Background

In randomized controlled trials, add-on brivaracetam (BRV) reduced seizure frequency in patients with drug-resistant focal epilepsy. Studies performed in a naturalistic setting are a useful complement to characterize the drug profile.

Objective

This multicentre study assessed the effectiveness and tolerability of adjunctive BRV in a large population of patients with focal epilepsy in the context of real-world clinical practice.

Methods

The BRIVAFIRST (BRIVAracetam add-on First Italian netwoRk STudy) was a retrospective, multicentre study including adult patients prescribed adjunctive BRV. Patients with focal epilepsy and 12-month follow-up were considered. Main outcomes included the rates of seizure‐freedom, seizure response (≥ 50% reduction in baseline seizure frequency), and treatment discontinuation. The incidence of adverse events (AEs) was also considered. Analyses by levetiracetam (LEV) status and concomitant use of strong enzyme-inducing antiseizure medications (EiASMs) and sodium channel blockers (SCBs) were performed.

Results

A total of 1029 patients with a median age of 45 years (33–56) was included. At 12 months, 169 (16.4%) patients were seizure-free and 383 (37.2%) were seizure responders. The rate of seizure freedom was 22.3% in LEV-naive patients, 7.1% in patients with prior LEV use and discontinuation due to insufficient efficacy, and 31.2% in patients with prior LEV use and discontinuation due to AEs (p < 0.001); the corresponding values for ≥ 50% seizure frequency reduction were 47.9%, 29.7%, and 42.8% (p < 0.001). There were no statistically significant differences in seizure freedom and seizure response rates by use of strong EiASMs. The rates of seizure freedom (20.0% vs. 16.6%; p = 0.341) and seizure response (39.7% vs. 26.9%; p = 0.006) were higher in patients receiving SCBs than those not receiving SCBs; 265 (25.8%) patients discontinued BRV. AEs were reported by 30.1% of patients, and were less common in patients treated with BRV and concomitant SCBs than those not treated with SCBs (28.9% vs. 39.8%; p = 0.017).

Conclusion

The BRIVAFIRST provided real-world evidence on the effectiveness of BRV in patients with focal epilepsy irrespective of LEV history and concomitant ASMs, and suggested favourable therapeutic combinations.

中文翻译：

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局灶性癫痫中的辅助布立西坦：来自布立瓦西坦添加的真实世界证据 第一个意大利网络研究 (BRIVAFIRST)

背景

在随机对照试验中，添加布立西坦 (BRV) 可降低耐药局灶性癫痫患者的癫痫发作频率。在自然主义环境中进行的研究是描述药物特征的有用补充。

客观的

这项多中心研究在真实世界临床实践的背景下评估了辅助 BRV 在大量局灶性癫痫患者中的有效性和耐受性。

方法

BRIVAFIRST（BRIVAracetam add-on First Italian network STudy）是一项回顾性、多中心研究，包括处方辅助 BRV 的成年患者。考虑了局灶性癫痫患者和 12 个月的随访。主要结果包括无癫痫发作率、癫痫发作反应（基线癫痫发作频率降低≥ 50%）和治疗停止率。还考虑了不良事件 (AE) 的发生率。进行了左乙拉西坦 (LEV) 状态和同时使用强酶诱导抗癫痫药物 (EiASMs) 和钠通道阻滞剂 (SCBs) 的分析。

结果

共纳入 1029 名中位年龄为 45 岁（33-56 岁）的患者。在 12 个月时，169 名 (16.4%) 患者没有癫痫发作，383 名 (37.2%) 是癫痫发作反应者。未使用 LEV 的患者无癫痫发作率为 22.3%，之前使用过 LEV 并因疗效不足而停药的患者为 7.1%，之前使用过 LEV 并因 AE 停药的患者为 31.2%（p  < 0.001）；≥ 50% 癫痫发作频率减少的相应值为 47.9%、29.7% 和 42.8% ( p  < 0.001)。使用强 EiASM 在癫痫发作自由度和癫痫发作反应率方面没有统计学上的显着差异。无癫痫发作率（20.0% 对 16.6%；p  = 0.341）和癫痫发作反应率（39.7% 对 26.9%；p = 0.006) 接受 SCB 的患者高于未接受 SCB 的患者；265 名 (25.8%) 患者停用 BRV。30.1% 的患者报告了 AE，并且在接受 BRV 和伴随 SCB 治疗的患者中比未接受 SCB 治疗的患者更少见（28.9% 对 39.8%；p  = 0.017）。

结论

BRIVAFIRST 提供了关于 BRV 在局灶性癫痫患者中的有效性的真实证据，无论 LEV 病史和伴随的 ASM，并提出了有利的治疗组合。