{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T05:00:58Z","timestamp":1787029258102,"version":"build-2736575974"},"reference-count":62,"publisher":"MDPI AG","issue":"7","license":[{"start":{"date-parts":[[2024,7,7]],"date-time":"2024-07-07T00:00:00Z","timestamp":1720310400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmaceuticals"],"abstract":"<jats:p>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.<\/jats:p>","DOI":"10.3390\/ph17070904","type":"journal-article","created":{"date-parts":[[2024,7,8]],"date-time":"2024-07-08T14:40:50Z","timestamp":1720449650000},"page":"904","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Pregnancy Recommendations Solely Based on Preclinical Evidence Should Be Integrated with Real-World Evidence: A Disproportionality Analysis of Certolizumab and Other TNF-Alpha Inhibitors Used in Pregnant Patients with Psoriasis"],"prefix":"10.3390","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4287-5510","authenticated-orcid":false,"given":"Mario","family":"Gaio","sequence":"first","affiliation":[{"name":"Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 80138 Naples, Italy"},{"name":"Section of Pharmacology \u201cL. Donatelli\u201d, Department of Experimental Medicine, University of Campania \u201cLuigi Vanvitelli\u201d, 80138 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Giovanna","family":"Vastarella","sequence":"additional","affiliation":[{"name":"Department of Women, Child and General and Special Surgery, University of Campania \u201cLuigi Vanvitelli\u201d, 80138 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Giuseppa","family":"Sullo","sequence":"additional","affiliation":[{"name":"AOU Policlinico, Universit\u00e0 degli Studi della Campania \u201cL. Vanvitelli\u201d, 80138 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9216-922X","authenticated-orcid":false,"given":"Cristina","family":"Scavone","sequence":"additional","affiliation":[{"name":"Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 80138 Naples, Italy"},{"name":"Section of Pharmacology \u201cL. Donatelli\u201d, Department of Experimental Medicine, University of Campania \u201cLuigi Vanvitelli\u201d, 80138 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Consiglia","family":"Riccardi","sequence":"additional","affiliation":[{"name":"Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 80138 Naples, Italy"},{"name":"Section of Pharmacology \u201cL. Donatelli\u201d, Department of Experimental Medicine, University of Campania \u201cLuigi Vanvitelli\u201d, 80138 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Rosaria","family":"Campitiello","sequence":"additional","affiliation":[{"name":"Department of Obstetrics and Gynaecology and Physiopathology of Human Reproduction, ASL Salerno, 84124 Salerno, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liberata","family":"Sportiello","sequence":"additional","affiliation":[{"name":"Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 80138 Naples, Italy"},{"name":"Section of Pharmacology \u201cL. Donatelli\u201d, Department of Experimental Medicine, University of Campania \u201cLuigi Vanvitelli\u201d, 80138 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Concetta","family":"Rafaniello","sequence":"additional","affiliation":[{"name":"Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, 80138 Naples, Italy"},{"name":"Section of Pharmacology \u201cL. Donatelli\u201d, Department of Experimental Medicine, University of Campania \u201cLuigi Vanvitelli\u201d, 80138 Naples, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2024,7,7]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"263","DOI":"10.1016\/S0140-6736(07)61128-3","article-title":"Pathogenesis and Clinical Features of Psoriasis","volume":"370","author":"Griffiths","year":"2007","journal-title":"Lancet Lond. 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