BACKGROUND: There has been limited evaluation of the association between vedolizumab trough concentration and clinical outcomes in patients with inflammatory bowel diseases (IBD). AIM: To perform a systematic review and meta-analysis to evaluate the potential role of therapeutic drug monitoring (TDM) for vedolizumab. METHODS: Through a systematic literature search through 28 February 2019, we identified five cohort studies (558 patients, 42% with ulcerative colitis) reporting the association between vedolizumab trough concentration and clinical outcomes in patients with IBD. We calculated mean difference (MD) in vedolizumab trough concentration in patients achieving vs not achieving clinical outcomes, and qualitatively synthesized thresholds associated with favourable outcomes. RESULTS: In patients with UC, median vedolizumab trough concentrations were consistently higher in patients achieving clinical remission (median, 14.3 μg/mL vs 10.5 μg/mL; MD, 5.1 μg/mL, 95% CI, 2.8-7.4) or endoscopic remission (median, 13.0 μg/mL vs 9.7; MD, 5.1 μg/mL, 95% CI, 2.2-7.9). In patients with CD, there was no significant difference in median vedolizumab trough concentrations in patients achieving vs not achieving clinical remission (MD, 2.0 μg/mL; 95% CI, -0.5 to 4.5) or endoscopic remission (MD, 3.6 μg/mL; 95% CI, -1.4 to 8.6). In patients with UC, week 6 vedolizumab trough concentrations ≥18.5-20.8 μg/mL, and maintenance trough concentrations ≥9.0-12.6 μg/mL were associated with favourable clinical outcomes. Antibodies to vedolizumab were reported in 1.7%-3.0% patients on maintenance therapy. CONCLUSION: Based on meta-analysis, patients with UC who achieve endoscopic and clinical remission have significantly higher vedolizumab trough concentration during maintenance therapy. Vedolizumab trough concentration >20 μg/mL at week 6, and >12 μg/mL during maintenance may be associated with better outcomes, though cause-effect relationship remains unclear. Prospective studies on reactive and proactive therapeutic drug monitoring of vedolizumab (vs empiric dose escalation) are warranted.
BACKGROUND: There has been limited evaluation of the association between vedolizumab trough concentration and clinical outcomes in patients with inflammatory bowel diseases (IBD). AIM: To perform a systematic review and meta-analysis to evaluate the potential role of therapeutic drug monitoring (TDM) for vedolizumab. METHODS: Through a systematic literature search through 28 February 2019, we identified five cohort studies (558 patients, 42% with ulcerative colitis) reporting the association between vedolizumab trough concentration and clinical outcomes in patients with IBD. We calculated mean difference (MD) in vedolizumab trough concentration in patients achieving vs not achieving clinical outcomes, and qualitatively synthesized thresholds associated with favourable outcomes. RESULTS: In patients with UC, median vedolizumab trough concentrations were consistently higher in patients achieving clinical remission (median, 14.3 μg/mL vs 10.5 μg/mL; MD, 5.1 μg/mL, 95% CI, 2.8-7.4) or endoscopic remission (median, 13.0 μg/mL vs 9.7; MD, 5.1 μg/mL, 95% CI, 2.2-7.9). In patients with CD, there was no significant difference in median vedolizumab trough concentrations in patients achieving vs not achieving clinical remission (MD, 2.0 μg/mL; 95% CI, -0.5 to 4.5) or endoscopic remission (MD, 3.6 μg/mL; 95% CI, -1.4 to 8.6). In patients with UC, week 6 vedolizumab trough concentrations ≥18.5-20.8 μg/mL, and maintenance trough concentrations ≥9.0-12.6 μg/mL were associated with favourable clinical outcomes. Antibodies to vedolizumab were reported in 1.7%-3.0% patients on maintenance therapy. CONCLUSION: Based on meta-analysis, patients with UC who achieve endoscopic and clinical remission have significantly higher vedolizumab trough concentration during maintenance therapy. Vedolizumab trough concentration >20 μg/mL at week 6, and >12 μg/mL during maintenance may be associated with better outcomes, though cause-effect relationship remains unclear. Prospective studies on reactive and proactive therapeutic drug monitoring of vedolizumab (vs empiric dose escalation) are warranted.
Authors: Asit Parikh; Timothy Leach; Tim Wyant; Catherine Scholz; Serap Sankoh; Diane R Mould; Terry Ponich; Irving Fox; Brian G Feagan Journal: Inflamm Bowel Dis Date: 2011-12-06 Impact factor: 5.325
Authors: Erwin Dreesen; Bram Verstockt; Sumin Bian; Magali de Bruyn; Griet Compernolle; Sophie Tops; Maja Noman; Gert Van Assche; Marc Ferrante; Ann Gils; Séverine Vermeire Journal: Clin Gastroenterol Hepatol Date: 2018-04-25 Impact factor: 11.382
Authors: Konstantinos Papamichael; Adam S Cheifetz; Gil Y Melmed; Peter M Irving; Niels Vande Casteele; Patricia L Kozuch; Laura E Raffals; Leonard Baidoo; Brian Bressler; Shane M Devlin; Jennifer Jones; Gilaad G Kaplan; Miles P Sparrow; Fernando S Velayos; Thomas Ullman; Corey A Siegel Journal: Clin Gastroenterol Hepatol Date: 2019-03-27 Impact factor: 11.382
Authors: Brian G Feagan; Paul Rutgeerts; Bruce E Sands; Stephen Hanauer; Jean-Frédéric Colombel; William J Sandborn; Gert Van Assche; Jeffrey Axler; Hyo-Jong Kim; Silvio Danese; Irving Fox; Catherine Milch; Serap Sankoh; Tim Wyant; Jing Xu; Asit Parikh Journal: N Engl J Med Date: 2013-08-22 Impact factor: 91.245
Authors: William J Sandborn; Brian G Feagan; Paul Rutgeerts; Stephen Hanauer; Jean-Frédéric Colombel; Bruce E Sands; Milan Lukas; Richard N Fedorak; Scott Lee; Brian Bressler; Irving Fox; Maria Rosario; Serap Sankoh; Jing Xu; Kristin Stephens; Catherine Milch; Asit Parikh Journal: N Engl J Med Date: 2013-08-22 Impact factor: 91.245
Authors: Parambir S Dulai; Emily C L Wong; Walter Reinisch; Jean-Frederic Colombel; John K Marshall; Neeraj Narula Journal: Inflamm Bowel Dis Date: 2022-10-03 Impact factor: 7.290
Authors: Ariela K Holmer; Robert Battat; Parambir S Dulai; Niels Vande Casteele; Nghia Nguyen; Anjali Jain; Ara Miralles; Jennifer Neill; Helen Le; Siddharth Singh; Jesus Rivera-Nieves; William J Sandborn; Brigid S Boland Journal: Therap Adv Gastroenterol Date: 2020-11-12 Impact factor: 4.409