affiliation":[{"name":"McGill University, Montreal, Quebec, Canada, and Research Institute of the McGill University Health Center, McGill University  Montreal Quebec Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristian B.","family":"Filion","sequence":"additional","affiliation":[{"name":"Centre of Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, Montreal, Quebec, Canada, and McGill University  Montreal Quebec Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7727-5879","authenticated-orcid":false,"given":"\u00c9velyne","family":"Vinet","sequence":"additional","affiliation":[{"name":"McGill University, Montreal, Quebec, Canada, and Research Institute of the McGill University Health Center, McGill University  Montreal Quebec Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,11,16]]},"reference":[{"key":"e_1_2_3_2_1","doi-asserted-by":"publisher","DOI":"10.1136\/gut.2006.108324"},{"key":"e_1_2_3_3_1","doi-asserted-by":"publisher","DOI":"10.1097\/MIB.0b013e318281f28f"},{"key":"e_1_2_3_4_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2015-208840"},{"key":"e_1_2_3_5_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2020.11.038"},{"key":"e_1_2_3_6_1","unstructured":"European Medicines Agency.Abbott Laboratories Limited withdraws its marketing authorisation application for Ozespa (briakinumab).2011. 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