{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,7]],"date-time":"2026-11-07T05:18:18Z","timestamp":1794028698642,"version":"4.8.0"},"reference-count":44,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2024,1,1]],"date-time":"2024-01-01T00:00:00Z","timestamp":1704067200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Janssen Cilag AB, Sweden"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Therap Adv Gastroenterol"],"published-print":{"date-parts":[[2024,1]]},"abstract":"<jats:sec><jats:title>Background:<\/jats:title><jats:p> Ustekinumab is used to treat inflammatory bowel disease mainly in patients failing anti-tumour necrosis factor (TNF)-agents. <\/jats:p><\/jats:sec><jats:sec><jats:title>Objectives:<\/jats:title><jats:p> To provide real-world data in unselected patients with Crohn\u2019s disease (CD), treated with ustekinumab. <\/jats:p><\/jats:sec><jats:sec><jats:title>Design:<\/jats:title><jats:p> Longitudinal retrospective study at four hospitals in Stockholm, Sweden. <\/jats:p><\/jats:sec><jats:sec><jats:title>Methods:<\/jats:title><jats:p> Disease activity (Harvey\u2013Bradshaw index and physician global assessment), laboratory parameters, endoscopic findings and drug persistence were assessed. Follow-up data were obtained in patients that stopped ustekinumab. <\/jats:p><\/jats:sec><jats:sec><jats:title>Results:<\/jats:title><jats:p> In total, 322 patients (median age 38\u2009years, 48% women) were included. All had luminal disease and 22% also fistulizing disease. A total of 271 (84%) had failed \u2a7e1 and 148 (46%) \u2a7e2 anti-TNF drugs; 34% failed vedolizumab. At inclusion, 93% had active disease; 28% were on oral corticosteroids and 18% on thiopurines. The median follow-up on treatment was 13.5\u2009months; overall 67% were followed at least 24\u2009months. By intention to treat analysis, response rate at 3 and 12\u2009months was 43% and 42%, respectively. Among patients with ongoing ustekinumab, 19% were in steroid-free remission at 3\u2009months and 64% at 12\u2009months. The median faecal calprotectin level decreased from 460\u2009\u00b5g\/g at baseline to 156\u2009\u00b5g\/g at 3\u2009months and was 182\u2009\u00b5g\/g at 12\u2009months. C-reactive protein remained stable at 4\u2009mg\/L whereas serum albumin increased slightly. About 31% of patients were withdrawn during the first 12\u2009months, mainly due to persisting disease activity 21%, adverse events 5%, bowel surgery 0.6% or malignancy 0.3%. The overall persistence on ustekinumab was 88%, 51%, 34% and 20% at 3, 12, 24 and 36\u2009months, respectively. Within 12\u2009months following withdrawal of ustekinumab in 121 patients, 64% had active disease most of the time, 68% needed another biologic and 24% underwent surgery. <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion:<\/jats:title><jats:p> Among difficult-to-treat patients with CD, ustekinumab was effective in the majority, with high drug persistence at 12 and 24\u2009months in combination with a favourable safety profile. <\/jats:p><\/jats:sec>","DOI":"10.1177\/17562848241242700","type":"journal-article","created":{"date-parts":[[2024,4,23]],"date-time":"2024-04-23T08:46:50Z","timestamp":1713862010000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":3,"title":["Long-term real-world data of ustekinumab in Crohn\u2019s disease: the Stockholm ustekinumab study"],"prefix":"10.1177","volume":"17","author":[{"given":"Francesca","family":"Bello","sequence":"first","affiliation":[{"name":"Karolinska Institutet, Department of Medicine Solna, Karolinska University Hospital, Centre for Digestive Health, Department of Gastroenterology, Dermatovenereology and Rheumatology, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samer","family":"Muhsen","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology, Department of Medicine, Danderyd Hospital, Danderyd, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haider","family":"Sabhan","sequence":"additional","affiliation":[{"name":"Gastroenterology Unit, Medical Department, St G\u00f6ran\u2019s Hospital, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexandra","family":"Borin","sequence":"additional","affiliation":[{"name":"Department of Medicine, South Hospital, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fredrik","family":"Johansson","sequence":"additional","affiliation":[{"name":"Medical Library at Danderyd Hospital, Danderyd, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charlotte","family":"H\u00f6\u00f6g","sequence":"additional","affiliation":[{"name":"Department of Upper Digestive Diseases, Karolinska University Hospital, Stockholm, Sweden Department of Medicine Huddinge, Karolinska Institutet, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ole","family":"Forsberg","sequence":"additional","affiliation":[{"name":"Janssen-Cilag AB, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christina","family":"Wennerstr\u00f6m","sequence":"additional","affiliation":[{"name":"Janssen-Cilag AB, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charlotte","family":"S\u00f6derman","sequence":"additional","affiliation":[{"name":"Department of Medicine Solna, Karolinska Institutet, Stockholm, Sweden Gastroenterology Unit, Medical Department, St G\u00f6ran\u2019s Hospital, Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mikael","family":"L\u00f6rdal","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology and Hepatology, Department of Medicine, Danderyd Hospital, Danderyd, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9334-1821","authenticated-orcid":false,"given":"Sven","family":"Almer","sequence":"additional","affiliation":[{"name":"Karolinska Institutet, Department of Medicine Solna, Karolinska University Hospital, Centre for Digestive Health, Department of Gastroenterology B4:09, Dermatovenereology and Rheumatology, SE-171 76 Stockholm, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2024,4,23]]},"reference":[{"key":"bibr1-17562848241242700","doi-asserted-by":"publisher","DOI":"10.1111\/apt.13445"},{"key":"bibr2-17562848241242700","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1215739"},{"key":"bibr3-17562848241242700","first-page":"412","volume":"11","author":"Vermeire S","year":"2017","journal-title":"J Crohns Colitis"},{"key":"bibr4-17562848241242700","doi-asserted-by":"publisher","DOI":"10.1016\/S2468-1253(21)00312-5"},{"key":"bibr5-17562848241242700","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1203572"},{"key":"bibr6-17562848241242700","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1602773"},{"key":"bibr7-17562848241242700","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1900750"},{"key":"bibr8-17562848241242700","doi-asserted-by":"publisher","DOI":"10.1111\/apt.14794"},{"key":"bibr9-17562848241242700","doi-asserted-by":"publisher","DOI":"10.1093\/ecco-jcc\/jjz110"},{"key":"bibr10-17562848241242700","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2018.06.035"},{"key":"bibr11-17562848241242700","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2012.02.004"},{"key":"bibr12-17562848241242700","doi-asserted-by":"publisher","DOI":"10.1111\/apt.14487"},{"key":"bibr13-17562848241242700","doi-asserted-by":"publisher","DOI":"10.1111\/apt.15371"},{"key":"bibr14-17562848241242700","doi-asserted-by":"publisher","DOI":"10.1111\/apt.14016"},{"key":"bibr15-17562848241242700","doi-asserted-by":"publisher","DOI":"10.1080\/00365521.2019.1624817"},{"key":"bibr16-17562848241242700","unstructured":"Stelara: EPAR \u2013 product information. Summary of product characteristics, https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/stelara-epar-product-information_en.pdf. 2023 (accessed 10 April 2024)."},{"key":"bibr17-17562848241242700","doi-asserted-by":"publisher","DOI":"10.1177\/2050640620902956"},{"key":"bibr18-17562848241242700","doi-asserted-by":"publisher","DOI":"10.1097\/MEG.0000000000001831"},{"key":"bibr19-17562848241242700","doi-asserted-by":"publisher","DOI":"10.1016\/j.dld.2020.10.040"},{"key":"bibr20-17562848241242700","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(07)61602-X"},{"key":"bibr21-17562848241242700","doi-asserted-by":"publisher","DOI":"10.1016\/j.jbi.2008.08.010"},{"key":"bibr22-17562848241242700","doi-asserted-by":"publisher","DOI":"10.1016\/j.jbi.2019.103208"},{"key":"bibr23-17562848241242700","doi-asserted-by":"publisher","DOI":"10.1080\/00365521.2020.1837929"},{"key":"bibr24-17562848241242700","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(80)92767-1"},{"key":"bibr25-17562848241242700","doi-asserted-by":"publisher","DOI":"10.1016\/S0016-5107(04)01878-4"},{"key":"bibr26-17562848241242700","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl-2015-309903"},{"key":"bibr27-17562848241242700","doi-asserted-by":"publisher","DOI":"10.1016\/0016-5085(90)90613-6"},{"key":"bibr28-17562848241242700","doi-asserted-by":"publisher","DOI":"10.3390\/jcm8122140"},{"key":"bibr29-17562848241242700","doi-asserted-by":"publisher","DOI":"10.3748\/wjg.v25.i31.4481"},{"key":"bibr30-17562848241242700","doi-asserted-by":"publisher","DOI":"10.5217\/ir.2019.00012"},{"key":"bibr31-17562848241242700","doi-asserted-by":"publisher","DOI":"10.1093\/ecco-jcc\/jjz008"},{"key":"bibr32-17562848241242700","doi-asserted-by":"publisher","DOI":"10.1093\/ecco-jcc\/jjz080"},{"key":"bibr33-17562848241242700","doi-asserted-by":"publisher","DOI":"10.1111\/apt.15706"},{"key":"bibr34-17562848241242700","doi-asserted-by":"publisher","DOI":"10.1093\/ibd\/izac168"},{"key":"bibr35-17562848241242700","doi-asserted-by":"publisher","DOI":"10.1080\/00365521.2021.1906946"},{"key":"bibr36-17562848241242700","doi-asserted-by":"publisher","DOI":"10.1093\/ecco-jcc\/jjab081"},{"key":"bibr37-17562848241242700","doi-asserted-by":"publisher","DOI":"10.5217\/ir.2021.00173"},{"key":"bibr38-17562848241242700","volume":"5","author":"Nagano K","year":"2023","journal-title":"Crohns Colitis"},{"key":"bibr39-17562848241242700","doi-asserted-by":"publisher","DOI":"10.1007\/s10620-022-07501-z"},{"key":"bibr40-17562848241242700","doi-asserted-by":"publisher","DOI":"10.14309\/ajg.0000000000002047"},{"key":"bibr41-17562848241242700","doi-asserted-by":"publisher","DOI":"10.1097\/MEG.0000000000002506"},{"key":"bibr42-17562848241242700","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2020.07.064"},{"key":"bibr43-17562848241242700","volume":"4","author":"Lee SD","year":"2022","journal-title":"Crohns Colitis"},{"key":"bibr44-17562848241242700","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2021.10.002"}],"container-title":["Therapeutic Advances in Gastroenterology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/17562848241242700","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/17562848241242700","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/17562848241242700","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,3,1]],"date-time":"2025-03-01T16:56:43Z","timestamp":1740848203000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/17562848241242700"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,1]]},"references-count":44,"alternative-id":["10.1177\/17562848241242700"],"URL":"https:\/\/doi.org\/10.1177\/17562848241242700","relation":{},"ISSN":["1756-2848","1756-2848"],"issn-type":[{"value":"1756-2848","type":"print"},{"value":"1756-2848","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,1]]},"article-number":"17562848241242700"}}