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Biologics for prevention of postoperative Crohn’s disease recurrence: A retrospective cohort study in China

Year: 2025

Type: article

Abstract: To the Editor: Patients with Crohn’s disease (CD) often undergo bowel resection due to complications. Indeed, bowel resection is not a curative approach and has relatively high rates of postoperative complications and recurrence.[1] The 10-year risk of having a second resection after the first is 35%, although more recent studies suggest that this may have decreased to closer to 30%.[2] How to prevent postoperative recurrence (POR) has become a major concern. Studies have shown that mesalazine and azathioprine do not effectively prevent POR and biologics have a better preventive effect. The relative efficacies of different biologics remain controversial, suggesting that further trials are needed. This study aimed to evaluate the effectiveness of prophylactic therapy in preventing POR after intestinal surgery in patients with CD in a real-world setting and to compare vedolizumab, ustekinumab, and infliximab for effectiveness, which is currently a gap in China. This study retrospectively analyzed patients with CD treated at Jinling Hospital, Medical School of Nanjing University, from March 2021 to August 2023. Inclusion criteria were: (1) Meeting the diagnostic criteria for CD in the 2023 Chinese national clinical practice guideline on diagnosis and management of Crohn’s disease;[1] (2) Undergoing intestinal surgery, including partial resection of the intestine, colon, and rectum; intestinal perforation repair surgery; stoma, etc.; (3) Undergoing biologics treatment according to the recommended dosage and modality within 6 months after surgery for at least 3 months. Exclusion criteria were: (1) Treatment limited to simple anal fistula surgery, appendectomy, or endoscopic dilatation; (2) missed visits or lack of clinical data. Ethical approval (No. 2022DZKY-048-02) and informed consent were obtained. The baseline clinical data were collected through the hospital’s electronic medical record system. The primary outcome was clinical recurrence at the end of follow-up. Disease severity was assessed clinically by the Crohn’s Disease Activity Index (CDAI), which defines clinical recurrence as a CDAI >150 and a CDAI increase of 100.[1] When a case relapsed, the treatment plan was changed according to the specific situation, including reoperation, switching to another biologic, co-administering immunosuppressants or hormones, re-induction, etc. The secondary outcome was the status of endoscopy recurrence. Endoscopic POR was considered with a Rutgeerts score ≥i2, and endoscopic remission with a Rutgeerts score 100 cm), esophagogastroduodenal lesions, young age at onset, and the need for steroid therapy at the initial disease onset.[1] In the present study, of the five examined risk factors, patients were more likely to have POR only with extensive lesions. In addition, cases requiring immunosuppressant therapy throughout the course of the disease were more likely to recur. The timing of immunosuppressant administration may be a relevant factor, and more severe or poorly controlled disease may require the use of immunosuppressants. This study analyzed the actual postoperative use of biologics in patients with CD, providing data for the efficacy of different biologics in the prevention of POR in China. The current study provided certain guidance and might be used as a reference for further clinical promotion and application. Since the definitions of clinical POR and Rutgeerts score have never been formally unified, all current diagnostic modalities had limitations.[5] Our findings get only a preliminary conclusion due to the lack of a control group treated with traditional medication. As this was an observational, non-interventional study, data on endoscopy were only available if it is deemed necessary by the patients’ physician. Therefore, some of the endoscopic POR data are missing and the results may be affected by inconsistent evaluation time. In conclusion, this study demonstrated that biologics (vedolizumab, ustekinumab, and infliximab) could effectively prevent POR. Ustekinumab might show a better preventive efficacy than infliximab. Patients administered immunosuppressants or with extensive lesions are more likely to undergo clinical POR.

Source: Chinese Medical Journal

DOI: 10.1097/cm9.0000000000003572