{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T14:52:22Z","timestamp":1786978342801,"version":"build-2736575974"},"reference-count":15,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2024,7,6]],"date-time":"2024-07-06T00:00:00Z","timestamp":1720224000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["bpspubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacology Res &amp; Perspec"],"published-print":{"date-parts":[[2024,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Data on the use of golimumab (GLM) during pregnancy are limited. This study evaluated pregnancy outcomes in women treated with GLM during pregnancy. Cumulative data on GLM\u2010exposed pregnancies from the Company's global safety database (GSD) are summarized. Cases were medically confirmed maternal exposures to GLM during pregnancy or within 3\u2009months prior to conception with a reported pregnancy outcome. Pregnancy outcomes (e.g., live births) and congenital anomalies in prospectively reported cases (i.e., pregnancy outcome not known when first reported to the company) are presented in a descriptive manner. As of May 31, 2022, 261 prospectively reported pregnancies exposed to GLM were reported in the GSD: 214 (82.0%) live births (including six sets of twins), 31 (11.9%) spontaneous abortions (including one set of twins), 13 (5.0%) induced\/elective abortions, 2 (0.8%) reported intrauterine death\/still birth, and 1 (0.4%) fetal adverse event in an ongoing pregnancy. The majority of pregnancies had exposure to GLM at least in the first trimester of pregnancy. In total, seven congenital anomalies (7\/261; 2.7%) were reported. Of these seven congenital anomalies, five were considered major according to EUROCAT classification version 1.4. Among the five prospectively reported congenital anomalies noted in live births (5\/214; 2.3%), four were classified as major (4\/214; 1.8%). The rates of adverse pregnancy outcomes and major congenital anomalies in prospectively reported pregnancy cases with exposure to GLM in the Company's GSD were consistent with published background rates for the general population.<\/jats:p>","DOI":"10.1002\/prp2.1240","type":"journal-article","created":{"date-parts":[[2024,7,6]],"date-time":"2024-07-06T06:23:36Z","timestamp":1720247016000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Exposure to golimumab during pregnancy: Results from the Company's global safety database"],"prefix":"10.1002","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6828-1975","authenticated-orcid":false,"given":"Marijo","family":"Otero\u2010Lobato","sequence":"first","affiliation":[{"name":"Janssen Biologics BV Medical Affairs  Leiden The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-7291-4639","authenticated-orcid":false,"given":"Adesoji","family":"Adeyemo","sequence":"additional","affiliation":[{"name":"Janssen Research and Development LLC  Raritan New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-5498-5995","authenticated-orcid":false,"given":"Michelle","family":"Higley","sequence":"additional","affiliation":[{"name":"Janssen Research and Development LLC  Titusville New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4519-3240","authenticated-orcid":false,"given":"Kathleen G.","family":"Lomax","sequence":"additional","affiliation":[{"name":"Janssen Research and Development LLC  Spring House Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6476-5526","authenticated-orcid":false,"given":"Anja","family":"Geldhof","sequence":"additional","affiliation":[{"name":"Janssen Biologics BV Medical Affairs  Leiden The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1052-058X","authenticated-orcid":false,"given":"Suzan","family":"Esslinger","sequence":"additional","affiliation":[{"name":"Cilag GmbH International Medical Affairs  Zug Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,7,6]]},"reference":[{"key":"e_1_2_13_2_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/key053"},{"key":"e_1_2_13_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2021.07.005"},{"key":"e_1_2_13_4_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2015-208840"},{"key":"e_1_2_13_5_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/keac551"},{"key":"e_1_2_13_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.41191"},{"key":"e_1_2_13_7_1","doi-asserted-by":"publisher","DOI":"10.1093\/ecco-jcc\/jjac115"},{"key":"e_1_2_13_8_1","unstructured":"Simponi\u00ae (golimumab).Summary of Product Characteristics (SmPC).https:\/\/www.ema.europa.eu\/en\/documents\/product\u2010information\/simponi\u2010epar\u2010product\u2010information_en.pdf. Accessed 22 November 2023"},{"key":"e_1_2_13_9_1","unstructured":"Committee for medicinal products for human use (CHMP).Guideline on the exposure to medicinal products during pregnancy: need for post\u2010authorisation data.https:\/\/www.ema.europa.eu\/en\/documents\/regulatory\u2010procedural\u2010guideline\/guideline\u2010exposure\u2010medicinal\u2010products\u2010during\u2010pregnancy\u2010need\u2010post\u2010authorisation\u2010data_en.pdf. Accessed 20 December 2023."},{"key":"e_1_2_13_10_1","volume-title":"EUROCAT Guide 1.4: Instruction for the Registration of Congenital Anomalies","author":"EUROCAT","year":"2013"},{"key":"e_1_2_13_11_1","doi-asserted-by":"publisher","DOI":"10.1093\/nar\/gkx1121"},{"issue":"1","key":"e_1_2_13_12_1","first-page":"S1","article-title":"THE CONCISE GUIDE TO PHARMACOLOGY 2019\/20: introduction and other protein targets","volume":"176","author":"Alexander SPH","year":"2019","journal-title":"Br J Pharmacol"},{"key":"e_1_2_13_13_1","first-page":"1","article-title":"Estimated pregnancy rates and rates of pregnancy outcomes for the United States, 1990\u20102008","volume":"60","author":"Ventura SJ","year":"2012","journal-title":"Natl Vital Stat Rep"},{"key":"e_1_2_13_14_1","volume-title":"Data & Statistics on Birth Defects","author":"Centers for Disease Control","year":"2020"},{"key":"e_1_2_13_15_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0256535"},{"key":"e_1_2_13_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.5878"}],"container-title":["Pharmacology Research &amp; Perspectives"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/prp2.1240","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,8,15]],"date-time":"2024-08-15T23:31:07Z","timestamp":1723764667000},"score":1,"resource":{"primary":{"URL":"https:\/\/bpspubs.onlinelibrary.wiley.com\/doi\/10.1002\/prp2.1240"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,7,6]]},"references-count":15,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2024,8]]}},"alternative-id":["10.1002\/prp2.1240"],"URL":"https:\/\/doi.org\/10.1002\/prp2.1240","archive":["Portico"],"relation":{},"ISSN":["2052-1707","2052-1707"],"issn-type":[{"value":"2052-1707","type":"print"},{"value":"2052-1707","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,7,6]]},"assertion":[{"value":"2024-04-25","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-06-20","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-07-06","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e1240"}}