Background

The LIR!C trial showed that laparoscopic ileocaecal resection is at least as good as anti-TNF in terms of quality of life and is cost-saving. Current aims were to compare the long-term outcome of both interventions and to identify factors associated with the failure of the initial therapeutic strategy.

Methods

Long-term data were retrospectively collected for patients who participated in the LIR!C trial, a multicentre, randomised controlled trial that compared a laparoscopic ileocaecal resection with infliximab for adult patients with non-stricturing and immunomodulator refractory ileocaecal Crohn’s disease. Outcomes of interest needed for (re-)surgery or anti-TNF, duration of treatment effect as well as the identification of factors associated with sustained treatment effect. The treatment effect was defined as the time without the need for additional Crohn-related treatment. Potential factors were defined a priori and analysed by multivariable Cox regression analysis.

Results

Median follow-up time was 63.5 [IQR 39 – 94.5] months. In the resection group, 18 (26.1%) patients started anti-TNF treatment while none of the patients required a second resection (Figure 1). Twenty-nine (42%) patients did not require additional Crohn-related treatment. In contrast, in the infliximab group, 31 (47.7%) patients underwent a Crohn-related resection. Duration of treatment effect was similar with a median (95% CI) time without additional treatment of 33 (15.1–50.9) and 34 (0–69.3) months in the resection and infliximab group respectively (log-rank p = 0.521). In both groups, prophylactic immunomodulators decreased the risk of additional treatment (HR 0.34 95% CI (0.16–0.69) and HR 0.49 95% CI (0.26–0.93), respectively).Figure 1.Need for anti-TNF and (re-)surgery

Conclusion

This long-term follow-up study of the LIR!C trial showed that after a median follow-up of 5 years the majority of patients who underwent resection were free of anti-TNF treatment, none required a second resection and almost half were free of any additional medical treatment for disease flares. Conversely, almost half of the patients in the infliximab group moved on to a Crohn-related resection. These data support early ileocaecal resection in Crohn’s disease patients not responding to conventional treatment.

中文翻译：

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OP03克罗恩病早期回盲肠切除后减少手术和药物治疗的需求：LIR！C试验的长期随访

背景

LIR！C试验表明，就生活质量而言，腹腔镜回盲肠切除术至少与抗TNF一样好，并且可以节省成本。当前的目的是比较两种干预措施的长期结果，并确定与初始治疗策略失败相关的因素。

方法

回顾性收集参与LIR！C试验的患者的长期数据，该试验是一项多中心，随机对照试验，该试验比较了腹腔镜回盲切除与英夫利昔单抗治疗非限制性和免疫调节性难治性回盲克罗恩病的成年患者。（再手术）或抗TNF所需的结果，治疗效果的持续时间以及与持续治疗效果相关的因素的识别。将治疗效果定义为无需其他克罗恩相关治疗的时间。先验定义潜在因素，并通过多变量Cox回归分析进行分析。

结果

中位随访时间为63.5 [IQR 39 – 94.5]个月。在切除组中，有18名（26.1％）患者开始抗TNF治疗，而没有患者需要再次切除（图1）。29名（42％）患者不需要其他与​​克罗恩病相关的治疗。相反，在英夫利昔单抗组中，有31名（47.7％）患者接受了克罗恩病相关的切除术。切除组和英夫利昔单抗组的中位治疗时间（95％CI）相似，而没有接受额外治疗分别为33（15.1–50.9）和34（0–69.3）个月（log-rank p = 0.521）。在两组中，预防性免疫调节剂均降低了进一步治疗的风险（HR 0.34 95％CI（0.16-0.69）和HR 0.49 95％CI（0.26-0.93））。图1.抗TNF和（re- ）手术

结论

这项对LIR！C试验的长期随访研究表明，在进行5年中位随访之后，大多数接受切除术的患者均未接受抗TNF治疗，而无需再次进行切除术，而几乎有一半无需进行切除疾病爆发的任何其他医学治疗方法。相反，英夫利昔单抗组中几乎一半的患者接受了克罗恩相关性切除。这些数据支持对常规治疗无反应的克罗恩病患者的早期回盲肠切除术。