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阿达木单抗或英夫利昔单抗预防克罗恩病术后早期复发:ENEIDA 登记研究结果。

Adalimumab or Infliximab for the Prevention of Early Postoperative Recurrence of Crohn Disease: Results From the ENEIDA Registry.

机构信息

Hospital Universitari Germans Trias i Pujol, Badalona, Catalonia, Spain.

Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEREHD), Madrid, Spain.

出版信息

Inflamm Bowel Dis. 2019 Oct 18;25(11):1862-1870. doi: 10.1093/ibd/izz084.

Abstract

BACKGROUND

Anti-tumor necrosis factor agents (anti-TNFs) are efficacious at preventing the postoperative recurrence (POR) of Crohn disease, as demonstrated in 2 randomized controlled trials. However, real-life data for infliximab or adalimumab in this setting are scarce. Our aim was to assess both the efficiency of anti-TNFs at preventing early POR of Crohn disease in clinical practice and the associated risk factors for POR.

METHODS

Patients in whom anti-TNFs were prescribed for the prevention of POR within 3 months after ileocolonic resection and who had an endoscopic assessment within 18 months were identified from the ENEIDA registry. Clinical and endoscopic features were collected within 18 months after surgery.

RESULTS

In total, 152 patients were included (55 treated with infliximab, 97 with adalimumab, and 39% with concomitant immunosuppressants). Anti-TNF treatment was started after a median time of 29 days (IQR 13-44) after surgery. Eighty-two percent of patients had at least one risk factor for POR, and 82% had been exposed to anti-TNFs before the index surgery. Overall, 34% had endoscopic POR (as defined using a Rutgeerts endoscopic score > i1); 14% had advanced endoscopic POR (>i2); and 20% had clinical POR, with no differences between infliximab and adalimumab. In the multivariate analysis, only perianal disease (odds ratio 2.73, 95% confidence interval [CI] 1.26-5.91) and rectal involvement (odds ratio 2.79, 95% CI 1.09-7.14) were independent predictors of endoscopic POR.

CONCLUSIONS

In clinical practice, anti-TNFs for the prevention of POR of Crohn disease are frequently used in patients experienced with anti-TNFs and with concomitant immunosuppressants. The efficacy of infliximab and adalimumab for POR prevention is similar and in accordance with the results obtained in randomized controlled trials.

摘要

背景

抗肿瘤坏死因子制剂(anti-TNFs)在预防克罗恩病的术后复发(POR)方面具有疗效,这在两项随机对照试验中得到了证实。然而,在这种情况下,关于英夫利昔单抗或阿达木单抗的真实数据却很少。我们的目的是评估在临床实践中抗 TNF 制剂预防克罗恩病早期 POR 的效果,以及 POR 的相关危险因素。

方法

从 ENEIDA 登记处中确定了在回肠结肠切除术后 3 个月内开具抗 TNF 制剂以预防 POR 并在 18 个月内进行内镜评估的患者。在手术后 18 个月内收集临床和内镜特征。

结果

共纳入 152 例患者(55 例接受英夫利昔单抗治疗,97 例接受阿达木单抗治疗,39%同时接受免疫抑制剂治疗)。抗 TNF 治疗在手术后中位数 29 天(IQR 13-44)后开始。82%的患者存在至少一个 POR 危险因素,且 82%的患者在指数手术前曾暴露于抗 TNF 制剂。总体而言,34%的患者存在内镜 POR(定义为 Rutgeerts 内镜评分>i1);14%的患者存在晚期内镜 POR(>i2);20%的患者存在临床 POR,英夫利昔单抗和阿达木单抗之间无差异。在多变量分析中,仅肛周疾病(优势比 2.73,95%置信区间 [CI] 1.26-5.91)和直肠受累(优势比 2.79,95% CI 1.09-7.14)是内镜 POR 的独立预测因素。

结论

在临床实践中,抗 TNF 制剂常用于预防克罗恩病 POR,且患者对抗 TNF 制剂和免疫抑制剂均有经验。英夫利昔单抗和阿达木单抗预防 POR 的疗效相似,与随机对照试验的结果一致。

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