KASID
Search
- Page Path
- HOME > Search
Original Article
- 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
PDF
Supplementary Material
PubReader
ePub - 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
