Intestinal Research

Original Articles

Inflammatory Bowel Diseases

Efficacy and safety of vedolizumab in ulcerative colitis in patients from Asian countries in the GEMINI 1 study: Choon Jin Ooi, Ida Normiha Hilmi, Hyo-Jong Kim, Umesh Jalihal, Deng-Chyang Wu, Dirk Demuth, Dirk Lindner, Shashi Adsul; Intest Res 2021;19(1):71-82. Published online September 4, 2020; DOI: https://doi.org/10.5217/ir.2019.09159

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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.

Citations

Citations to this article as recorded by

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Application of clinical decision support tools for predicting outcomes with vedolizumab therapy in patients with inflammatory bowel disease: A KASID multicentre study
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Yu Chen, Guolin Zhang, Yuewen Yang, Shuangshuang Zhang, Haozheng Jiang, Kang Tian, Arenbaoligao, Dapeng Chen
Biomedicine & Pharmacotherapy.2023; 157: 114081. CrossRef
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Frontiers in Pharmacology.2023;[Epub] CrossRef
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Mutational Analysis of MYH in Patients with Multiple Sporadic Adenomatous Polyps in Korea: Hansoo Kim, Hyo-Jong Kim, Sung-Gil Chi, Gwang-Ro Joo, Seok-Ho Dong, Byung-Ho Kim, Young-Woon Chang, Jung-Il Lee, Rin Chang; Intest Res 2005;3(1):27-32. Published online June 30, 2005

Abstract PDF: Background/Aims
Recently, germ-line mutation in the base-excision-repair gene MYH was identified to cause a novel autosomal recessive form of familial adenomatous polyposis (FAP). Interestingly, a striking evidence for MYH mutations within different ethnic groups has been demonstrated. We have screened 30 patients with multiple adenomatous polyps for MYH mutations to assess its prevalence and ethnic specificity in Korea. Methods: Thirty patients with multiple adenomatous polyps were examined for MYH mutations. Twenty-one men and 9 women presented at a median age of 62.3 years. The mean number of adenomas per patient was 10.0. Sixteen exonic regions and its intronic sequences were amplified by PCR and subjected to SSCP and DNA sequencing analyses. Results: None of the patients was identified to carry any truncating or sequence alterations in MYH. Our screening for the mutational regions, which were recognized from Caucasian patients or affected Indian families, also failed to detect sequence substitutions. Conclusions: Mutation in MYH may be rarely involved in the pathogenesis of multiple sporadic colorectal adenomas in Korea, although large-scale analysis will be required to clarify the presence of specific MYH variants in a subset of patients and its role for the predisposition of multiple colorectal adenomas in Korea. (Intest Res 2005;3:27-32)

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Association of Polymorphism in Monocyte Chemotactic Protein-1 Promoter with Ulcerative Colitis in Korean Population: Hansoo Kim, Hyo-Jong Kim, Joo-Ho Jung, * Gwang-Ro Joo, Seok-Ho Dong, Byung-Ho Kim, Young-Woon Chang, Jung-Il Lee, Rin Chang; Intest Res 2005;3(1):33-37. Published online June 30, 2005

Abstract PDF: Background/Aims
MCP-1 plays a pivotal role in inflammation and host response to infection by attracting mononuclear cells to tissues. Currently, striking evidence has been described that genetic polymorphism in the regulatory region of MCP-1 gene played a role in the pathogenesis of inflammatory bowel diseases. We have studied the expression of MCP-1 in UC patients and healthy controls to assess allelic frequency and genotypic distribution of the polymorphism (A/G) at position -2518 of MCP-1 promoter in patients with UC in Korean population. Methods: Forty-four patients, who were diagnosed with ulcerative colitis by endoscopic biopsy at Gastroenterology Clinic in Kyung Hee University Medical Center, and two hundred and forty-six healthy subjects were genotyped by polymerase chain reaction-based restriction fragment length polymorphism (PCR-RFLP). We compared the genotypes and allelic frequency of UC patients and controls. Results: Forty-four UC patients (32 males and 12 females: mean age, 48.0⁑13.6, range 28-80) and two hundred and forty-six healthy control subjects (80 males and 166 females: mean age, 51.0⁑12.6, range 30-81) were enrolled. G allele frequency in patients and controls were 45.55% and 60.13%, respectively. When the observed control and patient genotype frequencies were compared with expected values using 3⁓2 contingency table in the standard chi-square test, the genotype distributions in -2518 (A/G) of MCP-1 promoter for UC patients was significantly different (χ²=6.298, p=0.043). Compared with control data using 2⁓2 contingency table in the standard chi-square test, the frequency of A and G allele was also significantly different in UC patients (χ²= 6.626, OR=1.812, 95% CI=1.148-2.862, p=0.01). Conclusions: Genotype distributions and allelic frequencies in polymorphism of MCP-1 (-2518, A/G) were significantly different between UC patients and controls. This result is not consistent with previously reported frequency in Caucasian populations, which suggests the possible genetic heterogeneity between different ethnical groups in MCP-1 polymorphism. Larger-scale analysis on MCP-1 polymorphism from different ethnic patients is necessary to identify this issue. (Intest Res 2005;3:33-37)

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