TY - JOUR
T1 - A clinical decision support tool may help to optimise vedolizumab therapy in Crohn’s disease
AU - the GETAID OBSERV-IBD, VICTORY Cohorts Collaboration
AU - Dulai, Parambir S.
AU - Amiot, Aurelien
AU - Peyrin-Biroulet, Laurent
AU - Jairath, Vipul
AU - Serrero, Melanie
AU - Filippi, Jerome
AU - Singh, Siddharth
AU - Pariente, Benjamin
AU - Loftus, Edward V.
AU - Roblin, Xavier
AU - Kane, Sunanda
AU - Buisson, Anthony
AU - Siegel, Corey A.
AU - Bouhnik, Yoram
AU - Sandborn, William J.
AU - Lasch, Karen
AU - Rosario, Maria
AU - Feagan, Brian G.
AU - Bojic, Daniela
AU - Trang-Poisson, Caroline
AU - Shen, Bo
AU - Altwegg, Romain
AU - Sands, Bruce E.
AU - Colombel, Jean Frederic
AU - Carbonnel, Franck
AU - Kochhar, Gursimran
AU - Meserve, Joseph
AU - Barsky, Maria
AU - Boland, Brigid S.
AU - Gagniere, Charlotte
AU - Bigard, Marc Andre
AU - Zallot, Camille
AU - Grimaud, Jean Charles
AU - Hebuterne, Xavier
AU - Nachury, Maria
AU - Desreumaux, Pierre
AU - Del Tedesco, Emilie
AU - Bommelaer, Gilles
AU - Koliani-Pace, Jenna L.
AU - Stefanescu, Carmen
AU - Boureille, Arnaud
AU - Hirten, Robert
AU - Ungaro, Ryan
AU - Vaysse, Thibaud
AU - Bohm, Matthew
AU - Varma, Sashidhar
AU - Fischer, Monika
AU - Hudesman, David
AU - Chang, Shannon
AU - Bourrier, Anne
N1 - Publisher Copyright:
© 2019 The Authors. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd
PY - 2020/3/1
Y1 - 2020/3/1
N2 - 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.
AB - 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.
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U2 - 10.1111/apt.15609
DO - 10.1111/apt.15609
M3 - Article
C2 - 31867766
AN - SCOPUS:85076814772
SN - 0269-2813
VL - 51
SP - 553
EP - 564
JO - Alimentary Pharmacology and Therapeutics
JF - Alimentary Pharmacology and Therapeutics
IS - 5
ER -