{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T14:19:46Z","timestamp":1791814786881,"version":"4.3.4"},"reference-count":21,"publisher":"Oxford University Press (OUP)","issue":"8","license":[{"start":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:00:00Z","timestamp":1785542400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"DOI":"10.13039\/501100005416","name":"Norwegian Research Council","doi-asserted-by":"publisher","award":["263209"],"award-info":[{"award-number":["263209"]}],"id":[{"id":"10.13039\/501100005416","id-type":"DOI","asserted-by":"publisher"}]},{"name":"M\u00f8re & Romsdal Hospital Trust","award":["P-101661-01"],"award-info":[{"award-number":["P-101661-01"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,8,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background and Aims<\/jats:title>\n                    <jats:p>Anti-tumour necrosis factor (anti-TNF) treatment is effective in ulcerative colitis (UC). Optimal treatment duration is uncertain. This trial studies outcome after anti-TNF withdrawal compared to maintenance treatment in UC.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this prospective, multicentre, randomized, controlled, open-label non-inferiority study, patients in deep clinical, biochemical and endoscopic remission were randomized 1:1 to anti-TNF withdrawal or maintenance treatment. Primary endpoint was endoscopically confirmed remission (Mayo Endoscopic Score 0 or 1) after two years, including UC flares treated with anti-TNF, or non-biologic agents. Secondary endpoints were clinical remission, UC flare rate and treatment response. We needed 170 participants to show non-inferiority with a 15% margin.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Between June 2017 and December 2021, 172 UC patients from 19 Norwegian hospitals were randomized; 86 in each group. The per-protocol population was 163 patients. Nine patients were excluded due to consent withdrawal or protocol violation. Eighty percent (66\/82) of anti-TNF withdrawal and 96% (78\/81) of maintenance patients were in endoscopic remission after 2\u2009years. UC flares occurred in 52% (45\/86) of withdrawal and 12% (10\/86) of maintenance patients. Anti-TNF retreatment was successful in 74% (20\/27).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Two years after anti-TNF withdrawal in UC patients in deep remission, endoscopically confirmed remission rate was significantly lower compared to maintenance treatment. Non-inferiority could not be proven. UC flare rate after anti-TNF withdrawal was high, but most were successfully treated. The majority did not receive AZA. Importantly, 48% of anti-TNF withdrawal patients remained in steroid-free remission. No significant predictors for UC activity after anti-TNF withdrawal were identified.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>ClinicalTrials.gov (registration number NCT03011268), and EudraCT (registration number 2016-001409-18)<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ecco-jcc\/jjag110","type":"journal-article","created":{"date-parts":[[2026,7,13]],"date-time":"2026-07-13T11:24:54Z","timestamp":1783941894000},"source":"Crossref","is-referenced-by-count":2,"title":["Anti-TNF withdrawal or long-term treatment in ulcerative colitis (BIOSTOP): a multicentre open label, randomized controlled trial"],"prefix":"10.1093","volume":"20","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2014-8497","authenticated-orcid":false,"given":"Ingrid Prytz","family":"Berset","sequence":"first","affiliation":[{"name":"M\u00f8re og Romsdal Hospital Trust Gastroenterology Dep, , \u00c5sehaugen 5 , \u00c5lesund, 6017,","place":["Norway"]},{"name":"Institute of Clinical Medicine, Faculty of Medicine, University of Oslo , Oslo,","place":["Norway"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frode","family":"Lerang","sequence":"additional","affiliation":[{"name":"\u00d8stfold Hospital Trust Gastroenterology Dep, , Kalnes , Sarpsborg,","place":["Norway"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bj\u00f8rn","family":"Moum","sequence":"additional","affiliation":[{"name":"Institute of Clinical Medicine, Faculty of Medicine, University of Oslo , Oslo,","place":["Norway"]},{"name":"\u00d8stfold Hospital Trust Gastroenterology Dep, , Kalnes , Sarpsborg,","place":["Norway"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J\u00f8rgen","family":"Jahnsen","sequence":"additional","affiliation":[{"name":"Institute of Clinical Medicine, Faculty of Medicine, University of Oslo , Oslo,","place":["Norway"]},{"name":"Akershus University Hospital Trust Gastroenterology Dep, , L\u00f8renskog,","place":["Norway"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tore","family":"Grimstad","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Stavanger University Hospital , Stavanger,","place":["Norway"]},{"name":"Department of Clinical Science, University of Bergen , Bergen,","place":["Norway"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0876-8634","authenticated-orcid":false,"given":"Vendel","family":"Kristensen","sequence":"additional","affiliation":[{"name":"Institute of Clinical Medicine, Faculty of Medicine, University of Oslo , Oslo,","place":["Norway"]},{"name":"Oslo University Hospital Trust, Rikshospitalet & Ullev\u00e5l , Oslo,","place":["Norway"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H\u00e5vard","family":"Wiig","sequence":"additional","affiliation":[{"name":"S\u00f8rlandet Hospital Trust Gastroenterology Dep, , Kristiansand,","place":["Norway"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tone","family":"Aabrekk","sequence":"additional","affiliation":[{"name":"Vestfold Hospital Trust Gastroenterology Dep, , T\u00f8nsberg,","place":["Norway"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eivind","family":"Ness-Jenssen","sequence":"additional","affiliation":[{"name":"Nord-Tr\u00f8ndelag Hospital Trust Gastroenterology Dep, , Levanger,","place":["Norway"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sigrun","family":"Eskeland","sequence":"additional","affiliation":[{"name":"Vestre Viken Hospital Trust Gastroenterology Dep, , 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Hamar,","place":["Norway"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"\u00d8ystein","family":"Hovlid","sequence":"additional","affiliation":[{"name":"M\u00f8re og Romsdal Hospital Trust Gastroenterology Dep, , \u00c5sehaugen 5 , \u00c5lesund, 6017,","place":["Norway"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Magne","family":"Buset","sequence":"additional","affiliation":[{"name":"University hospital of North-Norway Gastroenterology Dep, , Harstad,","place":["Norway"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gro","family":"Riise","sequence":"additional","affiliation":[{"name":"Haukeland University Hospital Trust Gastroenterology Dep, , Bergen,","place":["Norway"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gunnar","family":"Horvei","sequence":"additional","affiliation":[{"name":"Haraldsplass Hospital , 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