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Early vedolizumab trough levels predict treatment persistence over the first year in inflammatory bowel disease.

ABSTRACT: Background:Data from trials of vedolizumab for inflammatory bowel disease and from real-world studies suggest an exposure-response relationship, such that vedolizumab trough levels may predict clinical and endoscopic outcomes. Objective:The purpose of this study was to evaluate in a prospective observational study the utility of an early vedolizumab trough level assay for predicting the first-year vedolizumab therapy outcome. Methods:This prospective observational study included consecutive inflammatory bowel disease patients. We measured vedolizumab trough levels and anti-vedolizumab antibodies at weeks 6 and 14. Clinical outcome was assessed at weeks 6, 14, 22 and 54. The primary endpoint was the correlation between early vedolizumab trough levels and vedolizumab persistence over the first year of treatment, defined as the maintenance of vedolizumab therapy due to sustained clinical benefit. Results:We included 101 patients initiating vedolizumab. A cut-off vedolizumab trough level of 16.55?µg/ml at week 14 predicted vedolizumab persistence within the first year of therapy, with 73.3% sensitivity and 59.4% specificity (p?=?0.0009). Week 14 vedolizumab trough level was significantly higher in patients with clinical remission at weeks 14, 22 and 54; and in patients achieving mucosal healing within 54 weeks. Conclusion:High vedolizumab trough level at week 14 was associated with a higher probability of maintaining vedolizumab therapy over the first year due to sustained clinical benefit.

SUBMITTER: Guidi L

PROVIDER: S-EPMC6826518 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Early vedolizumab trough levels predict treatment persistence over the first year in inflammatory bowel disease.

Guidi Luisa L Pugliese Daniela D Panici Tonucci Tommaso T Bertani Lorenzo L Costa Francesco F Privitera Giuseppe G Tolusso Barbara B Di Mario Clara C Albano Eleonora E Tapete Gherardo G Gremese Elisa E Papa Alfredo A Gasbarrini Antonio A Gasbarrini Antonio A Rapaccini Gian Ludovico GL Armuzzi Alessandro A

United European gastroenterology journal 20190903 9

<h4>Background</h4>Data from trials of vedolizumab for inflammatory bowel disease and from real-world studies suggest an exposure-response relationship, such that vedolizumab trough levels may predict clinical and endoscopic outcomes.<h4>Objective</h4>The purpose of this study was to evaluate in a prospective observational study the utility of an early vedolizumab trough level assay for predicting the first-year vedolizumab therapy outcome.<h4>Methods</h4>This prospective observational study inc ...[more]

PMID: 31700632

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Project description: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 ?g/mL vs 10.5 ?g/mL; MD, 5.1 ?g/mL, 95% CI, 2.8-7.4) or endoscopic remission (median, 13.0 ?g/mL vs 9.7; MD, 5.1 ?g/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 ?g/mL; 95% CI, -0.5 to 4.5) or endoscopic remission (MD, 3.6 ?g/mL; 95% CI, -1.4 to 8.6). In patients with UC, week 6 vedolizumab trough concentrations ?18.5-20.8 ?g/mL, and maintenance trough concentrations ?9.0-12.6 ?g/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 ?g/mL at week 6, and >12 ?g/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.

Dataset Information

Early vedolizumab trough levels predict treatment persistence over the first year in inflammatory bowel disease.

Publications

Early vedolizumab trough levels predict treatment persistence over the first year in inflammatory bowel disease.

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