本文由小咖机器人翻译整理

期刊来源：Lancet

原文链接：https://doi.org/10.1016/S0140-6736(24)00063-1

摘要内容如下：

背景

与阿柏西普2 mg相比，玻璃体内注射阿柏西普8 mg可改善新生血管性年龄相关性黄斑变性（NAMD）患者的治疗结果，并提供持续的疾病控制。

方法

PulSAR是一项3期、随机、三组、双盲、非劣效性、为期96周的试验，在全球223个地点进行。患有NAMD的成人按1:1:1的比例随机分配至阿柏西普8 mg每12周（8q12）、阿柏西普8 mg每16周（8q16）或阿柏西普2 mg每8周（2q8），所有组均在三个月的初始剂量后进行。从第16周开始，阿柏西普8 mg组患者的给药间隔缩短，前提是符合表明疾病活动的预先指定剂量方案修改标准。主要终点是第48周时最佳矫正视力（BCVA）相对于基线的变化。所有接受至少一剂研究治疗的患者均被纳入疗效和安全性分析。该试验已在ClinicalTrials.gov（NCT04423718）注册，目前正在进行中。

调查结果

在2020年8月11日至2021年7月30日期间随机接受阿柏西普8q12（n=336）、8q16（n=338）或2q8（n=337）治疗的1011名患者中，1009名患者接受了研究治疗（阿柏西普8q12 n=335；阿柏西普8q16 n=338；和阿柏西普2Q8（n=336）。与阿柏西普2q8相比，阿柏西普8q12和8q16的最佳矫正视力（BCVA）改善不明显（基线平均BCVA变化+6.7[SD 12.6]和+6.2[11.7]vs+7.6[12.2]）。阿柏西普8q12与2q8和8q16与2q8之间的最小二乘均数差异分别为-0.97（95%CI-2.87~0.92）和-1.14（-2.97~0.69）个字母（4个字母的非劣效性界值）。各组研究眼的眼部不良事件发生率相似（阿柏西普8q12 n=129[39%]；阿柏西普8q16 n=127[38%]；和阿柏西普2Q8（n=130[39%]）。

解释

阿柏西普8mg在延长给药间隔的情况下显示出疗效和安全性，这有可能改善NAMD患者的管理。

英文原文如下：

Abstracts

BACKGROUND  Intravitreal aflibercept 8 mg could improve treatment outcomes and provide sustained disease control in patients with neovascular age-related macular degeneration (nAMD), with extended dosing compared with aflibercept 2 mg.

METHODS  PULSAR is a phase 3, randomised, three-group, double-masked, non-inferiority, 96-week trial conducted across 223 sites worldwide. Adults with nAMD were randomised 1:1:1 to aflibercept 8 mg every 12 weeks (8q12), aflibercept 8 mg every 16 weeks (8q16), or aflibercept 2 mg every 8 weeks (2q8), following three initial monthly doses in all groups. From week 16, patients in the aflibercept 8 mg groups had their dosing interval shortened if pre-specified dose regimen modification criteria denoting disease activity were met. The primary endpoint was change from baseline in best-corrected visual acuity (BCVA) at week 48. All patients with at least one dose of study treatment were included in the efficacy and safety analyses. This trial is registered with ClinicalTrials.gov (NCT04423718) and is ongoing.

FINDINGS  Of 1011 patients randomised to aflibercept 8q12 (n=336), 8q16 (n=338), or 2q8 (n=337) between Aug 11, 2020, and July 30, 2021, 1009 patients received study treatment (aflibercept 8q12 n=335; aflibercept 8q16 n=338; and aflibercept 2q8 n=336). Aflibercept 8q12 and 8q16 showed non-inferior BCVA gains versus aflibercept 2q8 (mean BCVA change from baseline +6·7 [SD 12·6] and +6·2 [11·7] vs +7·6 [12·2] letters). The least squares mean differences between aflibercept 8q12 versus 2q8 and 8q16 versus 2q8, respectively, were -0·97 (95% CI -2·87 to 0·92) and -1·14 (-2·97 to 0·69) letters (non-inferiority margin at 4 letters). The incidence of ocular adverse events in the study eye was similar across groups (aflibercept 8q12 n=129 [39%]; aflibercept 8q16 n=127 [38%]; and aflibercept 2q8 n=130 [39%]).

INTERPRETATION  Aflibercept 8 mg showed efficacy and safety with extended dosing intervals, which has the potential to improve the management of patients with nAMD.

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