Capsule Endoscopy-Guided Proactive Treat-to-Target Versus Continued Standard Care in Patients With Quiescent Crohn's Disease: A Randomized Controlled Trial.

The value of video capsule endoscopy (VCE) to guide proactive treat-to-target optimization in CD was examined.

本研究检验了视频胶囊内镜（VCE）在指导克罗恩病（CD）积极治疗目标优化中的价值。

Methods

A randomized controlled trialof patients with small bowel-involved (L1/L3) CD in corticosteroid-free clinical remission (Crohn's Disease Activity Index < 150).

一项针对小肠受累（L1/L3）克罗恩病（CD）患者在无皮质类固醇临床缓解（克罗恩病活动指数<150）状态下的随机对照试验。

Patients ingested a VCE at baseline and those with a Lewis inflammatory score (LS) ≥ 350 were designated "high risk" and randomized to either treat-to-target treatment optimization or continued standard care.

患者在基线时进行了视频胶囊内镜检查（VCE），那些Lewis炎症评分（LS）≥350的患者被指定为“高风险”，并随机分配到目标治疗优化治疗或持续标准护理。

Treat-to-target was optimized by means of repeat VCE results every 6 months.

通过每6个月重复进行视频胶囊内镜检查(VCE)结果来优化治疗目标。

Patients with LS < 350 ("low risk") continued standard care.

LS < 350（“低风险”）的患者继续接受标准治疗。

The primary outcome was the rate of disease exacerbation (Crohn's Disease Activity Index increase > 70 points and score > 150 or hospitalization/surgery) in high-risk standard care vs treat-to-target groups at 24 months.

主要结果是高风险标准护理组与目标治疗组在24个月时疾病加重（克罗恩病活动指数增加>70点且分数>150或住院/手术）的比率。

Results

Of 118 patients screened, 60 were enrolled.

在118名筛查的患者中，有60名被纳入研究。

Treatment intensification in patients in the high-risk group allocated to proactive strategy comprised biologic dose escalation (n = 11 of 20), starting a biologic (n = 8 of 20), or swapping biologics (n = 1 of 20).

在被分配到积极策略的高风险组患者中，治疗强度的增加包括生物剂量的升级（n = 11/20），开始使用生物制剂（n = 8/20），或更换生物制剂（n = 1/20）。

The primary outcome, clinical flare by 24 months, occurred in 5 of 20 (25%) of high-risk treat-to-target patients vs 14 of 20 (70%) of the high-risk standard-care group (odds ratio, 0.14; 95% CI, 0.04-0.57; P = .006).

主要结果，即24个月内临床发作，在20名高风险目标治疗患者中有5名（25%）发生，而在20名高风险标准护理组患者中有14名（70%）发生（优势比，0.14；95%置信区间，0.04-0.57；P = .006）。

Mucosal healing was significantly more common among the treat-to-target group when determined by a cutoff LS < 350 (odds ratio, 4.5; 95% CI, 1.7-17.4; nominal P value = .03), but not by the combined scores of total LS < 450 and highest-segment LS < 350.

当以LS < 350为界值时，目标治疗组的粘膜愈合显著更常见（优势比，4.5；95%置信区间，1.7-17.4；名义P值=0.03），但通过总LS < 450和最高段LS < 350的综合评分则不然。

Among all patients continuing standard care (n = 40), baseline LS was numerically higher among relapsers vs nonrelapsers (450, 225-900 vs 225, 135-600, respectively; P = .07).

在所有继续标准治疗的患者（n = 40）中，复发者的基线LS数值在数值上高于非复发者（分别为450，225-900和225，135-600；P = .07）。

Of 221 VCEs ingested, there was a single (0.4%) temporarily retained spontaneously resolved event.

在221个吞入的视频胶囊内镜中，有一个（0.4%）暂时滞留后自行解决的事件。

Conclusions

A VCE-guided treat-to-target strategy for patients with CD in remission confers superior clinical outcomes compared with continued standard care.

对于处于缓解期的克罗恩病患者，采用视频胶囊内镜引导的目标治疗策略比持续的标准治疗能带来更优越的临床结果。

clinicaltrials

gov, Number: NCT03555058.

政府注册号：NCT03555058。