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Response Assessed by Ultrasonography as Target of Biological Treatment for Crohn's Disease.
Clinical Gastroenterology and Hepatology ( IF 12.6 ) Pub Date : 2019-12-20 , DOI: 10.1016/j.cgh.2019.10.042
Francesca Zorzi 1 , Subrata Ghosh 2 , Carlo Chiaramonte 1 , Elisabetta Lolli 1 , Martina Ventura 3 , Sara Onali 1 , Elena De Cristofaro 1 , Massimo C Fantini 1 , Livia Biancone 1 , Giovanni Monteleone 1 , Emma Calabrese 1
Affiliation  

Background & Aims

Mucosal healing, determined by ileocolonoscopy, is a goal for treatment of Crohn’s disease (CD), but this is an invasive assessment procedure. We investigated whether response to tumor necrosis factor (TNF) antagonists, determined by small-intestine contrast ultrasonography, associates with long-term outcomes.

Methods

We performed observational study of 80 patients with CD treated with anti-TNF agents for at least 1 year who underwent serial small intestine contrast ultrasonography (SICUS) at the University of Rome, in Italy. SICUS was used to evaluate disease site (based on bowel wall thickness), extent of lesions, and presence of complications. Inclusion criteria required pre-therapy SICUS with follow-up SICUS after 18 months. At second SICUS, patients were assigned to categories of complete or partial responder or non-responder. CD-related outcomes (corticosteroid need, hospitalization, and surgery) were assessed at 1 year from the second SICUS, using multivariate models, and were analyzed after long term follow up (5 years) using Kaplan-Meier survival analysis.

Results

Based on SICUS, after a median of 18 months, 36 patients (51%) were complete responders, 30 were partial responders (34%), and 13 were non-responders (15%). At 1 year from the second SICUS, no patients with a complete response, based on ultrasonography, underwent surgery, in comparison to partial responders (P = .0003) or non-responders (P = .001). Complete responders used smaller amounts of corticosteroids than partial responders (P = .0001) or non-responders (P < .0001). Complete responders required fewer hospitalizations than non-responders (P = .001). Kaplan-Meier survival analysis of long-term follow up data demonstrated a lower cumulative probability of need for surgery, hospitalization, and need for steroids among SICUS-categorized complete responders (P < .0001, P = .003 and P = .0001 respectively) than SICUS-categorized non-responders.

Conclusions

In patients with CD, response to anti-TNF agents, determined by SICUS, is associated with better long-term outcomes than partial or no response. Ultrasonographic assessment therefore provides a relatively non-invasive method for monitoring response to treatment in patients with CD.



中文翻译:

超声评估的反应作为克罗恩病生物治疗的目标。

背景与目标

通过回肠镜检查确定的粘膜愈合是治疗克罗恩病 (CD) 的目标,但这是一种侵入性评估程序。我们调查了对肿瘤坏死因子 (TNF) 拮抗剂的反应(由小肠超声造影确定)是否与长期结果相关。

方法

我们对 80 名接受抗 TNF 药物治疗至少 1 年的 CD 患者进行了观察性研究,这些患者在意大利罗马大学接受了连续小肠超声造影 (SICUS)。SIUS 用于评估疾病部位(基于肠壁厚度)、病变范围和并发症的存在。纳入标准要求治疗前 SICUS 和 18 个月后随访 SICUS。在第二次 SICUS 中,患者被分配到完全或部分反应者或无反应者类别。CD 相关结果(皮质类固醇需求、住院和手术)在第二次 SICUS 后 1 年使用多变量模型进行评估,并在长期随访(5 年)后使用 Kaplan-Meier 生存分析进行分析。

结果

根据 SICUS,中位时间为 18 个月后,36 名患者 (51%) 为完全反应者,30 名患者为部分反应者 (34%),13 名患者为无反应者 (15%)。在第二次 SICUS 后 1 年,与部分反应者 ( P = .0003) 或无反应者 ( P = .001)相比,超声检查显示完全反应的患者没有接受手术。与部分反应者 ( P = .0001) 或无反应者 ( P < .0001)相比,完全反应者使用较少量的皮质类固醇。完全反应者比无反应者需要更少的住院治疗(P =.001)。长期随访数据的 Kaplan-Meier 生存分析表明,在 SICUS 分类的完全缓解者中,需要手术、住院和需要类固醇的累积概率较低(分别为P < .0001、P = .003 和P = .0001 ) 比 SICUS 分类的无反应者。

结论

在 CD 患者中,由 SICUS 确定的对抗 TNF 药物的反应比部分反应或无反应与更好的长期结果相关。因此,超声评估提供了一种相对无创的方法来监测 CD 患者对治疗的反应。

更新日期:2019-12-20
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