Early vedolizumab trough levels predict treatment persistence over the first year in inflammatory bowel disease.
Crohn’s disease
Vedolizumab
therapeutic drug monitoring
ulcerative colitis
Journal
United European gastroenterology journal
ISSN: 2050-6406
Titre abrégé: United European Gastroenterol J
Pays: England
ID NLM: 101606807
Informations de publication
Date de publication:
11 2019
11 2019
Historique:
received:
31
05
2019
accepted:
06
08
2019
entrez:
9
11
2019
pubmed:
9
11
2019
medline:
9
11
2019
Statut:
ppublish
Résumé
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. 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. 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. 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 ( 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.
Sections du résumé
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 (
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.
Identifiants
pubmed: 31700632
doi: 10.1177/2050640619873784
pii: 10.1177_2050640619873784
pmc: PMC6826518
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Gastrointestinal Agents
0
vedolizumab
9RV78Q2002
Types de publication
Journal Article
Observational Study
Research Support, Non-U.S. Gov't
Langues
eng
Pagination
1189-1197Informations de copyright
© Author(s) 2019.
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