A clinical decision support tool may help to optimise vedolizumab therapy in Crohn's disease. Issue 5 (22nd December 2019)

• Record Type: Journal Article
• Authors: Dulai, Parambir S.; Amiot, Aurelien; Peyrin‐Biroulet, Laurent; Jairath, Vipul; Serrero, Melanie; Filippi, Jerome; Singh, Siddharth; Pariente, Benjamin; Loftus, Edward V.; Roblin, Xavier; Kane, Sunanda; Buisson, Anthony; Siegel, Corey A.; Bouhnik, Yoram; Sandborn, William J.; Lasch, Karen; Rosario, Maria; Feagan, Brian G.; Bojic, Daniela; Trang‐Poisson, Caroline; Shen, Bo; Altwegg, Romain; Sands, Bruce E.; Colombel, Jean‐Frederic; Carbonnel, Franck
• Other Names: Kochhar Gursimran investigator.; Meserve Joseph investigator.; Barsky Maria investigator.; Boland Brigid S investigator.; Gagniere Charlotte investigator.; Bigard Marc‐Andre investigator.; Zallot Camille investigator.; Grimaud Jean‐Charles investigator.; Hebuterne Xavier investigator.; Nachury Maria investigator.; Desreumaux Pierre investigator.; Del Tedesco Emilie investigator.; Bommelaer Gilles investigator.; Koliani‐Pace Jenna L investigator.; Stefanescu Carmen investigator.; Boureille Arnaud investigator.; Hirten Robert investigator.; Ungaro Ryan investigator.; Vaysse Thibaud investigator.; Bohm Matthew investigator.; Varma Sashidhar investigator.; Fischer Monika investigator.; Hudesman David investigator.; Chang Shannon investigator.; Bourrier Anne investigator.; Seksik Philippe investigator.; Beaugerie Laurent investigator.; Cosnes Jacques investigator.; Sokol Harry investigator.; Landman Cecilia investigator.; Lukin Dana investigator.; Weiss Aaron investigator.; Marteau Philippe investigator.; Dray Xavier investigator.; Nancey Stephane investigator.; Boschetti Gilles investigator.; Laharie David investigator.; Poullenot Florian investigator.; Allez Matthieu investigator.; Gornet Jean‐Marc investigator.; Baudry Clautilde investigator.; Savoye Guillaume investigator.; Moreau Jacques investigator.; Vuitton Lucine investigator.; Koch Stephane investigator.; Viennot Stephanie investigator.; Aubourg Alexandre investigator.; Picon Laurence investigator.; Pelletier Anne‐Laure investigator.; Sickersen Gaelle investigator.; Bouguen Guillaume investigator.; Abitbol Vered investigator.; Chaussade Stanislas investigator.; Nahon Stephane investigator.; Fumery Mathurin investigator.; Winkfield Betsy investigator.; Brixi‐Benmansour Hedia investigator.; Gincul Rodica investigator.; Barberis Jean‐Christophe investigator.; Bonaz Bruno investigator.; Michiels Christophe investigator.; Zerbib Frank investigator.; Bourrier de Beauregard Marie investigator.; Locher Christophe investigator.; Davin‐Couve Sophie investigator.; Poirette Armelle investigator.; Guillem Laurence investigator.; Stetiu‐Mocanu Monica investigator.; Philippe Beau investigator.; Beorchia Sylvain investigator.; Al Qaddi Jawad investigator.; Swaminath Arun investigator.;
• Is Part Of: Alimentary pharmacology & therapeutics. Volume 51:Issue 5(2020)
• Page Start: 553
• Page End: 564
• Publication Date: 2019-12-22
• Subjects: Digestive organs -- Diseases -- Treatment -- Periodicals; Digestive organs -- Effect of drugs on -- Periodicals; Gastrointestinal system -- Diseases -- Treatment -- Periodicals; Gastrointestinal system -- Effect of drugs on -- Periodicals; 615.73
• DOI: 10.1111/apt.15609
• Languages: English
• ISSNs: 0269-2813

Abstract

Summary: 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. Abstract : LINKED CONTENT This article is linked to Verstockt and Ferrante and Dulai papers. To view these articles, visit https://doi.org/10.1111/apt.15634 and https://doi.org/10.1111/apt.15671 .