Effectiveness and Safety of Adjunctive Cenobamate in People with Focal-Onset Epilepsy: Evidence from the First Interim Analysis of the BLESS Study.
IF 3.9
3区 医学
Q1 CLINICAL NEUROLOGY
引用次数: 0
Abstract
Introduction: Despite new anti-seizure medications (ASMs) being introduced into clinical practice, about one-third of people with epilepsy do not reach seizure control. Cenobamate is a novel tetrazole-derived carbamate compound with a dual mechanism of action. In randomized controlled trials, adjunctive cenobamate reduced the frequency of focal seizures in people with uncontrolled epilepsy. Studies performed in real-world settings are useful to complement this evidence and better characterize the drug profile.
Methods: The Italian BLESS ("Cenobamate in Adults With Focal-Onset Seizures") study is an observational cohort study aimed to evaluate the effectiveness, tolerability, and safety of adjunctive cenobamate in adults with uncontrolled focal epilepsy in the context of real-world clinical practice. The study is ongoing and conducted at 50 centers in Italy. This first interim analysis includes participants enrolled until June 2023 and with 12-week outcome data available.
Results: Forty participants with a median age of 36.5 (interquartile range [IQR] 26.0-47.5) years were included. The median monthly seizure frequency at baseline was 6.0 (IQR 2.5-17.3) seizures and 31 (77.5%) participants had failed four or more ASMs before cenobamate. At 12 weeks from starting cenobamate, the median reduction in monthly seizure frequency was 52.8% (IQR 27.1-80.3%); 22 (55.0%) participants had a ≥ 50% reduction in baseline seizure frequency and six (15.0%) reached seizure freedom. The median number of concomitant ASMs decreased from 3 (IQR 2-3) at baseline to 2 (IQR 2-3) at 12 weeks and the proportion of patients treated with > 2 concomitant ASMs decreased from 52.5% to 40.0%. Seven (17.5%) patients reported a total of 12 adverse events, 11 of which were considered adverse drug reactions to cenobamate.
Conclusion: In adults with uncontrolled focal seizures, the treatment with adjunctive cenobamate was well tolerated and was associated with improved seizure control and a reduction of the burden of concomitant ASMs.
Trial registration number: NCT05859854 (ClinicalTrials.gov Identifier).
对局灶性癫痫患者辅助使用塞诺巴马特的有效性和安全性：BLESS 研究首次中期分析的证据。
简介：尽管新的抗癫痫药物（ASMs）不断被引入临床实践，但仍有约三分之一的癫痫患者无法控制癫痫发作。仙诺巴马特是一种新型四氮唑衍生氨基甲酸酯化合物，具有双重作用机制。在随机对照试验中，辅助使用塞诺巴马特可以减少未受控制的癫痫患者的局灶性癫痫发作频率。在真实世界环境中进行的研究有助于补充这一证据，并更好地描述药物的特性：意大利 BLESS（"成人局灶性癫痫发作中的塞诺巴马特"）研究是一项观察性队列研究，目的是在实际临床实践中评估未受控制的成人局灶性癫痫患者辅助使用塞诺巴马特的有效性、耐受性和安全性。该研究正在意大利的 50 个中心进行。首次中期分析包括截至2023年6月的入组参与者，并提供了12周的结果数据：结果：共纳入 40 名参与者，中位年龄为 36.5 岁（四分位数间距 [IQR] 26.0-47.5）。基线时每月发作频率的中位数为 6.0 次（IQR 2.5-17.3 次），31 名参与者（77.5%）在服用西诺巴马特之前曾有四次或更多次 ASM 治疗失败。开始服用西诺巴马特 12 周后，每月发作频率减少的中位数为 52.8%（IQR 27.1-80.3%）；22 名参与者（55.0%）的基线发作频率减少了≥50%，6 名参与者（15.0%）达到了无发作状态。并发 ASM 的中位数从基线时的 3（IQR 2-3）降至 12 周时的 2（IQR 2-3），并发 ASM > 2 次的患者比例从 52.5% 降至 40.0%。7名（17.5%）患者共报告了12起不良事件，其中11起被认为是西诺巴马特的药物不良反应：对于无法控制的成人局灶性癫痫发作患者，辅以仙诺巴马特治疗的耐受性良好，且癫痫发作控制得到改善，同时伴发的ASMs也有所减少：NCT05859854（ClinicalTrials.gov Identifier）。
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来源期刊
Neurology and Therapy
CLINICAL NEUROLOGY-
CiteScore
5.40
自引率
8.10%
发文量
103
审稿时长
6 weeks
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