Department of Ophthalmology, University of Bonn, Germany.
Br J Ophthalmol. 2013 Sep;97(9):1161-7. doi: 10.1136/bjophthalmol-2013-303232. Epub 2013 Jul 13.
Evaluation of 1-year safety profile of intravitreal ranibizumab 0.5 mg in neovascular age-related macular degeneration (NV-AMD) within routine clinical practice.
The LUMINOUS programme comprises a prospective observational study assessing ranibizumab 'real-world' safety and clinical effectiveness across licensed indications worldwide and an annual retrospective pooled safety analysis from completed NV-AMD ranibizumab registries. 1-year data from four European registries are available. This retrospective pooled safety analysis assessed 1-year incidence rates for safety events of particular interest (key ocular or systemic events possibly related to the injection procedure or vascular endothelial growth factor inhibition) together with treatment exposure. Patients were treated according to local protocols within the ranibizumab licence.
Data of 4444 patients from registries in Germany (n=3470), the Netherlands (n=243), Belgium (n=260) and Sweden (n=471) were retrospectively pooled. Between 70.4% and 84.4% of enrolled patients completed 1 year of follow-up. Most frequent overall ocular events of particular interest were retinal pigment epithelial tears (27 patients; <1%) and intraocular pressure-related events (12 patients; <0.3%). Most frequent non-ocular event of particular interest was stroke (19 patients; 0.4%); annual incidence of stroke was low across all registries (0.0-0.5%).
Ranibizumab demonstrated favourable 1-year safety profile for NV-AMD in this routine clinical practice sample, consistent with previous reported trial data. Additional data from a larger patient population are needed to better describe the long-term safety profile of ranibizumab in routine clinical practice and further evaluate risk for infrequent but serious events in 'real-life' settings. The 5-year LUMINOUS prospective observational study will address this need.
评估常规临床实践中玻璃体内注射雷珠单抗 0.5mg 治疗新生血管性年龄相关性黄斑变性（NV-AMD）的 1 年安全性。
LUMINOUS 项目包括一项在全球范围内评估雷珠单抗在所有适应证下的“真实世界”安全性和临床疗效的前瞻性观察性研究，以及一项来自已完成 NV-AMD 雷珠单抗注册研究的年度回顾性汇总安全性分析。目前可提供四项欧洲注册研究的 1 年数据。这项回顾性汇总安全性分析评估了特定关注的安全性事件（可能与注射过程或血管内皮生长因子抑制相关的眼部或全身性关键事件）以及治疗暴露的 1 年发生率。患者根据雷珠单抗许可范围内的当地方案进行治疗。
汇总了来自德国（n=3470）、荷兰（n=243）、比利时（n=260）和瑞典（n=471）注册研究的 4444 例患者的数据。4444 例患者中有 70.4%至 84.4%完成了 1 年的随访。最常见的总体眼部特定关注事件是视网膜色素上皮撕裂（27 例；<1%）和与眼内压相关的事件（12 例；<0.3%）。最常见的非眼部特定关注事件是中风（19 例；0.4%）；所有注册研究的中风年发生率均较低（0.0-0.5%）。
在这项常规临床实践样本中，雷珠单抗治疗 NV-AMD 显示出有利的 1 年安全性，与先前报道的试验数据一致。需要来自更大患者群体的额外数据来更好地描述雷珠单抗在常规临床实践中的长期安全性，并进一步评估“真实世界”环境中罕见但严重事件的风险。为期 5 年的 LUMINOUS 前瞻性观察性研究将满足这一需求。
