Institute of Ophthalmology and Visual Science, Rutgers New Jersey Medical School, Newark, New Jersey.
Genentech, Inc., South San Francisco, California.
Ophthalmology. 2024 Nov;131(11):1258-1270. doi: 10.1016/j.ophtha.2024.05.025. Epub 2024 Jun 8.
Diabetic Retinopathy Clinical Research Network Protocol T suggests that the response to treatment among patients with diabetic macular edema (DME) may vary depending on baseline best-corrected visual acuity (BCVA). We evaluated the efficacy of faricimab 6 mg versus aflibercept 2 mg over 2 years in patients with DME and baseline BCVA of 20/50 or worse enrolled in faricimab phase III trials.
YOSEMITE and RHINE were identically designed, multicenter, randomized, double-masked, active comparator-controlled, noninferiority trials.
Adults ≥18 years of age with center-involving macular edema secondary to type 1 or 2 diabetes.
Patients were randomized to faricimab every 8 weeks (Q8W), faricimab personalized treat-and-extend (T&E) regimen, or aflibercept Q8W. Post hoc subgroup analyses were conducted using the intention-to-treat population with baseline BCVA of 20/50 or worse.
Changes in ETDRS BCVA and central subfield thickness (CST) from baseline to years 1 and 2 were compared between treatment arms using mixed-model repeated measures analyses.
In YOSEMITE and RHINE, respectively, 220 and 217 patients in the faricimab Q8W arm, 220 and 219 patients in the faricimab T&E arm, and 219 and 214 patients in the aflibercept Q8W arm showed baseline BCVA of 20/50 or worse. In both trials, mean change in ETDRS BCVA was comparable between treatments across trials at years 1 and 2. In YOSEMITE, adjusted mean change from baseline in CST (μm) at year 1 was greater with faricimab Q8W (-232.8; P < 0.0001) and faricimab T&E (-217.4; P = 0.0004) ) versus aflibercept Q8W (-190.4). In RHINE, this was faricimab Q8W (-214.2; P = 0.0006) and faricimab T&E (-206.6; P = 0.0116) versus aflibercept Q8W (-186.6). In both trials, change from baseline in CST at year 2 was greater with faricimab Q8W versus aflibercept. The median time to first CST of <325 μm and first absence of intraretinal fluid was shorter in the faricimab arms versus the aflibercept arm, with fewer injections on average.
In patients with DME and baseline ETDRS BCVA of 20/50 or worse, faricimab treatment resulted in comparable visual acuity, greater reduction in retinal thickness, and fewer injections compared with aflibercept.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
糖尿病视网膜病变临床研究网络协议 T 表明，糖尿病性黄斑水肿（DME）患者的治疗反应可能因基线最佳矫正视力（BCVA）而异。我们评估了 faricimab 6mg 与 aflibercept 2mg 在 DME 患者中的疗效，这些患者在 faricimab 三期试验中基线 BCVA 为 20/50 或更差。
Yosemite 和 Rhine 的设计完全相同，均为多中心、随机、双盲、活性对照、非劣效性试验。
年龄在 18 岁及以上的成年人，患有 1 型或 2 型糖尿病继发的中心性黄斑水肿。
患者被随机分配至 faricimab 每 8 周（Q8W）、faricimab 个体化治疗和延长（T&E）方案或 aflibercept Q8W。使用基线 BCVA 为 20/50 或更差的意向治疗人群进行了事后亚组分析。
使用混合模型重复测量分析比较治疗臂从基线到第 1 年和第 2 年 ETDRS BCVA 和中心子场厚度（CST）的变化。
在 Yosemite 和 Rhine 中，faricimab Q8W 组、faricimab T&E 组和 aflibercept Q8W 组分别有 220 名和 217 名、220 名和 219 名、219 名和 214 名患者基线 BCVA 为 20/50 或更差。在两项试验中，在第 1 年和第 2 年，两种治疗方法在试验之间的 ETDRS BCVA 变化均具有可比性。在 Yosemite 中，与 aflibercept Q8W 相比，faricimab Q8W（-232.8；P<0.0001）和 faricimab T&E（-217.4；P=0.0004）的 CST 从基线到第 1 年的平均变化更大。在 Rhine 中，faricimab Q8W（-214.2；P=0.0006）和 faricimab T&E（-206.6；P=0.0116）与 aflibercept Q8W（-186.6）相比，CST 从基线到第 1 年的平均变化更大。在两项试验中，faricimab Q8W 与 aflibercept 相比，CST 从基线到第 2 年的变化更大。与 aflibercept 相比，faricimab 组首次 CST<325μm 和首次无视网膜内液的时间更早，平均注射次数更少。
在基线 ETDRS BCVA 为 20/50 或更差的 DME 患者中，与 aflibercept 相比，faricimab 治疗可导致视力相当、视网膜厚度更大程度降低和注射次数更少。
金融披露（Financial Disclosure）：在本文结尾的脚注和披露中可以找到专有或商业披露。
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