{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T14:33:17Z","timestamp":1790087597855,"version":"4.0.1"},"reference-count":54,"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-nc\/4.0\/"}],"funder":[{"name":"Takeda Pharma Sp. z.o.o."}],"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>The Crohn\u2019s Disease (CD) Activity Index (CDAI), Inflammatory Bowel Disease (IBD) Questionnaire (IBDQ), and IBD-Fatigue (IBD-F) scale are useful patient-reported outcome (PRO) tools for assessing the treatment benefits of vedolizumab (VDZ) beyond clinical trial endpoints in patients with CD.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objectives:<\/jats:title><jats:p>To assess clinical response, clinical remission, steroid-free remission, changes from baseline for PROs, and safety in a real-world cohort of patients with moderate-to-severe active CD treated with VDZ.<\/jats:p><\/jats:sec><jats:sec><jats:title>Design:<\/jats:title><jats:p>POLONEZ II was a multicenter, observational, prospective study across 10 Polish centers from April 2020 to October 2023 for 54\u2009weeks in patients with CD eligible for reimbursed VDZ.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods:<\/jats:title><jats:p>Primary endpoints at week 54 (W54) were clinical response (\u2a7e70-point reduction in CDAI and &gt;25% reduction vs baseline), remission (CDAI score \u2a7d150), and steroid-free remission. Other outcomes were changes in PROs (CDAI score and health-related quality of life) and safety. Kaplan\u2013Meier survival analyses were performed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results:<\/jats:title><jats:p>Of 98 patients with CD, the mean age was 35.2\u2009years, 57.1% were male, and 72.4% had an ileocolonic disease. At W54 ( n\u2009=\u200998), 63.3% of patients achieved clinical response, 48.0% remission, and 36.0% steroid-free remission. The durability of clinical response, remission, and steroid-free remission (W14\u2013W54) were 68.9%, 62.9%, and 57.1%, respectively. By W54, a significant reduction in the PROs, such as the total CDAI score ( p\u2009&lt;\u20090.001), stool frequency ( p\u2009&lt;\u20090.001), abdominal pain score ( p\u2009&lt;\u20090.001), IBDQ ( p\u2009&lt;\u20090.001), IBD-F ( p\u2009&lt;\u20090.05), and fatigue impact on daily activities ( p\u2009&lt;\u20090.001), was observed. During VDZ treatment, arthralgia (23.7%\u20138.7%) and anemia (22.6%\u201315.9%) decreased between baseline and W54. Non-serious adverse events (SAEs; 12.2%), SAEs (7.1%), and VDZ-related rash (1.0%) were reported. Mean CD-related hospitalization duration decreased from baseline (10.2\u2009days) to the end of the study (5.3\u2009days).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion:<\/jats:title><jats:p>POLONEZ II demonstrated long-term real-world benefits of VDZ toward effectiveness, safety, and improved PROs and patients\u2019 quality of life.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration:<\/jats:title><jats:p>ENCePP (EUPAS32716).<\/jats:p><\/jats:sec>","DOI":"10.1177\/17562848241293938","type":"journal-article","created":{"date-parts":[[2024,11,21]],"date-time":"2024-11-21T05:39:50Z","timestamp":1732167590000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":8,"title":["Effectiveness and safety outcomes after long-term (54\u2009weeks) vedolizumab therapy for Crohn\u2019s disease: a prospective, real-world observational study including patient-reported outcomes (POLONEZ II)"],"prefix":"10.1177","volume":"17","author":[{"given":"Ariel","family":"Liebert","sequence":"first","affiliation":[{"name":"Department of Gastroenterology and Nutritional Disorders, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Toru\u0144, Bydgoszcz, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"K\u0142opocka","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Nutritional Disorders, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Toru\u0144, Bydgoszcz, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Agata","family":"Michalak","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Medical University of Lublin, Lublin, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7337-835X","authenticated-orcid":false,"given":"Halina","family":"Cichoz-Lach","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Medical University of Lublin, Lublin, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Renata","family":"Talar-Wojnarowska","sequence":"additional","affiliation":[{"name":"Department of Digestive Tract Diseases, Medical University of \u0141\u00f3d\u017a, \u0141\u00f3d\u017a, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Danuta","family":"Domz.a\u0142-Magrowska","sequence":"additional","affiliation":[{"name":"Department of Digestive Tract Diseases, Medical University of \u0141\u00f3d\u017a, \u0141\u00f3d\u017a, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"\u0141ukasz","family":"Konecki","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Military Institute of Medicine, Warsaw, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aleksandra","family":"Filipiuk","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Military Institute of Medicine, Warsaw, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9060-7652","authenticated-orcid":false,"given":"Micha\u0142","family":"Krogulecki","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Military Institute of Medicine, Warsaw, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Kopertowska-Majchrzak","sequence":"additional","affiliation":[{"name":"Department of Internal Diseases, General Hospital, Mie\u02dbdzych\u00f3d, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kamila","family":"Stawczyk-Eder","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Dietetics, and Internal Diseases, Poznan University Clinical Hospital, Pozna\u0144 University of Medical Sciences, Pozna\u0144, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katarzyna","family":"Waszak","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Dietetics, and Internal Diseases, Poznan University Clinical Hospital, Pozna\u0144 University of Medical Sciences, Pozna\u0144, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Piotr","family":"Eder","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Dietetics, and Internal Diseases, Poznan University Clinical Hospital, Pozna\u0144 University of Medical Sciences, Pozna\u0144, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edyta","family":"Zag\u00f3rowicz","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland"},{"name":"Department of Gastroenterology, Hepatology and Clinical Oncology, Medical Center of Postgraduate Education, Warsaw, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Izabela","family":"Smo\u0142a","sequence":"additional","affiliation":[{"name":"Department and Clinic of Gastroenterology, Hepatology and Internal Medicine, Faculty of Medicine, Wroc\u0142aw Medical University, Wroc\u0142aw, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Krzysztof","family":"Wojciechowski","sequence":"additional","affiliation":[{"name":"Department of Internal Diseases, The Independent Public Health Care Center, Tarczyn, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1355-4737","authenticated-orcid":false,"given":"Szymon","family":"Dryga\u0142a","sequence":"additional","affiliation":[{"name":"Szymon Dryga\u0142a Takeda Pharma Sp. z.o.o., St. Prosta 68, Warsaw, Mazovia Province 00-838, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2024,11,20]]},"reference":[{"key":"bibr1-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1097\/MPG.0b013e31805563f3"},{"key":"bibr2-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(12)60026-9"},{"key":"bibr3-17562848241293938","first-page":"16194","volume":"132","author":"Zag\u00f3rowicz E","year":"2022","journal-title":"Pol Arch Intern Med"},{"key":"bibr4-17562848241293938","doi-asserted-by":"publisher","DOI":"10.4137\/CGast.S12731"},{"key":"bibr5-17562848241293938","doi-asserted-by":"publisher","DOI":"10.2147\/JIR.S65979"},{"key":"bibr6-17562848241293938","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2021.614653"},{"key":"bibr7-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1186\/s41687-018-0044-7"},{"key":"bibr8-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1155\/2014\/792386"},{"key":"bibr9-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1111\/apt.13001"},{"key":"bibr10-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1016\/0016-5085(89)90905-0"},{"key":"bibr11-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1016\/j.crohns.2014.04.013"},{"key":"bibr12-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1093\/ecco-jcc\/jjv091"},{"key":"bibr13-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1007\/s12325-019-01151-w"},{"key":"bibr14-17562848241293938","doi-asserted-by":"publisher","DOI":"10.14309\/ajg.0000000000001954"},{"key":"bibr15-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1124\/jpet.109.153973"},{"key":"bibr16-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1080\/21645515.2019.1591139"},{"key":"bibr17-17562848241293938","doi-asserted-by":"publisher","DOI":"10.2217\/imt.12.85"},{"key":"bibr18-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1007\/s40261-016-0437-4"},{"key":"bibr19-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1093\/ecco-jcc\/jjad043"},{"key":"bibr20-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1215734"},{"key":"bibr21-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1215739"},{"key":"bibr22-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2014.05.008"},{"key":"bibr23-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1177\/17562848231151295"},{"key":"bibr24-17562848241293938","doi-asserted-by":"crossref","unstructured":"Michalak A, K\u0142opocka M, Liebert A, et al. Effectiveness and safety outcomes after long-term (54 weeks) vedolizumab therapy for Crohn\u2019s disease: a prospective, real-world observational study including patient-reported outcomes (POLONEZ II). Poster presented at UEG Week 2023 (Copenhagen, Denmark; October 14-17, 2023). No. PP 05 IBD.","DOI":"10.1177\/17562848241293938"},{"key":"bibr25-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1093\/ecco-jcc\/jjac190.0551"},{"key":"bibr26-17562848241293938","volume-title":"R: A language and environment for statistical computing","author":"R Core Team","year":"2021"},{"key":"bibr27-17562848241293938","unstructured":"STROBE. Strengthening the reporting of observational studies in epidemiology, https:\/\/www.strobe-statement.org\/ (2024, accessed 23 July 2024)."},{"key":"bibr28-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2019.05.067"},{"key":"bibr29-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1016\/j.dld.2018.07.040"},{"key":"bibr30-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1186\/s12876-020-01332-w"},{"key":"bibr31-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1177\/2050640620948802"},{"key":"bibr32-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1177\/1756284820936536"},{"key":"bibr33-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1177\/17562848211023386"},{"key":"bibr34-17562848241293938","author":"Bokemeyer B","year":"2023","journal-title":"Inflamm Bowel Dis"},{"key":"bibr35-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2019.04.040"},{"key":"bibr36-17562848241293938","doi-asserted-by":"publisher","DOI":"10.3389\/fmed.2020.00076"},{"key":"bibr37-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1111\/apt.13594"},{"key":"bibr38-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1097\/MIB.0000000000001039"},{"key":"bibr39-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(17)32641-7"},{"key":"bibr40-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1016\/j.gastrohep.2016.01.015"},{"key":"bibr41-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1111\/apt.15174"},{"key":"bibr42-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1177\/2050640620965106"},{"key":"bibr43-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1093\/ecco-jcc\/jjaa005"},{"key":"bibr44-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1111\/apt.14167"},{"key":"bibr45-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1093\/ibd\/izad075"},{"key":"bibr46-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1111\/apt.14419"},{"key":"bibr47-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1080\/00365521.2016.1256425"},{"key":"bibr48-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1186\/s12876-020-1164-0"},{"key":"bibr49-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1097\/MEG.0000000000002728"},{"key":"bibr50-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1111\/apt.16060"},{"key":"bibr51-17562848241293938","volume":"161","author":"Jeuring SFG","year":"2017","journal-title":"Ned Tijdschr Geneeskd"},{"key":"bibr52-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1016\/j.dld.2019.01.016"},{"key":"bibr53-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1093\/ecco-jcc\/jjab029"},{"key":"bibr54-17562848241293938","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2006.05.052"}],"container-title":["Therapeutic Advances in Gastroenterology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/17562848241293938","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/17562848241293938","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/17562848241293938","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,3,3]],"date-time":"2025-03-03T04:02:17Z","timestamp":1740974537000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/17562848241293938"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,1]]},"references-count":54,"alternative-id":["10.1177\/17562848241293938"],"URL":"https:\/\/doi.org\/10.1177\/17562848241293938","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":"17562848241293938"}}