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期刊来源：Nat Med

原文链接：https://doi.org/10.1038/s41591-024-02822-0

摘要内容如下：

侵蚀性手骨关节炎（OA）是一种流行的致残性疾病，治疗选择有限。在此，我们介绍了一项单中心、安慰剂对照、双盲、随机的2a期临床试验的结果，该试验使用了狄诺塞麦（一种核因子-κB配体抑制剂的受体激活剂），以评估其对糜烂性手OA的结构修饰的影响。患者随机接受为期48周的狄诺塞麦60mg每3个月（n=51，41名女性）或安慰剂（n=49，37名女性）治疗。主要（放射学）终点是第24周时根特大学总评分系统（GUSS）的变化，其中阳性变化对应于重塑，阴性变化对应于侵蚀性进展。次要终点是第48周GUSS的变化和第48周解剖阶段评分系统中新出现的侵蚀性关节的数量。基线时狄诺塞麦组目标关节的平均GUSS（标准差）为155.9（69.3），安慰剂组为158.7（46.8）。达到主要终点时，各组之间的估计差异为8.9（95%置信区间（CI）1.0至16.9；P=0.024）。该效果在第48周得到证实（基线校正GUSS（平均值的标准误差）狄诺塞麦和安慰剂分别为163.5（2.9）和149.2（3.9）；两组间估计差异为14.3（95%CI 4.6-24.0；P=0.00 3））。在患者水平上，在第48周，与狄诺塞麦组相比，安慰剂组出现了更多新的侵蚀性关节（比值比0.24（95%CI 0.08-0.72）；P=0.009）。与狄诺塞麦组（41名患者发生97例不良事件，占80%）相比，安慰剂组（44名患者发生125例不良事件，占90%）发生的不良事件更多。这些结果表明，狄诺塞麦通过诱导重塑和预防新的侵蚀性关节，对侵蚀性手OA具有结构修饰作用。欧盟临床试验注册标识符2015-003223-53。

英文原文如下：

Abstracts

Erosive hand osteoarthritis (OA) is a prevalent and disabling disease with limited treatment options. Here we present the results of a monocentric, placebo-controlled, double-blind, randomized phase 2a clinical trial with denosumab, a receptor activator of nuclear factor-κB ligand inhibitor, evaluating the effects on structure modification in erosive hand OA. Patients were randomized to 48 weeks treatment with denosumab 60 mg every 3 months (n = 51, 41 females) or placebo (n = 49, 37 females). The primary (radiographic) endpoint was the change in the total Ghent University Scoring System (GUSS) at week 24, where positive changes correspond to remodeling and negative changes to erosive progression. Secondary endpoints were the change in the GUSS at week 48 and the number of new erosive joints at week 48 by the anatomical phase scoring system. Baseline mean GUSS (standard deviation) of target joints was 155.9 (69.3) in the denosumab group and 158.7 (46.8) in the placebo group. The primary endpoint was met with an estimated difference between groups of 8.9 (95% confidence interval (CI) 1.0 to 16.9; P = 0.024) at week 24. This effect was confirmed at week 48 (baseline adjusted GUSS (standard error of the mean) denosumab and placebo were 163.5 (2.9) and 149.2 (3.9), respectively; with an estimated difference between groups of 14.3 (95% CI 4.6 to 24.0; P = 0.003)). At patient level, more new erosive joints were developed in the placebo group compared with denosumab at week 48 (odds ratio 0.24 (95% CI 0.08 to 0.72); P = 0.009). More adverse events occurred in the placebo group (125 events in 44 patients (90%)) compared with the denosumab group (97 events in 41 patients (80%)). These results demonstrate that denosumab has structure modifying effects in erosive hand OA by inducing remodeling and preventing new erosive joints. EU Clinical Trials Register identifier 2015-003223-53 .

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