A Randomized, Phase II Study Evaluating the Efficacy and Safety of Anakinra in the Treatment of Gout Flares
A Randomized, Phase II Study Evaluating the Efficacy and Safety of Anakinra in the Treatment of Gout Flares
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DOI：
10.1002/art.41699
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发表时间：
2021-08-01
影响因子：
13.3
通讯作者：
Terkeltaub, Robert
中科院分区：
文献类型：
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作者：
Saag, Kenneth G.;Khanna, Puja P.;Terkeltaub, Robert
目的比较阿那白滞素与曲安西龙治疗痛风发作的疗效和安全性。方法采用多中心、随机、双盲的方法，对非甾体类抗炎药和秋水仙碱治疗效果不佳的患者进行为期2年的随访。该研究旨在评估阿那白滞素（100或200 mg/天，持续5天）相对于曲安西龙（单次注射40 mg）的优效性，其主要终点是从基线至24-72小时，受影响最严重的关节（在0-100的视觉模拟量表上评分）的患者评估疼痛强度发生变化。次要结局指标包括：安全性、免疫原性以及患者和医生评估的总体应答。结果165例患者随机接受阿那白滞素（n = 110）或曲安西龙（n = 55）。中位年龄为55岁（范围25-83岁），87%为男性，平均病程为8.7年，前一年自我报告的发作平均次数为4.5次。共治疗了301例耀斑（214例使用阿那白滞素; 87例使用曲安西龙）。两种剂量的阿那白滞素和曲安西龙在第一次和随后的发作中提供了具有临床意义的患者评估疼痛强度的降低。对于首次发作，总阿那白滞素和曲安西龙的疼痛强度从基线到24-72小时的平均下降分别为-41.2和-39.4（P = 0.688）。阿那白滞素在大多数次要终点的表现优于曲安西龙。无非预期安全性结果。抗药抗体的存在与不良事件或疼痛减轻的改变无关。结论阿那白滞素在主要终点方面并不上级去炎松，但在疼痛缓解方面具有相当的疗效，并且在大多数次要终点方面更受青睐。阿那白滞素是一种有效的选择痛风发作时，常规治疗是不合适的。
Objective To evaluate the efficacy and safety of anakinra compared to triamcinolone in the treatment of gout flares. Methods Patients for whom nonsteroidal antiinflammatory drugs and colchicine were not suitable treatments were enrolled in this multicenter, randomized, double-blind study with follow-up for up to 2 years. The study was designed to assess superiority of anakinra (100 or 200 mg/day for 5 days) over triamcinolone (40 mg in a single injection) for the primary end point of changed patient-assessed pain intensity in the most affected joint (scored on a visual analog scale of 0-100) from baseline to 24-72 hours. Secondary outcome measures included: safety, immunogenicity, and patient- and physician-assessed global response. Results One hundred sixty-five patients were randomized to receive anakinra (n = 110) or triamcinolone (n = 55). The median age was 55 years (range 25-83), 87% were men, the mean disease duration was 8.7 years, and the mean number of self-reported flares during the prior year was 4.5. A total of 301 flares were treated (214 with anakinra; 87 with triamcinolone). Anakinra in both doses and triamcinolone provided clinically meaningful reduction in patient-assessed pain intensity in the first and subsequent flares. For the first flare, the mean decline in pain intensity from baseline to 24-72 hours for total anakinra and triamcinolone was -41.2 and -39.4, respectively (P = 0.688). Anakinra performed better than triamcinolone for most secondary end points. There were no unexpected safety findings. The presence of antidrug antibodies was not associated with adverse events or altered pain reduction. Conclusion Anakinra was not superior to triamcinolone for the primary end point, but had comparable efficacy in pain reduction and was favored for most secondary end points. Anakinra is an effective option for gout flares when conventional therapy is unsuitable.