Emory University, Emory Epilepsy Center, 12 Executive Park Drive NE, Atlanta, GA 30329, United States.
UCB Pharma, Hoge Mosten, 2, 4822 NH Breda, Netherlands.
Epilepsy Behav. 2024 Sep;158:109922. doi: 10.1016/j.yebeh.2024.109922. Epub 2024 Jul 5.
This analysis assessed the effectiveness and tolerability of brivaracetam (BRV) in older (≥65 years of age) and younger (≥16 to <65 years of age) adults with epilepsy. This was a subgroup analysis from EXPERIENCE/EPD332, a pooled analysis of individual patient records from multiple independent, non-interventional studies of patients with epilepsy starting BRV in Australia, Europe, and the United States. Included patients had ≥6 months of follow-up data. Outcomes included responders (≥50 % reduction from baseline in seizure frequency), seizure freedom (no seizures within 3 months before the time point), and continuous seizure freedom (no seizures from baseline) at 12 months; BRV discontinuation during the whole study follow-up; and treatment-emergent adverse events (TEAEs) at 3, 6, and 12 months. Patients with missing data after BRV discontinuation were deemed non-responders/not seizure-free. Analysis populations included the Full Analysis Set (FAS; patients who received ≥1 BRV dose and had seizure type and age documented at baseline) and the modified FAS (FAS patients who had ≥1 seizure recorded during baseline). The FAS was used for all outcomes except seizure reduction. The FAS included 147 (8.9 %) patients aged ≥65 years and 1497 (91.1 %) aged ≥16 to <65 years. Compared with the younger subgroup, patients aged ≥65 years had a longer median epilepsy duration (33.0 years [n = 144] vs 17.0 years [n = 1460]) and lower median seizure frequency at index (2.0 seizures/28 days [n = 129] vs 4.0 seizures/28 days [n = 1256]), and less commonly had >1 prior antiseizure medication (106/141 [75.2 %] vs 1265/1479 [85.5 %]). At 12 months, a numerically higher percentage of patients aged ≥65 years versus the younger subgroup achieved ≥50 % seizure reduction (46.5 % [n = 71] vs 36.0 % [n = 751]), seizure freedom (26.0 % [n = 100] vs 13.9 % [n = 1011]), and continuous seizure freedom (22.0 % [n = 100] vs 10.7 % [n = 1011]). During the whole study follow-up, 43/147 (29.3 %) patients aged ≥65 years and 508/1492 (34.0 %) aged ≥16 to <65 years discontinued BRV. The incidence of TEAEs since the prior visit was similar in both subgroups at 3 months (≥65 years vs ≥16 to <65 years: 38/138 [27.5 %] vs 356/1404 [25.4 %]), 6 months (19/119 [16.0 %] vs 176/1257 [14.0 %]), and 12 months (8/104 [7.7 %] vs 107/1128 [9.5 %]). This real-world analysis suggests BRV was effective in patients aged ≥65 years and ≥16 to <65 years, with numerically higher effectiveness in the older subgroup. BRV was well tolerated in both subgroups.
本分析评估了布里瓦卡坦（BRV）在老年（≥65 岁）和年轻（≥16 岁至<65 岁）癫痫患者中的疗效和耐受性。这是来自 EXPERIENCE/EPD332 的亚组分析，该分析是对来自澳大利亚、欧洲和美国的多个独立非干预性癫痫患者开始使用 BRV 的个体患者记录进行的汇总分析。纳入的患者有≥6 个月的随访数据。结果包括应答者（发作频率比基线降低≥50%）、无发作（在时间点前 3 个月内无发作）和连续无发作（从基线开始无发作）12 个月；BRV 在整个研究随访期间停药；以及在 3、6 和 12 个月时出现的治疗中出现的不良事件（TEAEs）。BRV 停药后数据缺失的患者被视为无应答者/无发作。分析人群包括全分析集（FAS；接受≥1 剂 BRV 且在基线时记录了发作类型和年龄的患者）和修改后的 FAS（在基线期间有≥1 次发作记录的 FAS 患者）。除了发作减少，FAS 用于所有结果。FAS 包括 147 名（8.9%）≥65 岁和 1497 名（91.1%）≥16 岁至<65 岁的患者。与年轻亚组相比，≥65 岁的患者癫痫持续时间中位数更长（33.0 年[n=144]与 17.0 年[n=1460]），指数期发作频率中位数更低（2.0 次发作/28 天[n=129]与 4.0 次发作/28 天[n=1256]），并且更常见有>1 种既往抗癫痫药物（106/141[75.2%]与 1265/1479[85.5%]）。在 12 个月时，与年轻亚组相比，≥65 岁的患者中有更高比例的患者达到≥50%的发作减少（46.5%[n=71]与 36.0%[n=751]）、无发作（26.0%[n=100]与 13.9%[n=1011]）和连续无发作（22.0%[n=100]与 10.7%[n=1011]）。在整个研究随访期间，43/147（29.3%）名≥65 岁的患者和 508/1492（34.0%）名≥16 岁至<65 岁的患者停止使用 BRV。在 3 个月时（≥65 岁组与≥16 岁至<65 岁组：38/138[27.5%]与 356/1404[25.4%]）、6 个月时（19/119[16.0%]与 176/1257[14.0%]）和 12 个月时（8/104[7.7%]与 107/1128[9.5%]），两个亚组中 TEAEs 的发生率相似。这项真实世界分析表明，BRV 在≥65 岁和≥16 岁至<65 岁的患者中有效，老年组的疗效更高。BRV 在两个亚组中均耐受良好。
