{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T18:28:01Z","timestamp":1793212081475,"version":"4.5.0"},"reference-count":14,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2024,8,1]],"date-time":"2024-08-01T00:00:00Z","timestamp":1722470400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2024,8]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>To present the main findings of a post\u2010authorization safety study assessing pregnancy and infant outcomes after prenatal golimumab exposure in a real\u2010world setting.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      This observational population\u2010based cohort study included data from pregnancies ending in 2006\u20132018 (Finland) or 2019 (Denmark, Sweden). Infants born to women with rheumatic diseases or ulcerative colitis diagnoses were identified. Based on prescription fills from 90\u2009days prior to pregnancy until delivery, infants were assigned to one of the four drug\u2010exposure cohorts:\n                      <jats:italic>golimumab<\/jats:italic>\n                      ,\n                      <jats:italic>other anti\u2010TNF biologics<\/jats:italic>\n                      ,\n                      <jats:italic>other biologics<\/jats:italic>\n                      , and\n                      <jats:italic>nonbiologic systemic therapy<\/jats:italic>\n                      , and the general population. Prevalence of adverse pregnancy outcomes, mortality, diagnoses of major congenital anomalies (MCA), and inpatient infections in the infants' first year of life were assessed. Odds ratios and 95% CIs were calculated for MCA and infection.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Among 134 infants in the golimumab cohort, none were stillborn or died in the first year of life. MCA were diagnosed in 4.5% of the infants in the\n                      <jats:italic>golimumab<\/jats:italic>\n                      cohort, versus 6.8%, 10.9%, 5.5%, and 4.6% in the\n                      <jats:italic>other anti\u2010TNF biologics<\/jats:italic>\n                      ,\n                      <jats:italic>other biologics<\/jats:italic>\n                      ,\n                      <jats:italic>nonbiologic systemic therapy<\/jats:italic>\n                      and general population cohorts, respectively. Inpatient infections were diagnosed in 11% of golimumab\u2010exposed infants, compared with 9%\u201311% of infants in the other cohorts. Unadjusted and selected adjusted comparisons showed no association between prenatal golimumab exposure and MCA or infection compared with the other exposure cohorts or general population.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The number of infants with prenatal golimumab exposure was low, but results are reassuringly consistent with the evidence available for other anti\u2010TNF biologics. Continued monitoring is needed.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/pds.5878","type":"journal-article","created":{"date-parts":[[2024,8,1]],"date-time":"2024-08-01T23:49:46Z","timestamp":1722556186000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Pregnancy and Infant Outcomes After Prenatal Exposure to Golimumab in Denmark, Finland, and Sweden 2006\u20132019"],"prefix":"10.1002","volume":"33","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7177-1713","authenticated-orcid":false,"given":"P\u00e4r","family":"Karlsson","sequence":"first","affiliation":[{"name":"Centre for Pharmacoepidemiology, Department of Medicine, Solna Karolinska Institutet  Stockholm Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2536-1577","authenticated-orcid":false,"given":"Karin","family":"Gembert","sequence":"additional","affiliation":[{"name":"Centre for Pharmacoepidemiology, Department of Medicine, Solna Karolinska Institutet  Stockholm Sweden"}],"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"}]},{"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\/0000-0001-8254-7525","authenticated-orcid":false,"given":"Mika","family":"Gissler","sequence":"additional","affiliation":[{"name":"Knowledge Brokers, Finnish Institute for Health and Welfare  Helsinki Finland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7631-4749","authenticated-orcid":false,"given":"Maarit\u00a0K.","family":"Leinonen","sequence":"additional","affiliation":[{"name":"Knowledge Brokers, Finnish Institute for Health and Welfare  Helsinki Finland"},{"name":"Teratology Information Service, Emergency Medicine and Services, University of Helsinki and Helsinki University Hospital  Helsinki Finland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6828-1975","authenticated-orcid":false,"given":"Marijo","family":"Otero\u2010Lobato","sequence":"additional","affiliation":[{"name":"Janssen Biologics BV, Medical Affairs  Leiden The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9341-3888","authenticated-orcid":false,"given":"Lars","family":"Pedersen","sequence":"additional","affiliation":[{"name":"Department of Clinical Epidemiology Aarhus University and Aarhus University Hospital  Aarhus Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5759-9366","authenticated-orcid":false,"given":"Carolyn\u00a0E.","family":"Cesta","sequence":"additional","affiliation":[{"name":"Centre for Pharmacoepidemiology, Department of Medicine, Solna Karolinska Institutet  Stockholm Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,8]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1080\/21645515.2020.1836919"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2015-208840"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.41191"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/keac551"},{"key":"e_1_2_9_6_1","unstructured":"\u201cSimponi (Golimumab). Summary of Product Characteristics \u201d2023 https:\/\/www.ema.europa.eu\/en\/documents\/product\u2010information\/simponi\u2010epar\u2010product\u2010information_en.pdf."},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.2147\/CLEP.S314959"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.2340\/00015555-2923"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1093\/rheumatology\/key053"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12884-023-06033-2"},{"issue":"6","key":"e_1_2_9_11_1","first-page":"1091","article-title":"Birth Outcomes in Women With Inflammatory Bowel Disease: Effects of Disease Activity and Drug Exposure","volume":"20","author":"Broms G.","year":"2014","journal-title":"Inflammatory Bowel Diseases"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2015.08.039"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/pds.4930"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/apt.15971"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/prp2.1240"}],"container-title":["Pharmacoepidemiology and Drug Safety"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/pds.5878","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,11,20]],"date-time":"2024-11-20T20:51:52Z","timestamp":1732135912000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/pds.5878"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,8]]},"references-count":14,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2024,8]]}},"alternative-id":["10.1002\/pds.5878"],"URL":"https:\/\/doi.org\/10.1002\/pds.5878","archive":["Portico"],"relation":{},"ISSN":["1053-8569","1099-1557"],"issn-type":[{"value":"1053-8569","type":"print"},{"value":"1099-1557","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,8]]},"assertion":[{"value":"2024-04-05","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-07-03","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-08-01","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e5878"}}