{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,2]],"date-time":"2026-06-02T12:02:54Z","timestamp":1780401774238,"version":"3.54.1"},"reference-count":38,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2026,6,2]],"date-time":"2026-06-02T00:00:00Z","timestamp":1780358400000},"content-version":"vor","delay-in-days":152,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,1,1]],"date-time":"2026-01-01T00:00:00Z","timestamp":1767225600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100008373","name":"Takeda Pharmaceutical Company","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008373","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Canadian Journal of Gastroenterology and Hepatology"],"published-print":{"date-parts":[[2026,1]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Inflammatory bowel disease (IBD) encompasses chronic gastrointestinal disorders that significantly impact patients\u2019 quality of life (QoL). While clinical trials support the efficacy and safety of vedolizumab, real\u2010world data linking its effectiveness to QoL\u2010related patient\u2010reported outcomes remain limited. This prospective observational study assessed the effects of 14\u2010week vedolizumab induction therapy on QoL (i.e., fatigue, mood, and sleep disturbances), clinical response, safety, and predictors of response.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      A total of 257 patients with ulcerative colitis (UC;\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009205) and Crohn\u2019s disease (CD;\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200952) received 14\u2010week vedolizumab induction therapy. Disease activity, QoL (assessed using the total Inflammatory Bowel Disease Questionnaire [IBDQ]), fatigue (Functional Assessment of Chronic Illness Therapy\u2010Fatigue [FACIT\u2010Fatigue]), mood and sleep disturbances (PROMIS Depression and Sleep Disturbance scales), and selected biomarkers were evaluated. Clinical response was assessed using the Mayo score for UC and Crohn\u2019s Disease Activity Index (CDAI) score for CD.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      At Week 14, clinical response was observed in 82% of UC patients and 82.7% of CD patients. Median total IBDQ scores increased by 45.0 points in UC and 31.5 points in CD (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.001). Median prorated FACIT\u2010Fatigue scores increased by 5.0 points in both groups (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.001), while median prorated PROMIS Sleep Disturbance and Depression T\u2010scores decreased (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.05). Improvement in QoL was moderately correlated with clinical response (\n                      <jats:italic>r<\/jats:italic>\n                      \u2009=\u20090.5). In logistic regression analysis, baseline patient characteristics indicative of advanced disease were associated with a reduced likelihood of clinical and QoL response to treatment. A total of 28 adverse events were reported, including 11 serious events and four treatment\u2010related events.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Vedolizumab reduced disease activity and led to a rapid improvement in QoL during the 14\u2010week induction therapy in patients with IBD. Clinical response was positively correlated with QoL improvement. Predictors of reduced response were consistent with features of advanced disease.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1155\/cjgh\/9955621","type":"journal-article","created":{"date-parts":[[2026,6,2]],"date-time":"2026-06-02T11:09:17Z","timestamp":1780398557000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Clinical Response and Improvement of the Quality of Life, Fatigue, Mood, and Sleep Disturbances During Vedolizumab Induction Therapy in Polish Patients With Moderate\u2010to\u2010Severe Ulcerative Colitis or Crohn\u2019s 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