{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T15:08:32Z","timestamp":1791472112155,"version":"4.3.4"},"reference-count":33,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2025,6,30]],"date-time":"2025-06-30T00:00:00Z","timestamp":1751241600000},"content-version":"vor","delay-in-days":74,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Celltrion, Inc"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,6,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background and Aims<\/jats:title>\n                    <jats:p>In the LIBERTY phase 3 studies in Crohn\u2019s disease (CD) or ulcerative colitis (UC), maintenance CT-P13 subcutaneous (SC) 120\u00a0mg was more effective than placebo after 1 year. Here we report 2-year data from the LIBERTY open-label extensions.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Two randomized, placebo-controlled, double-blind studies evaluated the efficacy and safety of CT-P13 SC maintenance in moderate-to-severe CD or UC. Responders to CT-P13 intravenous induction were randomized at week (W) 10 to CT-P13 SC 120\u00a0mg or placebo biweekly, until W54. From W22, dose adjustment to CT-P13 SC 240\u00a0mg was permitted for loss of response. At W56, patients could enter an open-label extension, receiving CT-P13 SC 120\u00a0mg (or 240\u00a0mg if dose-adjusted), biweekly, until W102.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The extension comprised 278\/343 (81.0%) and 348\/438 (79.5%) patients in the CD and UC studies, respectively. In those continuing on-study, efficacy (non-responder imputation) was well maintained in the CT-P13 SC group at W102: 63.5% (as-observed: 70.5%) and 49.0% (as-observed: 58.8%) of CD patients (N\u2005=\u2005192) achieved clinical remission and endoscopic response, respectively; 45.1% (as-observed: 60.1%) and 41.4% (as-observed: 52.4%) of UC patients (N\u2005=\u2005237) achieved clinical remission and endoscopic-histologic mucosal improvement, respectively. No new safety signals were identified from longer-term CT-P13 SC treatment or starting CT-P13 SC 120\u00a0mg after placebo, with similar adverse event rates for patients undergoing dose adjustment to CT-P13 SC 240\u00a0mg from CT-P13 SC 120\u00a0mg or placebo.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>CT-P13 SC is an effective and well-tolerated long-term maintenance treatment in moderate-to-severe CD and UC.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>ClinicalTrials.gov identifiers<\/jats:title>\n                    <jats:p>NCT03945019 (CD) and NCT04205643 (UC).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ecco-jcc\/jjaf060","type":"journal-article","created":{"date-parts":[[2025,4,12]],"date-time":"2025-04-12T17:24:24Z","timestamp":1744478664000},"source":"Crossref","is-referenced-by-count":8,"title":["Subcutaneous infliximab (CT-P13 SC) as maintenance therapy for Crohn\u2019s disease and ulcerative colitis: 2-year results from open-label extensions of two randomized controlled trials (LIBERTY)"],"prefix":"10.1093","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6472-249X","authenticated-orcid":false,"given":"Jean-Frederic","family":"Colombel","sequence":"first","affiliation":[{"name":"Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai , New York, NY ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3314-7960","authenticated-orcid":false,"given":"William J","family":"Sandborn","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Department of Medicine, University of California San Diego , La Jolla, CA ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6807-9822","authenticated-orcid":false,"given":"Stefan","family":"Schreiber","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine I, University Hospital Schleswig-Holstein , Kiel 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Hepatology, Feeding Disorders and Pediatrics, Children\u2019s Memorial Health Institute , Warsaw ,","place":["Poland"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8416-0639","authenticated-orcid":false,"given":"Roman","family":"Kulynych","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Endoscopy, Zaporizhzhia Regional Clinical Hospital , Zaporizhzhia ,","place":["Ukraine"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1322-2457","authenticated-orcid":false,"given":"Maciej","family":"Gonciarz","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Internal Medicine, Military Institute of Medicine-National Research Institute , Warsaw ,","place":["Poland"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Artur","family":"So\u0142tysiak","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology 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