Inflammatory Bowel Disease Center, University of Chicago Medicine, Chicago, USA.
New York Medical College, New York, USA.
Inflamm Bowel Dis. 2018 Feb 15;24(3):502-509. doi: 10.1093/ibd/izx054.
Clinical and endoscopic recurrence are common after surgery in Crohn's disease (CD). Vedolizumab has been increasingly used to treat CD, however, its effectiveness in preventing postoperative recurrence remains unknown. We aimed to investigate the use of vedolizumab in the postoperative setting and compare the risk of recurrence between patients receiving vedolizumab and anti-tumor necrosis factor (TNF)-α agents.
Medical records of CD patients who underwent surgery between April 2014 and June 2016 were reviewed. We first analyzed how frequently vedolizumab is used to prevent postoperative recurrence and compared the patient characteristics with those being treated with other therapies. Furthermore, the rates of endoscopic remission, defined as a simple endoscopic score for CD of 0, at 6-12 months after surgery were compared between patients receiving vedolizumab and anti-TNF-α agents. Clinical, biological, and histologic outcomes such as Harvey-Bradshaw index, C-reactive protein, and histologic inflammation also were compared between the 2 groups. Risks of recurrence were assessed by univariate, multivariate, and propensity score-matched analyses.
Among 203 patients that underwent a CD related surgery, 22 patients received vedolizumab as postoperative treatment. There were 58, 38, and 16 patients who received anti-TNF-α agents, immunomodulators, and metronidazole, respectively, whereas 69 patients were monitored without any medication. Patients receiving vedolizumab were young and frequently had perianal disease. Patients postoperatively treated with vedolizumab or anti-TNF-α agents were mostly treated with the same agent pre- and postoperatively. Rate of endoscopic remission at 6-12 months in the vedolizumab group was 25%, which was significantly lower as compared to anti-TNF-α agent group (66%, P = 0.01). Vedolizumab use was the only factor that was associated with an increased risk of endoscopic recurrence on both univariate (odds ratio (OR) 5.58, 95% confidence interval (CI) 1.51-24.3, P = 0.005) and multivariate analysis (OR 5.77, 95%CI 1.71-19.4, P = 0.005). The results were supported by a propensity score-matched analysis demonstrating lower rates of endoscopic remission (25 vs 69%, P = 0.03) in patients treated with vedolizumab as compared to anti-TNF-α agents.
In the present retrospective cohort study of real-world experience, vedolizumab was shown to be commonly used as postoperative treatment for CD especially in high risk patients. Multivariate and propensity score-matched analyses showed that postoperative endoscopic recurrence in CD was higher with vedolizumab than with anti-TNF-α agents, but further investigation including controlled trials is required before determining the utility of vedolizumab in preventing postoperative recurrence of CD.
克罗恩病(CD)患者手术后常出现临床和内镜复发。维得利珠单抗已被越来越多地用于治疗 CD,但预防术后复发的效果尚不清楚。我们旨在研究维得利珠单抗在术后的应用,并比较接受维得利珠单抗和抗肿瘤坏死因子(TNF)-α 药物治疗的患者之间的复发风险。
回顾 2014 年 4 月至 2016 年 6 月间接受手术的 CD 患者的病历。我们首先分析了维得利珠单抗用于预防术后复发的频率,并比较了接受该药治疗和其他治疗的患者的特征。此外,比较了术后 6-12 个月接受维得利珠单抗和抗 TNF-α 药物治疗的患者内镜缓解率(定义为克罗恩病内镜简单评分 0 分)。还比较了两组之间临床、生物学和组织学结局,如 Harvey-Bradshaw 指数、C 反应蛋白和组织学炎症。通过单变量、多变量和倾向评分匹配分析评估复发风险。
在 203 例接受 CD 相关手术的患者中,22 例接受维得利珠单抗作为术后治疗。58、38 和 16 例患者分别接受了抗 TNF-α 药物、免疫调节剂和甲硝唑治疗,而 69 例患者未接受任何药物治疗。接受维得利珠单抗治疗的患者年轻,常合并肛周疾病。术后接受维得利珠单抗或抗 TNF-α 药物治疗的患者大多在术前和术后接受相同的药物治疗。维得利珠单抗组 6-12 个月的内镜缓解率为 25%,显著低于抗 TNF-α 药物组(66%,P=0.01)。在单变量(比值比(OR)5.58,95%置信区间(CI)1.51-24.3,P=0.005)和多变量分析(OR 5.77,95%CI 1.71-19.4,P=0.005)中,维得利珠单抗的使用是唯一与内镜复发风险增加相关的因素。倾向评分匹配分析结果支持这一结果,表明与接受抗 TNF-α 药物治疗的患者相比,接受维得利珠单抗治疗的患者内镜缓解率更低(25%比 69%,P=0.03)。
在本项回顾性队列研究中,维得利珠单抗被广泛用于 CD 的术后治疗,特别是在高危患者中。多变量和倾向评分匹配分析表明,CD 患者术后内镜复发的风险用维得利珠单抗治疗比用抗 TNF-α 药物治疗更高,但在确定维得利珠单抗在预防 CD 术后复发中的效用之前,还需要包括对照试验在内的进一步研究。