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

  • Luisa Guidi
    UOC Medicina Interna e Gastroenterologia Columbus Fondazione Policlinico Universitario A. Gemelli IRCCS Rome Italy
  • Daniela Pugliese
    UOC Medicina Interna e Gastroenterologia Columbus Fondazione Policlinico Universitario A. Gemelli IRCCS Rome Italy
  • Tommaso Panici Tonucci
    UOC Medicina Interna e Gastroenterologia Columbus Fondazione Policlinico Universitario A. Gemelli IRCCS Rome Italy
  • Lorenzo Bertani
    Department of Translational Research and New Technologies in Medicine and Surgery University of Pisa Pisa Italy
  • Francesco Costa
    Department of General Surgery and Gastroenterology IBD UNIT-AOUP Pisa Italy
  • Giuseppe Privitera
    UOC Medicina Interna e Gastroenterologia Columbus Fondazione Policlinico Universitario A. Gemelli IRCCS Rome Italy
  • Barbara Tolusso
    UOC Reumatologia Fondazione Policlinico Universitario A. Gemelli IRCCS Rome Italy
  • Clara Di Mario
    UOC Reumatologia Fondazione Policlinico Universitario A. Gemelli IRCCS Rome Italy
  • Eleonora Albano
    Department of Translational Research and New Technologies in Medicine and Surgery University of Pisa Pisa Italy
  • Gherardo Tapete
    Department of Translational Research and New Technologies in Medicine and Surgery University of Pisa Pisa Italy
  • Elisa Gremese
    Università Cattolica del Sacro Cuore Rome Italy
  • Alfredo Papa
    UOC Medicina Interna e Gastroenterologia Columbus Fondazione Policlinico Universitario A. Gemelli IRCCS Rome Italy
  • Antonio Gasbarrini
    Università Cattolica del Sacro Cuore Rome Italy
  • Gian Ludovico Rapaccini
    UOC Medicina Interna e Gastroenterologia Columbus Fondazione Policlinico Universitario A. Gemelli IRCCS Rome Italy
  • Alessandro Armuzzi
    UOC Medicina Interna e Gastroenterologia Columbus Fondazione Policlinico Universitario A. Gemelli IRCCS Rome Italy

抄録

<jats:sec><jats:title>Background</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Objective</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>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 (<jats:italic>p</jats:italic> = 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.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>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.</jats:p></jats:sec>

収録刊行物

被引用文献 (1)*注記

もっと見る

問題の指摘

ページトップへ