ArticleTherapeutic advances in gastroenterology2024
Effectiveness and safety outcomes after long-term (54 weeks) vedolizumab therapy for Crohn's disease: a prospective, real-world observational study including patient-reported outcomes (POLONEZ II).
Article in Therapeutic advances in gastroenterology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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Who cites it
5 citing papers in PubMed.
- Five-Year Persistence of Vedolizumab in Crohn's Disease: Results from a Real-World Cohort.Journal of clinical medicine · 2026Article
- Clinical Response and Improvement of the Quality of Life, Fatigue, Mood, and Sleep Disturbances During Vedolizumab Induction Therapy in Polish Patients With Moderate-to-Severe Ulcerative Colitis or Crohn's Disease.Canadian journal of gastroenterology & hepatology · 2026Observational
- Multicenter Evaluation of the First Validated German-Language Fatigue Questionnaire for Patients with Chronic Inflammatory Bowel Diseases.Journal of clinical medicine · 2025Article
- Risk of malnutrition increases in the year prior to surgery among patients with inflammatory bowel disease.Therapeutic advances in gastroenterology · 2025Article
- Effectiveness and safety outcomes after long-term (54 weeks) vedolizumab therapy for Crohn's disease: a prospective, real-world observational study including patient-reported outcomes (POLONEZ II).Therapeutic advances in gastroenterology · 2024Article
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Authors and funding
17 authors.
Funding
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Abstract
Background: The Crohn's 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. Objectives: 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. Design: POLONEZ II was a multicenter, observational, prospective study across 10 Polish centers from April 2020 to October 2023 for 54 weeks in patients with CD eligible for reimbursed VDZ. Methods: Primary endpoints at week 54 (W54) were clinical response (⩾70-point reduction in CDAI and >25% reduction vs baseline), remission (CDAI score ⩽150), and steroid-free remission. Other outcomes were changes in PROs (CDAI score and health-related quality of life) and safety. Kaplan-Meier survival analyses were performed. Results: Of 98 patients with CD, the mean age was 35.2 years, 57.1% were male, and 72.4% had an ileocolonic disease. At W54 ( Conclusion: POLONEZ II demonstrated long-term real-world benefits of VDZ toward effectiveness, safety, and improved PROs and patients' quality of life. Trial registration: ENCePP (EUPAS32716).
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