Arthritis Rheumatol:乌司奴单抗治疗系统性红斑狼疮的1年疗效和安全性

2019-11-28 xiangting MedSci原创 发表于上海

乌司奴单抗在1年内对SLE患者持续有效,其安全性与其他适应症一致。

这项研究在一项系统性红斑狼疮(SLEII临床试验中评估了乌司奴单抗的疗效和安全性。

纳入那些尽管已经接受标准治疗,但仍临床活动的SLE患者(SLE国际合作诊所标准)。活动性疾病定义为SLE疾病活动性指数2000SLEDAI-2K)评分≥6和大不列颠群岛狼疮评估组指数(BILAGA≥1/BILAG B评分≥2。患者(n=102)被随机分配(32)接受乌司奴单抗(第0周约6mg/kg静脉注射,然后从第8周开始每8周皮下注射90 mg)或匹配的安慰剂治疗,此外这些患者均接受标准治疗。第24周时,安慰剂组转为每8周皮下注射乌司奴单抗90mg,最初的乌司奴单抗组继续治疗至40周。在意向治疗人群中使用SLEDAI-2KSLE应答者指数 4SRI-4)、医师整体评估、皮肤和关节病指标评估疗效的维持情况。

24周的主要终点分析中,乌司奴单抗组(62%)的SRI-4反应率明显高于安慰剂组(33%)(p=0.006),并维持至48周(63.3%)。在乌司奴单抗组中,其他疾病指标的应答率一直维持到48周。在转为乌司奴单抗治疗的安慰剂组患者(n=33)中,也注意到疗效指标应答率的升高。在所有接受乌司奴单抗治疗的患者中,56周内81.7%的患者有≥1AE15.1%出现≥1个严重AE。未观察到死亡、恶性肿瘤、机会性感染或结核病例。

乌司奴单抗在1年内对SLE患者持续有效,其安全性与其他适应症一致。

原始出处:

Ronald F. van Vollenhoven. Maintenance of efficacy and safety of ustekinumab through 1 year in a randomized phase II trial of patients with active systemic lupus erythematosus. Arthritis Rheumatol. 25 November 2019.

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    2019-11-30 zhaojie88
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    2019-11-30 zhouqu_8
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    2019-11-28 内科新手

    谢谢梅斯提供这么好的信息,学到很多

    0

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