雷珠单抗 0.5mg 治疗初发糖尿病黄斑水肿的有效性和安全性：真实世界全球 LUMINOUS 研究结果。
Effectiveness and safety of ranibizumab 0.5 mg in treatment-naïve patients with diabetic macular edema: Results from the real-world global LUMINOUS study.
机构信息
Centre for Vision Research, Department of Ophthalmology and Westmead Institute for Medical Research, University of Sydney, Sydney, NSW, Australia.
Ivey Eye Institute, Schulich School of Medicine, Western University, Ontario, Canada.
出版信息
PLoS One. 2020 Jun 3;15(6):e0233595. doi: 10.1371/journal.pone.0233595. eCollection 2020.
PURPOSE
To assess the one-year effectiveness and safety of ranibizumab 0.5 mg in treatment- naïve patients with diabetic macular edema (DME) enrolled in the real-world LUMINOUS study.
PATIENTS AND METHODS
A 5-year, prospective, observational, open-label, global study which recruited 30,138 patients across all approved indications. Consenting patients (≥18 years) who were treatment-naïve or previously treated with ranibizumab or other ocular treatments were treated as per the local ranibizumab label. Here, we present the change in visual acuity (VA) (Early Treatment Diabetic Retinopathy Study letter score; primary treated eye) at Year 1, as well as the change in VA based on injection frequencies (≤4 and ≥5), treatment exposure, and the overall adverse events (AEs) and serious AEs (SAEs) in treatment-naïve DME patients.
RESULTS
Of the 4,710 DME patients enrolled in the study, 1,063 were treatment-naïve. At baseline, mean age was 64.5 years, 54.7% were male, and 69.2% were white. At 1 year, mean VA letter score improved by +3.5 (n = 502) from a baseline of 57.7 with a mean of 4.5 injections. Presented by injection frequencies ≤4 and ≥5, VA letter score gains were 0.5 (n = 264) and 6.9 (n = 238) from baseline letter scores of 56.6 and 59.0, respectively. Over 5 years, the incidence of ocular/non-ocular AEs and SAEs was 7.2%/10.1% and 0.3%/5.8%, respectively. No endophthalmitis cases were reported.
CONCLUSIONS
The LUMINOUS study included patients with DME with more diverse baseline characteristics than those in randomized clinical trials. The 1-year data showed improvement in VA with low number of injections in treatment- naïve patients with DME. Greater VA gains were observed in patients who received ≥5 injections. No new safety findings were identified. LUMINOUS confirms the effectiveness and safety of ranibizumab for the treatment of patients with DME in a real-world clinical practice.
目的
评估雷珠单抗 0.5mg 治疗初治糖尿病性黄斑水肿（DME）患者的一年疗效和安全性，该研究数据来自真实世界的 LUMINOUS 研究。
方法
这是一项为期 5 年的前瞻性、观察性、开放性、全球性研究，共纳入了 30138 名符合所有批准适应证的患者。纳入的患者（≥18 岁）为初治患者或既往接受过雷珠单抗或其他眼部治疗，均按照当地雷珠单抗说明书进行治疗。本研究主要报告了初治 DME 患者在第 1 年时视力（VA）（早期治疗糖尿病视网膜病变研究字母评分；主要治疗眼）的变化，以及基于注射频率（≤4 次和≥5 次）、治疗暴露情况以及总体不良事件（AE）和严重不良事件（SAE）的 VA 变化。
结果
在这项研究中，4710 名 DME 患者中有 1063 名患者为初治患者。在基线时，患者平均年龄为 64.5 岁，54.7%为男性，69.2%为白人。在第 1 年时，502 名患者的 VA 字母评分平均提高了+3.5（从基线的 57.7 提高到 61.2），平均注射 4.5 次。根据注射频率≤4 次和≥5 次，VA 字母评分的提高分别为 0.5（n=264）和 6.9（n=238），基线 VA 字母评分分别为 56.6 和 59.0。在 5 年期间，眼部/非眼部 AE 和 SAE 的发生率分别为 7.2%/10.1%和 0.3%/5.8%。未报告眼内炎病例。
结论
LUMINOUS 研究纳入的 DME 患者的基线特征比随机临床试验中的患者更为多样化。1 年数据显示，初治 DME 患者注射次数较少就能提高 VA。接受≥5 次注射的患者 VA 提高更明显。未发现新的安全性发现。LUMINOUS 研究证实了雷珠单抗治疗 DME 患者的有效性和安全性，且这些结果来自于真实世界的临床实践。
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