Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD 21218, USA.
Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD 21218, USA.
Epilepsy Behav. 2021 Mar;116:107796. doi: 10.1016/j.yebeh.2021.107796. Epub 2021 Feb 7.
A large proportion of patients with focal-onset epilepsy have frequent seizures despite treatment with newer anti-seizure medications (ASMs). We describe our experience optimizing cenobamate treatment for 49 patients treated at one center for up to eight years. We assessed the influence of treatment response on measurements of quality of life (QOLIE). Forty-nine patients were evaluated from three cenobamate regulatory trials: two open-label extensions of randomized placebo-controlled studies and one open-label safety study at the Johns Hopkins Hospital (JHU). Patients had focal-onset seizures despite treatment with one to three ASMs and were 18 years of age and older. Patients kept seizure diaries for the duration of the study and had tri-monthly evaluations. Seizure responder rates were determined, and patients with long-term seizure freedom (≥six months seizure free) were identified. Cenobamate doses were adjusted within the range of 100-400 mg/day. Johns Hopkins Hospital patients who were continuing treatment when the studies ended (n = 37) were administered the QOLIE-31 survey and a separate survey to assess changes in independence and epilepsy-linked disability at the end of the study at JHU. Thirty-seven of 49 (76%) patients continued treatment for three to eight years (median 5.6 years). In their final three months of treatment, 45% of patients achieved ≥75% seizure reduction, 29% had ≥90% reduction, and 16% were seizure free (responder rates computed with n = 49). Posttraumatic etiologies did not reduce treatment responses. Increased dosage of cenobamate across 150-400 mg/day range was significantly associated with higher responder rates (p < 0.001). High seizure responses-particularly ≥90% reduction-correlated with high QOLIE scores. Patients with drug-resistant focal-onset epilepsy had stable treatment responses during up to eight years of cenobamate treatment. Patients often tolerated high doses of cenobamate; high responders appeared to benefit with high QOLIE scores.
尽管使用了新型抗癫痫药物 (ASM),但仍有很大一部分局灶性癫痫发作的患者经常发作。我们描述了我们在一个中心优化依诺巴比妥治疗的经验,该中心对 49 名患者进行了长达八年的治疗。我们评估了治疗反应对生活质量 (QOLIE) 测量的影响。从三项依诺巴比妥监管试验评估了 49 名患者:两项随机安慰剂对照研究的开放标签扩展和约翰霍普金斯医院 (JHU) 的一项开放标签安全性研究。患者在接受一种至三种 ASM 治疗后仍有局灶性发作,年龄在 18 岁及以上。患者在研究期间保留癫痫发作日记,并每三个月进行一次评估。确定了癫痫发作缓解率,并确定了长期无癫痫发作 (≥6 个月无癫痫发作) 的患者。依诺巴比妥剂量在 100-400mg/天的范围内调整。当研究结束时,约翰霍普金斯医院的继续治疗的患者 (n=37) 接受了 QOLIE-31 调查和一项单独的调查,以评估研究结束时在 JHU 独立性和癫痫相关残疾的变化。49 名患者中的 37 名 (76%) 接受了三至八年的治疗 (中位数 5.6 年)。在最后三个月的治疗中,45%的患者达到了≥75%的癫痫发作减少,29%的患者减少了≥90%,16%的患者无癫痫发作 (根据 n=49 计算缓解率)。创伤后病因并未降低治疗反应。依诺巴比妥剂量在 150-400mg/天范围内增加与更高的缓解率显著相关 (p<0.001)。高癫痫发作反应-特别是≥90%的减少-与高 QOLIE 评分相关。药物难治性局灶性癫痫发作患者在长达八年的依诺巴比妥治疗期间治疗反应稳定。患者通常能耐受高剂量的依诺巴比妥;高反应者似乎受益于高 QOLIE 评分。