托西利祖马布对接受葡萄糖皮质类药物治疗的多发性肌痛病患者的疾病活性的影响:随机临床试验
Valérie Devauchelle-Pensec1,2, Guillermo Carvajal-Alegria1,2, Emmanuelle Dernis3
1Rheumatology Department, Brest University Hospital, Brest, France.
JAMA
|September 20, 2022
概括
在多发性肌痛患者中,托西利祖马布显著改善了疾病的活性,并减少了普得尼松的使用. 这种插白素-6 (IL-6) 抗剂为这种疾病提供了有前途的治疗选择.
科学领域:
- 关节病学
- 免疫学
- 临床试验
背景情况:
- 葡萄糖皮质类药物依赖性多发性肌痛性风湿症 (PMR) 的治疗选择有限.
- 干白素-6 (IL-6) 抗剂在活跃的PMR中显示出降低疾病活性的潜力.
研究的目的:
- 为了比较托西利祖马布与安慰剂的疗效,在患有活跃的,依赖葡萄糖皮质激素的多肌性肌痛患者中.
主要方法:
- 这是一项双盲,安慰剂对照的随机临床试验,涉及101名PMR患者.
- 患者在24周内每4周内接受静脉注射托西利祖马布 (8 mg/ kg) 或安慰剂,同时接受标准化的普德尼松减量疗法.
主要成果:
- 主要终点在托西利祖马布组达到67. 3%,而在安慰剂组达到31. 4% (P < 0. 001).
- 托西利祖马布显著降低了C反应蛋白 (CRP) 水平和需要普德尼松的患者比例.
- 感染是最常见的不良事件,发生在46. 9%的托西利祖马布组和39. 2%的安慰剂组.
结论:
- 与安慰剂相比,托西利祖马布在治疗活跃多发性肌痛方面表现出更高的疗效,从而降低了对普得尼松的需求.
- 需要进一步的研究来证实这些发现,并评估tocilizumab在PMR治疗中的益处危害平衡.
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