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A safe biologic (CZP) was considered as the reference group. Odds ratios (ORs) for CMs were calculated for each non\u2010TNFi biologic (including abatacept, anakinra, belimumab, ixekizumab, rituximab, secukinumab, tocilizumab, ustekinumab and vedolizumab), versus CZP (quantitative assessment). Then, CM patterns were reviewed in consultation with a clinical geneticist (qualitative assessment).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>ORs were not statistically significant except for belimumab and vedolizumab (similar in magnitude). Except for vedolizumab, no specific CM patterns were observed for the included non\u2010TNFi biologics. Three cases of corpus callosum agenesis (CCA) were identified for vedolizumab (versus none in CZP and other investigated non\u2010TNFi biologics). Two of the CCA cases were associated with other neurological CMs (one cerebral ventriculomegaly with microcephaly and one polymicrogyria). This may indicate that these CCAs are related to undiagnosed genetic alterations or are associated with the underlying maternal disease, although a definite relationship with vedolizumab exposure cannot be ruled out.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>No special safety signal was identified regarding the occurrence of CMs after exposure to abatacept (<jats:italic>n<\/jats:italic>\u2009=\u200964), anakinra (<jats:italic>n<\/jats:italic>\u2009=\u200920), belimumab (<jats:italic>n<\/jats:italic>\u2009=\u200993), ixekizumab (<jats:italic>n<\/jats:italic>\u2009=\u200929), rituximab (<jats:italic>n<\/jats:italic>\u2009=\u200957), secukinumab (<jats:italic>n<\/jats:italic>\u2009=\u2009128), tocilizumab (<jats:italic>n<\/jats:italic>\u2009=\u2009124) and ustekinumab (<jats:italic>n<\/jats:italic>\u2009=\u2009215). Regarding observed CCAs in the vedolizumab group (<jats:italic>n<\/jats:italic>\u2009=\u2009113), no firm conclusions can be made based on available information.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bcp.15471","type":"journal-article","created":{"date-parts":[[2022,7,27]],"date-time":"2022-07-27T13:54:13Z","timestamp":1658930053000},"page":"5378-5388","source":"Crossref","is-referenced-by-count":23,"title":["Reported congenital malformations after exposure to non\u2010tumour necrosis factor inhibitor biologics: A retrospective comparative study in EudraVigilance"],"prefix":"10.1111","volume":"88","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7130-2749","authenticated-orcid":false,"given":"Nafise","family":"Ghalandari","sequence":"first","affiliation":[{"name":"Department of Rheumatology Erasmus University Medical Center  Rotterdam The Netherlands"},{"name":"Medicines Evaluation Board (MEB)  Utrecht The Netherlands"},{"name":"Academic Center of Inflammunity Erasmus University Medical Center  Rotterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hubertina J. 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