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Effectiveness of ustekinumab in postoperative Crohn's disease management: Evidence from a Chinese multicenter cohort
Xian-Zong Ma, Xing-Zhao Han, Wen-Yu Zhang, Feng Tian, Xu-Chun Zhou, Lin-Yan Zhou, Yong-Sheng Teng, Ling Lei, Jian-Qiu Sheng, Peng Jin, Xin-Mei Zhao, Yan Jia
Xian-Zong Ma, Jian-Qiu Sheng, Peng Jin, Yan Jia, Senior Department of Gastroenterology, The First Medical Center of Chinese PLA General Hospital, Beijing 100853, China
Xian-Zong Ma, Jian-Qiu Sheng, Peng Jin, Yan Jia, Department of Gastroenterology, The Seventh Medical Center of Chinese PLA General Hospital, Beijing 100700, China
Xing-Zhao Han, Xin-Mei Zhao, Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou 510515, Guangdong Province, China
Xing-Zhao Han, Xin-Mei Zhao, Guangdong Provincial Key Laboratory of Gastroenterology, Institute of Gastroenterology of Guangdong Province, Guangzhou 510515, Guangdong Province, China
Wen-Yu Zhang, School of Nursing, Capital Medical University, Beijing 100853, China
Feng Tian, Lin-Yan Zhou, Department of Gastroenterology, Shengjing Hospital of China Medical University, Shenyang 110004, Liaoning Province, China
Xu-Chun Zhou, Ling Lei, Department of Gastroenterology, The First Affiliated Hospital of Chongqing Medical University, Chongqing 400016, China
Yong-Sheng Teng, Department of Gastroenterology, Chongqing General Hospital, Chongqing University, Chongqing 401147, China
Co-first authors: Xian-Zong Ma and Xing-Zhao Han.
Co-corresponding authors: Xin-Mei Zhao and Yan Jia.
Author contributions: Ma XZ and Han XZ contribute equally to this study as co-first authors; Zhao XM and Jia Y contribute equally to this study as co-corresponding authors; Ma XZ and Jia Y conceived and designed the study; Ma XZ, Han XZ, Zhou LY, Zhou XC, Lei L, Ma XZ, Tian F, Zhao XM and Jia Y participated in data acquisition; Ma XZ and Zhang WY performed data analysis and interpretation; Ma XZ, Zhang WY, Teng YS and Jia Y participated in preparing the manuscript; Ma XZ, Jia Y, Sheng JQ, Teng YS and Jin P reviewed and edited the manuscript; Ma XZ, Jia Y, Zhao XM, Tian F and Zhou XC supervised the study; all authors critically revised the manuscript for important intellectual property and approved submitting this manuscript.
Supported by the Capital Health Development Scientific Research Project, No. 2018-1-5091; and National Natural Science Foundation of China, No. 82500685.
Institutional review board statement: The present study was approved by the Ethics Committee of the Seventh Medical Center of Chinese PLA General Hospital (Approval No. S2024-093-01).
Informed consent statement: The requirement for informed consent was waived owing to the retrospective nature of this study.
Conflict-of-interest statement: The authors have no conflict of interest related to the manuscript.
Data sharing statement: The original anonymous dataset is available on request from the corresponding author at
jiayan328@163.com.
Corresponding author: Yan Jia, Professor, Department of Gastroenterology, The Seventh Medical Center of Chinese PLA General Hospital, No. 5 Nanmencang, Dongcheng District, Beijing 100700, China.
jiayan328@163.com
Received: November 26, 2025
Revised: December 31, 2025
Accepted: January 28, 2026
Published online: April 28, 2026
Processing time: 142 Days and 22.5 Hours
BACKGROUND
Postoperative recurrence (POR) of Crohn’s disease (CD) is a major therapeutic challenge.
AIM
To evaluate ustekinumab (UST) for the POR management in CD in a Chinese multicenter cohort.
METHODS
This retrospective analysis included postoperative CD patients with ≥ 2 high-risk features receiving UST at four tertiary centers. Patients were stratified into a first-line group (biologic-naïve, n = 45) and a second-line group (prior biologic failure, n = 26). The primary outcome was endoscopic improvement (≥ a 1-point reduction in the Rutgeerts score). Multivariate generalized estimating equations (GEE) were used to identify therapeutic response predictors.
RESULTS
Overall, 81.7% achieved endoscopic improvement, with 36.6% achieving complete remission. Clinical remission reached 91.5% with a significant Harvey-Bradshaw Index reduction (5.5 ± 2.8 to 2.1 ± 1.7, P value < 0.001). The GEE multivariate analysis identified first-line UST therapy (OR = 1.727, 95%CI: 1.042-2.862, P = 0.034) and shorter disease duration (OR = 0.979, 95%CI: 0.967-0.992, P = 0.001) as independent predictors of endoscopic improvement. Significant improvements were observed in nutritional parameters (i.e., albumin and hemoglobin) and inflammatory markers (i.e., C-reactive protein and fecal occult blood positivity). Adverse events occurred in 9.9% of patients. These were all mild-to-moderate severity.
CONCLUSION
UST demonstrated significant effectiveness and a favorable safety profile for the management of POR in CD. These findings support its use as an effective therapeutic option, particularly under a first-line setting, and provide valuable evidence to optimize postoperative management strategies for CD recurrence in Chinese populations.
Core Tip: This multicenter study demonstrated that ustekinumab (UST) effectively addressed the management of postoperative recurrence in patients with Crohn's disease in China. Results showed high rates of endoscopic (81.7%) and clinical remission (91.5%) at 24 weeks. A multivariate analysis identified first-line UST use and shorter disease duration as independent predictors of superior outcomes. The favorable safety profile supports UST as a potent therapeutic option, particularly when initiated early as a first-line biologic strategy for postoperative management.
