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The real-world outcomes of vedolizumab in patients with ulcerative colitis in Korea: a multicenter retrospective study

Authors
 Byong Duk Ye  ;  Jae Hee Cheon  ;  Ki Hwan Song  ;  Joo Sung Kim  ;  Young-Ho Kim  ;  Hyuk Yoon  ;  Kang-Moon Lee  ;  Sang-Bum Kang  ;  Byung Ik Jang  ;  Jae Jun Park  ;  Tae Oh Kim  ;  Dae-Wook Lee  ;  Chee Yoong Foo  ;  Jeong Eun Shin  ;  Dong Il Park 
Citation
 THERAPEUTIC ADVANCES IN GASTROENTEROLOGY, Vol.14 : 17562848211024769, 2021-07 
Journal Title
THERAPEUTIC ADVANCES IN GASTROENTEROLOGY
ISSN
 1756-283X 
Issue Date
2021-07
Keywords
Korea ; remission ; response ; ulcerative colitis ; vedolizumab
Abstract
Aim: This study examined the real-world effectiveness and safety outcomes of vedolizumab in ulcerative colitis (UC) patients who had failed anti-tumor necrosis factor (anti-TNF) therapy in Korea.

Methods: A retrospective chart review study was conducted in adults with moderate to severely active UC who had failed anti-TNF agents and subsequently received vedolizumab. Clinical response and clinical remission at week 6 and 14 after vedolizumab initiation was evaluated. Safety outcomes were also reported. Outcome rates were compared with a matched sub-cohort derived from the open-label sub-cohort of the GEMINI 1 trial using the optimal matching method.

Results: A total of 105 patients (mean age, 45.3 years; 63.8% male) were included. At week 6, 55.8% (n = 43/77) achieved a clinical response and 18.2% (n = 14/77) achieved clinical remission. At week 14, 73.2% (n = 52/71) achieved a clinical response and 39.4% (n = 28/71) achieved clinical remission. When non-response imputation was used, the clinical response rate at week 6 and week 14 were 40.1% (n = 43/105) and 49.5% (n = 52/105) respectively. Of the 105 patients, 16 (15.2%) experienced at least one adverse event. The matched analysis showed that the clinical response rate at week 6 was higher in the matched sub-cohort of this study (24/47, 51.1%) versus the matched sub-cohort from the GEMINI 1 open-label cohort (12/47, 34.3%, p = 0.019). The clinical remission rates at week 6 were similar (7/47, 14.9% versus 9/47, 19.1%, p = 0.785).

Conclusions: In the real-world setting, vedolizumab is effective and well tolerated within the first 14 weeks of use in Korea. The proportion of patients experiencing clinical response and clinical remission at 6 and 14 weeks appeared to be largely consistent with that observed in real-world studies from other regions and populations.
Files in This Item:
T202126080.pdf Download
DOI
10.1177/17562848211024769
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Park, Jae Jun(박재준)
Cheon, Jae Hee(천재희) ORCID logo https://orcid.org/0000-0002-2282-8904
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/190452
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