Anakinra for the treatment of acute gout flares: a randomized, double-blind, placebo-controlled, active-comparator, non-inferiority trial
Anakinra for the treatment of acute gout flares: a randomized, double-blind, placebo-controlled, active-comparator, non-inferiority trial
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DOI：
10.1093/rheumatology/key402
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发表时间：
2019-08-01
期刊：
影响因子：
5.5
通讯作者：
van de laar, Mart A. F. J.
中科院分区：
文献类型：
--
作者：
Janssen, Carly A.;Voshaar, Martijn A. H. Oude;van de laar, Mart A. F. J.
目标。在一项随机、双盲、安慰剂对照、主动比较、非劣效性 (NI) 试验中评估阿那白滞素治疗急性痛风发作的有效性和安全性。方法。经晶体证实急性痛风发作的患者被随机（1:1）接受阿那白滞素治疗或照常治疗（自由选择：秋水仙碱、萘普生或泼尼松）。主要终点是基线与第 2 天平均疼痛评分之间的变化（按五点评分量表测量）。如果在协方差模型分析中评估的按方案 (PP) 和意向治疗 (ITT) 人群中，治疗组之间疼痛评分变化数值差异的 95% CI 上限不超过 NI 限值 0.4，则可确定阿那白滞素 NI，有利于照常治疗。次要结局包括安全性评估、5 天后疼痛、肿胀、压痛和治疗反应的改善，使用线性混合模型和二元逻辑回归模型进行评估。结果。 43 名患者接受阿那白滞素治疗，45 名患者照常接受治疗。在 PP（-0.13；-0.44，0.18）和 ITT（-0.18；-0.44，0.08）人群中，阿那白滞素的治疗效果并不劣于常规治疗（平均差；95% CI）。任一治疗组均未观察到意外或不常见（严重）不良事件。次要结果分析表明，两组患者的痛风症状均报告了类似的显着减轻。结论。阿那白滞素治疗急性痛风发作的疗效不逊色于常规治疗，这表明阿那白滞素是治疗急性痛风发作的有效替代疗法。
Objectives. To evaluate the efficacy and safety of anakinra in treating acute gout flares in a randomized, double-blind, placebo-controlled, active comparator, non-inferiority (NI) trial.Methods. Patients with a crystal-proven acute gout flare were randomized (1: 1) to treatment with anakinra or treatment as usual (free choice: either colchicine, naproxen or prednisone). The primary end point was the change in pain between baseline and the averaged pain score on days 2- measured on a five-point rating scale. NI of anakinra would be established if the upper bound of the 95% CI of the numeric difference in changed pain scores between treatment groups did not exceed the NI limit of 0.4 in favour of treatment as usual, in the per-protocol (PP) and intention-to-treat (ITT) populations, assessed in an analysis of covariance model. Secondary outcomes included safety assessments, improvement in pain, swelling, tenderness and treatment response after 5 days, assessed using linear mixed models and binary logistic regression models.Results. Forty-three patients received anakinra and 45 treatment as usual. Anakinra was non-inferior (mean difference; 95% CI) to treatment as usual in both the PP (-0.13; -0.44, 0.18) and ITT (-0.18; -0.44, 0.08) populations. No unexpected or uncommon (serious) adverse events were observed in either treatment arm. Analyses of secondary outcomes showed that patients in both groups reported similar significant reductions in their gout symptoms.Conclusion. Efficacy of anakinra was shown to be non-inferior to treatment as usual for the treatment of acute gout flares, suggesting that anakinra is an effective treatment alternative for acute gout flares.