Sustained seizure reduction, treatment simplification, and high retention with cenobamate: A 12-month real-world study in refractory and ultra-refractory focal epilepsy

IF 3.4 3区医学 Q2 CLINICAL NEUROLOGY

Epilepsia Open Pub Date : 2026-10-19 Epub Date: 2026-08-05 DOI:10.1002/epi4.70299

Francesca Cutropia, Maria Teresa Di Claudio, Marta Robustella, Umberto Costantino, Carmela Pia Ferro, Giuseppe Miscio, Elena Conte, Nicola Amoroso, Orazio Nicolotti, Cosimo Damiano Altomare, Massimo Carella, Antonella Liantonio, Paola Imbrici, Giuseppe d'Orsi

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Abstract

Objective

To assess the 12-month clinical impact of cenobamate (CNB) in adults with drug-resistant focal epilepsy in clinical practice, exploring whether outcomes differed according to prior antiseizure medication (ASM) exposure.

Methods

This single-center, retrospective, observational, real-world study included 91 adults stratified by the number of prior ASMs: ≤ 6 prior ASMs (n = 44) and > 6 prior ASMs (n = 47). Outcomes assessed at 3, 6, and 12 months included monthly seizure frequency, seizure freedom, retention rate, CNB dose, concomitant ASM burden, and adverse drug reactions (ADRs).

Results

In the overall cohort, mean monthly seizure frequency decreased from 28.77 at baseline to 22.73 (3 months), 19.37 (6 months), and 14.58 (12 months), representing mean reductions of 21%, 33%, and 49%, respectively. Seizure freedom was achieved by 12% (11/91) of patients at 3 months, 13% (11/87) at 6 months, and 19% (16/82) at 12 months. Treatment retention rate was 100% at 3 months, 95.6% at 6 months, and 90.1% at 12 months. Both subgroups showed clinical benefit, but outcomes were more favorable in patients with ≤ 6 prior ASMs, who had a lower baseline seizure burden and higher 12-month seizure freedom than those with > 6 prior ASMs (29% vs. 10%). At 12 months, most patients were receiving CNB doses of 200 mg or higher, and 79% were maintained on ≤ 2 concomitant ASMs. Overall, 38.5% (35/91) of patients reported at least one ADR (most frequently somnolence, vertigo, and asthenia).

Significance

In this real-world cohort of adults with drug-resistant focal epilepsy, CNB was associated with sustained seizure reduction, high 12-month retention rate, and acceptable tolerability, while most patients were maintained on a low concomitant ASM burden during follow-up. Improvement was observed even in highly treatment-experienced patients, although outcomes were more favorable in those with lower prior ASM burden, supporting the hypothesis that earlier CNB positioning may provide greater efficacy.

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持续的癫痫发作减少，治疗简化和高保留：一项12个月的真实世界研究难治性和超难治性局灶性癫痫。

目的：在临床实践中评估cenobamate （CNB）对成人耐药局灶性癫痫患者12个月的临床影响，探讨结果是否因既往抗癫痫药物（ASM）暴露而不同。方法：这项单中心、回顾性、观察性、真实世界的研究纳入了91名成年人，按既往asm的数量分层：≤6例asm （n = 44）和bb60例asm （n = 47）。在3、6和12个月时评估的结果包括每月癫痫发作频率、癫痫发作自由度、保留率、CNB剂量、伴随的ASM负担和药物不良反应（adr）。结果：在整个队列中，平均每月癫痫发作频率从基线时的28.77次下降到22.73次（3个月）、19.37次（6个月）和14.58次（12个月），平均分别下降了21%、33%和49%。3个月时12%（11/91）的患者癫痫发作自由，6个月时13%(11/87)，12个月时19%（16/82）。治疗保留率3个月为100%，6个月为95.6%，12个月为90.1%。两个亚组均显示出临床获益，但结果更有利的是既往asm≤6次的患者，其基线癫痫发作负担较低，12个月癫痫发作自由度高于既往asm≤6次的患者（29%对10%）。在12个月时，大多数患者接受200 mg或更高剂量的CNB， 79%的患者维持≤2次伴发asm。总体而言，38.5%（35/91）的患者报告了至少一种不良反应（最常见的是嗜睡、眩晕和虚弱）。意义：在这个现实世界的成人耐药局灶性癫痫队列中，CNB与持续的癫痫发作减少、12个月的高保留率和可接受的耐受性相关，而大多数患者在随访期间保持了较低的ASM伴随负担。即使在治疗经验丰富的患者中也观察到改善，尽管先前ASM负担较低的患者结果更有利，支持早期CNB定位可能提供更大疗效的假设。

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