Long-Term Efficacy of Cenobamate by Focal Seizure Subtype: Post-hoc Analysis of an Open-Label Extension Study
Abstract number :
1.31
Submission category :
7. Anti-seizure Medications / 7E. Other
Year :
2023
Submission ID :
492
Source :
www.aesnet.org
Presentation date :
12/2/2023 12:00:00 AM
Published date :
Authors :
Presenting Author: Arkady Nisman, PharmD – SK Life Science, Inc.
William E. Rosenfeld, MD – Comprehensive Epilepsy Care Center for Children and Adults; Louis Ferrari, RPh, MBA – SK Life Science, Inc.
Rationale:
Cenobamate is an antiseizure medication (ASM) approved in the US (XCOPRI®) and Europe (ONTOZRY®) for the treatment of adults with focal seizures. Here we report long-term efficacy outcomes by focal seizure subtypes from a post-hoc analysis of the open-label extension (OLE) of an 18-week double-blind, phase 2 study (Krauss GL, et al. Lancet Neurol. 2020).
Methods:
In total, 437 adults 18-70 years old with uncontrolled focal seizures (focal aware motor [FAM], focal impaired awareness [FIA], or focal to bilateral tonic-clonic [FBTC] seizures) despite treatment with stable doses of one to three ASMs were enrolled in the phase 2 study. Patients entering the OLE underwent a two week blinded conversion to a target dose of cenobamate 300 mg once daily (max dose 400 mg/day) (Klein P, et al. Neurology. 2022).
Results:
A total of 355/437 randomized patients (81.2%) entered the OLE and had any OLE seizure data; 73 (20.6%), 318 (89.6%), and 130 (36.6%) patients had FAM, FIA, and FBTC seizures at study baseline, respectively (patients may have had ≥ 1 seizure subtype). Any consecutive ≥ 12-month duration of 100% seizure reduction was achieved by 29.8% (17/57), 30.8% (76/247), and 65.7% (65/99) of patients with FAM, FIA, and FBTC seizures (Figure 1). Any consecutive ≥24-month duration of 100% seizure reduction was achieved by 21.3% (10/47), 27.4% (57/208), and 59.6% (53/89) of patients with FAM, FIA, and FBTC seizures, respectively. Among patients over time, the percentage of patients achieving 100% seizure reduction during 12-month intervals was highest among the FBTC seizures subtype (Figure 2A). The percentage of patients achieving ≥90% seizure reduction in the FAM, FIA, and FBTC seizure subtypes was 31.6% (18/57), 32.1% (77/240), and 61.1% (58/95) during >12-24 months and increased to 46.3% (19/41), 44% (81/184), and 74.7% (56/75) during >48-60 months (Figure 2B).
Conclusions: Notable rates of 90% and 100% seizure reduction were achieved in all focal seizure subtypes over time through >48-60 months, with the greatest reductions occurring in the FBTC subtype. Results from this post-hoc analysis support the long-term efficacy of cenobamate across focal seizure types.
Funding: Funded by SK Life Science, Inc.
Anti-seizure Medications