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Original Articles
- Inflammatory Bowel Diseases
- Efficacy and safety of vedolizumab in Crohn’s disease in patients from Asian countries in the GEMINI 2 study
- Rupa Banerjee, Sai Wei Chuah, Ida Normiha Hilmi, Deng-Chyang Wu, Suk-Kyun Yang, Dirk Demuth, Dirk Lindner, Shashi Adsul
- Intest Res 2021;19(1):83-94. Published online December 31, 2020
- DOI: https://doi.org/10.5217/ir.2019.09160
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Abstract
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Supplementary Material
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ePub - 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. -
Citations
Citations to this article as recorded by
- A Comprehensive Review of the Role of Biologics and Small-Molecule Therapies in the Long-Term Management of Crohn’s Disease
Syeda F Zaidi, Keval B Patel, Maria Gabriela Cerdas, Ekanta Timalsina, Abirami Rajendiran, Duaa Behbehani, Sara Mahmood Aljallawi, Gnaneswar Pendurthi, Saad Ullah, Mounia N Bellaha, Tsion Gebregiorgis, Zahra Nazir
Cureus.2025;[Epub] CrossRef - Comparative efficacy and safety of subcutaneous infliximab and vedolizumab in patients with Crohn’s disease and ulcerative colitis included in randomised controlled trials
Laurent Peyrin‐Biroulet, Perttu Arkkila, Alessandro Armuzzi, Silvio Danese, Marc Ferrante, Jordi Guardiola, Jørgen Jahnsen, Edouard Louis, Milan Lukáš, Walter Reinisch, Xavier Roblin, Philip J Smith, Taek Kwon, Jeeyoung Kim, Sangwook Yoon, Dong-Hyeon Kim
BMC Gastroenterology.2024;[Epub] CrossRef - A Review on Nanosystem-Based Delivery of Tofacitinib for Enhanced Treatment of Autoimmune Diseases and Inflammation
Thi-Thao-Linh Nguyen, Van-An Duong
BioNanoScience.2024; 14(2): 2048. CrossRef - Application of clinical decision support tools for predicting outcomes with vedolizumab therapy in patients with inflammatory bowel disease: A KASID multicentre study
Kyuwon Kim, Jae Jun Park, Hyuk Yoon, Jun Lee, Kyeong Ok Kim, Eun Sun Kim, Su Young Kim, Sun‐Jin Boo, Yunho Jung, Jun Hwan Yoo, Sung Wook Hwang, Sang Hyoung Park, Suk‐Kyun Yang, Byong Duk Ye
Alimentary Pharmacology & Therapeutics.2024; 59(12): 1539. CrossRef - The treatment of inflammatory bowel disease with monoclonal antibodies in Asia
Yu Chen, Guolin Zhang, Yuewen Yang, Shuangshuang Zhang, Haozheng Jiang, Kang Tian, Arenbaoligao, Dapeng Chen
Biomedicine & Pharmacotherapy.2023; 157: 114081. CrossRef - Real-World Evidence of Effectiveness and Safety of Vedolizumab for Inflammatory Bowel Disease in Taiwan: A Prospective Nationwide Registry (VIOLET) Study
Wei-Chen Lin, Wei-Chen Tai, Chung-Hsin Chang, Chia-Hung Tu, I-Che Feng, Ming-Jium Shieh, Chen-Shuan Chung, Hsu-Heng Yen, Jen-Wei Chou, Jau-Min Wong, Yu-Hwa Liu, Tien-Yu Huang, Chiao-Hsiung Chuang, Tzung-Jiun Tsai, Feng-Fan Chiang, Chien-Yu Lu, Wen-Hung Hs
Inflammatory Bowel Diseases.2023; 29(11): 1730. CrossRef - Factors associated with the prescription of probiotics in patients with inflammatory bowel disease: a cross-sectional study
Joo Kyung Kim, Jae Hee Cheon
Journal of Yeungnam Medical Science.2023; 40(1): 37. CrossRef - Concomitant ankylosing spondylitis can increase the risk of biologics or small molecule therapies to control inflammatory bowel disease
Yu Kyung Jun, Hyuk Yoon, Seong-Joon Koh, A Hyeon Kim, Kwang Woo Kim, Jun Won Park, Hyun Jung Lee, Hyoun Woo Kang, Jong Pil Im, Young Soo Park, Joo Sung Kim
Intestinal Research.2023; 21(2): 244. CrossRef - The Risk of Tuberculosis in Patients With Inflammatory Bowel Disease Treated With Vedolizumab or Ustekinumab in Korea
Myeong Geun Choi, Byong Duk Ye, Suk-Kyun Yang, Tae Sun Shim, Kyung-Wook Jo, Sang Hyoung Park
Journal of Korean Medical Science.2022;[Epub] CrossRef - Comparative efficacy and safety of infliximab and vedolizumab therapy in patients with inflammatory bowel disease: a systematic review and meta-analysis
Laurent Peyrin-Biroulet, Perttu Arkkila, Alessandro Armuzzi, Silvio Danese, Jordi Guardiola, Jørgen Jahnsen, Charles Lees, Edouard Louis, Milan Lukáš, Walter Reinisch, Xavier Roblin, Minyoung Jang, Han Geul Byun, Dong-Hyeon Kim, Sung Jeong Lee, Raja Atrey
BMC Gastroenterology.2022;[Epub] CrossRef - Personalized medicine in inflammatory bowel disease: Perspectives on Asia
Su Hyun Park, Sang Hyoung Park
Journal of Gastroenterology and Hepatology.2022; 37(8): 1434. CrossRef - Prevention of postoperative recurrence in Crohn’s disease: the never-ending story
Jung-Bin Park, Sang Hyoung Park
Intestinal Research.2022; 20(3): 279. CrossRef - Viral Hepatitis in Patients with Inflammatory Bowel Disease
Seung Hwan Shin, Sang Hyoung Park
The Korean Journal of Gastroenterology.2022; 80(2): 51. CrossRef - Management of inflammatory bowel disease beyond tumor necrosis factor inhibitors: novel biologics and small-molecule drugs
Soo-Young Na, You Sun Kim
The Korean Journal of Internal Medicine.2022; 37(5): 906. CrossRef - Natural history of inflammatory bowel disease: a comparison between the East and the West
Eun Mi Song, Suk-Kyun Yang
Intestinal Research.2022; 20(4): 418. CrossRef - Treatment of inflammatory bowel diseases: focusing on biologic agents and new therapies
Hyo Yeop Song, Geom Seog Seo
Journal of the Korean Medical Association.2021; 64(9): 605. CrossRef - Current status of inflammatory bowel diseases in Korea
Suk-Kyun Yang
Journal of the Korean Medical Association.2021; 64(9): 572. CrossRef
- A Comprehensive Review of the Role of Biologics and Small-Molecule Therapies in the Long-Term Management of Crohn’s Disease
- 11,279 View
- 177 Download
- 16 Web of Science
- 17 Crossref
- 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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Abstract
PDFSupplementary MaterialPubReaderePub
- 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- Efficacy and safety of vedolizumab in elderly and younger patients with moderate-to-severe ulcerative colitis: a retrospective real-world study in China
Hao Zhang, Xue-Li Ding, Yong-Hong Xu, Jun Wu, Yue-Yuan Wang, Shu-Xian Liu, Jing Yan, Hua Liu, Zi-Bin Tian, Ai-Ling Liu
BMC Gastroenterology.2025;[Epub] CrossRef - Application of clinical decision support tools for predicting outcomes with vedolizumab therapy in patients with inflammatory bowel disease: A KASID multicentre study
Kyuwon Kim, Jae Jun Park, Hyuk Yoon, Jun Lee, Kyeong Ok Kim, Eun Sun Kim, Su Young Kim, Sun‐Jin Boo, Yunho Jung, Jun Hwan Yoo, Sung Wook Hwang, Sang Hyoung Park, Suk‐Kyun Yang, Byong Duk Ye
Alimentary Pharmacology & Therapeutics.2024; 59(12): 1539. CrossRef - Clinical performance of fecal calprotectin, lactoferrin, and hemoglobin for evaluating the disease activity of IBD and detecting colorectal tumors
Tsukasa Yamakawa, Takakazu Miyake, Yoshihiro Yokoyama, Tomoe Kazama, Yuki Hayashi, Daisuke Hirayama, Shinji Yoshii, Hiro‐o Yamano, Satoshi Takahashi, Hiroshi Nakase
JGH Open.2024;[Epub] CrossRef - The role and prospect of tofacitinib in patients with ulcerative colitis
Jun Lee
Intestinal Research.2023; 21(1): 168. CrossRef - The treatment of inflammatory bowel disease with monoclonal antibodies in Asia
Yu Chen, Guolin Zhang, Yuewen Yang, Shuangshuang Zhang, Haozheng Jiang, Kang Tian, Arenbaoligao, Dapeng Chen
Biomedicine & Pharmacotherapy.2023; 157: 114081. CrossRef - Effectiveness and safety of vedolizumab for ulcerative colitis: a single-center retrospective real-world study in China
Kaituo Huang, Jing Liu, Wenhao Xia, Chuwen Tian, Lingya Yao, Qian Cao, Haotian Chen
Frontiers in Pharmacology.2023;[Epub] CrossRef - The effectiveness and safety of vedolizumab induction for moderate to severe ulcerative colitis for Asia patient: A real practice observational study
Chia-Jung Kuo, Puo-Hsien Le, Wei-Chen Tai, Keng-Liang Wu, Hsu-Heng Yen, Chih-Wei Yen, Shui-Yi Tung, Chen-Shuan Chung, Ming-Yao Su, Cheng-Tang Chiu
Journal of the Formosan Medical Association.2022; 121(9): 1689. CrossRef - Vedolizumab does not increase perioperative surgical complications in patients with inflammatory bowel disease, cohort study
Vitaliy Y. Poylin, Jose Cataneo Serrato, Jonathan Pastrana Del Valle, Joseph D. Feuerstein
Intestinal Research.2022; 20(1): 72. CrossRef - Comparative effectiveness of second-line biological therapies for ulcerative colitis and Crohn’s disease in patients with prior failure of anti-tumour necrosis factor treatment
Hye Kyung Hyun, Hyun-Soo Zhang, Jongwook Yu, Eun Ae Kang, Jihye Park, Soo Jung Park, Jae Jun Park, Tae Il Kim, Won Ho Kim, Jae Hee Cheon
BMC Gastroenterology.2022;[Epub] CrossRef - The Risk of Tuberculosis in Patients With Inflammatory Bowel Disease Treated With Vedolizumab or Ustekinumab in Korea
Myeong Geun Choi, Byong Duk Ye, Suk-Kyun Yang, Tae Sun Shim, Kyung-Wook Jo, Sang Hyoung Park
Journal of Korean Medical Science.2022;[Epub] CrossRef - Personalized medicine in inflammatory bowel disease: Perspectives on Asia
Su Hyun Park, Sang Hyoung Park
Journal of Gastroenterology and Hepatology.2022; 37(8): 1434. CrossRef - Oral beclomethasone dipropionate as an add-on therapy and response prediction in Korean patients with ulcerative colitis
Kyuwon Kim, Hee Seung Hong, Kyunghwan Oh, Jae Yong Lee, Seung Wook Hong, Jin Hwa Park, Sung Wook Hwang, Dong-Hoon Yang, Jeong-Sik Byeon, Seung-Jae Myung, Suk-Kyun Yang, Byong Duk Ye, Sang Hyoung Park
The Korean Journal of Internal Medicine.2022; 37(6): 1140. CrossRef - Viral Hepatitis in Patients with Inflammatory Bowel Disease
Seung Hwan Shin, Sang Hyoung Park
The Korean Journal of Gastroenterology.2022; 80(2): 51. CrossRef - Management of inflammatory bowel disease beyond tumor necrosis factor inhibitors: novel biologics and small-molecule drugs
Soo-Young Na, You Sun Kim
The Korean Journal of Internal Medicine.2022; 37(5): 906. CrossRef - Natural history of inflammatory bowel disease: a comparison between the East and the West
Eun Mi Song, Suk-Kyun Yang
Intestinal Research.2022; 20(4): 418. CrossRef - Treatment of inflammatory bowel diseases: focusing on biologic agents and new therapies
Hyo Yeop Song, Geom Seog Seo
Journal of the Korean Medical Association.2021; 64(9): 605. CrossRef - Combination of vedolizumab and immunomodulators in ulcerative colitis
P Pinton
Journal of Gastroenterology and Hepatology.2021; 36(12): 3556. CrossRef - Adalimumab, Infliximab, and Vedolizumab in Treatment of Ulcerative Colitis: A Long-Term Retrospective Study in a Tertiary Referral Center
Ann-Lorie Gagnon, William Beauchesne, Laurence Tessier, Charles David, Djamal Berbiche, Alexandre Lavoie, Alban Michaud-Herbst, Karine Tremblay
Crohn's & Colitis 360.2021;[Epub] CrossRef - Vedolizumab in Inflammatory Bowel Disease: West versus East
Prasanta Debnath, Pravin M. Rathi
Inflammatory Intestinal Diseases.2021; 6(1): 1. CrossRef
- Efficacy and safety of vedolizumab in elderly and younger patients with moderate-to-severe ulcerative colitis: a retrospective real-world study in China
- 9,531 View
- 259 Download
- 18 Web of Science
- 19 Crossref
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