| アブストラクト | Treatment for pregnant women with psoriasis is limited by the lack of information typically related to clinical trials. While anti-tumor necrosis factor (TNF) drugs offer therapeutic benefits, their safety during pregnancy is a concern. Notably, certolizumab is comparatively safer than adalimumab, etanercept, infliximab, and golimumab according to the current recommendations. Thus, this study aimed to conduct a pharmacovigilance comparative analysis of maternal and neonatal outcomes associated with certolizumab versus other anti-TNF drugs by using data from EudraVigilance. A descriptive analysis was performed of Individual Case Safety Reports (ICSRs) associated with an anti-TNF drug and related to the pregnant patients with psoriasis from 2009 and 2023, focusing our analysis on the specific pregnancy outcomes and fetal/neonatal disorders. The most common pregnancy-related adverse event was spontaneous abortion, predominantly related to adalimumab and certolizumab. Certolizumab was also reported in cases of caesarean section, gestational diabetes, abortion, fetal death, fetal distress syndrome, pre-eclampsia, and premature separation of placenta. Generally, the findings from our study depicted a safety profile that overlapped for each anti-TNF drug, both in maternal/neonatal outcomes and other adverse events, suggesting no substantial differences between treatments. We advocate for further investigations before making concrete recommendations. |
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| ジャーナル名 | Pharmaceuticals (Basel, Switzerland) |
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| 投稿日 | 2024/7/27 |
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| 投稿者 | Gaio, Mario; Vastarella, Maria Giovanna; Sullo, Maria Giuseppa; Scavone, Cristina; Riccardi, Consiglia; Campitiello, Maria Rosaria; Sportiello, Liberata; Rafaniello, Concetta |
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| 組織名 | Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 80138;Naples, Italy.;Section of Pharmacology "L. Donatelli", Department of Experimental Medicine,;University of Campania "Luigi Vanvitelli", 80138 Naples, Italy.;Department of Women, Child and General and Special Surgery, University of;Campania "Luigi Vanvitelli", 80138 Naples, Italy.;AOU Policlinico, Universita degli Studi della Campania "L. Vanvitelli", 80138;Department of Obstetrics and Gynaecology and Physiopathology of Human;Reproduction, ASL Salerno, 84124 Salerno, Italy. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39065754/ |
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