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

  • Luisa Guidi (Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Department of Gastroenterology, Catholic University of the Sacred Heart) (Creator)
  • Daniela Pugliese (Creator)
  • Tommaso Panici Tonucci (Creator)
  • Lorenzo Bertani (Creator)
  • Francesco Costa (Creator)
  • Giuseppe Privitera (Creator)
  • Barbara Tolusso (Creator)
  • Clara Di Mario (Contributor)
  • Eleonora Albano (Creator)
  • Gherardo Tapete (Creator)
  • Elisa Gremese (Catholic University of the Sacred Heart, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Immunology Core Facility, Fondazione Policlinico Universitario Agostino Gemelli IRCCS) (Creator)
  • Alfredo Papa (Creator)
  • Antonio Gasbarrini (Creator)
  • Gian Ludovico Rapaccini (Creator)
  • Alessandro Armuzzi (Catholic University of the Sacred Heart, IBD Center, IRCCS Istituto Clinico Humanitas - Rozzano (Milano), Fondazione Policlinico Universitario Agostino Gemelli IRCCS) (Creator)

Dataset

Description

BackgroundData 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.ObjectiveThe 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.MethodsThis 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.ResultsWe 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.ConclusionHigh 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.
Dati resi disponibili2019
EditoreSAGE Journals

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