{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,3]],"date-time":"2026-11-03T19:20:37Z","timestamp":1793733637562,"version":"4.6.1"},"reference-count":16,"publisher":"Oxford University Press (OUP)","issue":"7","license":[{"start":{"date-parts":[[2024,2,4]],"date-time":"2024-02-04T00:00:00Z","timestamp":1707004800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100005205","name":"Janssen Research and Development, LLC","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100005205","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100017183","name":"Janssen Scientific Affairs, LLC","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100017183","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,8,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background and Aims<\/jats:title>\n                    <jats:p>Previously published long-term safety data reported a favourable ustekinumab safety profile for the treatment of inflammatory bowel disease [IBD]. We present the final cumulative safety data from pooled ustekinumab IBD phase 2\/3 clinical studies through 5 years in Crohn\u2019s disease [CD] and 4 years in ulcerative colitis [UC].<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In phase 3 studies, patients received a single intravenous placebo or ustekinumab [130 mg or ~6 mg\/kg] induction dose followed by subcutaneous maintenance doses of placebo or ustekinumab [90 mg q8w or q12w]. Analyses included all patients who received one dose of study treatment and included patients who were biologic-na\u00efve and patients with a history of biologic failure. Safety outcomes are summarized and presented using number of events per 100 patient-years of follow-up and corresponding 95% confidence intervals.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In this final pooled safety analysis, 2575 patients were treated with ustekinumab with 4826 patient-years of follow-up. Rates of key safety events, including major adverse cardiac events and malignancies, were similar between placebo and ustekinumab or not higher for ustekinumab. Opportunistic infections, including tuberculosis, and malignancies were reported infrequently. Rates of key safety events in the IBD group were no higher in the ustekinumab group than in the placebo group for both patients who were biologic-na\u00efve or who had a history of biologic failure. No lymphomas or cases of posterior reversible encephalopathy syndrome [formerly known as reversible posterior leukoencephalopathy syndrome] were reported.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The final cumulative ustekinumab safety data through 5 years in CD and 4 years in UC demonstrated favourable safety compared to placebo and continue to support the well-established safety profile across all approved indications.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical trials.gov numbers<\/jats:title>\n                    <jats:p>NCT00265122, NCT00771667, NCT01369329, NCT01369342, NCT01369355, NCT02407236<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ecco-jcc\/jjae013","type":"journal-article","created":{"date-parts":[[2024,2,2]],"date-time":"2024-02-02T16:13:08Z","timestamp":1706890388000},"page":"1091-1101","source":"Crossref","is-referenced-by-count":47,"title":["Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis Through 5 Years in Crohn\u2019s Disease and 4 Years in Ulcerative Colitis"],"prefix":"10.1093","volume":"18","author":[{"given":"Subrata","family":"Ghosh","sequence":"first","affiliation":[{"name":"APC Microbiome Ireland, College of Medicine and Health, University College Cork , Cork , Ireland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian G","family":"Feagan","sequence":"additional","affiliation":[{"name":"Western University and Alimentiv Inc. , London, ON , Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elyssa","family":"Ott","sequence":"additional","affiliation":[{"name":"Formerly of Janssen Scientific Affairs, LLC , Horsham, PA , USA"},{"name":"Merck & Co., Inc. Current affiliation: , Rahway, NJ , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher","family":"Gasink","sequence":"additional","affiliation":[{"name":"Formerly of Janssen Scientific Affairs, LLC , Horsham, PA , USA"},{"name":"Intercept Pharmaceuticals Current affiliation: , Morristown, NJ , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bridget","family":"Godwin","sequence":"additional","affiliation":[{"name":"Formerly of Janssen Scientific Affairs, LLC , Horsham, PA , USA"},{"name":"Janssen Research & Development, LLC , Spring House, PA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Colleen","family":"Marano","sequence":"additional","affiliation":[{"name":"Janssen Research & Development, LLC , Spring House, PA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ye","family":"Miao","sequence":"additional","affiliation":[{"name":"Janssen Research & Development, LLC , Spring House, PA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tony","family":"Ma","sequence":"additional","affiliation":[{"name":"Janssen Scientific Affairs, LLC , Horsham, PA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7199-6851","authenticated-orcid":false,"suffix":"Jr.","given":"Edward V","family":"Loftus","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine and Science , Rochester, MN , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William J","family":"Sandborn","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, University of California San Diego , La Jolla, CA , USA"},{"name":"Mirador Therapeutics , San Diego, CA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7341-1351","authenticated-orcid":false,"given":"Silvio","family":"Danese","sequence":"additional","affiliation":[{"name":"IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele Milano , Milan , Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria T","family":"Abreu","sequence":"additional","affiliation":[{"name":"University of Miami Miller School of Medicine , Miami, FL , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruce E","family":"Sands","sequence":"additional","affiliation":[{"name":"Dr. Henry D. 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