Sen H Nida, Levy-Clarke Grace, Faia Lisa J, Li Zhuqing, Yeh Steven, Barron Karyl S, Ryan John G, Hammel Keri, Nussenblatt Robert B
National Eye Institute, NIH, Bethesda, MD 20892, USA.
Am J Ophthalmol. 2009 Nov;148(5):696-703.e1. doi: 10.1016/j.ajo.2009.06.003. Epub 2009 Aug 6.
To provide preliminary data regarding the safety and efficacy of high-dose intravenous daclizumab (Zenapax; Roche Inc, Nutley, New Jersey, USA) therapy for the treatment of juvenile idiopathic arthritis (JIA)-associated active anterior uveitis.
Interventional case series; open-label prospective, phase II pilot study.
Six patients were recruited into the study and received daclizumab therapy at doses of 8 mg/kg at baseline, 4 mg/kg at week 2, and 2 mg/kg every 4 weeks thereafter, for a total of 52 weeks. The study was done at the National Eye Institute between June 29, 2005 and July 9, 2008. The primary outcome was a two-step decrease in inflammation grade assessed at week 12. Primary safety outcome was assessed at weeks 2 and 4. The ocular inflammation was assessed according to the Standardization of Uveitis Nomenclature criteria.
Four of the 6 participants achieved two-step reduction in anterior chamber cells according to Standardization of Uveitis Nomenclature Working Group grading scheme for anterior chamber cells 12 weeks into the study and met the primary efficacy endpoint. One additional patient responded to reinduction whereas 1 patient failed reinduction and was considered an ocular treatment failure. Visual acuity improved from a mean of 68 Early Treatment Diabetic Retinopathy Study letters in the worse eye to a mean of 79.6 letters (2 Snellen lines). Three participants were terminated before 52 weeks: First, because of a rash possibly induced by daclizumab; Second, because of ocular treatment failure; and Last, because of uncontrolled systemic manifestations of JIA.
High-dose intravenous daclizumab can help reduce active inflammation in active JIA-associated anterior uveitis; however, patients need to be monitored for potential side effects. Larger randomized trials are needed to better assess treatment effect and safety.
提供有关大剂量静脉注射达利珠单抗（赛尼哌；罗氏公司，美国新泽西州纳特利）治疗青少年特发性关节炎（JIA）相关活动性前葡萄膜炎的安全性和有效性的初步数据。
干预性病例系列；开放标签前瞻性II期试点研究。
6名患者被纳入研究，在基线时接受8mg/kg剂量的达利珠单抗治疗，第2周接受4mg/kg剂量治疗，此后每4周接受2mg/kg剂量治疗，共52周。该研究于2005年6月29日至2008年7月9日在美国国立眼科研究所进行。主要结局是在第12周评估的炎症等级两步降低。主要安全性结局在第2周和第4周评估。根据葡萄膜炎命名标准对眼部炎症进行评估。
根据葡萄膜炎命名工作组前房细胞分级方案，6名参与者中有4名在研究12周时前房细胞减少了两步，并达到了主要疗效终点。另有1名患者再次诱导治疗有反应，而1名患者再次诱导治疗失败，被视为眼部治疗失败。视力从较差眼的平均68个早期糖尿病视网膜病变研究字母提高到平均79.6个字母（2行斯内伦视力表）。3名参与者在52周前终止治疗：第一名是因为可能由达利珠单抗引起的皮疹；第二名是因为眼部治疗失败；最后一名是因为JIA的全身表现未得到控制。
大剂量静脉注射达利珠单抗有助于减轻JIA相关活动性前葡萄膜炎的活动性炎症；然而，需要对患者进行潜在副作用的监测。需要进行更大规模的随机试验，以更好地评估治疗效果和安全性。
