选择性白细胞吸附术在激素依赖且免疫抑制剂/生物制剂疗效不佳或不耐受的活动性UC患者中的安全性和疗效研究：第12周的中期研究结果

来源：医学界消化频道

翻译及述评：上海瑞金医院消化内科  顾于蓓

选择性白细胞吸附术在激素依赖且免疫抑制剂和（或）生物制剂疗效不佳或不耐受的活动性溃疡性结肠炎患者中的安全性和疗效研究（ART试验）：第12周的中期研究结果。

Safety and efficacy of granulocyte/monocyte apheresis in steroid-dependent active ulcerative colitis with insufficient response or intolerance to immunosuppressants and/or biologics (ART trial): 12-week interim results.[J].

摘要：

背景和目的：对于激素依赖且免疫抑制剂和（或）生物制剂疗效不佳或不耐受的活动性溃疡性结肠炎患者来说，往往所剩的治疗选择较少。选择性白细胞吸附术在上述患者中被证实具有临床疗效。

方法：这是一项单臂、开放性的多中心研究，共有英国、法国和德国的18个医学中心共同参与研究。受试者纳入标准为18-75岁的中重度激素依赖且免疫抑制剂和（或）生物制剂疗效不佳或不耐受的活动性溃疡性结肠炎患者。所有受试者均接受了≥5周的选择性白细胞吸附术治疗。初步研究终点设立为在第12周的临床缓解率[临床活动指数≤4]。

结果：该研究共纳入86例受试者，研究第12周时在意向性治疗组中约33/84[39.3%]的受试者获得临床缓解。而47/84[56.0%]的受试者获得临床应答（临床活动指数下降≥3分）。对于既往免疫抑制剂和生物制剂治疗失效者中，30%通过选择性白细胞吸附术治疗获得临床缓解；在所有受试者中通过选择性白细胞吸附术治疗而达到无激素缓解或无激素应答的比率分别为22.6%和35.7%。此外，受试者的生活质量评分[短期健康值]在第12周时明显提高[p＜0.0001]。大多数的不良事件都是轻中度的。

结论：在这项大型队列中提示在第12周时选择性白细胞吸附术对既往激素依赖且免疫抑制剂和（或）生物制剂疗效不佳或不耐受的活动性溃疡性结肠炎患者具有显著的临床疗效和良好的安全性。这项研究结果与既往研究结果一致，认可了选择性白细胞吸附术在难治性溃疡性结肠炎患者中的治疗价值。

Dignass A, Akbar A, Hart A, et al. Journal of Crohn S & Colitis, 2016.

Abstract

Background and Aims: Patients with active, steroid-dependent ulcerative colitis with insufficient response or intolerance to immunosuppressants and/or biologic therapies have limited treatment options. Adacolumn, a granulocyte/monocyte adsorptive apheresis device, has shown clinical benefit in these patients. This study aimed to provide additional clinical data regarding the safety and efficacy of Adacolumn in this patient subgroup.

Methods: This single-arm, open-label, multicentre trial [ART] was conducted at 18 centres across the UK, France, and Germany. Eligible patients were 18–75 years old with moderate-to-severe, steroiddependent active ulcerative colitis with insufficient response or intolerance to immunosuppressants and/or biologics. Patients received ≥ 5 weekly apheresis sessions with Adacolumn. The primary endpoint was clinical remission rate [clinical activity index ≤ 4] at Week 12.

Results: In all, 86 patients were enrolled. At Week 12, 33/84 [39.3%] of patients in the intentionto-treat population achieved clinical remission, with 47/84 [56.0%] achieving a clinical response [clinical activity index reduction of ≥ 3]. Clinical remission was achieved in 30.0% of patients with previous immunosuppressant and biologic failure; steroid-free clinical remission and response were observed in 22.6% and 35.7% of these patients, respectively. Scale] significantly improved at Week 12 [p < 0.0001]. The majority of adverse events were of mild/moderate intensity.

Conclusions: At Week 12, Adacolumn provided significant clinical benefit in a large cohort of steroid-dependent ulcerative colitis patients with previous failure to immunosuppressant and/or biologic treatment, with a favourable safety profile. These results are consistent with previous studies and support Adacolumn use in this difficult-to-treat patient subgroup

评述：选择性白细胞吸附术起源于日本，目前在东西方各国被应用于多种自身免疫疾病的治疗。该技术利用白细胞吸附柱将受试者体内过度活跃的炎症因子及细胞进行吸附，从而达到抗炎作用。在我国该技术在初期的临床试验中已证实对溃疡性结肠炎和克罗恩病均具有较好诱导和维持缓解的疗效，尤其在轻中度难治性炎症性肠病中较其他临床方案更具优势。该技术不良反应较小、使用禁忌症也较少，可作为临床上炎症性肠病患者较好的治疗选择。但该技术的价格较为昂贵，这可能会限制其广泛使用。

作者简介：

顾于蓓，医学博士

上海瑞金医院消化内科，主治医师，长期从事难治性炎症性肠病诊治工作，2014年赴CCF进修，现任中国医师协会肛肠分会炎症性肠病组委员。

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