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

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.

Safety and Effectiveness of Vedolizumab in Patients with Moderate-to-Severe Ulcerative Colitis: An Interim Analysis of a Japanese Post-Marketing Surveillance Study

“…A post hoc analysis of GEMINI 1 [ 10 ], the pivotal clinical trial of vedolizumab in patients with UC, demonstrated significantly higher clinical response rates after vedolizumab induction at week 6 in both TNFα inhibitor-naïve (53.1%) and TNFα-experienced patients (39.0%) as compared with placebo in TNFα inhibitor-naïve (26.3%) and TNFα-experienced patients (20.6%). In a Korean real-world study of patients with UC whose disease had to failed to respond to TNFα inhibitor therapy, the week 6 clinical response rate was 51.1% in GEMINI 1–matched subjects [ 12 ]. A phase 3 clinical trial of vedolizumab in Japanese patients also showed a significantly higher clinical response rate at week 10 in TNFα inhibitor-naïve patients (53.2%) in comparison with placebo controls (36.6%).…”

“…However, response to treatments for UC may vary across ethnic populations [ 8 ]. Although a study in Korea reported real-world effectiveness and safety outcomes of vedolizumab in patients with UC [ 12 ], post-marketing surveillance data for vedolizumab in Japanese patients is lacking.…”

Effectiveness of vedolizumab and ustekinumab as second biologic agent in achieving target outcomes in tumor necrosis factor antagonists experienced patients with inflammatory bowel disease (enroll-ex study)

“…A retrospective study examined the real-world effectiveness and safety outcomes of vedolizumab in patients with UC who had failed anti-TNF therapy in Korea ( Ye et al, 2021 ). The study included 105 patients and authors found that within the first 14 weeks of use, vedolizumab is effective and well tolerated in the real-world setting.…”

Application of clinical decision support tools for predicting outcomes with vedolizumab therapy in patients with inflammatory bowel disease: A KASID multicentre study

“…Several studies have reported the favourable efficacy and safety profiles of VDZ in Asian IBD populations 13–17 and have identified a similar pharmacokinetic profile of VDZ between Asian and non‐Asian patients with moderately‐to‐severely active CD and UC 18 . Nonetheless, uncertainty remains regarding whether these CDSTs can be effectively utilised in Asian populations in real‐world practice.…”