Badr Mostafa, Helmstaedter Christoph, Moskau-Hartmann Susanna, Pukropski Jan, Witt Juri-Alexander, Rüber Theodor, Dague Karmele Olaciregui, Baumgartner Tobias, Rademacher Michael, Surges Rainer, von Wrede Randi
Department of Epileptology, University Hospital Bonn, Bonn, Germany.
Brain Behav. 2025 May;15(5):e70567. doi: 10.1002/brb3.70567.
Pharmacoresistance imposes a high burden on people with epilepsy (PWE). Recently authorized cenobamate (CNB) offers new hope with high efficacy reported in phase III and early real-world studies. Here, we present data from a reasonably sized monocentric cohort, complementing the knowledge derived from clinical practice.
We retrospectively analyzed medical records of all PWE treated with CNB from market entry to July 31, 2023.
After an average of 1.1 years, follow-up data were available for 262 out of 280 PWE, who received at least one dose of CNB. The average CNB dose was 183 ± 98 mg/d, with a mean number of anti-seizure medications (ASM) of 2.9 ± 1 per patient. A total of 36% of the patients showed ≥ 50% reduction in seizure frequency (10.7% were seizure-free), whilst 12.3% reported increased seizure frequency. Seizure freedom was associated with concomitant perampanel or GABA receptor modulators. No predictors of treatment response were found. Side effects were reported by 38%, alertness issues being most prevalent (19%). The retention rate amounted to 72% and was associated with response status, dose of CNB, side effects, and age at CNB introduction. Among those who discontinued CNB, 55% experienced side effects and 89% showed no meaningful seizure reduction. Regarding co-medication, the withdrawal of lamotrigine, brivaracetam, clobazam, or lacosamide was associated with higher rates of non-response.
In this large cohort of 262 PWE, CNB proved very efficient with a high retention rate over one year. Co-medication with perampanel or GABA receptor modulators was linked to seizure-freedom. The overall positive impression of CNB is further supported.
药物抵抗给癫痫患者（PWE）带来了沉重负担。最近获批的司替戊醇（CNB）带来了新希望，III期试验和早期真实世界研究报告显示其疗效显著。在此，我们展示了来自一个规模合理的单中心队列的数据，以补充从临床实践中获得的知识。
我们回顾性分析了从上市至2023年7月31日期间所有接受CNB治疗的PWE的病历。
平均1.1年后，280例接受至少一剂CNB治疗的PWE中有262例获得了随访数据。CNB的平均剂量为183±98毫克/天，每位患者的抗癫痫药物（ASM）平均数量为2.9±1种。共有36%的患者癫痫发作频率降低≥50%（10.7%无癫痫发作），而12.3%的患者报告癫痫发作频率增加。无癫痫发作与同时使用吡仑帕奈或GABA受体调节剂有关。未发现治疗反应的预测因素。38%的患者报告有副作用，其中警觉性问题最为常见（19%）。保留率为72%，与反应状态、CNB剂量、副作用以及开始使用CNB时的年龄有关。在停用CNB的患者中，55%经历了副作用，89%的患者癫痫发作无明显减少。关于联合用药，停用拉莫三嗪、布瓦西坦、氯巴占或拉考酰胺与更高的无反应率有关。
在这个由262例PWE组成的大型队列中，CNB被证明非常有效，一年的保留率很高。与吡仑帕奈或GABA受体调节剂联合用药与无癫痫发作有关联。这进一步支持了对CNB的总体积极印象。
