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

Autor: 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
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: Therapeutic Advances in Gastroenterology, Vol 14 (2021)
Druh dokumentu: article
ISSN: 1756-2848
17562848
DOI: 10.1177/17562848211024769
Popis: 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.
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