DOP098AI tool distinguishes differences in endoscopic disease activity in ulcerative colitis where humans could not: data from the TITRATE trial

Abstract Background Endoscopic activity indices for ulcerative colitis (UC) demonstrate limited accuracy, particularly in acute severe UC (ASUC). Artificial intelligence-based scoring (AI) may enhance this. We investigated whether the DovaVision UC AI tool could detect differences in endoscopic response rates between personalised and standard infliximab (IFX) dosing in ASUC patients enrolled in the prospective randomised TITRATE trial, that were previously not detected with human assessment. Methods In TITRATE, adult IFX-naive steroid-refractory ASUC patients were randomised 1: 1 to standard dosing (SD) or personalised dosing (PD) with IFX. After an initial 5 mg/kg IFX infusion, patients in the SD group received 5 mg/kg IFX at week 2 and 6. In the PD arm, additional 5 mg/kg IFX infusions were administered guided by a Bayesian pharmacokinetic algorithm (iDose™) aiming to achieve prospectively defined target IFX serum concentrations until day 42. Endoscopies were recorded at baseline and at week 6. Definitions of endoscopic response were ≥2-point improvement in UC endoscopic index of severity (UCEIS) and ≥1-point improvement in Mayo endoscopic subscore (MES) at week 6 compared to baseline. Patients with missing endoscopic data were classified as non-responders. Endoscopic activity was previously scored on blinded videos by 2 independent human experts, with a third for adjudication (1). Here, we applied the DovaVision UC AI tool to the blinded videos. This scored the UCEIS and MES on individual frames and aggregated results to yield final procedure-level scores. Results In total, 48 patients were randomised to PD (n = 23) or SD (n = 25) (Table 1). Human UCEIS or MES assessments could not distinguish differences in response rates (UCEIS: 13 (56. 5%) in the PD and 11 (44. 0%) in the SD group (p = 0. 540) ; MES: 14 (60. 8%) in PD and 10 (40. 0%) in SD group (p = 0. 250) ) (1). Using AI-assessed UCEIS, 27/48 (56. 2%) patients achieved endoscopic response, comprising 18/23 (78. 3%) in the PD and 9/25 (36. 0%) in the SD group (p = 0. 004). Using AI-assessed MES, 24/48 patients (50. 0%) responded (16/23 (69. 6%) in PD and 8/25 (32. 0%) in SD group (p = 0. 020) ) (Figure 1). Conclusion In ASUC patients treated with IFX, the AI tool was able to detect endoscopic response at 6 weeks of IFX treatment, regardless of the endoscopic activity index that was used. The AI tool could also distinguish response rate differences between personalised and standard dosing of IFX. In the original study, human UCEIS or MES assessments could not distinguish such differences. This is the first IBD study in which AI was able to distinguish treatment effects between different treatment strategies, demonstrating its potential to fundamentally improve clinical trial methodology. References: 1. K Gecse, J Van Oostrom, S Rietdijk, S O Frigstad, G Doherty, P Irving, D Laharie, F de Voogd, K Hammersboen Bjorlykke, D R Mould, J James, L Anchling, M Hulshoff, M Löwenberg, R Mathot, E Clasquin, K Kaasen Jorgensen, G D’Haens, DOP056 TDM-Based Dose-Intensification of Infliximab is not Superior to Standard Dosing in Patients with Acute Severe Ulcerative Colitis: Results from the TITRATE Study, Journal of Crohn’s and Colitis, Volume 19, Issue Supplement₁, January 2025, Pages i194–i195, https: //doi. org/10. 1093/ecco-jcc/jjae190. 0095 Conflict of interest: Gecse, Krisztina B.: Grant: Abbvie, Pfizer Inc, Celltrion and Galapagos/Alfasigma Personal Fees: Consultancy fees from AbbVie, Galapagos, Gilead, Immunic Therapeutics, Janssen Pharmaceuticals, Pfizer Inc. , and Takeda and speaker’s honoraria from Celltrion, Eli Lilly, Janssen Pharmaceuticals, Pfizer Inc. and Takeda. Van Oostrom, Joep: No conflict of interest Sunny, Gurm: Other: Speaker fees from Tillott’s and Takeda Rietdijk, S.: none Frigstad, Svein-Oskar: none Doherty, Glen: Research or Education Grants (last 36 months): Abbvie, Pfizer, Janssen, Takeda, Tillotts, Celltrion, Abbott, Dr Falk, Amgen Speaker/Meeting Honoraria (Last 36 months): Abbvie, Dr Falk, Galapagos/Alfa Sigma, GSK de Voogd, Floris: Personal Fees: Speaker and/or honoraria fees from AbbVie, Galapagos, Janssen, Pfizer and Takeda Hammersboen Bjorlykke, Kristin: none Mould, Diane: Employee of Baysient James, John: none Anchling, Leslie: Employee of Buhlmann Laboratories Hulshoff, Melanie: - Löwenberg, Mark: No relevant CoI to disclose Irving, Peter Miles: Grant: MSD, Pfizer, Takeda, Celltrion, Galapagos Personal Fees: AbbVie, Arena, BMS, Boomerang Medical, Celgene, Celltrion, Falk Pharma, Ferring, Galapagos, Genentech, Gilead, Hospira, Janssen, Lilly, MSD, Pfizer, Pharmacosmos, Prometheus, Roche, Sandoz, Samsung Bioepis, Sapphire Medical, Sandoz, Shire, Takeda, Tillotts, Topivert, VH2, Vifor Pharma, Warner Chilcott Laharie, David: Personal Fees: Board, consulting and lecture fees from Abbvie, Alfasigma, Amgen, Biocon, Celltrion, Ferring, Fresenius-Kabi, Johnson & Johnson, Lilly, MSD, Pfizer, Sandoz and Takeda Neefjes-Borst, Andra: none Mathot, Ron: none Clasquin, Esme: none Jørgensen, Kristin Kaasen: Personal Fees: Roche, BMS, Celltrion, Norgine Byrne, Michael: Founder and shareholder, Dova Health Intelligence 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