{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T15:02:26Z","timestamp":1790262146470,"version":"4.1.0"},"reference-count":42,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2026,7,9]],"date-time":"2026-07-09T00:00:00Z","timestamp":1783555200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,7,9]],"date-time":"2026-07-09T00:00:00Z","timestamp":1783555200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100008897","name":"Janssen Pharmaceutica","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008897","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2026,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background and Aims<\/jats:title>\n                    <jats:p>While randomised controlled trials have demonstrated the efficacy of ustekinumab for treating Crohn's disease (CD), real\u2010world effectiveness and patient experience in heterogeneous clinical populations remain less well characterised. We aimed to assess the effectiveness and safety of ustekinumab in routine clinical care incorporating patient\u2010reported outcomes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This prospective multicentre study recruited adult patients initiating ustekinumab for CD as part of routine clinical care across 22 UK hospitals. Study visits were conducted at baseline and at Weeks 8, 16\/20, 56, 80 and 104. Data collected included participant demographics, disease phenotype, previous treatment history, disease activity scores, laboratory measures, dosing regimens, patient\u2010reported outcomes (patient experience, quality of life [QoL] and treatment satisfaction) and adverse events. The primary outcome was corticosteroid\u2010free clinical remission (defined as mHBI\u2009&lt;\u20095) at Week 56.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Six hundred one participants were recruited between October 2019 and August 2023, with 20% na\u00efve to advanced therapies. At baseline, 43% of participants were assessed as being in clinical remission according to mHBI, whereas only 12% had quiescent disease per the IBD\u2010Control questionnaire. The primary endpoint was achieved by 33% of participants (95% CI, 30%\u201337%). Cumulative probabilities of ustekinumab persistence were 78% at 1\u2009year and 63% at 2\u2009years. The IBD\u2010Control\u20108 score showed improvement from baseline to Week 8, increasing from a median of 5 (IQR: 2\u201310) to 12 (IQR: 8\u201314), though QoL impairment remained evident in many participants. Most adverse events were mild and consistent with the established safety profile of ustekinumab.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In this large real\u2010world cohort, ustekinumab treatment was associated with sustained improvements in both clinical outcomes and QoL measures. Our data suggest that patients treated in clinical practice differ markedly from Phase 3 trial participants. QoL, and not only disease activity as assessed using a conventional disease activity score, may play a significant role in the decision to initiate ustekinumab. Systematic integration of QoL measures into routine care may improve patient care and treatment outcomes.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/apt.70833","type":"journal-article","created":{"date-parts":[[2026,7,10]],"date-time":"2026-07-10T04:41:53Z","timestamp":1783658513000},"page":"1097-1109","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Real\u2010World Effectiveness, Safety and Quality of Life With Ustekinumab for the Treatment of Crohn's Disease: Results of the UK Ustekinumab Real World Evidence Study (UndieS) Study Group"],"prefix":"10.1111","volume":"64","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0102-5739","authenticated-orcid":false,"given":"David","family":"Young","sequence":"first","affiliation":[{"name":"Pharmacy Department University Hospital Southampton NHS Foundation Trust  Southampton UK"},{"name":"Faculty of Medicine University of Southampton  Southampton UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-2933-0079","authenticated-orcid":false,"given":"Cheryl","family":"Booker","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology University Hospital Southampton NHS Foundation Trust  Southampton UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4057-9200","authenticated-orcid":false,"given":"Mark","family":"Samaan","sequence":"additional","affiliation":[{"name":"IBD Centre, Guy's and St Thomas' NHS Foundation Trust  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5942-9149","authenticated-orcid":false,"given":"Klaartje","family":"Kok","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology Barts Health NHS Trust  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-1897-9842","authenticated-orcid":false,"given":"Fiona","family":"Donovan","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology St George's University Hospitals NHS Foundation Trust  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7141-6076","authenticated-orcid":false,"given":"Ailsa","family":"Hart","sequence":"additional","affiliation":[{"name":"Inflammatory Bowel Disease Unit St Mark's Hospital  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5307-552X","authenticated-orcid":false,"given":"James","family":"Batchelor","sequence":"additional","affiliation":[{"name":"Faculty of Medicine University of Southampton  Southampton UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jimmy","family":"Limdi","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology Northern Care Alliance NHS Foundation Trust  Manchester UK"},{"name":"Faculty of Biology, Medicine &amp; Health University of Manchester  Manchester UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1825-3239","authenticated-orcid":false,"given":"Keith","family":"Bodger","sequence":"additional","affiliation":[{"name":"Department of Health Data Science, Institute of Population Health University of Liverpool  Liverpool UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9659-3247","authenticated-orcid":false,"given":"J. 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