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静脉注射戈利穆马布在患有多关节性青少年异常性关节炎的儿童中:一项开放式标签III期研究的长期扩展

Hermine I Brunner¹, César Pacheco-Tena², Ingrid Louw³

¹H.I. Brunner, MD, MSc, MBA, D.J. Lovell, MD, MPH, Cincinnati Children's Hospital Medical Center, Division of Rheumatology, University of Cincinnati, Cincinnati, Ohio, USA; hermine.brunner@cchmc.org.

The Journal of rheumatology

|August 1, 2024

概括

静脉注射戈利穆马布 (IV戈利穆马布) 在252周的时间里,在患有多关节性青少年异常性关节炎 (pcJIA) 的儿童中,证明了持续的药理动力学,安全性和有效性. 在GO-VIVA长期扩展研究中,该疗法显示出持久的临床反应和可接受的安全性.

科学领域:

儿科风湿病学儿科风湿病学
药理动力学和药物新陈代谢
免疫学免疫学免疫学

背景情况:

青少年异常性关节炎 (JIA) 是一种慢性自身免疫性疾病,影响儿童.
多关节性JIA (pcJIA) 涉及多个关节,可能导致严重的残疾.
静脉注射戈利穆马布是一种针对瘤缩因子-alpha.alpha的生物治疗.

研究的目的:

评估静脉注射 (IV) 戈利穆马布的药理动力学 (PK),免疫性,临床疗效和安全性,用于患有活性PCJIA的儿科患者.
评估GO-VIVA研究的开放性扩展中,通过252周对IV戈利穆马布治疗的长期结果.
为了确定是否保持临床响应和安全性,继续输液戈利穆马布治疗.

主要方法:

来自GO-VIVA研究的参与者继续输液戈利马布 (每8周一次80 mg/m2) 被纳入了这一长期延长 (LTE).
药理动力学和安全性分别被评估到第244周和第252周;临床反应被评估到第116周.
临床结局包括JIA-American College of Rheumatology (ACR) 的反应和10个关节的临床青少年关节炎疾病活动评分 (cJADAS10).

主要成果:

平均稳定状态低谷谷度从第52周到第244周保持稳定.
抗戈利穆马布抗体率是一致的,JIA-ACR反应率通常维持到116周.
严重不良事件和严重感染率每100个患者年分别为7.7和3.9,直到252周.

结论:

静脉注射戈利穆马布在儿科PCJIA患者中提供了足够的PK暴露,稳定的安全性和免疫性.
大多数参与者实现了最小的疾病活性,表明了持久的临床反应.
在这一群体中,IV戈利穆马布在长期治疗中表现出可接受的风险-益处概况.

关键词:

生物疗法是一种生物疗法.疾病修饰性抗风湿药物疾病修饰性抗风湿药物静脉注射的戈利穆马布可以使用.多关节性过程的青少年异常性关节炎.

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