P277 Real life effectiveness and safety of vedolizumab induction and maintenance therapy for Korean IBD patients in whom anti-TNF treatment failed: a prospective cohort study

Kim, Jeewon; Ham, Nam Seok; Oh, Eui Geum; Song, Eun Mi; Youn, E.J.; Kwon, Eunja; Cho, Y K; Hwang, Sung Wook; Park, S H; Yang, Dong‐Jin; Js, Byeon; Myung, S.-J.; Sk, Yang; Ye, B D

doi:10.1093/ecco-jcc/jjy222.401

Cited by 4 publications

(7 citation statements)

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“…This study provides some real-world data on the effectiveness and safety of vedolizumab in UC patients which are consistent with that seen in patients from Asian countries in our study. Another real-world study, conducted in South Korea, focused on treatment-refractory IBD patients (UC, n = 18), all of whom had failed prior anti-TNF therapy [ 21 ]; over 57 weeks of treatment, induction and maintenance therapy with vedolizumab appeared to be effective, with an acceptable safety profile. Given the relative paucity of literature, additional real-world evidence on the use of vedolizumab for UC in Asian countries are still needed.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of vedolizumab in ulcerative colitis in patients from Asian countries in the GEMINI 1 study

et al. 2021

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Background/Aims: The efficacy and safety of vedolizumab in moderate to severely active ulcerative colitis (UC) have been demonstrated in the GEMINI 1 study (NCT00783718). This post-hoc exploratory analysis sought to establish the efficacy and safety of vedolizumab in a subgroup of patients from Asian countries with UC from GEMINI 1.Methods: Efficacy outcomes of interest were clinical response, clinical remission and mucosal healing at week 6 (induction phase); and clinical remission, durable clinical response, durable clinical remission, mucosal healing and glucocorticoid-free remission at week 52 (maintenance phase). Differences in outcome rates between vedolizumab and placebo in Asian countries (Hong Kong, India, Malaysia, Singapore, South Korea, and Taiwan) were assessed using descriptive analyses, and efficacy and safety compared between Asian and non-Asian countries.Results: During induction, in Asian countries (n = 58), clinical response rates at week 6 with vedolizumab and placebo were 55.2% and 24.1%, respectively (difference 31.0%; 95% confidence interval: 7.2%–54.9%). In non-Asian countries (n = 316), response rates at week 6 with vedolizumab and placebo were 45.9% and 25.8%, respectively. During maintenance, in Asian countries, clinical remission rates at 52 weeks with vedolizumab administered every 8 weeks, vedolizumab administered every 4 weeks and placebo were 9.1%, 36.8%, and 31.6%, respectively; corresponding rates for mucosal healing were 45.5%, 47.4%, and 47.4%, respectively. Vedolizumab was well-tolerated; adverse event frequency was comparable in Asian and non-Asian countries.Conclusions: In patients from Asian countries, the efficacy and safety of vedolizumab in treatment of UC were broadly consistent with that in the overall study population.

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Section: Discussionmentioning

confidence: 99%

Efficacy and safety of vedolizumab in ulcerative colitis in patients from Asian countries in the GEMINI 1 study

et al. 2021

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“…Our study adds to the limited data currently available on the use of vedolizumab in IBD in patients from Asian countries. Recent studies from Japan [ 23 , 24 ] (involving 292 patients with UC and 157 with CD, as part of a bridging study), Singapore [ 25 ] (involving 28 patients with CD), Taiwan [ 26 ] (involving 24 patients with IBD), and South Korea [ 27 ] (involving 36 patients with treatment-refractory CD) also support the benefits of vedolizumab in this population. There does, however, remain a need for additional real-world evidence to better characterize the effectiveness and safety of vedolizumab in CD, in real clinical practice.…”

Section: Discussionmentioning

confidence: 96%

Efficacy and safety of vedolizumab in Crohn’s disease in patients from Asian countries in the GEMINI 2 study

et al. 2021

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Background/Aims: The efficacy and safety of vedolizumab in moderate-to-severely active Crohn’s disease (CD) were demonstrated in the GEMINI 2 study (NCT00783692). This post-hoc exploratory analysis aimed to assess the efficacy and safety of vedolizumab in the subgroup of patients from Asian countries.Methods: During the induction phase (doses at day 1, 15), clinical remission, enhanced clinical response, and change in C-reactive protein at 6 weeks; during the maintenance phase, clinical remission, enhanced clinical response, glucocorticoid-free remission and durable clinical remission at 52 weeks, were the efficacy outcomes of interest. Efficacy and safety of vedolizumab compared to placebo were assessed in Asian countries (Hong Kong, India, Malaysia, Singapore, South Korea, and Taiwan) using descriptive analyses.Results: During the induction phase, in Asian countries (n = 51), 14.7% of the vedolizumab-treated patients achieved clinical remission at week 6 compared to none with placebo (difference, 14.7%; 95% confidence interval, 15.8%–43.5%). In non-Asian countries (n = 317), the remission rate at week 6 with vedolizumab was 14.5%. During maintenance, in Asian countries, clinical remission rates at 52 weeks with vedolizumab administered every 4 weeks, vedolizumab administered every 8 weeks and placebo were 41.7%, 36.4%, and 0%, respectively; while enhanced clinical response rates were 41.7%, 63.6%, and 42.9%, respectively. During induction, 39.7% of patients with vedolizumab experienced an adverse event compared to 58.8% of patients with placebo, and vedolizumab was generally well-tolerated.Conclusions: This post-hoc analysis demonstrates the treatment effect and safety of vedolizumab in moderateto-severely active CD in patients from Asian countries.

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“…Limited Asian specific real-world studies concerning UC patients using vedolizumab have been reported or presented previously. [20][21][22][23] This study adds to this body of evidence, showing favorable effectiveness at week 6 after administration of…”

Section: Discussionmentioning

confidence: 99%

“…However, based on other real-world studies reported so far, it is suggestive that the safety profiles of vedolizumab approximate the understanding generated from the key clinical trials data, particularly the GEMINI studies. 9 , 13 , 15 , 22 , 24 …”

Section: Discussionmentioning

confidence: 99%

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

Cheon

Song³

et al. 2021

Therap Adv Gastroenterol

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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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P277 Real life effectiveness and safety of vedolizumab induction and maintenance therapy for Korean IBD patients in whom anti-TNF treatment failed: a prospective cohort study

Cited by 4 publications

References 0 publications

Efficacy and safety of vedolizumab in ulcerative colitis in patients from Asian countries in the GEMINI 1 study

Efficacy and safety of vedolizumab in ulcerative colitis in patients from Asian countries in the GEMINI 1 study

Efficacy and safety of vedolizumab in Crohn’s disease in patients from Asian countries in the GEMINI 2 study

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

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