Efficacy, durability, and safety of faricimab up to every 16 weeks in patients with neovascular age-related macular degeneration: 1-year results from the Japan subgroup of the phase 3 TENAYA trial,Japanese Journal of Ophthalmology

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Efficacy, durability, and safety of faricimab up to every 16 weeks in patients with neovascular age-related macular degeneration: 1-year results from the Japan subgroup of the phase 3 TENAYA trial
Japanese Journal of Ophthalmology ( IF 2.1 ) Pub Date : 2023-04-11 , DOI: 10.1007/s10384-023-00985-w
Ryusaburo Mori ₁ , Shigeru Honda ₂ , Fumi Gomi ₃ , Akitaka Tsujikawa ₄ , Hideki Koizumi ₅ , Haruka Ochi ₆ , Shino Ohsawa ₆ , Annabelle Ayame Okada ₇ ,

Affiliation

Purpose

To evaluate the 1-year efficacy, durability, and safety of faricimab versus aflibercept in patients with neovascular age-related macular degeneration (nAMD) enrolled in the Japan subgroup of the TENAYA trial.

Study design

TENAYA (NCT03823287) was a global, phase 3, multicenter, randomized, active comparator–controlled, double-masked, noninferiority, parallel-group, 112-week trial. After completion of global enrollment, additional patients were enrolled in the Japan extension of TENAYA.

Methods

Treatment-naïve patients aged ≥ 50 years with nAMD were randomized (1:1) to intravitreal faricimab 6 mg up to every 16 weeks (Q16W) after 4 initial Q4W doses based on disease activity at weeks 20 and 24 or aflibercept 2 mg Q8W after 3 initial Q4W doses. Primary endpoint was mean change in best-corrected visual acuity (BCVA) from baseline averaged over weeks 40, 44, and 48. Anatomical/durability outcomes were assessed.

Results

Overall, 133 patients were included in the TENAYA Japan subgroup analysis (faricimab, n = 66; aflibercept, n = 67). The adjusted mean (95% confidence interval) BCVA changes were + 7.1 (4.6‒9.7) and + 7.7 (5.2‒10.1) letters in the faricimab and aflibercept treatment groups, respectively. At week 48, 66.1%, 22.6%, and 11.3% of patients in the faricimab group were on Q16W, Q12W, Q8W and dosing intervals, respectively. Ocular adverse event rates were similar between treatment groups (faricimab, n = 14 [21.2%] versus aflibercept, n = 17 [25.4%]).

Conclusion

The TENAYA Japan subgroup analysis showed that faricimab up to Q16W had sustained efficacy with an acceptable safety profile. These findings are consistent with the global TENAYA and LUCERNE findings.

中文翻译：

每 16 周一次 faricimab 在新生血管性年龄相关性黄斑变性患者中的疗效、持久性和安全性：来自 3 期 TENAYA 试验日本亚组的 1 年结果

目的

评估 faricimab 与阿柏西普在 TENAYA 试验日本亚组中入组的新生血管性年龄相关性黄斑变性 (nAMD) 患者的 1 年疗效、持久性和安全性。

学习规划

TENAYA (NCT03823287) 是一项全球性、3 期、多中心、随机、活性对照药对照、双盲、非劣效性、平行组、为期 112 周的试验。在全球招募完成后，更多患者被招募到 TENAYA 的日本扩展中。

方法

根据第 20 周和第 24 周的疾病活动，在 4 次初始 Q4W 剂量后随机（1:1）接受玻璃体腔注射 faricimab 6 mg 每 16 周一次（Q16W）或阿柏西普 2 mg Q8W 3 次初始 Q4W 剂量。主要终点是第 40、44 和 48 周内最佳矫正视力 (BCVA) 相对于基线的平均变化。评估了解剖学/耐久性结果。

结果

总体而言，133 名患者被纳入 TENAYA 日本亚组分析（faricimab，n = 66；aflibercept，n = 67）。在 faricimab 和阿柏西普治疗组中，调整后的平均 BCVA 变化（95% 置信区间）分别为 + 7.1 (4.6-9.7) 和 + 7.7 (5.2-10.1) 个字母。第 48 周时，faricimab 组中分别有 66.1%、22.6% 和 11.3% 的患者处于 Q16W、Q12W、Q8W 和给药间隔。治疗组之间的眼部不良事件发生率相似（faricimab，n = 14 [21.2%] 与 aflibercept，n = 17 [25.4%]）。