Objectives To assess the efficacy and safety of adalimumab on uveitis in patients with early onset, chronic, juvenile idiopathic arthritis (JIA)-associated or idiopathic anterior uveitis and an inadequate response to topical steroids and methotrexate (MTX). Methods Patients aged 4 years or more with ocular inflammation quantified by laser flare photometry (LFP) ≥30 photon units/ms were double-blindly randomised (1:1) to 2 groups, one treated with placebo and one with adalimumab subcutaneously at a dose of 24 mg/m2 in patients aged <13 years, 40 mg in the others, every other week. The primary outcome was response at month 2 (M2) defined as a 30% reduction of inflammation on LFP in the assessable eye with more severe baseline inflammation and no worsening on slit lamp examination. From M2 to M12, all patients received adalimumab. Results At M2, among 31 patients included in intention-to-treat analysis, there were 9/16 responders on adalimumab and 3/15 on placebo (P=0.038, Χ2 test; relative risk=2.81, 95% CI 0.94 to 8.45; risk difference: 36.3%, 95% CI 2.1 to 60.6); there was no significant difference using the Standardised Uveitis Nomenclature classification criteria of improvement. Thirty patients continued the trial after M2 and received adalimumab (open-label phase), 29 reached M12. There were seven serious adverse events none related to study treatment. Conclusions This trial is in favour of using adalimumab in patients with early onset, chronic anterior uveitis, which is in most cases associated with JIA, in case of inadequate response to topical therapy and MTX. LFP could be a valuable tool to assess early treatment efficacy. Trial registration number NCT01385826.

中文翻译：

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ADJUVITE：一项阿达木单抗治疗早发性、慢性、幼年特发性关节炎相关前葡萄膜炎的双盲、随机、安慰剂对照试验

目的 评估阿达木单抗对早发性、慢性、幼年特发性关节炎 (JIA) 相关或特发性前葡萄膜炎以及对局部类固醇和甲氨蝶呤 (MTX) 反应不足的患者葡萄膜炎的疗效和安全性。方法 将 4 岁或 4 岁以上的眼部炎症患者通过激光耀斑光度法 (LFP) 定量≥30 光子单位 / ms 双盲随机 (1:1) 分为两组，一组接受安慰剂治疗，另一组接受皮下注射阿达木单抗。 13 岁以下患者为 24 mg/m2，其他患者为 40 mg，每隔一周。主要结果是第 2 个月 (M2) 时的反应，定义为可评估眼 LFP 炎症减少 30%，基线炎症更严重，裂隙灯检查无恶化。从 M2 到 M12，所有患者均接受阿达木单抗治疗。结果在 M2，在意向治疗分析中包括的 31 名患者中，阿达木单抗有 9/16 有反应，安慰剂有 3/15（P=0.038，Χ2 检验；相对风险 = 2.81，95% CI 0.94 至 8.45；风险差异：36.3 %, 95% CI 2.1 至 60.6)；使用标准化葡萄膜炎命名分类标准改善没有显着差异。30 名患者在 M2 后继续试验并接受阿达木单抗（开放标签阶段），29 名患者达到 M12。有七次严重不良事件与研究治疗无关。结论 本试验支持在对局部治疗和 MTX 反应不足的情况下，在大多数情况下与 JIA 相关的早发性慢性前葡萄膜炎患者中使用阿达木单抗。LFP 可能是评估早期治疗效果的宝贵工具。试验注册号 NCT01385826。