Anti-inflammatory therapy with low-dose IL-2 in acute coronary syndromes: a randomized phase 2 trial.

Low-dose interleukin-2 (IL-2) has been shown to increase Treg cell levels, potentially providing an immunomodulatory strategy in ACSs.

低剂量白细胞介素-2（IL-2）已被证明可以增加Treg细胞水平，这可能为ACS提供了一种免疫调节策略。

The IVORY trial was a double-blind, placebo-controlled, phase 2 trial in which patients presenting with ACSs and high-sensitivity C-reactive protein levels >2 mg l-1 were randomized in a 1:1 ratio to receive subcutaneous low-dose IL-2 (1.5 × 106 IU) or placebo for 8 weeks.

IVORY试验是一项双盲、安慰剂对照的2期临床试验，其中出现急性冠脉综合征且高敏C反应蛋白水平>2 mg l-1的患者按1:1的比例随机接受皮下低剂量IL-2（1.5 × 10^6 IU）或安慰剂治疗，为期8周。

[18F]Fluorodeoxyglucose positron emission tomography-computed tomography of the ascending aorta and carotid arteries was performed before and after treatment.

在治疗前后，对升主动脉和颈动脉进行了[18F]氟脱氧葡萄糖正电子发射断层扫描-计算机断层扫描。

Here the primary outcome was the difference in arterial inflammation in the index vessel (the vessel with the highest average maximum target-to-background ratio pre-treatment) on follow-up imaging between the two groups (placebo = 29 (female-to-male ratio (F-to-M) = 6:23); low-dose IL-2 = 31 (F-to-M = 3:28)).

这里的主要结果是两组之间（安慰剂组=29（女性与男性比例（F-to-M）=6:23）；低剂量IL-2组=31（F-to-M=3:28））在随访影像中，指数血管（治疗前平均最大靶目标-背景比最高的血管）的动脉炎症差异。

At the end of treatment, arterial inflammation was -0.171 (-7.7%) lower in the low-dose IL-2 group compared to the placebo group (95% confidence interval-0.308 to -0.034, P = 0.015).

治疗结束时，与安慰剂组相比，低剂量IL-2组的动脉炎症降低了0.171（-7.7%）（95%置信区间-0.308至-0.034，P=0.015）。

In secondary efficacy analyses, the difference in arterial inflammation between the low-dose IL-2 and placebo groups was greater (-8.3%, P = 0.009) in more inflamed segments and low-dose IL-2 treatment increased Treg cell levels compared to placebo (P < 0.0001).

在次要疗效分析中，低剂量IL-2组与安慰剂组之间的动脉炎症差异在炎症较重的部位更为显著（-8.3%，P=0.009），并且低剂量IL-2治疗相比安慰剂增加了调节性T细胞（Treg细胞）水平（P<0.0001）。

Low-dose IL-2 treatment appeared to be safe, with no major adverse cardiovascular events at the 2-year follow-up, compared to three patients with such events in the placebo group.

低剂量IL-2治疗似乎安全，在2年的随访期间没有主要的不良心血管事件，而安慰剂组有三名患者出现此类事件。

In conclusion, in patients with ACSs, low-dose IL-2 safely increases Treg cell levels and reduces arterial inflammation.

总之，在急性冠脉综合征患者中，低剂量IL-2安全地增加调节性T细胞水平并减少动脉炎症。

The clinical benefit of low-dose IL-2 requires validation in larger studies.

低剂量IL-2的临床益处需要在更大规模的研究中进行验证。

ClinicalTrials.gov registration: NCT04241601 .

临床试验注册：NCT04241601 .