Ann Rheum Dis:贝利木单抗治疗儿童系统性红斑狼疮的安全性和疗效

2020-07-27 xiangting MedSci原创

儿童SLE患者静脉注射贝利木单抗的药代动力学和收益-风险情况与成人的研究一致,每4周10mg/kg的剂量是合适的。

这项正在进行的2期、随机、安慰剂对照、双盲研究评估了静脉注射贝利木单抗对儿童系统性红斑狼疮(cSLE)的疗效、安全性和药代动力学。

患者(5-17岁)被随机分组接受每4周静脉注射贝利木单抗10mg/kg或安慰剂治疗,此外还进行标准SLE治疗。主要终点:SLE应答者指数(SRI4)应答率(第52周)。关键的次要终点:使用50和30替代定义达到小儿风湿病国际试验组织/美国风湿病学会(PRINTO/ACR)反应的患者比例(第52周),以及通过SRI4和父母幸福感整体评估(父母整体评估)达到持续应答的患者比例(第44-52周)。评估了安全性和药代动力学。研究不足以进行统计检验。

共有93例患者被随机分组​​(贝利木单抗组,n=53;安慰剂组,n=40)。第52周时,贝利木单抗组的SRI4应答者在数量上多于安慰剂(52.8%vs 43.6%;OR 1.49(95%CI为0.64-3.46))。贝利木单抗组PRINTO/ACR 30替代(52.8%vs 27.5%;OR 2.92(95%CI 1.19-7.17))和PRINTO/ACR 50(60.4%vs 35.0%; OR 2.74(95%CI 1.15-6.54))应答比安慰剂组更常见。SRI4(贝利木单抗43.4%;安慰剂41.0%; OR 1.08(95%CI 0.46-2.52))和父母整体评估(贝利木单抗59.1%;安慰剂33.3%;OR 3.49(95%CI 1.23-9.91)的持续应答也是如此。据报道,在17.0%的贝利木单抗患者和35.0%的安慰剂患者中出现严重不良事件;1例死亡(安慰剂)。第52周时,贝利木单抗谷浓度的几何平均值(95%CI)为56.2(45.2-69.8)μg/mL。

儿童SLE患者静脉注射贝利木单抗的药代动力学和收益-风险情况与成人的研究一致,每4周10mg/kg的剂量是合适的。

原始出处:

Hermine I Brunner. Safety and efficacy of intravenous belimumab in children with systemic lupus erythematosus: results from a randomised, placebo-controlled trial. Ann Rheum Dis. 17 July 2020.

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    2020-07-29 zhouqu_8
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    2020-07-27 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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