{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T17:24:55Z","timestamp":1787160295538,"version":"build-2736575974"},"reference-count":51,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2021,1,1]],"date-time":"2021-01-01T00:00:00Z","timestamp":1609459200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"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":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Therap Adv Gastroenterol"],"published-print":{"date-parts":[[2021,1]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>\n                      Vedolizumab, a humanized antibody targeting the \u03b1\n                      <jats:sub>4<\/jats:sub>\n                      \u03b2\n                      <jats:sub>7<\/jats:sub>\n                      integrin, was proven to be effective in the treatment of moderate-to-severe ulcerative colitis (UC) in randomized clinical trials. The aim of the POLONEZ study is to determine the demographic and clinical characteristics of the patients with UC treated with vedolizumab within the scope of the National Drug Program in Poland and to assess the real-world effectiveness and safety of vedolizumab in the study population. Here we report the demographic and clinical characteristics of these patients.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>This prospective study included adult patients eligible for UC treatment with vedolizumab who were recruited from 12 centers in Poland between February and November 2019. Collected data included sex, age, disease duration, presence of extraintestinal manifestations or comorbidities, status of previous biologic treatment, and current concomitant treatment. Disease extent was determined according to the Montreal classification, and disease activity was measured with the Mayo Score.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>A total of 100 (55 biologic-na\u00efve and 45 biologic-exposed) patients were enrolled in the study (51% female, median age 35 years). Among biologic-exposed patients (mostly infliximab-treated), 57% had failed to respond to the therapy. The disease duration was significantly shorter in biologic-na\u00efve (median 5 years) than in biologic-exposed (8 years, p\u2009=\u20090.004) or biofailure patients (7 years, p\u2009=\u20090.04). In the overall population the median Total Mayo Score was 10. Disease extent and activity were similar between the subgroups.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>Our study indicates that patients treated with vedolizumab in Poland receive the drug relatively early after UC diagnosis, but their disease is advanced. More than half of the patients had not been treated with biologic drugs before initiating vedolizumab. The study was registered in ENCePP database (EUPAS34119).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Lay summary<\/jats:title>\n                    <jats:p>Characteristics of patients treated for ulcerative colitis with vedolizumab in Poland Treatment of moderate-to-severe ulcerative colitis (UC) with the integrin antagonist vedolizumab became available within the Polish National Drug Program (NDP) in 2018. In this study, for the first time, we provide detailed demographic and clinical characteristics of 100 patients (median age 35 years, 51% female) treated with vedolizumab in Poland, of whom 55 were biologic-na\u00efve and 45 biologic-exposed. The median duration of disease was 6 years. The disease duration was shorter in biologic-na\u00efve than in biologic-exposed patients. Most patients were affected by extensive colitis (52%) or left-sided colitis (42%). Median disease activity was 10 according to the Total Mayo Score. Sixty-eight patients received concomitant systemic corticosteroids and 45 patients received immunomodulators. Our findings indicate that Polish patients receiving vedolizumab have a high disease activity and are treated relatively early after UC diagnosis. This might be due to the criteria for inclusion of a patient in the NDP.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/17562848211036456","type":"journal-article","created":{"date-parts":[[2021,8,31]],"date-time":"2021-08-31T02:32:23Z","timestamp":1630377143000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":7,"title":["Characteristics of patients with moderate-to-severe ulcerative colitis treated with vedolizumab: results from a Polish multicenter, prospective, observational real-life study (the POLONEZ study)"],"prefix":"10.1177","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7337-835X","authenticated-orcid":false,"given":"Halina","family":"Cicho\u017c-Lach","sequence":"first","affiliation":[{"name":"Department of Gastroenterology, Medical University of Lublin, Lublin, 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"}]},{"given":"Maria","family":"Kopertowska-Majchrzak","sequence":"additional","affiliation":[{"name":"Department of Internal Diseases, General Hospital, Mi\u0119dzych\u00f3d, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Piotr","family":"Eder","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Dietetics, and Internal Diseases, Poznan University of Medical Sciences, H. \u015awi\u0119cicki University Hospital, Pozna\u0146, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kamila","family":"Stawczyk-Eder","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Dietetics, and Internal Diseases, Poznan University of Medical Sciences, H. \u015awi\u0119cicki University Hospital, Pozna\u0146, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katarzyna","family":"Waszak","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Dietetics, and Internal Diseases, Poznan University of Medical Sciences, H. \u015awi\u0119cicki University Hospital, Pozna\u0146, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Renata","family":"Talar-Wojnarowska","sequence":"additional","affiliation":[{"name":"Department of Digestive Tract Diseases, Medical University of Lodz, \u0141\u00f3d\u017a, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hubert","family":"Zatorski","sequence":"additional","affiliation":[{"name":"Department of Digestive Tract Diseases, Medical University of Lodz, \u0141\u00f3d\u017a, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Solarska-P\u00f3\u0142ch\u0142opek","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, The Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland"},{"name":"Department of Gastroenterology, Hepatology and Clinical Oncology, The Medical Center of Postgraduate Education, Warsaw, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jaros\u0142aw","family":"Chmielnicki","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Specialist Hospital, Ko\u0144skie, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rafa\u0142","family":"Filip","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology with IBD Unit, Clinical Hospital No. 2, Rzesz\u00f3w, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"P\u0119kala","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology with IBD Unit, Clinical Hospital No. 2, Rzesz\u00f3w, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Janiak","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Medical University of Gda\u0144sk, Gda\u0144sk, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Krzysztof","family":"Skrobot","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Medical University of Gda\u0144sk, Gda\u0144sk, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ewa","family":"Kasi\u0144ska","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Military Institute of Medicine, Warsaw, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Micha\u0142","family":"Krogulecki","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Military Institute of Medicine, Warsaw, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Piotr","family":"Kr\u00f3likowski","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Military Institute of Medicine, Warsaw, 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":"Ariel","family":"Liebert","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":"El\u017cbieta","family":"Poniewierka","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Wroc\u0142aw Medical University, Wroc\u0142aw, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Izabela","family":"Smo\u0142a","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Wroc\u0142aw Medical University, Wroc\u0142aw, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anita","family":"G\u0105siorowska","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, University Clinical Hospital Military Memorial Medical Academy\u2014Central Veterans\u2019 Hospital, \u0141\u00f3d\u017a, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aleksandra","family":"Kaczka","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, University Clinical Hospital Military Memorial Medical Academy\u2014Central Veterans\u2019 Hospital, \u0141\u00f3d\u017a, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joanna","family":"Wypych","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Surgery and Nutrition, Copernicus Hospital, Gda\u0144sk, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8300-7624","authenticated-orcid":false,"given":"Krzysztof","family":"Wojciechowski","sequence":"additional","affiliation":[{"name":"Takeda Pharma Sp.z.o.o., Medical Affairs, 00-838 Warsaw, Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Szymon","family":"Dryga\u0142a","sequence":"additional","affiliation":[{"name":"Pharma Sp.z.o.o., 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