P0328A clinical decision support tool reliably predicts deep remission with vedolizumab for Crohn’s disease

Abstract Background Over the past two decades, several advanced therapies have become available for patients with Crohn’s disease (CD). However, remission rates in clinical trials often remain below 50%. Clinical decision support tools may guide therapeutic choices, thereby enabling personalised medicine. This study aimed to evaluate the performance of the Clinical Decision Support Tool for vedolizumab (VDZ) in the LOVE-CD trial.1 Methods We analysed data from the open-label, multicentre LOVE-CD study, in which CD patients with early and late disease were treated with VDZ undergoing an endoscopy at week 0, 26 and 52.2 The Clinical Decision Support Tool (CDST), developed and validated by Dulai et al., includes five parameters (i.e. absence of prior bowel surgery, absence of prior anti-TNF therapy, absence of fistulising disease, baseline albumin and C-reactive protein levels).1, 3 The tool stratifies patients into low, intermediate, and high probability groups for clinical VDZ response. Receiver operating characteristic (ROC) curve analyses and the Akaike Information Criterion (AIC) were used to evaluate the discriminatory performance of the CDST, as well as modifications of the CDST incorporating SES-CD scores at baseline and disease duration. The original CDST endpoint was corticosteroid-free clinical remission (CF-CR) at week 26, and for the present analysis, endoscopic remission (ER) and deep remission (combined CF-CR and ER) were also assessed. Results Out of the 260 patients included in LOVE-CD, 245 had evaluable data for the current analysis, comprising 80 patients with early and 165 with late CD (table 1). Based on the original CDST, 26/245 (10.6%) patients were predicted as low, 146/245 (59.6%) as intermediate and 73/245 (29.8%) as high probability for VDZ response. CF-CR at week 26 was achieved by 78.3% of high probability patients, 53.9% of intermediate patients and 46.2% of low probability patients (p = 0.010). The original CDST showed moderate performance in predicting CF clinical remission at week 26 (ROC-AUC 0.672), which did not improve with the addition of SES-CD scores at baseline and disease duration in the model. The original CDST model performed best for predicting deep remission at week 26 and slightly improved its performance when baseline SES-CD and disease duration were incorporated (ROC-AUC 0.738). Conclusion CDST demonstrated fair discriminatory ability for predicting corticosteroid-free clinical remission at week 26 in CD patients receiving VDZ treatment. The model achieved superior predictive accuracy for deep remission at week 26, even without incorporating baseline endoscopy. This decision tool improves patient stratification and supports treatment decisions. References: 1. Dulai, P.S., et al., Development and Validation of a Scoring System to Predict Outcomes of Vedolizumab Treatment in Patients With Crohn’s Disease. Gastroenterology, 2018. 155(3): p. 687–695.e10. 2. D’Haens, G.R., et al., Vedolizumab in early and late Crohn’s disease (LOVE-CD): a phase 4 open-label cohort study. The Lancet Gastroenterology & Hepatology, 2025. 3. Dulai, P.S., et al., A clinical decision support tool may help to optimise vedolizumab therapy in Crohn’s disease. Aliment Pharmacol Ther, 2020. 51(5): p. 553–564. Conflict of interest: Mrs. Oldenburg, Lotte: No conflict of interest Baert, Filip J.: Grant: AbbVie, Amgen, EG, J & J, Takeda. Personal Fees: AbbVie, Abivax, Alpha Sigma, Arena, BMS,,Celltrion, Eli Lilly, Falk, Ferring, Fresenius, Galapagos, J & J, Pfizer, Sandoz, Takeda, Vifor. Bossuyt, Peter: Grant support for research from AbbVie, EG Consulting fee from AbbVie, Bristol Meyers Squibb, CIRC, Galapagos, Janssen, Jeito capital, Lilly, Pentax, Pfizer, PSI-CRO, Roche, Takeda, Tetrameros Speakers fee from AbbVie, AMC ICP, Amgen, Bristol Myers Squibb, Celltrion, Dr Falk Benelux, EG, Galapagos, Globalport, Lilly, Medtalks, Materia Prima, Pentax, Springer Media Hoentjen, Frank: Frank Hoentjen has served on advisory boards or as speaker for Abbvie, CCRN, Janssen, Takeda, Pfizer, Celltrion, Teva, Amgen and Pendopharm, and has received independent research funding from Celltrion, Janssen, Abbvie, and Takeda. Clasquin, Esme: No conflict of interest Molnár, Tamás: Conflict of interest: Tamás Molnár has received speaker’s honoraria from MSD, AbbVie, Egis, Goodwill Pharma, Takeda, Pfizer, Janssen, Sandoz, Phytotec, Roche, Fresenius, Teva, Celltrion, Stada, BMS, Ferring, EwoPharma and SOBI Löwenberg, Mark: No conflict of interest Vermeire, Séverine: Grant: AbbVie, Pfizer, Takeda,J & J, Galapagos Personal Fees: AbbVie - AbolerIS Pharma - AgomAb - Alimentiv - Arena Pharmaceuticals - AstraZeneca - Avaxia- BMS - Boehringer Ingelheim - Celgene - CVasThera - Dr Falk Pharma - Ferring - Galapagos - Genentech-Roche - Gilead - GSK - Hospira - Imidomics - Janssen -J & J - Lilly - Materia Prima - MiroBio - Morphic - MrMHealth - Mundipharma - MSD - Pfizer - Prodigest - Progenity - Promakhos Therapeutics - Prometheus - Robarts Clinical Trials - Second Genome - Shire - Surrozen - Takeda - Theravance - Tillots Pharma AG - Zealand Pharma - Other: AbbVie, MSD, Takeda, Ferring, Genentech/Roche, Shire, Pfizer Inc, Galapagos, Mundipharma, D’Haens, Geert: Grant: Pfizer, BMS, Johnson and Johnson, Abbvie, Alimentiv BV, Eli Lilly, Takeda, Prometheus Laboratories Personal Fees: Abbvie, Abivax, Agomab, Alimentiv, Anaptys Bio, AstraZeneca, Bristol Meiers Squibb, Boehringer Ingelheim, Celltrion, Eli Lilly, Exeliom Biosciences, Galapagos, Glaxo Smith Kline, Dr Falk Pharma, Pfizer, Johnson and Johnson, Merck, Mirador, Polpharma, Procise Diagnostics, Prometheus Biosciences, Sorriso Pharma, Spyre, Takeda, Ventyx