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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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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 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
- 9,863 View
- 261 Download
- 18 Web of Science
- 19 Crossref
- Inflammatory bowel diseases
- Tacrolimus for ulcerative colitis in children: a multicenter survey in Japan
- Tadahiro Yanagi, Kosuke Ushijima, Hidenobu Koga, Takeshi Tomomasa, Hitoshi Tajiri, Reiko Kunisaki, Takashi Isihige, Hiroyuki Yamada, Katsuhiro Arai, Atsushi Yoden, Tomoki Aomatsu, Satoru Nagata, Keiichi Uchida, Yoshikazu Ohtsuka, Toshiaki Shimizu
- Intest Res 2019;17(4):476-485. Published online August 31, 2019
- DOI: https://doi.org/10.5217/ir.2019.00027
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Abstract
PDFSupplementary MaterialPubReaderePub
- Background/Aims
Tacrolimus is effective for refractory ulcerative colitis in adults, while data for children is sparse. We aimed to evaluate the effectiveness and safety of tacrolimus for induction and maintenance therapy in Japanese children with ulcerative colitis.
Methods
We retrospectively reviewed the multicenter survey data of 67 patients with ulcerative colitis aged < 17 years treated with tacrolimus between 2000 and 2012. Patients’ characteristics, disease activity, Pediatric Ulcerative Colitis Activity Index (PUCAI) score, initial oral tacrolimus dose, short-term (2-week) and long-term (1-year) outcomes, steroid-sparing effects, and adverse events were evaluated. Clinical remission was defined as a PUCAI score < 10; treatment response was defined as a PUCAI score reduction of ≥ 20 points compared with baseline.
Results
Patients included 35 boys and 32 girls (median [interquartile range] at admission: 13 [11–15] years). Thirty-nine patients were steroid-dependent and 26 were steroidrefractory; 20 had severe colitis and 43 had moderate colitis. The initial tacrolimus dose was 0.09 mg/kg/day (range, 0.05–0.12 mg/kg/day). The short-term clinical remission rate was 47.8%, and the clinical response rate was 37.3%. The mean prednisolone dose was reduced from 19.2 mg/day at tacrolimus initiation to 5.7 mg/day at week 8 (P< 0.001). The adverse event rate was 53.7%; 6 patients required discontinuation of tacrolimus therapy.
Conclusions
Tacrolimus was a safe and effective second-line induction therapy for steroid-dependent and steroid-refractory ulcerative colitis in Japanese children. -
Citations
Citations to this article as recorded by- Management of paediatric ulcerative colitis, part 2: Acute severe colitis—An updated evidence‐based consensus guideline from the European Society of Paediatric Gastroenterology, Hepatology and Nutrition and the European Crohn's and Colitis Organization
Amit Assa, Marina Aloi, Stephanie Van Biervliet, Jiri Bronsky, Javier M. di Carpi, Marco Gasparetto, Laura Gianolio, Hannah Gordon, Iva Hojsak, Alexandra S. Hudson, Séamus Hussey, Johan Van Limbergen, Erasmo Miele, Lorenzo Norsa, Ola Olén, Gianluca Pellin
Journal of Pediatric Gastroenterology and Nutrition.2025; 81(3): 816. CrossRef - Real‐world effectiveness of ustekinumab and vedolizumab in TNF‐exposed pediatric patients with ulcerative colitis
Perseus V. Patel, Amy Zhang, Balu Bhasuran, Vignesh G. Ravindranath, Melvin B. Heyman, Sofia G. Verstraete, Atul J. Butte, Michael J. Rosen, Vivek A. Rudrapatna
Journal of Pediatric Gastroenterology and Nutrition.2024; 78(5): 1126. CrossRef - CXCR2 Activated JAK3/STAT3 Signaling Pathway Exacerbating Hepatotoxicity Associated with Tacrolimus
Xiao Chen, Ke Hu, Yue Zhang, Su-Mei He, Dong-Dong Wang
Drug Design, Development and Therapy.2024; Volume 18: 6331. CrossRef - Medical management of pediatric inflammatory bowel disease in the Asia‐Pacific region: A position paper by the Asian Pan‐Pacific Society for Pediatric Gastroenterology, Hepatology, and Nutrition (APPSPGHAN) PIBD Working Group
Way Seah Lee, Katsuhiro Arai, George Alex, Suporn Treepongkaruna, Kyung Mo Kim, Chee Liang Choong, Karen S. C. Mercado, Andy Darma, Anshu Srivastava, Marion M. Aw
Journal of Gastroenterology and Hepatology.2023; 38(4): 523. CrossRef - Clinical outcome of ulcerative colitis with severe onset in children: a multicenter prospective cohort study
Ryusuke Nambu, Katsuhiro Arai, Takahiro Kudo, Takatsugu Murakoshi, Reiko Kunisaki, Tatsuki Mizuochi, Sawako Kato, Hideki Kumagai, Mikihiro Inoue, Takashi Ishige, Takeshi Saito, Atsuko Noguchi, Toshifumi Yodoshi, Shin-Ichiro Hagiwara, Naomi Iwata, Shigeo N
Journal of Gastroenterology.2023; 58(5): 472. CrossRef - Oral Tacrolimus in Steroid Refractory and Dependent Pediatric Ulcerative Colitis—A Systematic Review and Meta‐Analysis
Rishi Bolia, Akhil Goel, Pooja Semwal, Anshu Srivastava
Journal of Pediatric Gastroenterology and Nutrition.2023; 77(2): 228. CrossRef - Tacrolimus as an alternative treatment for patients with juvenile idiopathic arthritis
Susumu Yamazaki, Masaki Shimizu, Yuko Akutsu, Asami Shimbo, Masaaki Mori
Modern Rheumatology.2022; 32(4): 783. CrossRef - 3D printed tacrolimus suppositories for the treatment of ulcerative colitis
Iria Seoane-Viaño, Jun Jie Ong, Asteria Luzardo-Álvarez, Miguel González-Barcia, Abdul W. Basit, Francisco J. Otero-Espinar, Alvaro Goyanes
Asian Journal of Pharmaceutical Sciences.2021; 16(1): 110. CrossRef - Does cytomegalovirus load predict the outcome of acute severe ulcerative colitis?
You Sun Kim
Intestinal Research.2021; 19(4): 357. CrossRef - Tacrolimus in pediatric ulcerative colitis: does it have a role?
Seung Kim
Intestinal Research.2019; 17(4): 441. CrossRef
- Management of paediatric ulcerative colitis, part 2: Acute severe colitis—An updated evidence‐based consensus guideline from the European Society of Paediatric Gastroenterology, Hepatology and Nutrition and the European Crohn's and Colitis Organization
- 17,158 View
- 248 Download
- 13 Web of Science
- 10 Crossref
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