The real-world efficacy and safety of faricimab in neovascular age-related macular degeneration: the TRUCKEE study

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The real-world efficacy and safety of faricimab in neovascular age-related macular degeneration: the TRUCKEE study – 6 month results
Eye ( IF 2.8 ) Pub Date : 2023-05-12 , DOI: 10.1038/s41433-023-02553-5
Arshad M Khanani _{1,

2} , Aamir A Aziz ₂ , Hannah Khan ₂ , Ashwin Gupta ₃ , Ohidul Mojumder ₁ , Aigerim Saulebayeva ₁ , Ashkan M Abbey ₄ , David R P Almeida ₅ , Robert L Avery ₆ , Himanshu K Banda ₇ , Mark R Barakat ₈ , Ramanath Bhandari ₉ , Emmanuel Y Chang ₁₀ , Sara J Haug ₁₁ , Nikolas J S London ₁₂ , Luke Mein ₁₃ , Veeral S Sheth ₁₄ , Jeremy D Wolfe ₁₅ , Michael A Singer ₁₃ , Carl J Danzig ₁₆

Affiliation

Sierra Eye Associates, Reno, NV, USA.
University of Nevada, Reno School of Medicine, Reno, NV, USA.
Vanderbilt University School of Medicine, Nashville, TN, USA.
Texas Retina Associates, Dallas, TX, USA.
Erie Retinal Surgery, Erie, PA, USA.
California Retina Consultants, Santa Barbara, CA, USA.
Sound Retina, Tacoma, WA, USA.
Retinal Consultants of Arizona, Phoenix, AZ, USA.
Springfield Clinic Eye Institute, Springfield, IL, USA.
Retina & Vitreous of Texas, Houston, TX, USA.
Southwest Eye Consultants, Durango, CO, USA.
Retina Consultants San Diego, San Diego, CA, USA.
Medical Center Ophthalmology Associates, San Antonio, TX, USA.
University Retina, Chicago, IL, USA.
Associated Retinal Consultants, Royal Oak, MI, USA.
Rand Eye Institute, Deerfield Beach, FL, USA.

Background/Objective

Investigate real-world patients receiving faricimab for the treatment of neovascular age-related macular degeneration (nAMD).

Subjects/Methods

Multicenter, retrospective chart review was conducted on patients treated with faricimab for nAMD from February 2022 to September 2022. Collected data includes background demographics, treatment history, best-corrected visual acuity (BCVA), anatomic changes, and adverse events as safety markers. The main outcome measures are changes in BCVA, changes in central subfield thickness (CST) and adverse events. Secondary outcome measures included treatment intervals and presence of retinal fluid.

Results

After one injection of faricimab, all eyes (n = 376), previously-treated (n = 337) and treatment-naïve (n = 39) eyes demonstrated a + 1.1 letter (p = 0.035), a + 0.7 letter (p = 0.196) and a + 4.9 letter (p = 0.076) improvement in BCVA, respectively, and a − 31.3 μM (p < 0.001), a − 25.3 μM (p < 0.001) and a − 84.5 μM (p < 0.001) reduction in CST, respectively. After three injections of faricimab, all eyes (n = 94), previously-treated (n = 81) and treatment-naïve (n = 13) eyes demonstrated a + 3.4 letter (p = 0.03), a + 2.7 letter (p = 0.045) and a + 8.1 letter (p = 0.437) improvement in BCVA, and a − 43.4 μM (p < 0.001), a − 38.1 μM (p < 0.001) and a − 80.1 μM (p < 0.204) reduction in CST, respectively. One case of intraocular inflammation was observed after four injections of faricimab and resolved with topical steroids. One case of infectious endophthalmitis was treated with intravitreal antibiotics and resolved.

Conclusions

Faricimab has demonstrated improvement or maintenance of visual acuity for patients with nAMD, along with rapid improvement of anatomical parameters. It has been well-tolerated with low incidence of treatable intraocular inflammation. Future data will continue to investigate faricimab for real-world patients with nAMD.

中文翻译：

Faricimab 在新生血管性年龄相关性黄斑变性中的真实疗效和安全性：TRUCKEE 研究 – 6 个月结果

背景/目标

研究接受 Faricimab 治疗新生血管性年龄相关性黄斑变性 (nAMD) 的真实患者。

主题/方法

对 2022 年 2 月至 2022 年 9 月接受 Faricimab 治疗 nAMD 的患者进行了多中心、回顾性图表审查。收集的数据包括背景人口统计、治疗史、最佳矫正视力 (BCVA)、解剖学变化和作为安全标记的不良事件。主要结果指标是 BCVA 的变化、中央子区域厚度 (CST) 的变化和不良事件。次要结果指标包括治疗间隔和视网膜液的存在。

结果

注射一次 Faricimab 后，所有眼睛 ( n = 376)、既往治疗过的眼睛 ( n = 337) 和未治疗过的眼睛 ( n = 39) 均表现出 a + 1.1 字母 ( p = 0.035)、a + 0.7 字母 ( p = BCVA 分别提高 (0.196) 和 + 4.9 个字母 ( p = 0.076)，BCVA 分别降低 - 31.3 μM ( p < 0.001)、a - 25.3 μM ( p < 0.001) 和 a - 84.5 μM ( p < 0.001)分别为 CST。注射 3 次 Faricimab 后，所有眼睛 ( n = 94)、既往治疗过的眼睛 ( n = 81) 和未治疗过的眼睛 ( n = 13) 均表现出 a + 3.4 字母 ( p = 0.03)、a + 2.7 字母 ( p = BCVA 提高 0.045) 和 + 8.1 个字母 ( p = 0.437)，CST 降低 - 43.4 μM ( p < 0.001)、a - 38.1 μM ( p < 0.001) 和 a - 80.1 μM ( p < 0.204)，分别。注射四次 Faricimab 后观察到一例眼内炎症，并用局部类固醇解决。 1 例感染性眼内炎接受玻璃体内抗生素治疗并得到缓解。