PMID- 37166016 OWN - NLM STAT- MEDLINE DCOM- 20240129 LR - 20240206 IS - 1899-5276 (Print) IS - 1899-5276 (Linking) VI - 33 IP - 1 DP - 2024 Jan TI - Real-world effectiveness and safety of vedolizumab induction therapy for ulcerative colitis: A prospective nationwide Polish observational study. PG - 69-77 LID - 10.17219/acem/162969 [doi] AB - BACKGROUND: Vedolizumab is recommended as a first-line biological treatment, along with other biological drugs, in ulcerative colitis (UC) patients in whom conventional therapy failed and as a second-line biological treatment following a failure of a tumor necrosis factor alpha (TNF-alpha) antagonist. OBJECTIVES: We aimed to assess the real-world effectiveness and safety of vedolizumab induction therapy in UC patients treated in the scope of the National Drug Program (NDP) in Poland. MATERIAL AND METHODS: The endpoints were the proportions of patients who reached clinical response, clinical remission and mucosal healing at week 14. Partial Mayo scores, Mayo subscores and C-reactive protein (CRP) levels were also evaluated. RESULTS: Our study population consisted of 100 patients (55 biologic-naive and 45 biologic-exposed). The median total Mayo score at baseline was 10 (interquartile range (IQR): 9-11), and 52 patients (52%) had extensive colitis. The clinical response at week 14 was achieved in 83 (83%) and clinical remission in 24 (24%) cases. Mucosal healing was observed in 56 (62%) patients at week 14. In patients with prior failure of biologic treatment (n = 25), 17 (68%) responded to vedolizumab treatment. A decrease in the median CRP level (from 3.7 mg/L to 2.6 mg/L) and the median total Mayo score (from 10 to 4) was observed. No new safety concerns were recorded and no patients discontinued the treatment due to adverse events (AEs). CONCLUSIONS: Vedolizumab was effective and safe as induction therapy for UC in a Polish real-world population including patients with severely active UC and a low number of patients with prior biological treatment failures. FAU - Zagorowicz, Edyta AU - Zagorowicz E AD - Department of Oncological Gastroenterology, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland. AD - Department of Gastroenterology, Hepatology and Clinical Oncology, Centre of Postgraduate Medical Education, Warsaw, Poland. FAU - Cichoz-Lach, Halina AU - Cichoz-Lach H AD - Department of Gastroenterology, Medical University of Lublin, Poland. FAU - Kopertowska-Majchrzak, Maria AU - Kopertowska-Majchrzak M AD - Department of Internal Diseases, General Hospital, Miedzychod, Poland. FAU - Eder, Piotr AU - Eder P AD - Department of Gastroenterology, Dietetics and Internal Diseases, H. Swiecicki University Hospital, Poznan University of Medical Sciences, Poland. FAU - Stawczyk-Eder, Kamila AU - Stawczyk-Eder K AD - Department of Gastroenterology, Dietetics and Internal Diseases, H. Swiecicki University Hospital, Poznan University of Medical Sciences, Poland. FAU - Talar-Wojnarowska, Renata AU - Talar-Wojnarowska R AD - Department of Digestive Tract Diseases, Medical University of Lodz, Poland. FAU - Zatorski, Hubert AU - Zatorski H AD - Department of Digestive Tract Diseases, Medical University of Lodz, Poland. FAU - Solarska-Polchlopek, Anna AU - Solarska-Polchlopek A AD - Department of Oncological Gastroenterology, Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland. AD - Department of Gastroenterology, Hepatology and Clinical Oncology, Centre of Postgraduate Medical Education, Warsaw, Poland. FAU - Filip, Rafal AU - Filip R AD - Department of Gastroenterology with Inflammatory Bowel Disease Unit, Clinical Hospital No. 2, Rzeszow, Poland. FAU - Janiak, Maria AU - Janiak M AD - Department of Gastroenterology and Hepatology, Medical University of Gdansk, Poland. FAU - Skrobot, Krzysztof AU - Skrobot K AD - Department of Gastroenterology and Hepatology, Medical University of Gdansk, Poland. FAU - Klopocka, Maria AU - Klopocka M AD - Department of Gastroenterology and Nutritional Disorders, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, Poland. FAU - Liebert, Ariel AU - Liebert A AD - Department of Gastroenterology and Nutritional Disorders, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, Poland. FAU - Kaczka, Aleksandra AU - Kaczka A AD - Department of Gastroenterology, Military Medical Academy Memorial Teaching Hospital - Central Veterans' Hospital, Lodz, Poland. FAU - Wojciechowski, Krzysztof AU - Wojciechowski K AD - Medical Affairs, Takeda Pharma sp. z o.o., Warsaw, Poland. FAU - Drygala, Szymon AU - Drygala S AD - Medical Affairs, Takeda Pharma sp. z o.o., Warsaw, Poland. FAU - Michalak, Agata AU - Michalak A AD - Department of Gastroenterology, Medical University of Lublin, Poland. LA - eng PT - Journal Article PT - Observational Study PL - Poland TA - Adv Clin Exp Med JT - Advances in clinical and experimental medicine : official organ Wroclaw Medical University JID - 101138582 RN - 9RV78Q2002 (vedolizumab) RN - 0 (Gastrointestinal Agents) RN - 0 (Biological Products) RN - 0 (Antibodies, Monoclonal, Humanized) SB - IM MH - Humans MH - *Colitis, Ulcerative/drug therapy MH - Poland MH - Prospective Studies MH - Induction Chemotherapy MH - Gastrointestinal Agents/adverse effects MH - *Biological Products/therapeutic use MH - Treatment Outcome MH - Remission Induction MH - *Antibodies, Monoclonal, Humanized OTO - NOTNLM OT - National Drug Program OT - induction therapy OT - real-world evidence OT - ulcerative colitis OT - vedolizumab EDAT- 2023/05/11 13:18 MHDA- 2024/01/29 06:44 CRDT- 2023/05/11 06:53 PHST- 2022/04/22 00:00 [received] PHST- 2022/07/17 00:00 [revised] PHST- 2023/04/03 00:00 [accepted] PHST- 2024/01/29 06:44 [medline] PHST- 2023/05/11 13:18 [pubmed] PHST- 2023/05/11 06:53 [entrez] AID - 10.17219/acem/162969 [doi] PST - ppublish SO - Adv Clin Exp Med. 2024 Jan;33(1):69-77. doi: 10.17219/acem/162969.