{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T18:28:38Z","timestamp":1793212118181,"version":"4.5.0"},"reference-count":24,"publisher":"Oxford University Press (OUP)","issue":"7","license":[{"start":{"date-parts":[[2020,9,23]],"date-time":"2020-09-23T00:00:00Z","timestamp":1600819200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100005205","name":"Janssen Research & Development","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005205","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,6,15]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Ustekinumab is currently approved globally in Crohn\u2019s disease (CD) and psoriatic diseases. Recent phase 3 data demonstrate safety\/efficacy in ulcerative colitis (UC). Crohn\u2019s disease and UC phase 3 programs had similar study designs, facilitating integrated safety analyses.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Data from 6 ustekinumab phase 2\/3 CD and UC studies were pooled, and safety was evaluated through 1 year. Patients received 1 placebo or ustekinumab (generally 130 mg or ~6 mg\/kg) intravenous induction, then subcutaneous (90 mg) maintenance every 8\/12 weeks. Analyses incorporated all patients who received \u22651 ustekinumab dose. Safety outcomes are presented as percentages of patients (induction) and as number of patients with events per 100 patient-years of follow-up (through 1 year). For key safety events, 95% confidence intervals (CIs) are provided, as appropriate. Hazard ratios with 95% CIs from time-to-event analyses for serious adverse events and serious infections were also performed.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Through 1 year, 2574 patients received ustekinumab (1733 patient-years of follow-up). The number of patients with adverse events per 100 patient-years (placebo 165.99 [95% CI, 155.81\u2013176.67] vs ustekinumab 118.32 [95% CI, 113.25\u2013123.55]), serious AEs (27.50 [95% CI, 23.45\u201332.04] vs 21.23 [95% CI, 19.12\u201323.51]), infections (80.31 [95% CI, 73.28\u201387.84] vs 64.32 [95% CI, 60.60\u201368.21]), serious infections (5.53 [95% CI, 3.81\u20137.77] vs 5.02 [95% CI, 4.02\u20136.19]), and malignancies excluding nonmelanoma skin cancer (0.17 [95% CI, 0.00\u20130.93] vs 0.40 [95% CI, 0.16\u20130.83]) were similar between placebo and ustekinumab.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>The safety profile of ustekinumab across the pooled inflammatory bowel disease population through 1 year was favorable and generally comparable to placebo. These data are consistent with the established safety profile of ustekinumab across indications.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>ClinicalTrials.gov numbers<\/jats:title>\n                  <jats:p>NCT00265122; NCT00771667; NCT01369329; NCT01369342; NCT01369355; NCT02407236.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ibd\/izaa236","type":"journal-article","created":{"date-parts":[[2020,9,23]],"date-time":"2020-09-23T06:44:32Z","timestamp":1600843472000},"page":"994-1007","source":"Crossref","is-referenced-by-count":114,"title":["Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis of Results from Phase 2\/3 Studies"],"prefix":"10.1093","volume":"27","author":[{"given":"William J","family":"Sandborn","sequence":"first","affiliation":[{"name":"University of California San Diego , La Jolla, CA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Brian G","family":"Feagan","sequence":"additional","affiliation":[{"name":"Robarts Clinical Trials, Robarts Research Institute, Western University , London, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Silvio","family":"Danese","sequence":"additional","affiliation":[{"name":"Humanitas Clinical Research Center-IRCCS and Humanitas University, Department of Biomedical Sciences , Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher D","family":"O\u2019Brien","sequence":"additional","affiliation":[{"name":"Janssen Research & Development, LLC , Spring House, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elyssa","family":"Ott","sequence":"additional","affiliation":[{"name":"Janssen Scientific Affairs, LLC , Horsham, 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":"Thomas","family":"Baker","sequence":"additional","affiliation":[{"name":"Janssen Scientific Affairs, LLC , Horsham, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yiying","family":"Zhou","sequence":"additional","affiliation":[{"name":"Janssen Research & Development, LLC , Spring House, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sheri","family":"Volger","sequence":"additional","affiliation":[{"name":"Janssen Research & Development, LLC , Spring House, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ilia","family":"Tikhonov","sequence":"additional","affiliation":[{"name":"Janssen Research & Development, LLC , Spring House, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher","family":"Gasink","sequence":"additional","affiliation":[{"name":"Janssen Scientific Affairs, LLC , Horsham, PA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruce E","family":"Sands","sequence":"additional","affiliation":[{"name":"Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai , New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Subrata","family":"Ghosh","sequence":"additional","affiliation":[{"name":"Institute of Translational Medicine and NIHR Biomedical Research Center, University of Birmingham , United Kingdom"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2020,9,23]]},"reference":[{"key":"2023112215504002000_CIT0001","doi-asserted-by":"crossref","first-page":"861","DOI":"10.1111\/j.1365-2133.2012.10901.x","article-title":"Long-term efficacy of ustekinumab in patients with moderate-to-severe psoriasis: results from the PHOENIX 1 trial through up to 3 years","volume":"166","author":"Kimball","year":"2012","journal-title":"Br J Dermatol."},{"key":"2023112215504002000_CIT0002","doi-asserted-by":"crossref","first-page":"1535","DOI":"10.1111\/jdv.12046","article-title":"Long-term efficacy of 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