| アブストラクト | AIMS: To evaluate the number and nature of reported congenital malformations (CMs) after intrauterine exposure to non-tumour necrosis factor inhibitor biologics (non-TNFi biologics) compared to certolizumab pegol (CZP). METHODS: A retrospective comparative study was conducted in the EudraVigilance (EV) database. A safe biologic (CZP) was considered as the reference group. Odds ratios (ORs) for CMs were calculated for each non-TNFi 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). RESULTS: 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-TNFi biologics. Three cases of corpus callosum agenesis (CCA) were identified for vedolizumab (versus none in CZP and other investigated non-TNFi 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. CONCLUSION: No special safety signal was identified regarding the occurrence of CMs after exposure to abatacept (n = 64), anakinra (n = 20), belimumab (n = 93), ixekizumab (n = 29), rituximab (n = 57), secukinumab (n = 128), tocilizumab (n = 124) and ustekinumab (n = 215). Regarding observed CCAs in the vedolizumab group (n = 113), no firm conclusions can be made based on available information. |
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| ジャーナル名 | British journal of clinical pharmacology |
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| 投稿日 | 2022/7/28 |
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| 投稿者 | Ghalandari, Nafise; Crijns, Hubertina J M J; Bergman, Jorieke E H; Dolhain, Radboud J E M; van Puijenbroek, Eugene P; Hazes, Johanna M W |
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| 組織名 | Department of Rheumatology, Erasmus University Medical Center, Rotterdam, The;Netherlands.;Medicines Evaluation Board (MEB), Utrecht, The Netherlands.;Academic Center of Inflammunity, Erasmus University Medical Center, Rotterdam,;The Netherlands.;Department of Genetics, Eurocat Northern Netherlands, University of Groningen,;University Medical Center Groningen, Groningen, The Netherlands.;Unit of Pharmacotherapy, -Epidemiology & -Economics, Faculty of Science and;Engineering, University of Groningen, Groningen, The Netherlands.;Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/35894810/ |
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