- Inflammatory Bowel Diseases
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Efficacy and safety of a new vedolizumab subcutaneous formulation in Japanese patients with moderately to severely active ulcerative colitis
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Taku Kobayashi, Hiroaki Ito, Toshifumi Ashida, Tadashi Yokoyama, Masakazu Nagahori, Tomoki Inaba, Mitsuhiro Shikamura, Takayoshi Yamaguchi, Tetsuharu Hori, Philippe Pinton, Mamoru Watanabe, Toshifumi Hibi
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Intest Res 2021;19(4):448-460. Published online August 18, 2020
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DOI: https://doi.org/10.5217/ir.2020.00026
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 Abstract
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- Background/Aims
A subgroup analysis was conducted in Japanese patients with moderate to severe ulcerative colitis (UC) enrolled in the phase 3 VISIBLE 1 study, which evaluated the safety and efficacy of a new vedolizumab subcutaneous (SC) formulation.
Methods
Eligible patients received open-label infusions of vedolizumab 300 mg intravenous (IV) at weeks 0 and 2 in the induction phase. Patients with clinical response by complete Mayo score at week 6 entered the double-blind maintenance phase and were randomized to vedolizumab 108 mg SC every 2 weeks, placebo, or vedolizumab 300 mg IV every 8 weeks. The primary endpoint was clinical remission (complete Mayo score ≤ 2 points; no individual subscore > 1 point) at week 52.
Results
Of 49 patients who entered the induction phase, 22 out of 49 patients (45%) had clinical response at week 6 and were randomized to vedolizumab 108 mg SC (n = 10), placebo (n = 10), or vedolizumab 300 mg IV (n = 2). At week 52, 4 out of 10 patients (40%) who received vedolizumab SC had clinical remission versus 2 out of 10 patients (20%) who received placebo (difference: 20% [95% confidence interval, –27.9 to 61.8]). Two patients (2/10, 20%) who received vedolizumab SC experienced an injection-site reaction versus none who received placebo.
Conclusions
Our results indicate that the efficacy of vedolizumab SC in a subgroup of Japanese patients with UC are similar with those in the overall VISIBLE 1 study population, and with those established with vedolizumab IV. The safety and tolerability of vedolizumab SC were generally similar to that established for vedolizumab IV. (ClinicalTrials.gov ID NCT02611830; EudraCT 2015-000480-14)
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Citations
Citations to this article as recorded by  - Valoración de la transición de vedolizumab intravenoso a subcutáneo en pacientes con enfermedad inflamatoria intestinal
Carmen Amor Costa, Cristina Suárez Ferrer, Laura García Ramírez, Eduardo Martín-Arranz, Joaquín Poza Cordón, José Luis Rueda García, María Sánchez Azofra, Irene González Diaz, Clara Amiama Roig, María Dolores Martín-Arranz
Gastroenterología y Hepatología.2025; 48(3): 502201. CrossRef - Evaluation of the transition from intravenous to subcutaneous vedolizumab in patients with inflammatory bowel disease
Carmen Amor Costa, Cristina Suárez Ferrer, Laura García Ramírez, Eduardo Martín-Arranz, Joaquín Poza Cordón, José Luis Rueda García, María Sánchez Azofra, Irene González Diaz, Clara Amiama Roig, María Dolores Martín-Arranz
Gastroenterología y Hepatología (English Edition).2025; 48(3): 502201. CrossRef - Vedolizumab subcutaneous formulation maintenance therapy for patients with IBD: a systematic review and meta-analysis
Qiong Hu, Xing-zhou Tang, Fang Liu, De-wu Liu, Bo Cao
Therapeutic Advances in Gastroenterology.2023;[Epub] CrossRef - Network meta-analysis on efficacy and safety of different biologics for ulcerative colitis
Xinqiao Chu, Yaning Biao, Chengjiang Liu, Yixin Zhang, Chenxu Liu, Ji-zheng Ma, Yufeng Guo, Yaru Gu
BMC Gastroenterology.2023;[Epub] CrossRef - Vedolizumab as the first line of biologic therapy for ulcerative colitis and Crohn's disease – a systematic review with meta-analysis
Mohamed Attauabi, Gorm Roager Madsen, Flemming Bendtsen, Jakob Benedict Seidelin, Johan Burisch
Digestive and Liver Disease.2022; 54(9): 1168. CrossRef - AJM300 (carotegrast methyl), an oral antagonist of α4-integrin, as induction therapy for patients with moderately active ulcerative colitis: a multicentre, randomised, double-blind, placebo-controlled, phase 3 study
Katsuyoshi Matsuoka, Mamoru Watanabe, Toshihide Ohmori, Koichi Nakajima, Tetsuya Ishida, Yoh Ishiguro, Kazunari Kanke, Kiyonori Kobayashi, Fumihito Hirai, Kenji Watanabe, Hidehiro Mizusawa, Shuji Kishida, Yoshiharu Miura, Akira Ohta, Toshifumi Kajioka, To
The Lancet Gastroenterology & Hepatology.2022; 7(7): 648. CrossRef - Microbial changes in stool, saliva, serum, and urine before and after anti-TNF-α therapy in patients with inflammatory bowel diseases
Yong Eun Park, Hye Su Moon, Dongeun Yong, Hochan Seo, Jinho Yang, Tae-Seop Shin, Yoon-Keun Kim, Jin Ran Kim, Yoo Na Lee, Young-Ho Kim, Joo Sung Kim, Jae Hee Cheon
Scientific Reports.2022;[Epub] CrossRef - Effectiveness and Safety of Golimumab in Patients with Ulcerative Colitis: A Multicenter, Prospective, Postmarketing Surveillance Study
Jongwook Yu, Soo Jung Park, Hyung Wook Kim, Yun Jeong Lim, Jihye Park, Jae Myung Cha, Byong Duk Ye, Tae Oh Kim, Hyun-Soo Kim, Hyun Seok Lee, Su Young Jung, Youngdoe Kim, Chang Hwan Choi
Gut and Liver.2022; 16(5): 764. CrossRef - Inflammatory Bowel Disease Patients’ Acceptance for Switching from Intravenous Infliximab or Vedolizumab to Subcutaneous Formulation: The Nancy Experience
Clotilde Remy, Bénédicte Caron, Celia Gouynou, Vincent Haghnejad, Elodie Jeanbert, Patrick Netter, Silvio Danese, Laurent Peyrin-Biroulet
Journal of Clinical Medicine.2022; 11(24): 7296. CrossRef - Targeting Immune Cell Trafficking – Insights From Research Models and Implications for Future IBD Therapy
Maximilian Wiendl, Emily Becker, Tanja M. Müller, Caroline J. Voskens, Markus F. Neurath, Sebastian Zundler
Frontiers in Immunology.2021;[Epub] CrossRef - Subcutaneous vedolizumab in moderately to severely active ulcerative colitis or Crohn’s disease: a profile of its use
Sheridan M. Hoy
Drugs & Therapy Perspectives.2021; 37(12): 563. CrossRef - AJM300 (Carotegrast Methyl), an Oral Antagonist of α4-Integrin, as Induction Therapy for Patients with Moderately Active Ulcerative Colitis: A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase 3 Study
Katsuyoshi Matsuoka, Mamoru Watanabe, Toshihide Ohmori, Kouichi Nakajima, Tetsuya Ishida, Yoh Ishiguro, Kazunari Kanke, Kiyonori Kobayashi, Fumihito Hirai, Kenji Watanabe, Hidehiro Mizusawa, Shuji Kishida, Yoshiharu Miura, Akira Ohta, Toshifumi Kajioka, T
SSRN Electronic Journal .2021;[Epub] CrossRef
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- Inflammatory Bowel Diseases
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Efficacy of biologic therapies for biologic-naïve Japanese patients with moderately to severely active ulcerative colitis: a network meta-analysis
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Toshifumi Hibi, Isao Kamae, Philippe Pinton, Lyann Ursos, Ryuichi Iwakiri, Greg Hather, Haridarshan Patel
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Intest Res 2021;19(1):53-61. Published online April 22, 2020
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DOI: https://doi.org/10.5217/ir.2019.09146
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Abstract
PDFSupplementary MaterialPubReaderePub
- Background/Aims
Several biologic therapies are approved in Japan to treat moderately to severely active ulcerative colitis (UC), but there are no published comparative efficacy studies in a Japanese population. We compared the efficacy of biologics approved in Japan (adalimumab, infliximab, golimumab, and vedolizumab) for treating biologic-naïve patients with UC at their approved doses.
Methods
A targeted literature review identified 4 randomized controlled trials of biologics for UC in biologicnaïve Japanese patients. For each study, efficacy outcome data from induction (weeks 6–12) and maintenance (weeks 30–60) treatment were extracted for analysis. Treatment effects on clinical response, clinical remission, and mucosal healing relative to the average placebo results across all trials were estimated using network meta-analyses followed by transformation into probabilities and odds ratios (OR).
Results
At the end of induction, the likelihood of clinical response and clinical remission was highest with infliximab (OR: 2.12 and 2.35, respectively) and vedolizumab (OR: 2.10 and 2.32, respectively); the likelihood of mucosal healing was highest with infliximab (OR: 2.24) and adalimumab (OR: 1.86). During maintenance, the likelihood of clinical response and clinical remission was highest with vedolizumab (OR: 6.44 and 4.68, respectively) and golimumab (OR: 5.13 and 3.84, respectively); the likelihood of mucosal healing was significantly higher than placebo with all biologics.
Conclusions
All active treatments were efficacious compared with placebo. Infliximab and vedolizumab had the highest odds for induction of clinical response, remission, and mucosal healing. Golimumab and vedolizumab had numerically higher odds of achieving efficacy outcomes in the maintenance phase.
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Citations
Citations to this article as recorded by - Effectiveness of adalimumab in severe ulcerative colitis: A systematic review and a meta‐analysis
Saleh Azadbakht, Masomeh Seighali, Salehe Azadbakht, Morteza Azadbakht
Health Science Reports.2024;[Epub] CrossRef - Efficacy and Safety of Etrasimod in Patients with Ulcerative Colitis in Japan: Data from the Phase 3 ELEVATE UC 12 and ELEVATE UC 40 JAPAN Trials
Ken Takeuchi, Tadakazu Hisamatsu, Hiroshi Nakase, Katsuyoshi Matsuoka, Michael Keating, Hirotoshi Yuasa, Motoki Oe, Shoko Arai, Rafal Mazur, Toshifumi Hibi
Digestion.2024; : 1. CrossRef - Selection of anti-cytokine biologics by pretreatment levels of serum leucine-rich alpha-2 glycoprotein in patients with inflammatory bowel disease
Takahiro Amano, Takeo Yoshihara, Shinichiro Shinzaki, Yuko Sakakibara, Takuya Yamada, Naoto Osugi, Satoshi Hiyama, Yoko Murayama, Koji Nagaike, Hideharu Ogiyama, Toshio Yamaguchi, Yuki Arimoto, Ichizo Kobayashi, Shoichiro Kawai, Satoshi Egawa, Takashi Kiz
Scientific Reports.2024;[Epub] CrossRef - The role and prospect of tofacitinib in patients with ulcerative colitis
Jun Lee
Intestinal Research.2023; 21(1): 168. CrossRef - Infectious complications in patients with inflammatory bowel disease in Asia: the results of a multinational web-based survey in the 8th Asian Organization for Crohn’s and Colitis meeting
Yu Kyung Jun, Seong-Joon Koh, Dae Seong Myung, Sang Hyoung Park, Choon Jin Ooi, Ajit Sood, Jong Pil Im
Intestinal Research.2023; 21(3): 353. CrossRef - Diagnosis, management, and prevention of infectious complications in inflammatory bowel disease: variations among Asian countries
Ji Eun Baek, Sung Wook Hwang
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Soo-Young Na
The Korean Journal of Medicine.2023; 98(5): 223. CrossRef - Biomarker dynamics during infliximab salvage for acute severe ulcerative colitis: C-reactive protein (CRP)-lymphocyte ratio and CRP-albumin ratio are useful in predicting colectomy
Danny Con, Bridgette Andrew, Steven Nicolaides, Daniel R van Langenberg, Abhinav Vasudevan
Intestinal Research.2022; 20(1): 101. CrossRef - How to Choose the Biologic Therapy in a Bio-naïve Patient with Inflammatory Bowel Disease
Viviana Laredo, Carla J. Gargallo-Puyuelo, Fernando Gomollón
Journal of Clinical Medicine.2022; 11(3): 829. CrossRef - Impact of Immunosuppressive Therapy on the Performance of Latent Tuberculosis Screening Tests in Patients with Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis
Chan Hyuk Park, Jung Ho Park, Yoon Suk Jung
Journal of Personalized Medicine.2022; 12(3): 507. CrossRef - The Prognostic Value of Residual Nonrectal Inflammation in Ulcerative Colitis
Eun Ae Kang
Gut and Liver.2022; 16(3): 487. 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
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Jongwook Yu, Soo Jung Park, Hyung Wook Kim, Yun Jeong Lim, Jihye Park, Jae Myung Cha, Byong Duk Ye, Tae Oh Kim, Hyun-Soo Kim, Hyun Seok Lee, Su Young Jung, Youngdoe Kim, Chang Hwan Choi
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The Korean Journal of Gastroenterology.2022; 80(2): 72. CrossRef - Improvement in Medication Adherence after Pharmacist Intervention Is Associated with Favorable Clinical Outcomes in Patients with Ulcerative Colitis
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