Background & Aims

Crohn's disease (CD) patients included in the Tailored Treatment With Infliximab for Active Crohn's Disease (TAILORIX) trial started infliximab in combination with an immunosuppressant for 1 year. The aim of the present study was to determine the long-term disease course beyond the study period.

Methods

We compared the outcomes of patients who did or did not reach the primary end point of the TAILORIX trial, defined as sustained corticosteroid-free clinical remission from weeks 22 through 54, with no ulcers on ileocolonoscopy at week 54. The primary outcome of this follow-up study was the progression-free survival of CD defined by anal or major abdominal surgery, CD-related hospitalization, or the need for a new systemic CD treatment.

Results

The 95 patients (median disease duration, 4.5 mo; interquartile range, 1.0–56.6 mo) analyzed, including 45 (47%) who achieved the primary end point, were followed up for a median duration of 64.2 months (interquartile range, 57.6–69.9 mo) after the end of the study period. There was no significant difference in CD progression-free survival at 1, 3, and 5 years between patients who achieved the TAILORIX primary end point and patients who did not (P = .64). No difference was observed between both groups for each component of CD progression: anal surgery, major abdominal surgery, CD-related hospitalization, or the need for a new systemic CD treatment.

Conclusions

Achieving a sustained clinical remission off steroids with complete endoscopic remission in this cohort of 95 patients with early CD was not associated with less disease progression. Prospective trials to define the therapeutic goals that change the natural history of CD and prevent complications are needed.

中文翻译：

---

一年内无类固醇的深度缓解并不能预防克罗恩病的进展：来自 TAILORIX 试验的长期数据

背景与目标

英夫利昔单抗治疗活动性克罗恩病 (TAILORIX) 试验的克罗恩病 (CD) 患者开始使用英夫利昔单抗联合免疫抑制剂 1 年。本研究的目的是确定超出研究期的长期病程。

方法

我们比较了达到或未达到 TAILORIX 试验主要终点（定义为第 22 周至第 54 周持续无皮质类固醇临床缓解，第 54 周回结肠镜检查无溃疡）患者的结局。向上研究是由肛门或腹部大手术、CD 相关住院或需要新的全身 CD 治疗定义的 CD 无进展生存期。

结果

分析了 95 名患者（中位病程 4.5 个月；四分位距，1.0-56.6 个月），包括 45 名（47%）达到主要终点的患者，中位随访时间为 64.2 个月（四分位距，57.6- 69.9 mo) 研究期结束后。达到 TAILORIX 主要终点的患者与未达到 TAILORIX 主要终点的患者在 1、3 和 5 年的 CD 无进展生存期没有显着差异 ( P  = .64)。对于 CD 进展的每个组成部分，两组之间没有观察到差异：肛门手术、腹部大手术、CD 相关住院或需要新的全身 CD 治疗。

结论

在这个由 95 名早期 CD 患者组成的队列中，使用类固醇实现持续临床缓解并内镜下完全缓解与疾病进展的减少无关。需要前瞻性试验来确定改变 CD 自然史和预防并发症的治疗目标。