P1043Unsupervised machine learning to identify distinct CDAI-based response patterns to guselkumab in participants with Crohn’s disease: Post hoc analysis of the pooled GRAVITI and GALAXI 2/3 studies

Abstract Background Crohn’s disease(CD) trials often report efficacy using only binary endpoints(clinical remission/endoscopic response), aggregating outcomes of all participants(pts) at specified timepoints. Individual longitudinal efficacy trends using pt-level clinical data helps to understand response dynamics in relationship to outcome, and may help optimize personalized IBD treatment. AI, such as machine learning(ML), may identify patterns/predictors of individual treatment response in pts with CD. Guselkumab(GUS) is an IL-23p19 subunit antagonist. Unsupervised ML was used to identify clusters of GUS-treated pts by individual Crohn’s Disease Activity Index(CDAI)-based response trajectories. Methods Unsupervised ML approach with latent class trajectory modeling was applied using CDAI scores from weeks(Wks)0-48 of individual GUS-treated pts with moderate to severely active CD from three Phase 3, randomized, double-blind, treat-through trials: GRAVITI(GV; SC induction E:14.3%) E:21.4%). Conclusion Unsupervised ML using CDAI scores of GUS-treated pts detected 5 distinct response clusters in GRAVITI and GALAXI. Through Wk48, distinct pt groups were separated by degrees/dynamics of clinical response, which were similar with SC and IV induction. Further analyses of pt characteristics related to these response patterns may direct long-term therapies and aid in an individualized treatment approach to IBD. References: 1. Hart A, Panaccione R, Steinwurz F, et al. Gastroenterology 2025;169:308-325. 2. Panaccione R, Danese S, Feagan BG, et al. Gastroenterology 2024;166:S1057b. 3. Panaccione R, Feagan BG, Afzali A, et al. Lancet 2025;406:358-375. Conflict of interest: Schreiber, Stefan Wolfgang: Personal Fees: AbbVie, Alfasigma, Amgen, Arena, Biogen, Boehringer Ingelheim, Bristol Meyers Squibb, Celgene, Celltrion, Falk, Ferring, Fresenius Kabi, Galapagos, Gilead, IMAB, Janssen, Lilly, MSD, Mylan, Novartis, Pfizer, Protagonist, Provention Bio, Roche, Sandoz/Hexal, Shire, Takeda, Theravance 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 Reinisch, Walter: Personal Fees: WR has served as a speaker for AbbVie, Alfasigma, Celltrion, Ferring, JNJ, Galapagos Medice, Lilly, MSD, Roche, Pfizer, Sobi, Takeda, as a consultant for AbbVie, Agomab, Alfasigma, Alvotech, Amgen, Anaptys Bio, AOP Orphan, Boehringer Ingelheim, Bristol Myers Squibb, Calyx, Celltrion, Eli Lilly, Galapagos, Gilead, Index Pharma, Janssen, Medahead, Merck, Microbiotica, Pfizer, Sanofi, Teva, Takeda as an advisory board member for AbbVie, Alfasigma, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celltrion, Galapagos, JNJ, Pfizer, Teva and has received research funding from AbbVie, JNJ, Sandoz, Sanofi, Takeda. Hart, Ailsa: Grant: Takeda Personal Fees: Abbvie, Amgen, Arena, AZ, Falk, Celltrion, Eli Lilly, Ferring, Genentech/ Roche, GSK, Pfizer, Takeda, Napp, Pharmacosmos, Janssen (J&J), Bristol-Myers Squibb, Gilead, Galapagos, Alfasigma Rani, Sudheer: S. Rani is an employees of Johnson & Johnson and may own stock/stock options in Johnson & Johnson. Olurinde, Mobolaji: Employee of Johnson & Johnson and own company stock/stock options. Van Rampelbergh, Rian: Employee of Johnson&Johnson Gao, Long-Long: L-L Gao is an employee of Johnson & Johnson and may own stock/stock options in Johnson & Johnson. Yang, Zijiang: Z. Yang is an employee of Johnson & Johnson and may own stock/stock options in Johnson & Johnson. Hoops, Timothy: Contract employee of Johnson & Johnson J&J stock holder Valiathan, Chandni: C. Valiathan was an employee of Johnson & Johnson at the time of these analyses and may own stock/stock options in Johnson & Johnson. Dulai, Parambir: Grant: Takeda, Bristol Meyer Squibb, Merck, Genentech, Geneoscopy Personal Fees: Abbvie, Abivax, Alimentiv, Bristol Meyer Squibb, Boehringer Ingelheim, Celltrion, Cristcot, Genentech, Geneoscopy, Janssen, Lilly, Merck, Pfizer, Sanofi, Takeda