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Ann Rheum Dis:瑞莎珠单抗治疗对活动性银屑病关节炎的疗效和安全性分析

2021-11-25 MedSci原创 MedSci原创

与安慰剂相比,瑞莎珠单抗治疗可显著改善关键疾病结局,并且对Bio-IR和/或csDMARD-IR的PsA患者具有良好的耐受性。

瑞莎珠单抗是一种白细胞介素23抑制剂,正在研究用于治疗银屑病关节炎(PsA)患者。KEEPsAKE的2期和3期试验探究了瑞莎珠单抗与安慰剂在既往对2种以下生物疗法(Bio-IR)和/或1种以上常规合成疾病缓解抗风湿药反应不足或不耐受的活动性PsA患者(csDMARD-IR)中的疗效和安全性。

近日,风湿病领域顶级期刊Annals of the Rheumatic Diseases上发表了一篇研究文章,该研究报告了PsA患者采用瑞莎珠单抗治疗的第24周的结局。

研究人员将Bio-IR和/或csDMARD-IR的PsA成人随机进行分组,在24周的双盲治疗期间,受试者在第0、第4和第16周接受皮下注射150mg瑞莎珠单抗或安慰剂治疗。该研究的主要终点是第24周美国风湿病学会评分(ACR20)改善≥20%的患者比例,该研究的次要终点评估PsA患者的关键领域和患者报告的结局。

该研究共有444名患者(中位年龄为53岁,范围为23-84岁)被随机分配至接受瑞莎珠单抗(n=224)或安慰剂(n=220)治疗;206名患者(46.5%)为Bio-IR患者。在治疗后的第24周,与安慰剂相比,接受瑞莎珠单抗治疗的患者达到ACR20的主要终点(51.3% vs. 26.5%,p<0.001)和所有次要终点(p<0.05)的比例明显更高。瑞莎珠单抗治疗和安慰剂治疗的患者分别报告了4.0%和5.5%的严重不良事件;据报道,严重感染分别为0.9%和2.3%。

由此可见,与安慰剂相比,瑞莎珠单抗治疗可显著改善关键疾病结局,并且对Bio-IR和/或csDMARD-IR的PsA患者具有良好的耐受性。

原始出处:

Andrew Östör,et al.Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 2 trial.Ann Rheum Dis.2021.https://ard.bmj.com/content/early/2021/11/23/annrheumdis-2021-221048

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    2021-11-27 lmm397
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