ARD:托珠单抗治疗新发风湿性多肌痛(PMR-SPARE):一项2/3期随机对照试验

2022-07-03 MedSci原创 MedSci原创

该研究发现在接受快速糖皮质激素减量的新发风湿性多肌痛患者中,托珠单抗在持续无糖皮质激素缓解、复发时间和累积糖皮质激素剂量方面优于安慰剂。

目的风湿性多肌痛是50岁以上人群中第二常见的炎症性风湿病。糖皮质激素治疗非常有效,但许多患者需要治疗数年,需要有效的糖皮质激素减量剂。

方法在这项双盲、多中心2/3期临床试验中,研究团队将来自三个中心的36名新发风湿性多肌痛患者随机分配接受皮下注射抗IL-6托珠单抗(每周162mg)或安慰剂治疗16周(比例为 1:1)。所有患者均接受口服强的松,在11周内从20 mg逐渐减量至0mg主要终点是第16周无糖皮质激素缓解的患者比例;评估了关键的次要终点,包括第一次复发的时间和第16周和第24周的累积糖皮质激素剂量。

结果 2017 1120日至20191028日,对39名患者进行了资格筛查;19 名患者接受了托珠单抗治疗,17名患者接受了安慰剂治疗。在第16周,托珠单抗组19名患者中有12名(63.2%)和安慰剂组17名患者中有2名(11.8%p=0.002)达到无糖皮质激素缓解,对应的OR12.995% CI2.273.6) 支持托珠单抗首次复发的平均 (±SD) 时间分别为130±1382±11 (p=0.007),中位(IQR)累积糖皮质激素剂量分别为 727 (721842) mg935 (8611244) mgp= 0.003)。在5名安慰剂患者和1名托珠单抗患者中观察到严重不良事件。

结论:该研究发现在接受快速糖皮质激素减量的新发风湿性多肌痛患者中,托珠单抗在持续无糖皮质激素缓解、复发时间和累积糖皮质激素剂量方面优于安慰剂。

出处:Bonelli M, Radner H, Kerschbaumer A, et al. Tocilizumab in patients with new onset polymyalgia rheumatica (PMR-SPARE): a phase 2/3 randomised controlled trial. Annals of the Rheumatic Diseases 2022;81:838-844.

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    2023-01-28 amyloid
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    2022-08-23 gostraight
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