Arthritis Rheumatol:洛瑞文特治疗膝关节骨关节炎的2期随机试验

2020-05-21 xiangting MedSci原创

这项2a期、概念验证试验未达到主要终点;然而,它确定了一个可以评估洛瑞文特潜在疗效的目标人群。

这项研究旨在评估中重度症状性膝关节骨关节炎(OA)中,新型Wnt通路调节剂洛瑞文特(SM04690)治疗疼痛和抑制结构进展的安全性和疗效。

在这项为期52周,2a期、多中心、随机、双盲、安慰剂(PBO)对照、剂量范围试验中,受试者分别接受单次2mL关节内注射0.03mg、0.07mg或0.23 mg洛瑞文特或PBO。通过WOMAC疼痛[0-100]和WOMAC功能[0-100]子量表的变化以及影像学关节间隙宽度(mJSW)评估疗效。分别进行基线校正后的协方差分析与多重插补以评估疗效。这项概念验证研究评估了意向性治疗人群以及预先确定的单侧症状性(UNI)受试者组和另外一个没有广泛疼痛的单侧症状性受试者的事后亚组(UNI WP-)。

455名受试者被随机分组​​。主要终点是与PBO比较,第13周WOMAC疼痛有所改善。任一剂量组均未达到主要终点(从基线的变化0.03mg,-23.3±2.2;0.07mg,-23.5±2.1;0.23mg,-21.3±2.2;PBO,‐22.1±2.1;P均>0.05)。所有组(包括PBO)均显示出较基线具有临床意义的改善(≥20分)。第52周评估了反应的持久性。第52周在预先确定的UNI和事后UNI WP组中,与PBO相比,0.07mg洛瑞文特明显改善了WOMAC疼痛(组间差异[95%CIs]:UNI,-8.73 [-17.44,-0.03],P=0.049;UNI WP-,-11.21[-20.99,-1.43],P=0.025)和WOMAC功能(UNI,-10.26[-19.82,-0.69],P=0.036;UNI WP-,-13.38[‐24.33,‐2.43],P=0.017)。与基线相比,第52周mJSW的平均变化在0.03mg队列为-0.04mm,在0.07mg队列为-0.09mm,在0.23mg队列为-0.16mm,在PBO组为-0.14mm。第52周时,没有一个治疗组mJSW的变化与PBO有统计学显著差异。在两个单侧亚组中,第52周与PBO比较,0.07mg剂量显著增加了mJSW(UNI,0.39mm [0.06,0.72],P=0.021;UNI WP-,0.42mm[0.04,0.80],P=0.032)。0.03mg和0.23mg剂量组的变化与PBO均无统计学差异。洛瑞文特的安全性和耐受性良好。

这项2a期、概念验证试验未达到主要终点;然而,它确定了一个可以评估洛瑞文特潜在疗效的目标人群。

原始出处:

Yusuf Yazici. Lorecivivint, a Novel Intra‐articular CLK/DYRK1A Inhibitor and Wnt Pathway Modulator for Treatment of Knee Osteoarthritis: A Phase 2 Randomized Trial. Arthritis Rheumatol.20 May 2020.

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    2020-09-13 lisa438
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    2020-05-23 lmm397
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    2020-05-23 zhaojie88
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    2020-05-21 肿瘤克星

    高质量研究,读起来真爽,谢谢梅斯

    0

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