SCI TOP 10

当前位置:首页>SCI TOP 10

Gevokizumab治疗自身免疫性非坏死性前巩膜炎:一项I/II期临床试验

Knickelbein JE, Tucker WR, Bhatt N, et al.

期刊名称:American Journal of Ophthalmology

卷期:2016年第172卷

摘要

目的:旨在评价抗白细胞介素1β(IL-1β)单克隆抗体gevokizumab治疗活动性,非感染性,非坏死性前巩膜炎的安全性和潜在疗效。设计:一项1/2期,非随机,前瞻性,单组试验性试验。方法:招募了8名活动性,非感染性,非坏死性前巩膜炎患者,患者至少有1只眼巩膜炎分级为+ 1+31名患者招募了两只眼,共9只眼(4只眼+1,1只眼+24只眼+3)。基线时患者接受1次皮下注射60mg gevokizumab,然后每4周注射一次,至12周。每次就诊时进行完全物理和眼检查。主要预后指标是与基线相比,0+ 4级巩膜炎研究眼分级至少下降2级,或降至0级(根据16周标准成像分级系统)。次要预后指标包括视敏度,眼内压和巩膜分级趋势。符合主要预后指标的参与者有资格在研究中继续多达52周,并且每4周接受额外的gevokizumab注射直到第36周,然后在第40周和52周进行2次安全性分析。结果:首次gevokizumab注射后2周(中位数),来自7例患者的7只眼睛符合主要预后指标。没有发现视力或眼内压明显变化。没有与研究药物相关的严重不良事件。共报道了43种不良反应,其中93%为轻度,95%为非眼性,仅14%认为可能由研究治疗引起。结论:这项小型研究结果表明,使用gevokizumab阻断IL-1β可能对活动性,非感染性前巩膜炎有益,并且gevokizumab耐受性良好。还需更大的随机试验来评估Gevokizumab在治疗非坏死性前巩膜炎中的真正疗效。

PURPOSE:To evaluate the safety and potential efficacy of gevokizumab, an anti-interleukin 1β (IL-1β) monoclonal antibody, in the treatment of active, noninfectious, non-necrotizing anterior scleritis.DESIGN:Phase 1/2, open label, nonrandomized, prospective, single-arm pilot trial.METHODS:Eight patients with active, noninfectious, non-necrotizing anterior scleritis with a scleral inflammatory grade of+1 to+3 in at least 1 eye were enrolled. In 1 patient both eyes were enrolled, for a total of 9 eyes (4 eyes with+1, 1 eye with+2, and 4 eyes with+3). Patients received 1 subcutaneous injection of 60mg gevokizumab at baseline and then every 4weeks for 12weeks. Complete physical and ocular examinations were performed at each visit. The primary outcome was at least a 2-step reduction or reduction to grade 0 in scleral inflammation on a 0 to+4 scale according to a standardized photographic scleritis grading system by 16weeks in the study eye compared to baseline. Secondary outcomes included changes in visual acuity, intraocular pressure, and trends in scleral grading. Participants who met the primary outcome were eligible to continue in the study for up to 52weeks and received additional gevokizumab injections every 4weeks until week 36, followed by 2 safety visits at weeks 40 and 52.RESULTS:Seven eyes from 7 patients met the primary outcome within a median time of 2weeks following the first gevokizumab injection. No definitive changes in visual acuity or intraocular pressure were identified. There were no serious adverse events related to the study drug. A total of 43 adverse effects were reported, with 93% described as mild, 95% as nonocular, and only 14% deemed possibly caused by the investigational treatment.CONCLUSIONS:The results of this small study suggest that blockage of IL-1β using gevokizumab may be beneficial in treating active, noninfectious anterior scleritis and that gevokizumab is well tolerated. Larger randomized trials are warranted to assess the true efficacy of gevokizumab in the treatment of non-necrotizing anterior scleritis.


点击下载

CopyRight 2016  兴齐100版权所有 京ICP证060955号
技术支持:示剑网络   http://100.sinqi.com/