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Expert Review of Clinical Pharmacology Volume 17, 2024 - Issue 4
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Original Research

Exposure–efficacy relationship of vedolizumab subcutaneous and intravenous formulations in Crohn’s disease and ulcerative colitis

Geert D’Haensa Department of Gastroenterology, Amsterdam University Medical Centers, Amsterdam, NetherlandsCorrespondence[email protected]
View further author information
,
Maria Rosariob Takeda Development Center Americas Inc, Cambridge, MA, USAView further author information
,
Daniel Polhamusc Metrum Research Group, Tariffville, CT, USAView further author information
,
Nathanael L. Dirksc Metrum Research Group, Tariffville, CT, USAView further author information
,
Chunlin Chenb Takeda Development Center Americas Inc, Cambridge, MA, USAView further author information
,
Krisztina Kisfalvib Takeda Development Center Americas Inc, Cambridge, MA, USAView further author information
,
Christian Agbotonb Takeda Development Center Americas Inc, Cambridge, MA, USAView further author information
,
Séverine Vermeired Translational Research in GastroIntestinal Disorders, University Hospitals Leuven, Leuven, BelgiumView further author information
,
Brian G. Feagane Robarts Clinical Trials, Western University, London, Ontario, CanadaView further author information
&
William J. Sandbornf Division of Gastroenterology, University of California San Diego, La Jolla, CA, USAView further author information
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Pages 403-412 | Received 02 Oct 2023, Accepted 09 Feb 2024, Published online: 05 Mar 2024

References

  • Takeda Pharmaceuticals America Inc. ENTYVIO highlights of prescribing information. Deerfied, IL: Takeda Pharmaceuticals America Inc.; 2020.
  • Takeda Pharma A/S. Entyvio summary of product characteristics. Copenhagen, Denmark: Takeda Pharma A/S; 2020.
  • Feagan BG, Rutgeerts P, Sands BE, et al. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013;369(8):699–710. doi: 10.1056/NEJMoa1215734
  • Sandborn WJ, Baert F, Danese S, et al. Efficacy and safety of vedolizumab subcutaneous formulation in a randomized trial of patients with ulcerative colitis. Gastroenterology. 2020;158(3):562–572.e12. doi: 10.1053/j.gastro.2019.08.027
  • Sandborn WJ, Feagan BG, Rutgeerts P, et al. Vedolizumab as induction and maintenance therapy for Crohn’s disease. N Engl J Med. 2013;369(8):711–721. doi: 10.1056/NEJMoa1215739
  • Vermeire S, D’Haens G, Baert F, et al. Efficacy and safety of subcutaneous vedolizumab in patients with moderately to severely active Crohn’s disease: results from the VISIBLE 2 randomised trial. J Crohns Colitis. 2021;16(1):27–38. doi: 10.1093/ecco-jcc/jjab133
  • Ward MG, Sparrow MP, Roblin X. Therapeutic drug monitoring of vedolizumab in inflammatory bowel disease: current data and future directions. Therap Adv Gastroenterol. 2018;11:1756284818772786. doi: 10.1177/1756284818772786
  • Rosario M, French JL, Dirks NL, et al. Exposure-efficacy relationships for vedolizumab induction therapy in patients with ulcerative colitis or Crohn’s disease. J Crohns Colitis. 2017;11(8):921–929. doi: 10.1093/ecco-jcc/jjx021
  • Rosario M, Dirks NL, Gastonguay MR, et al. Population pharmacokinetics-pharmacodynamics of vedolizumab in patients with ulcerative colitis and Crohn’s disease. Aliment Pharmacol Ther. 2015;42(2):188–202. doi: 10.1111/apt.13243
  • Rosario M, Polhamus D, Chen C, et al. P490 A vedolizumab population pharmacokinetic model including intravenous and subcutaneous formulations for patients with ulcerative colitis. J Crohns Colitis. 2019;13(Supplement 1):S357. doi: 10.1093/ecco-jcc/jjy222.614
  • Casteele NV, Sandborn WJ, Feagan BG, et al. S0652 Real world exposure-response relationship of vedolizumab in inflammatory bowel disease: a pooled multicenter observational cohort analysis of clinical and modeled pharmacological data. Am J Gastroenterol. 2020;115(Supplement):S326–S327. doi: 10.14309/01.ajg.0000704656.65634.c9
  • Osterman MT, Rosario M, Lasch K, et al. Vedolizumab exposure levels and clinical outcomes in ulcerative colitis: determining the potential for dose optimisation. Aliment Pharmacol Ther. 2019;49(4):408–418. doi: 10.1111/apt.15113
  • Gils A, Dreesen E, Compernolle G, et al. OP020 recent anti-TNF exposure predicts lower vedolizumab trough concentrations in patients with Crohn’s disease. J Crohns Colitis. 2017;11(Supplement 1):S12. doi: 10.1093/ecco-jcc/jjx002.019
  • Bancil A, Stevens M, Kok K. P590 which biomarkers have an effect on therapeutic vedolizumab drug levels? A retrospective analysis from a London tertiary centre. J Crohns Colitis. 2021;15(Supplement 1):S540. doi: 10.1093/ecco-jcc/jjab076.711
  • Biancheri P, Di Sabatino A, Rovedatti L, et al. Effect of tumor necrosis factor-α blockade on mucosal addressin cell-adhesion molecule-1 in Crohn’s disease. Inflamm Bowel Dis. 2013;19(2):259–264. doi: 10.1097/MIB.0b013e31828100a4
  • Sandborn W, Wolf D, D’Haens G, et al. P510 dose escalation of subcutaneous vedolizumab in patients with ulcerative colitis: a post hoc analysis of the VISIBLE trial data. J Crohns Colitis. 2020;14(Supplement 1):S442–S443. doi: 10.1093/ecco-jcc/jjz203.639
  • Wolf D, Danese S, Matthews B, et al. 634 transitioning from vedolizumab IV to vedolizumab SC in patients with ulcerative colitis: results from the VISIBLE program. Am J Gastroenterol. 2019;114(1):S369–S370. doi: 10.14309/01.ajg.0000592072.55730.89

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