Real-world effectiveness and safety of vedolizumab induction therapy for ulcerative colitis: a prospective nationwide Polish observational study
Authors/Creators
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Edyta Zagórowicz1
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Halina Cichoż-Lach2
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Maria Kopertowska-Majchrzak3
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Piotr Eder4
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Kamila Stawczyk-Eder4
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Renata Talar-Wojnarowska5
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Hubert Zatorski5
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Anna Solarska-Półchłopek1
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Rafał Filip6
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Maria Janiak7
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Krzysztof Skrobot7
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Maria Kłopocka8
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Ariel Liebert8
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Aleksandra Kaczka9
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Krzysztof Wojciechowski10
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Szymon Drygała10
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Agata Michalak2
- 1. Department of Oncological Gastroenterology, Maria Skłodowska-Curie National Research Institute of Oncology, Warsaw, Poland; Department of Gastroenterology, Hepatology and Clinical Oncology, Centre of Postgraduate Medical Education, Warsaw, Poland
- 2. Department of Gastroenterology, Medical University of Lublin, Lublin, Poland
- 3. Department of Internal Diseases, General Hospital, Międzychód, Poland
- 4. Department of Gastroenterology, Dietetics, and Internal Diseases, Poznan University of Medical Sciences, H. Święcicki University Hospital, Poznań, Poland
- 5. Department of Digestive Tract Diseases, Medical University of Łódź, Łódź, Poland
- 6. Department of Gastroenterology with IBD Unit, Clinical Hospital No. 2, Rzeszów, Poland
- 7. Department of Gastroenterology and Hepatology, Medical University of Gdańsk, Gdańsk, Poland
- 8. Department of Gastroenterology and Nutritional Disorders, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Toruń, Bydgoszcz, Poland
- 9. Department of Gastroenterology, University Clinical Hospital Military Memorial Medical Academy - Central Veterans' Hospital, Łódź, Poland
- 10. Takeda Pharma sp. z o.o., Medical Affairs, Warsaw, Poland
Description
Supplementary Table 1. Changes in Mayo subscales from week 0 to week 14 of induction therapy with vedolizumab in biologic-naïve, biologic-exposed, and biofailure patients with ulcerative colitis.
Supplementary Table 2. Adverse events in patients with ulcerative colitis treated with vedolizumab using MedDRA 23.0 terminology.
Supplementary Figure 1. Clinical effectiveness of vedolizumab in induction therapy for ulcerative colitis in a group of responders. (A) Clinical remission at week 14; (B) Partial Mayo score at week 0 and 14; (C) C-reactive protein levels at week 0 and 14. Boxes correspond to median values and interquartile ranges, error bars represent min-max.
Supplementary Figure 2. Percentage of patients receiving concomitant corticosteroids at week 0 and 14 in the overall study population (A) and in a subgroup of responders (B); Doses of prednisolone equivalent (without budesonide) at week 0 and 14 in the overall study population (C), in a subgroup of responders (D), and only in patients currently treated with corticosteroids (E). Boxes correspond to median values and interquartile ranges, error bars represent min-max.
