Effectiveness and safety of adjunctive cenobamate in people with focal-onset epilepsy: Interim results after 24-week observational period from the BLESS study.

IF 6.6 1区医学 Q1 CLINICAL NEUROLOGY

Epilepsia Pub Date : 2025-03-15 DOI:10.1111/epi.18357

Simona Lattanzi, Fedele Dono, Giuseppe d'Orsi, Alfredo D'Aniello, Mariangela Panebianco, Paolo Bonanni, Carlo Di Bonaventura, Elisa Montalenti, Antonio Gambardella, Federica Ranzato, Giada Pauletto, Elena Tartara, Angela La Neve, Francesca Bisulli, Giampaolo Vatti, Patrizia Pulitano, Claudio Liguori, Giovanni Assenza, Alfonso Giordano, Pietro Pignatta, Vincenzo Belcastro, Michela Cecconi, Simone Beretta, Chiara Pizzanelli, Marianna Pezzella, Massimo Gangitano, Maurizio Elia, Rosaria Renna, Catello Vollono, Angelo Pascarella, Luciana Tramacere, Giovanni De Maria, Daniela Audenino, Maria Pia Pasolini, Loretta Giuliano, Rosita Galli, Gionata Strigaro, Monica Puligheddu, Angelo Labate, Pietro Penza, Stefano Quadri, David Stokelj, Giovanni Boero, Elisa Fallica, Monica Santo Sabato, Giovanni Falcicchio, Nicoletta Foschi, Michela Procaccini, Valentina Villano, Gabriele Camattari, Fabiano Mele, Barbara Roncari, Giancarlo Di Gennaro

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引用次数: 0

Abstract

Objective: Cenobamate is an antiseizure medication (ASM) with a dual mechanism of action that was recently approved for the treatment of focal seizures in adults. This analysis aimed to describe the outcomes at 12 and 24 weeks after starting cenobamate therapy in a real-world setting.

Methods: BLESS [NCT05859854] is an ongoing, observational, retrospective and prospective cohort study to evaluate the real-world effectiveness and safety of adjunctive cenobamate in adults with uncontrolled focal epilepsy. Subgroup analysis was performed in subjects with 2 to 3 previous ASMs (early users) and those with >3 previous ASMs (late users).

Results: The second interim analysis of the BLESS study included 388 participants with a median (interquartile range) age of 43.0 (31.0-54.0) years. They had a median of 6.0 (4.0-9.0) prior ASMs and a median of 7.2 (3.0-20.6) monthly seizures at baseline. The median monthly seizure frequency was reduced by 59.9% (19.2%-87.3%) from baseline to 24 weeks; 229 (59.0%) subjects had a ≥50% seizure frequency reduction, and 44 (11.3%) showed sustained seizure freedom. The proportion of participants taking ≤2 concomitant ASMs increased from 217 (56.5%) at baseline to 239 (65.7%) at 24 weeks. Among the early users (n = 76, 19.6%), the median reduction in monthly seizure frequency at 24 weeks was 78.0% (50.0-97.1%), and 76.3% of subjects had a ≥50% response rate. The frequency of adverse drug reactions (ADRs) was 5.3% and 23.4% in early and late users. The most frequent ADRs were somnolence, dizziness, and balance disorder; after the occurrence of ADRs, 63.5% of participants maintained the prescribed dose, and 5.2% permanently discontinued treatment.

Significance: Cenobamate was effective in reducing seizure frequency in a real-world setting and showed a manageable safety profile. The treatment with cenobamate also reduced the burden of concomitant ASMs in both early and late users.

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辅助治疗局灶性癫痫的有效性和安全性：BLESS研究24周观察期后的中期结果

目的：Cenobamate是一种具有双重作用机制的抗癫痫药物（ASM），最近被批准用于治疗成人局灶性癫痫发作。该分析旨在描述在现实环境中开始化疗后12周和24周的结果。方法：BLESS [NCT05859854]是一项正在进行的、观察性的、回顾性的、前瞻性队列研究，旨在评估成人局灶性癫痫不受控制的辅助治疗的有效性和安全性。亚组分析2 ~ 3次asm患者（早期使用者）和3次asm患者（晚期使用者）。结果：BLESS研究的第二次中期分析包括388名参与者，年龄中位数（四分位数范围）为43.0岁（31.0-54.0）。在基线时，他们的平均asm为6.0（4.0-9.0）次，平均每月癫痫发作7.2次（3.0-20.6）次。从基线到24周，中位月癫痫发作频率降低59.9% (19.2%-87.3%)；229例（59.0%）患者癫痫发作频率降低≥50%，44例（11.3%）患者癫痫发作持续自由。同时服用≤2种asm的受试者比例从基线时的217例（56.5%）增加到24周时的239例（65.7%）。在早期使用者中（n = 76, 19.6%）， 24周时月癫痫发作频率的中位数降低为78.0%(50.0% -97.1%)，76.3%的受试者反应率≥50%。早期和晚期用药不良反应发生率分别为5.3%和23.4%。最常见的不良反应是嗜睡、头晕和平衡障碍；发生不良反应后，63.5%的参与者维持处方剂量，5.2%的参与者永久停止治疗。意义：Cenobamate在现实环境中有效降低癫痫发作频率，并显示出可控的安全性。用cenobamate治疗也减轻了早期和晚期使用者伴随的asm负担。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Epilepsia 医学-临床神经学

CiteScore

10.90

自引率

10.70%

发文量

319

审稿时长

2-4 weeks

期刊介绍： Epilepsia is the leading, authoritative source for innovative clinical and basic science research for all aspects of epilepsy and seizures. In addition, Epilepsia publishes critical reviews, opinion pieces, and guidelines that foster understanding and aim to improve the diagnosis and treatment of people with seizures and epilepsy.