Eslicarbazepine Acetate Monotherapy in Post-traumatic Epilepsy: A Post Hoc Analysis from a Randomized, Double Blind, Non-inferiority Clinical Trial (BIA-2093-311)
Abstract number :
2.245
Submission category :
7. Anti-seizure Medications / 7B. Clinical Trials
Year :
2022
Submission ID :
2205166
Source :
www.aesnet.org
Presentation date :
12/4/2022 12:00:00 PM
Published date :
Nov 22, 2022, 05:28 AM
Authors :
Joana Moreira, PharmD – BIAL- Portela & Ca, S.A.,; joana Branco-Santos, MD – BIAL- Portela & Ca, S.A.,; helena Brigas, MD – BIAL- Portela & Ca, S.A.,; filipa Gonçalves, MD – BIAL- Portela & Ca, S.A.,; guillermo Castilla-Fernández, MD – BIAL- Portela & Ca, S.A.,; Miguel M fonseca, MD – BIAL- Portela & Ca, S.A.,; ana Pereira, MD – BIAL- Portela & Ca, S.A.,; Helena Gama, MD – BIAL- Portela & Ca, S.A.,
Rationale: Post-traumatic epilepsy (PTE) is one of the most common and disabling sequelae of traumatic brain injury (BMC Neurology. 2021, 21:301). We aim to determine efficacy and safety/tolerability of eslicarbazepine acetate (ESL) monotherapy vs. controlled-release carbamazepine (CBZ-CR) in PTE patients.
Methods: BIA-2093-311 was a phase III double-blind, randomized, parallel-group study, which demonstrated non-inferiority of ESL vs. CBZ-CR for seizure freedom (SF) rates (Epilepsia. 2018, 59(2):479-491). A post hoc analysis was conducted for PTE vs. non-PTE patients to compare efficacy and safety.
Results: Of the 813 patients included, 525 (64,6%) had unknown aetiology and were excluded from the analysis. Of the remaining 288 patients, 80 (27,8%) had PTE (ESL, n= 35; CBZ-CR, n= 45) and 208 (72,2%) were non-PTE (ESL, n=97; CBZ-CR, n=111). The average risk difference (ARD) between ESL vs. CBZ-CR arms in SF was similar in PTE and non-PTE groups, ARD= -8,04% (-28,65%, 11,70%; 95% CI) and ARD =-5.05% (-7,51%, 17,88%), respectively. In the PTE group, treatment emerging adverse events (TEAEs) were reported by 82,9% and 73,3% of patients in ESL and CBZ-CR groups; related TEAEs: 42,9% (ESL) and 53,3% (CBZ-CR); related TEAEs leading to discontinuation: 11,4% (ESL) and 11,1% (CBZ-CR). In non-PTE group, TEAEs were reported by 81,4% and 81,1% of patients in ESL and CBZ-CR groups; related TEAEs: 39,2% (ESL) and 59,5% (CBZ-CR) of patients; related TEAEs leading to discontinuation: 10,3% (ESL) and 22,5% (CBZ-CR). No significant difference in TEAEs incidences were observed for ESL vs. CBZ-CR in PTE patients. In non-PTE group, ESL had lower discontinuation due to related TEAEs.
Conclusions: No significant differences were observed in ARD of SF and in safety and tolerability between ESL and CBZ-CR in PTE patients. In non-PTE patients, ESL was associated with fewer discontinuations due to related TEAEs although these results should be interpreted with caution due to small sample size and post hoc analysis nature. ESL monotherapy may be an effective and well tolerated treatment option for patients with PTE.
Funding: BIAL- Portela & Ca, S.A., S. Mamede do Coronado, Portugal
Anti-seizure Medications