Comparison of the Efficacy of Different Biologic Agents in Preventing Postoperative Endoscopic Recurrence of Crohn's Disease

This retrospective cohort study aims to compare the efficacy of different biologics in preventing postoperative endoscopic recurrence in Crohn's disease (CD). It plans to include 198 adult patients who underwent bowel resection and initiated prophylactic biologic therapy between January 1, 2015, and April 1, 2025. Patients will be divided into anti-TNF (e.g., infliximab, adalimumab) and non-anti-TNF (e.g., vedolizumab, ustekinumab) groups based on the biologic started within 6 weeks post-surgery. The primary outcome is endoscopic recurrence (Rutgeerts score ≥ i2) at 6-12 months postoperatively. Secondary outcomes include severe endoscopic recurrence, clinical recurrence, recurrence at different anastomotic sites, CD-related rehospitalization, reoperation, drug persistence, the POCER postoperative endoscopic index, and histopathological changes in the bowel and mesenteric fat. Subgroup analyses will explore treatment effects by recurrence risk stratification and resection extent. Using retrospective data collection, the study will apply multivariate regression and survival analysis to provide real-world evidence for optimizing postoperative biologic selection.

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease (CD); Inflamatory Bowel Disease
• Intervention / Treatment: Biological: Infliximab; Biological: Adalimumab; Biological: Vedolizumab; Biological: Ustekinumab (UST)

Detailed Description

This study is a retrospective cohort study aiming to compare the efficacy of different biologics in preventing endoscopic recurrence after surgery for Crohn's disease (CD). It plans to include 198 adult CD patients who underwent intestinal resection and initiated prophylactic biologic therapy between January 1, 2015, and April 1, 2025. Patients will be divided into an anti-TNF group (e.g., infliximab, adalimumab) and a non-anti-TNF group (e.g., vedolizumab, ustekinumab) based on the biologic agent used within six weeks post-surgery. The primary outcome is the rate of endoscopic recurrence (Rutgeerts score ≥ i2) at 6-12 months postoperatively. Secondary outcomes include the rate of severe endoscopic recurrence, clinical recurrence, recurrence at different anastomotic sites, CD-related rehospitalization, reoperation, drug persistence, the POCER postoperative endoscopic index, and pathological changes in the intestinal tissue and mesenteric fat. Subgroup analyses will be conducted to explore differences in efficacy across varying levels of recurrence risk and resection extent. Through retrospective data collection and statistical analyses including multivariate regression and survival analysis, this study aims to provide real-world evidence to optimize the selection of postoperative biologic therapy in clinical practice.

• Study Type: Observational
• Enrollment (Estimated): 198

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 201505
      • Recruiting
      • The Tenth People's Hospital of Shanghai
      • Contact: Xiaolei Wang, MD, PhD; Phone Number: 13817267967; Email: wangxiaolei@tongji.edu.cn
      • Contact: Email: wangxiaolei@tongji.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This retrospective cohort study will include adult patients with Crohn's disease who underwent CD-related intestinal resection at Shanghai Tenth People's Hospital between January 1, 2015 and April 1, 2025. Eligible patients initiated postoperative prophylactic biologic therapy within 6 weeks after surgery and had available postoperative follow-up data, including endoscopic assessment within 6 to 12 months after surgery or other clinical data for recurrence evaluation. Patients will be grouped according to the type of postoperative prophylactic biologic therapy, including anti-TNF biologics and non-anti-TNF biologics.

Description

Inclusion Criteria:

• Age ≥18 years.
• Diagnosis of Crohn's disease according to the European Crohn's and Colitis Organisation (ECCO) guideline criteria, based on clinical, laboratory, endoscopic, radiologic, and histopathologic findings.
• Underwent Crohn's disease-related intestinal resection, including ileocolonic resection, segmental small bowel resection, or segmental colonic resection.
• Initiated postoperative prophylactic biologic therapy within 6 weeks after surgery.
• Maintained postoperative prophylactic biologic therapy for at least 3 to 6 months.
• Completed at least one evaluable postoperative ileocolonoscopy within 6 to 12 months after surgery for assessment of the Rutgeerts score, or had available clinical, radiologic, ultrasonographic, or laboratory data for evaluation of clinical recurrence.

Exclusion Criteria:

• Diagnosis of other intestinal diseases, including intestinal Behçet's disease, ulcerative colitis, intestinal tuberculosis, or intestinal malignancy.
• Intestinal surgery mainly performed for non-IBD conditions, such as intestinal malignancy.
• No postoperative endoscopic evaluation within 6 to 12 months after surgery, or endoscopic quality insufficient for Rutgeerts score assessment, and lack of adequate clinical, radiologic, ultrasonographic, or laboratory data for recurrence assessment.
• Irregular use of postoperative prophylactic therapy due to severe comorbidities, serious infection, or other reasons, making treatment efficacy difficult to evaluate.
• Other conditions considered by the investigators to be inappropriate for inclusion.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Postoperative anti-TNF biologics group; Patients with Crohn's disease who underwent CD-related intestinal resection and initiated postoperative prophylactic anti-TNF biologic therapy within 6 weeks after surgery, including infliximab or adalimumab. All treatments were prescribed as part of routine clinical care, and this retrospective observational study did not assign any intervention.	Biological: Infliximab; Infliximab was used as postoperative prophylactic biologic therapy for Crohn's disease according to routine clinical practice. The recommended regimen was 5 mg/kg intravenously at weeks 0, 2, and 6, followed by maintenance treatment every 8 weeks.; Biological: Adalimumab; Adalimumab was used as postoperative prophylactic biologic therapy for Crohn's disease according to routine clinical practice. The recommended regimen was 160 mg subcutaneously at week 0, 80 mg at week 2, and 40 mg every 2 weeks from week 4 onward.
Postoperative non-anti-TNF biologics group; Patients with Crohn's disease who underwent CD-related intestinal resection and initiated postoperative prophylactic non-anti-TNF biologic therapy within 6 weeks after surgery, including vedolizumab or ustekinumab. All treatments were prescribed as part of routine clinical care, and this retrospective observational study did not assign any intervention.	Biological: Vedolizumab; Vedolizumab was used as postoperative prophylactic biologic therapy for Crohn's disease according to routine clinical practice. The recommended regimen was 300 mg intravenously at weeks 0, 2, and 6, followed by maintenance treatment every 8 weeks.; Biological: Ustekinumab (UST); Ustekinumab was used as postoperative prophylactic biologic therapy for Crohn's disease according to routine clinical practice. The recommended regimen included a weight-based intravenous induction dose, followed by 90 mg subcutaneously every 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endoscopic recurrence rate	The proportion of patients with endoscopic recurrence, defined as a Rutgeerts score ≥ i2 on ileocolonoscopy performed 6 to 12 months after CD-related intestinal resection.	6 to 12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe endoscopic recurrence rate	The proportion of patients with severe endoscopic recurrence, defined as a Rutgeerts score ≥ i3 on postoperative ileocolonoscopy.	6 to 12 months after surgery
Clinical recurrence rate	The proportion of patients with clinical recurrence, defined as worsening Crohn's disease-related symptoms supported by endoscopic, radiologic, ultrasonographic, laboratory, or medical record evidence, or requiring treatment escalation, hospitalization, or reoperation due to Crohn's disease activity.	Up to 5 years after surgery
Long-term endoscopic recurrence rate	The proportion of patients with endoscopic recurrence during long-term follow-up, defined as a Rutgeerts score ≥ i2 on follow-up endoscopy.	3 and 5 years after surgery
Crohn's disease-related rehospitalization rate	The proportion of patients requiring rehospitalization due to Crohn's disease activity, complications, or treatment-related problems during follow-up.	Up to 5 years after surgery
Crohn's disease-related reoperation rate	The proportion of patients requiring repeat abdominal surgery due to Crohn's disease recurrence or related complications during follow-up.	Up to 5 years after surgery
Drug persistence	Time from initiation of postoperative prophylactic biologic therapy to treatment discontinuation, switch to another biologic or immunomodulator, or discontinuation due to intolerance or adverse events.	Up to 5 years after treatment initiation

Collaborators and Investigators

• Sponsor: Shanghai 10th People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: July 6, 2026
• First Submitted That Met QC Criteria: July 6, 2026
• First Posted (Actual): July 10, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 6, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: efficacy; recurrence; Crohn's disease; postoperative; biologics
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Pathological Conditions, Signs and Symptoms; Recurrence; Crohn Disease; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Adalimumab; Infliximab; Ustekinumab; vedolizumab
• Other Study ID Numbers: SHSY-IEC-6.0/26K14/P01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO