A clinical decision support tool may help to optimise vedolizumab therapy in Crohn's disease
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Parambir S. Dulai
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Laurent Peyrin-Biroulet
- Fonction : Auteur
- PersonId : 764350
- ORCID : 0000-0003-2536-6618
- IdRef : 087640147
Sunanda Kane
- Fonction : Auteur
Anthony Buisson
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- PersonId : 763185
- ORCID : 0000-0002-6347-409X
- IdRef : 167502484
Karen Lasch
- Fonction : Auteur
Daniela Bojic
- Fonction : Auteur
Bruce E. Sands
- Fonction : Auteur
Gursimran Kochhar
- Fonction : Auteur
Joseph Meserve
- Fonction : Auteur
Maria Barsky
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Brigid S. Boland
- Fonction : Auteur
Jenna L. Koliani-Pace
- Fonction : Auteur
Robert Hirten
- Fonction : Auteur
Ryan Ungaro
- Fonction : Auteur
Matthew Bohm
- Fonction : Auteur
Sashidhar Varma
- Fonction : Auteur
David Hudesman
- Fonction : Auteur
Shannon Chang
- Fonction : Auteur
Philippe Seksik
- Fonction : Auteur
- PersonId : 761210
- IdHAL : seksik-philippe
- ORCID : 0000-0003-3596-9893
- IdRef : 085638374
Harry Sokol
- Fonction : Auteur
- PersonId : 801170
- IdHAL : harry-sokol
- ORCID : 0000-0002-2914-1822
- IdRef : 128516313
Dana Lukin
- Fonction : Auteur
Aaron Weiss
- Fonction : Auteur
Matthieu Allez
- Fonction : Auteur
- PersonId : 762385
- ORCID : 0000-0002-2012-7522
- IdRef : 050201581
Mathurin Fumery
- Fonction : Auteur
- PersonId : 774088
- ORCID : 0000-0002-2337-2902
- IdRef : 170096289
Marie Bourrier De Beauregard
- Fonction : Auteur
Beau Philippe
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Arun Swaminath
- Fonction : Auteur
Getaid Observ-Ibd
- Fonction : Auteur
Victory Cohorts Collaboration
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Résumé
Background A clinical decision support tool (CDST) has been validated for predicting treatment effectiveness of vedolizumab (VDZ) in Crohn's disease. Aim To assess the utility of this CDST for predicting exposure-efficacy and disease outcomes. Methods Using data from three independent datasets (GEMINI, GETAID and VICTORY), we assessed clinical remission rates and measured VDZ exposure, rapidity of onset of action, response to dose optimisation and progression to surgery by CDST-defined response groups (low, intermediate and high). Results A linear relationship existed between CDST-defined groups, measured VDZ exposure, rapidity of onset of action and efficacy in GEMINI through week 52 (P < 0.001 at all time points across three CDST-defined groups). In GETAID, CDST predicted differences in clinical remission at week 14 (AUC = 0.68) and rapidity of onset of action (P = 0.04) between probability groups. The high-probability patients did not benefit from shortening of infusion intervals, and differences in onset of action between the high-intermediate and low-probability groups within GETAID were no longer significant when including low-probability patients who received a week 10 infusion. CDST predicted a twofold increase in surgery risk over 12 months of VDZ therapy among low- to intermediate-probability vs high-probability patients (adjusted HR 2.06, 95% CI 1.33-3.21). Conclusions We further extended the clinical utility of a previously validated VDZ CDST, which accurately predicts at baseline exposure-efficacy relationships and rapidity of onset of action and could be used to help identify patients who would most benefit from interval shortening and those most likely to require surgery while on active therapy.