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Faricimab personalised treatment interval dosing dynamics illustrated with patient case profiles: YOSEMITE and RHINE phase 3 diabetic macular oedema trials

机译:Faricimab 个性化治疗间隔给药动态与患者病例概况说明:YOSEMITE 和 RHINE 3 期糖尿病性黄斑水肿试验

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Purpose: To illustrate treatment frequency dynamics with patient case profiles from the identical phase 3 YOSEMITE/RHINE (NCT03622580/NCT03622593) trials of faricimab (a bispecific antibody designed to inhibit angiopoietin-2 and vascular endothelial growth factor-A). Durability of faricimab effect in the personalised treatment interval (PTI) arm was a key objective of YOSEMITE/ RHINE. Methods: Diabetic macular oedema patients from YOSEMITE/RHINE received either faricimab 6.0 mg every eight weeks (Q8W, n = 630), faricimab 6.0 mg PTI (n = 632) or aflibercept 2.0 mg Q8W (n = 626). The PTI algorithm is a protocol-driven regimen based on the treat-and-extend concept; dosing intervals were adjusted in 4-week increments (up to Q16W) using pre-specified central subfield thickness and visual acuity criteria. Achievement of treatment intervals (Q4W, Q8W, Q12W or Q16W) and additional anatomical endpoints were assessed at week 52. Results: In YOSEMITE/RHINE, faricimab demonstrated non-inferior vision gains compared to aflibercept (faricimab Q8W: 10.7/11.8; faricimab PTI: 11.6/10.8; aflibercept: 10.9/10.3 letters), improved anatomic outcomes (mean central subfield thickness change: faricimab Q8W: -206.6/-195.8; faricimab PTI: -196.5/-187.6; aflibercept: -170.3/-170.1 μm), and extended dosing potential at year 1. Week 52 PTI treatment intervals and proportion of patients achieving them were: Q16W (>50), ≥Q12W (>70), Q8W (16) and Q4W (12). Representative cases and associated retinal images of PTI dosing dynamics (baseline-week 52) will be presented. Conclusion: This post-hoc analysis of individualised treatment frequency dynamics illustrates how the faricimab PTI algorithm was used effectively to optimise treatment intervals according to heterogeneous needs of patients with diabetic macular oedema. Faricimab PTI arm demonstrated durability of faricimab effect, with ~52 of patients on Q16W and ~72 on ≥Q12W treatment intervals at week 52.
机译:目的:通过法瑞西单抗(一种旨在抑制血管生成素-2和血管内皮生长因子-A)的相同 3 期 YOSEMITE/RHINE (NCT03622580/NCT03622593) 试验的患者病例概况来说明治疗频率动态。法瑞昔单抗效应在个性化治疗间隔 (PTI) 组中的持久性是优胜美地/莱茵河的一个关键目标。方法:来自优胜美地/莱茵的糖尿病性黄斑水肿患者每八周接受法瑞昔单抗 6.0 mg (Q8W, n = 630)、法瑞昔单抗 6.0 mg PTI (n = 632) 或阿柏西普 2.0 mg Q8W (n = 626)。PTI 算法是一种基于治疗和扩展概念的协议驱动方案;使用预先指定的中央子视野厚度和视力标准以 4 周的增量(最高 Q16W)调整给药间隔。在第 52 周评估治疗间隔(Q4W、Q8W、Q12W 或 Q16W)和其他解剖终点的实现情况。结果:在优胜美地/莱茵河中,与阿柏西普相比,法瑞西单抗显示出非劣效的视力增益(法瑞西单抗Q8W:10.7/11.8;法瑞西普PTI:11.6/10.8;阿柏西普:10.9/10.3 字母),改善解剖学结局(平均中央亚视野厚度变化:法瑞西单抗Q8W:-206.6/-195.8;法瑞西单抗PTI:-196.5/-187.6;阿柏西普:-170.3/-170.1μm),并在第1年延长了给药潜力。第 52 周 PTI 治疗间隔和达到这些间隔的患者比例为:Q16W (>50%)、≥Q12W (>70%)、Q8W (16%) 和 Q4W (12%)。将介绍 PTI 给药动态(基线-第 52 周)的代表性病例和相关视网膜图像。结论:这项对个体化治疗频率动态的事后分析说明了 faricimab PTI 算法如何根据糖尿病性黄斑水肿患者的异质性需求有效地优化治疗间隔。Faricimab PTI 组表现出 faricimab 作用的持久性,在第 52 周时,~52% 的患者接受 Q16W 治疗,~72% 的患者接受 ≥Q12W 治疗间隔。

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