Effectiveness and Safety of Adjunctive Cenobamate in People with Focal-Onset Epilepsy: Evidence from the First Interim Analysis of the BLESS Study

被引：3

作者：

Lattanzi, Simona ^{[1
]}

Ranzato, Federica ^{[2
]}

Di Bonaventura, Carlo ^{[3
]}

Bonanni, Paolo ^{[4
]}

Gambardella, Antonio ^{[5
]}

Tartara, Elena ^{[6
]}

Assenza, Giovanni ^{[7
]}

Procaccini, Michela ^{[8
]}

Falsetto, Nathalie ^{[8
]}

Villano, Valentina ^{[8
]}

Camattari, Gabriele ^{[8
]}

Ori, Alessandra ^{[9
]}

Di Gennaro, Giancarlo ^{[10
]}

机构：

[1] Marche Polytech Univ, Dept Expt & Clin Med, Neurol Clin, Ancona, Italy

[2] San Bortolo Hosp, Reg Adult Epilepsy Ctr, Neurol Unit, Vicenza, Italy

[3] Sapienza Univ Rome, Dept Human Neurosci, Policlin Umberto 1, Rome, Italy

[4] IRCCS Eugenio Medea, Sci Inst, Epilepsy & Clin Neurophysiol Unit, Conegliano, TV, Italy

[5] Magna Graecia Univ Catanzaro, Inst Neurol, Catanzaro, Italy

[6] IRCCS Mondino Fdn, Epilepsy Ctr, ERN EpiCare, Pavia, Italy

[7] Univ Campus Biomed, Dept Med, Unit Neurol Neurophysiol Neurobiol, Rome, Italy

[8] Angelini Pharm SPA, Rome, Italy

[9] IQVIA Medineos, Modena, Italy

[10] IRCCS Neuromed, Pozzilli, IS, Italy

来源：

NEUROLOGY AND THERAPY | 2024年 / 13卷 / 04期

关键词：

Antiepileptic; Cenobamate; Effectiveness; Epilepsy; Focal seizure; Italian clinical practice; Observational; Real-world evidence; Safety; MULTICENTER; EFFICACY; SEIZURES; DRUG;

D O I：

10.1007/s40120-024-00634-5

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

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.

引用

页码：1203 / 1217

页数：15