KASID
Search
- Page Path
- HOME > Search
Original Articles
- Inflammatory Bowel Diseases
- Efficacy and safety of a new vedolizumab subcutaneous formulation in Japanese patients with moderately to severely active ulcerative colitis
- Taku Kobayashi, Hiroaki Ito, Toshifumi Ashida, Tadashi Yokoyama, Masakazu Nagahori, Tomoki Inaba, Mitsuhiro Shikamura, Takayoshi Yamaguchi, Tetsuharu Hori, Philippe Pinton, Mamoru Watanabe, Toshifumi Hibi
- Intest Res 2021;19(4):448-460. Published online August 18, 2020
- DOI: https://doi.org/10.5217/ir.2020.00026
-
Abstract
PDF
Supplementary Material
PubReader
ePub - 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) -
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 - Treatment discontinuation rates due to lack of efficacy through 1 year of maintenance treatment with vedolizumab or subcutaneous infliximab in patients with inflammatory bowel disease: a systematic literature review and meta-analysis
Marc Ferrante, Laurent Peyrin-Biroulet, Perttu Arkkila, Alessandro Armuzzi, Jean-Frédéric Colombel, Silvio Danese, Roberto Faggiani, Jordi Guardiola, Stephen B. Hanauer, Jorgen Jahnsen, Walter Reinisch, Xavier Roblin, Philip J. Smith, Taek Sang Kwon, Seun
Therapeutic Advances in Gastroenterology.2025;[Epub] 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
- Valoración de la transición de vedolizumab intravenoso a subcutáneo en pacientes con enfermedad inflamatoria intestinal
- 10,910 View
- 500 Download
- 12 Web of Science
- 13 Crossref
- Inflammatory Bowel Diseases
- Population pharmacokinetics of vedolizumab in Asian and non-Asian patients with ulcerative colitis and Crohn’s disease
- Hiroyuki Okamoto, Nathanael L. Dirks, Maria Rosario, Tetsuharu Hori, Toshifumi Hibi
- Intest Res 2021;19(1):95-105. Published online July 10, 2020
- DOI: https://doi.org/10.5217/ir.2019.09167
-
Abstract
PDFSupplementary MaterialPubReaderePub
- Background/Aims
Vedolizumab is indicated for moderately-to-severely active ulcerative colitis (UC) and Crohn’s disease (CD). Because multiple factors may result in different pharmacokinetics and clinical efficacies, understanding determinants of vedolizumab clearance may enhance dose and treatment strategies. The aim was to characterize vedolizumab pharmacokinetics in Asian and non-Asian UC and CD patients.
Methods
Population pharmacokinetic analysis for repeated measures, using data from 5 studies, was conducted using nonlinear mixed-effects modeling. A Bayesian estimation approach in NONMEM 7.3 was utilized to leverage the predominantly sparse data available for this analysis with results from a prior population pharmacokinetic analysis of vedolizumab.
Results
Vedolizumab pharmacokinetics were described by a 2-compartment model with parallel linear and nonlinear elimination. Using reference covariate values, linear elimination half life of vedolizumab was 24.7 days for anti-vedolizumab antibody (AVA)-negative patients and 18.1 days for AVA-positive patients; linear clearance (CLL) was 0.165 L/day for AVA-negative patients and 0.246 L/day for AVA-positive patients; central (Vc) and peripheral compartment volumes of distribution were 3.16 L and 1.84 L, respectively. Interindividual variabilities (percent coefficient of variation) were 30.8% for CLL and 19% for Vc; interoccasion variability on CLL was 20.3%; residual variance was 17.8%. For albumin, body weight and AVA, only extreme values were identified as potentially clinically important predictors of CLL. The effect of race (Asian/non-Asian) and diagnosis (UC/CD) on CLL was negligible and likely not of clinical importance.
Conclusions
Pharmacokinetic parameters were similar in Asian and non-Asian patients with moderately-to-severely active UC and CD. This analysis supports use of vedolizumab flat-fixed dosing in these patients. (Clinicaltrials.gov Identifiers: NCT00783718 (GEMINI 1); NCT00783692 (GEMINI 2). CCT 101; NCT02039505 and CCT-001; NCT02038920) -
Citations
Citations to this article as recorded by- Vedolizumab in inflammatory bowel disease: pharmacokinetics and the role of immunomodulator co-therapy
Aviv Pudipeddi, Thanaboon Chaemsupaphan, Arteen Arzivian, Yong-Sul Kim, Sudarshan Paramsothy, Viraj Kariyawasam, Rupert W. Leong
Therapeutic Advances in Gastroenterology.2026;[Epub] CrossRef - Association of early vedolizumab trough levels with clinical, biochemical, endoscopic response and drug optimization during maintenance therapy in patients with inflammatory bowel diseases
Kyuwon Kim, A-Ran Yoon, Kyunghwan Oh, Hee Seung Hong, Jae Yong Lee, Seung Wook Hong, Sung Wook Hwang, Sang Hyoung Park, Dong-Hoon Yang, Jeong-Sik Byeon, Seung-Jae Myung, Byong Duk Ye
Scientific Reports.2026;[Epub] CrossRef - Placebo Rates in Crohn’s Disease Randomized Clinical Trials: An Individual Patient Data Meta-Analysis
Virginia Solitano, Malcolm Hogan, Siddharth Singh, Silvio Danese, Laurent Peyrin-Biroulet, Guangyong Zou, Yuhong Yuan, Bruce E. Sands, Brian G. Feagan, Parambir S. Dulai, Neeraj Narula, Christopher Ma, Vipul Jairath
Gastroenterology.2025; 168(2): 344. CrossRef - Model-informed precision dosing in inflammatory bowel diseases
Arno R. Bourgonje, Marla C. Dubinsky, Ron J. Keizer, Erwin Dreesen, Paola Mian
Trends in Pharmacological Sciences.2025; 46(1): 9. CrossRef - Does one model fit all mAbs? An evaluation of population pharmacokinetic models
Stefan P. H. van den Berg, Philine E. A. Adolfsen, Thomas P.C. Dorlo, Theo Rispens
mAbs.2025;[Epub] CrossRef - Long-Term Outcomes and Prognostic Factors for Vedolizumab-Treated Japanese Patients with Ulcerative Colitis
Shinya Fukushima, Takehiko Katsurada, Takahiro Ito, Atsuo Maemoto, Fumika Orii, Toshifumi Ashida, Masanao Nasuno, Hiroki Tanaka, Katsuyoshi Ando, Mikihiro Fujiya, Yoshihiro Yokoyama, Satoshi Motoya, Hiroshi Nakase
Inflammatory Intestinal Diseases.2025; 11(1): 1. CrossRef - Monitorización terapéutica de los fármacos biológicos en la enfermedad inflamatoria intestinal. Documento de Posicionamiento del Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU)
Francisco Rodríguez-Moranta, Federico Argüelles-Arias, Joaquín Hinojosa del Val, Marisa Iborra Colomino, M. Dolores Martín-Arranz, Luis Menchén Viso, Fernando Muñoz Núñez, Elena Ricart Gómez, José Germán Sánchez-Hernández, Teresa Valdés-Delgado, Jordi Gua
Gastroenterología y Hepatología.2024; 47(5): 522. 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 - Therapeutic drug monitoring in inflammatory bowel diseases. Position statement of the Spanish Working Group on Crohn’s Disease and Ulcerative Colitis
Francisco Rodríguez-Moranta, Federico Argüelles-Arias, Joaquín Hinojosa del Val, Marisa Iborra Colomino, M. Dolores Martín-Arranz, Luis Menchén Viso, Fernando Muñoz Núñez, Elena Ricart Gómez, José Germán Sánchez-Hernández, Teresa Valdés-Delgado, Jordi Gua
Gastroenterología y Hepatología (English Edition).2024; 47(5): 522. CrossRef - Machine Learning for Predicting Biologic Agent Efficacy in Ulcerative Colitis: An Analysis for Generalizability and Combination with Computational Models
Philippe Pinton
Diagnostics.2024; 14(13): 1324. CrossRef - Vedolizumab Clearance as a Surrogate Marker for Remission in Inflammatory Bowel Disease Patients: Insights from Real-World Pharmacokinetics
Srđan Marković, Đorđe Kralj, Petar Svorcan, Tamara Knežević Ivanovski, Olga Odanović, Sanja Obradović, Ana Homšek, Marija Jovanović, Rada Savić, Katarina M. Vučićević
Pharmaceutics.2024; 16(12): 1629. CrossRef - Review and External Evaluation of Population Pharmacokinetic Models for Vedolizumab in Patients with Inflammatory Bowel Disease: Assessing Predictive Performance and Clinical Applicability
Marija Jovanović, Ana Homšek, Srđan Marković, Đorđe Kralj, Petar Svorcan, Tamara Knežević Ivanovski, Olga Odanović, Katarina Vučićević
Biomedicines.2024; 13(1): 43. CrossRef - Real world population pharmacokinetic study in children and young adults with inflammatory bowel disease discovers novel blood and stool microbial predictors of vedolizumab clearance
Ruben J. Colman, Tomoyuki Mizuno, Keizo Fukushima, David B. Haslam, Jeffrey S. Hyams, Brendan Boyle, Joshua D. Noe, Geert R. D'Haens, Johan Van Limbergen, Kelly Chun, Jane Yang, Lee A. Denson, Nicholas J. Ollberding, Alexander A. Vinks, Phillip Minar
Alimentary Pharmacology & Therapeutics.2023; 57(5): 524. CrossRef - Drug Clearance in Patients with Inflammatory Bowel Disease Treated with Biologics
Tina Deyhim, Adam S. Cheifetz, Konstantinos Papamichael
Journal of Clinical Medicine.2023; 12(22): 7132. 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 - 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 - Population Pharmacokinetics and Exposure–Response Analyses of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease
Omoniyi J. Adedokun, Zhenhua Xu, Christopher Gasink, Ken Kowalski, William J. Sandborn, Brian Feagan
Clinical Therapeutics.2022; 44(10): 1336. 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 - Evaluating and Improving Neonatal Gentamicin Pharmacokinetic Models Using Aggregated Routine Clinical Care Data
Dominic M. H. Tong, Jasmine H. Hughes, Ron J. Keizer
Pharmaceutics.2022; 14(10): 2089. 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 - Personalized Medicine of Monoclonal Antibodies in Inflammatory Bowel Disease: Pharmacogenetics, Therapeutic Drug Monitoring, and Beyond
Antonello Di Paolo, Giacomo Luci
Frontiers in Pharmacology.2021;[Epub] CrossRef - Vedolizumab Immunogenicity With Long‐Term or Interrupted Treatment of Patients With Inflammatory Bowel Disease
Timothy Wyant, Lili Yang, Richard A. Lirio, Maria Rosario
The Journal of Clinical Pharmacology.2021; 61(9): 1174. CrossRef - Combination of vedolizumab and immunomodulators in ulcerative colitis
P Pinton
Journal of Gastroenterology and Hepatology.2021; 36(12): 3556. CrossRef - Vedolizumab in Inflammatory Bowel Disease: West versus East
Prasanta Debnath, Pravin M. Rathi
Inflammatory Intestinal Diseases.2021; 6(1): 1. CrossRef
- Vedolizumab in inflammatory bowel disease: pharmacokinetics and the role of immunomodulator co-therapy
- 9,816 View
- 296 Download
- 21 Web of Science
- 24 Crossref
First
Prev
