Crohn Disease (CD), Inflamatory Bowel Disease
Conditions
Keywords
Crohn's disease, biologics, postoperative, recurrence, efficacy
Brief summary
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.
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.
Interventions
BIOLOGICALInfliximab
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.
BIOLOGICALAdalimumab
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.
BIOLOGICALVedolizumab
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.
BIOLOGICALUstekinumab (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.
Sponsors
Shanghai 10th People's Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endoscopic recurrence rate | 6 to 12 months after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severe endoscopic recurrence rate | 6 to 12 months after surgery | The proportion of patients with severe endoscopic recurrence, defined as a Rutgeerts score ≥ i3 on postoperative ileocolonoscopy. |
| Clinical recurrence rate | Up to 5 years after surgery | 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. |
| Long-term endoscopic recurrence rate | 3 and 5 years after surgery | The proportion of patients with endoscopic recurrence during long-term follow-up, defined as a Rutgeerts score ≥ i2 on follow-up endoscopy. |
| Crohn's disease-related rehospitalization rate | Up to 5 years after surgery | The proportion of patients requiring rehospitalization due to Crohn's disease activity, complications, or treatment-related problems during follow-up. |
| Crohn's disease-related reoperation rate | Up to 5 years after surgery | The proportion of patients requiring repeat abdominal surgery due to Crohn's disease recurrence or related complications during follow-up. |
| Drug persistence | Up to 5 years after treatment initiation | 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. |
Countries
China
Outcome results
None listed