What question did this study set out to answer?

This research aims to determine if integrating clinical data and patient-reported outcomes can better stratify ulcerative colitis patients in remission based on their long-term outcomes.

January 23, 2026

P0506Data-driven subphenotyping predicts Ulcerative Colitis subtype with high risk for relapse in Japan

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This research aims to determine if integrating clinical data and patient-reported outcomes can better stratify ulcerative colitis patients in remission based on their long-term outcomes.
Analyzed data from a multicentre, prospective patient registry involving 2,006 ulcerative colitis patients in Japan.
Collected clinical and PRO data, including pain, fatigue, and daily activity from patients in remission.
Used clustering analysis and correlation matrix to categorize the patient cohort into distinct groups; validated with a separate patient set.
Conducted longitudinal analysis to compare relapse, colon resection, and hospitalization rates among identified clusters.
Identified three reproducible clusters of patients based on quality of life and laboratory profiles.
The cluster with lower quality of life and average lab results showed significantly higher relapse rates over a 3-year follow-up.
The other two clusters maintained better quality of life scores, indicating their lower relapse risk.

Resumen

Abstract Background Ulcerative colitis (UC) is a heterogeneous disease with variable clinical outcomes, yet management typically relies on standardised strategies and routine clinical biomarkers and endoscopic evaluation. Patients in clinical remission usually present with normal levels of biomarkers, however, symptom burden experienced by patients may reveal additional heterogeneity even in remission. It remains unclear whether symptomatic and biomarker heterogeneity reflects patients clinical outcome. This study aimed to investigate whether integration of clinical and patient-reported outcome (PRO) data can stratify patients in remission based on long-term outcomes. Methods This is a study using the data of a multicentre, prospective patient registry, called YOURS, consisting of 2,006 patients with UC in five ingestigational sites in Japan, conducted from Dec 2018 to Jun 2022. In this study, clinical information including laboratory values and PRO data including pain, fatigue, and daily activity were obtained from patients with UC in remission, and were retrospectively analysed. A feature correlation matrix and heatmap using continuous variables served as input for clustering analysis. Additional visualisation was performed using factor analysis of mixed data (FAMD) to clarify variable contributions. The cohort was divided into test (n = 365) group, from one of the five sites, and validation (n = 982) groups from the remaining four sites. Longitudinal analysis compared relapse, colon resection, and hospitalisation rates among detected clusters. Results Three reproducible clusters were identified in both test and validation datasets. When comparing the three clusters in each dataset; one cluster was characterized by lower quality-of-life (QOL) and average laboratory (lab) profiles, while the other two clusters showed preserved QOL scores either with or without distinct lab profiles. The cluster with lower QOL and average lab profiles demonstrated increased relapse rates during 3-year follow-up in each dataset, compared with the respective other two clusters. Conclusion Integration of PRO data and clinical data enables the identification of distinctive subphenotypes among patients with UC in remission. These clusters reveal differences in relapse risk and symptom experience that are not captured by traditional biomarkers alone. Stratifying patients using combined clinical and QOL data may facilitate more precise, individualised management strategies. References: Yamazaki H, Matsuoka K, Fernandez J, et al. Ulcerative colitis outcomes research in Japan: protocol for an observational prospective cohort study of YOURS (YOu and Ulcerative colitis: Registry and Social network). BMJ Open 2019; 9: e030134. Matsuoka K, Yamazaki H, Nagahori M, et al. Association of ulcerative colitis symptom severity and proctocolectomy with multidimensional patient-reported outcomes: a cross-sectional study. J Gastroenterol 2023; 58: 751-65. Conflict of interest: Mikami, Yohei: No conflict of interest Yamazaki, Hajime: Consulting: Magmitt Pharmaceutical Co. Ltd. Payment or honoraria for lectures: Janssen Pharmaceutical Co. Ltd., Mitsubishi Tanabe Pharma, Kowa Co. Ltd., AstraZeneca K.K., Kyorin Pharmaceutical Co. Ltd., Mundipharma K.K., Takeda Pharmaceutical Co. Ltd. Hisamatsu, Tadakazu: Grant support: Mitsubishi Tanabe Pharma Corporation, EA pharma Co. Ltd., AbbVie GK, JIMRO Co. Ltd., Zeria Pharmaceutical Co. Ltd., Kyorin Pharmaceutical Co. Ltd., Nippon Kayaku Co. Ltd., Takeda Pharmaceutical Co. Ltd., Pfizer Inc., Boston Scientific Corporation, Kissei Pharmaceutical Co. Ltd., Mochida Pharmaceutical Co. Ltd. Consulting: EA pharma Co. Ltd., AbbVie GK, Janssen Pharmaceutical K.K., Pfizer Inc., Mitsubishi Tanabe Pharma Corporation, JIMRO Co., Mochida Pharmaceutical Co. Ltd., Bristol Myers Squibb, Eli Lilly and Company, Gilead Sciences Inc., Abivax, MSD, Chugai. Lecture fee: EA Pharma Co. Ltd., AbbVie GK, Janssen Pharmaceutical K.K., Pfizer Inc., Mitsubishi Tanabe Pharma Corporation, JIMRO Co., Mochida Pharmaceutical Co., Ltd., Bristol Myers Squibb, Eli Lilly and Company, Gilead Sciences Inc., Kyorin Pharmaceutical Co. Ltd., Takeda Pharmaceutical Co. Ltd., Kissei Pharmaceutical Co. Ltd. Nagahori, Masakazu: I have received lecture fees and others from for the past three years from the companies below. Pfizer Inc. Takeda Pharmaceutical Company Limited Mochida Pharmaceutical Co., Ltd. AbbVie GK Mitsubishi Tanabe Pharma Corporation Zeria Pharmaceutical Co., Ltd. Janssen Pharmaceutical K.K. Kyorin Pharmaceutical Co., Ltd. Gilead Sciences, Inc. Kobayashi, Taku: Grant: AbbVie, Alfresa Pharma, Bristol Myers Squibb, Celtrion, EA Pharma, Eli Lilly, Gilead Sciences, Janssen, JIMRO, Kyorin Pharmaceutical, Mitsubishi Tanabe, Miyarisan, Mochida Pharmaceutical, Nippon Kayaku, Otsuka Holdings, Pfizer, Samsung Medicine Co. Sekisui Medical, Takeda, Zeria Pharmaceutical, Helmsley Charitable Trust. Personal Fees: AbbVie GK, Alfresa Pharma Corporation, Alimentiv, Bristol Myers Squibb, Celltrion, Covidien, EA Pharma, Eli Lilly, Ferring Pharmaceuticals, Galapagos, Gilead Sciences, Janssen Pharmaceutical K.K., JIMRO Co. Ltd., Kissei Pharmaceutical Co. Ltd., Kyorin Pharmaceutical Co. Ltd., Mitsubishi Tanabe Pharma Corporation, Mochida Pharmaceutical Co. Ltd., MSD, Nippon Kayaku Co. Ltd., Pfizer Japan Inc., Sekisui Medical, Takeda Pharmaceutical Co. Ltd., Zeria Pharmaceutical Co. Ltd. Yonezawa, Maria: No conflict of interest Katsuura, Aya: Shareholder: Takeda Pharmaceutical Co. Ltd. Other: Employee of Takeda Pharmaceutical Co. Ltd. Fukuhara, Shuichi: No conflict of interest Matsuoka, Katsuyoshi: Grant: Abbvie Inc., Mochida Pharmaceutical Co., Ltd., EA Pharma, ZERIA Pharmaceutical Co., Ltd., Nippon Kayaku Co., Ltd., JIMRO Co., Ltd. Personal Fees: Mitsubishi Tanabe Pharma, Janssen Pharmaceutical K.K., AbbVie Inc., EA Pharma Co., Ltd., Takeda Pharmaceutical Co., Ltd., Mochida Pharmaceutical Co., Ltd., ZERIA Pharmaceutical Co., Ltd., Nippon Kayaku Co., Ltd., Pfizer Inc., Kyorin Pharmaceutical Co., Ltd., Eli Lilly Japan K.K., Kissei Pharmaceutical Co., Ltd., Gilead Sciences, Celltrion Healthcare, Bristol-Myers Squibb

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