Department of Paediatrics, Rheumatology Unit, Anna Meyer Children's Hospital, University of Florence, Viale Pieraccini, Firenze 24 50139, Italy.
Institute for Maternal and Child Health - IRCCS "Burlo Garofolo" - Trieste, University of Trieste, Trieste, Italy.
Pediatr Rheumatol Online J. 2013 Apr 15;11:16. doi: 10.1186/1546-0096-11-16. eCollection 2013.
Nonetheless biologic modifier therapies are available treatment strategies for sight-threatening uveitis in children, the lack of evidence from head-to-head randomized controlled studies limits our understanding of timing of therapy when to commence therapy, which agent to choose and how long to continue treatment, and, in case of failure, if switching to another anti-TNF-α strategy might be eventually an option. Our aim was to compare the efficacy of Adalimumab when used as first anti-TNFα therapy versus Adalimumab used after the failure of a previous anti-TNFα (Infliximab) in an open-label, comparative, multi-center, cohort study of childhood chronic uveitis.
26 patients (14 F, 12 M; median age: 8.6 years) with refractory, non-infectious active uveitis were enrolled. Due to the refractory course of uveitis to previous DMARD treatment, Group 1 received Adalimumab (24 mg/sq mt, every 2 weeks), as first anti-TNFα choice; Group 2 received Adalimumab, as second anti-TNFα drug, due to the loss of efficacy of Infliximab, administered after a period of at least 1 year. Both groups received Adalimumab for at least 1 year of treatment. Primary outcome was, once remission was achieved, the time to a first relapse.
14 children (10 with JIA, 3 with idiopathic uveitis, 1 with Behçet's disease) were recruited in Group 1; 12 children (7 with JIA, 3 with idiopathic uveitis, 1 with early-onset sarcoidosis, 1 with Behçet's disease) in Group 2. Group 2 showed a lower probability to steroid discontinuation during the first 12 months of treatment (Mantel-Cox χ(2)4.12, p<0.04). In long-term follow-up, Group 1 had higher probability of uveitis remission during the time of treatment on Adalimumab (median ±SE: 18 ±1.1 vs 4 ±0.6 months, CI 95%: 15.6-27.5 vs 2.7-5.2, Mantel-Cox χ(2)10.12, p<0.002).
Even if limited to a relatively small group, our study suggests a better efficacy of Adalimumab when used as first anti-TNFα treatment in childhood chronic uveitis.
尽管有生物调节剂治疗可供选择，但对于儿童威胁视力的葡萄膜炎，缺乏头对头随机对照研究的证据限制了我们对何时开始治疗、选择哪种药物以及治疗持续时间的理解，如果治疗失败，是否可以最终选择另一种抗 TNF-α策略。我们的目的是比较阿达木单抗作为一线抗 TNFα 治疗与阿达木单抗在先前抗 TNFα（英夫利昔单抗）治疗失败后的疗效，这是一项开放性、对照、多中心、儿童慢性葡萄膜炎队列研究。
26 名（14 名女性，12 名男性；中位年龄：8.6 岁）患有难治性、非感染性活动性葡萄膜炎的患者入组。由于先前 DMARD 治疗的葡萄膜炎病程难治，第 1 组接受阿达木单抗（24mg/sq mt，每 2 周）作为一线抗 TNFα 选择；第 2 组由于英夫利昔单抗疗效丧失，在至少 1 年的时间后接受阿达木单抗作为二线抗 TNFα 药物。两组均接受至少 1 年的阿达木单抗治疗。主要结局是一旦达到缓解，首次复发的时间。
第 1 组招募了 14 名儿童（10 名患有 JIA，3 名患有特发性葡萄膜炎，1 名患有 Behçet 病）；第 2 组招募了 12 名儿童（7 名患有 JIA，3 名患有特发性葡萄膜炎，1 名患有早发性结节病，1 名患有 Behçet 病）。第 2 组在治疗的前 12 个月中更有可能停止使用类固醇（Mantel-Cox χ(2)4.12，p<0.04）。在长期随访中，第 1 组在接受阿达木单抗治疗期间更有可能缓解葡萄膜炎（中位数±SE：18±1.1 与 4±0.6 个月，CI 95%：15.6-27.5 与 2.7-5.2，Mantel-Cox χ(2)10.12，p<0.002）。
即使限于相对较小的组，我们的研究表明，阿达木单抗作为儿童慢性葡萄膜炎的一线抗 TNFα 治疗具有更好的疗效。
