BACKGROUND & AIMS Few data are available on the effects of tumor necrosis factor (TNF) antagonist therapy for patients with internal fistulizing Crohn's disease (CD) and there is debate regarding the risk of abscess. We aimed to assess the long-term efficacy and safety of anti-TNF therapy for patients with internal fistulas. METHODS We performed a retrospective study of data collected from the Groupe d'Etude Thérapeutique des Affections Inflammatoires Digestives trial, from January 1, 2000, through December 31, 2017. Our final analysis included 156 patients who began treatment with an anti-TNF agent for CD with internal fistula (83 men; median disease duration, 4.9 y). The primary end point was the onset of a major abdominal surgery. Secondary analysis included disappearance of the fistula tract during follow-up evaluation and safety. The Kaplan-Meier method was used for statistical analysis. RESULTS After a median follow-up period of 3.5 years, 68 patients (43.6%) underwent a major abdominal surgery. The cumulative probabilities for being surgery-free were 83%, 64%, and 51% at 1, 3, and 5 years, respectively. A concentration of C-reactive protein >18 mg/L, an albumin concentration <36 g/L, the presence of an abscess at the fistula diagnosis, and the presence of a stricture were associated independently with the need for surgery. The cumulative probabilities of fistula healing, based on imaging analyses, were 15.4%, 32.3%, and 43.9% at 1, 3, and 5 years, respectively. Thirty-two patients (20.5%) developed an intestinal abscess and 4 patients died from malignancies (3 intestinal adenocarcinomas). One patient died from septic shock 3 months after initiation of anti-TNF therapy. CONCLUSIONS In a retrospective analysis of data from a large clinical trial, we found that anti-TNF therapy delays or prevents surgery for almost half of patients with CD and luminal fistulas. However, anti-TNF therapy might increase the risk for sepsis-related death or gastrointestinal malignancies.

中文翻译：

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肿瘤坏死因子拮抗剂治疗内瘘性克罗恩病的疗效和安全性。

背景和目的 关于肿瘤坏死因子 (TNF) 拮抗剂治疗内瘘型克罗恩病 (CD) 患者的效果的数据很少，并且存在关于脓肿风险的争论。我们旨在评估抗 TNF 治疗内瘘患者的长期疗效和安全性。方法 我们对从 2000 年 1 月 1 日至 2017 年 12 月 31 日的 Groupe d'Etude Therapeutique des Affects Inflammatoires Digestives 试验收集的数据进行了回顾性研究。我们的最终分析包括 156 名开始接受抗 TNF 药物治疗的患者。 CD 内瘘（83 名男性；中位病程，4.9 年）。主要终点是腹部大手术的开始。次要分析包括在随访评估和安全性期间瘘管消失。Kaplan-Meier 方法用于统计分析。结果 在中位随访 3.5 年之后，68 名患者（43.6%）接受了腹部大手术。在 1、3 和 5 年时，免手术的累积概率分别为 83%、64% 和 51%。C 反应蛋白浓度 >18 mg/L、白蛋白浓度 <36 g/L、瘘管诊断时存在脓肿以及存在狭窄与手术需要独立相关。根据影像学分析，瘘管愈合的累积概率在 1、3 和 5 年时分别为 15.4%、32.3% 和 43.9%。32 名患者（20.5%）发生肠脓肿，4 名患者死于恶性肿瘤（3 名肠腺癌）。一名患者在开始抗 TNF 治疗 3 个月后死于感染性休克。结论 在对大型临床试验数据的回顾性分析中，我们发现抗 TNF 治疗延迟或阻止了几乎一半的 CD 和腔瘘患者的手术。然而，抗 TNF 治疗可能会增加败血症相关死亡或胃肠道恶性肿瘤的风险。