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Ann Rheum Dis:阿达木单抗治疗幼年特发性关节炎相关性前葡萄膜炎的ADJUVITE研究

2017-12-24 xiangting MedSci原创

这项试验支持如果对局部治疗和MTX反应不良,在早发性慢性前葡萄膜炎患者中使用阿达木单抗。

这项研究在对局部类固醇和甲氨蝶呤(MTX)反应不良,早发性慢性幼年特发性关节炎(JIA)相关性或特发性前葡萄膜炎患者中,评估了阿达木单抗对葡萄膜炎的疗效和安全性。

将使用激光闪辉光度法(LFP)≥30个光子单位/ ms定量测量眼部炎症的4岁以上患者,双盲随机(1:1)分为2组。其中一组使用安慰剂;另一组使用阿达木单抗皮下注射,年龄<13岁的剂量为24 mg / m2,其他为每隔一周40 mg。主要结局是第2个月时的反应(M2),定义为基线炎症更重的可评估眼LFP炎症减轻30%,裂隙灯检查没有恶化。从M2到M12,所有患者接受阿达木单抗。

在M2,纳入意向治疗分析的31例患者中,有9/16例对阿达木单抗有应答和3/15例对安慰剂应答(P = 0.038,Χ 2检验;相对风险= 2.81,95%CI 0.94-8.45 ;风险差值:36.3%,95%可信区间2.1-60.6); 改善使用标准化葡萄膜炎命名分类标准没有显著差异。30例患者在M2后继续试验并接受阿达木单抗(开放标签期),29例达到M12。有7个严重不良事件,均与研究治疗无关。

这项试验支持如果对局部治疗和MTX反应不良,在早发性慢性前葡萄膜炎(多数情况下与JIA相关)患者中使用阿达木单抗。LFP是评估早期疗效的有价值工具。

原始出处:

Pierre Quartier, et al. ADJUVITE: a double-blind, randomised, placebo-controlled trial of adalimumab in early onset, chronic, juvenile idiopathic arthritis-associated anterior uveitis. Ann Rheum Dis. 23 December 2017. 

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    2017-12-26 lmm397
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    2017-12-24 1e0e5697m83(暂无匿称)

    henhao

    0

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