Effectiveness and safety of early add-on therapy with brivaracetam in patients with poorly controlled focal seizures in routine clinical practice : BRIV-add study

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Abstract

Objective: To evaluate the effectiveness and safety of brivaracetam (BRV) as an add-on therapy in patients with focal onset seizures who did not achieve seizure freedom with antiseizure medication (ASM) monotherapy in routine clinical practice. Methods: This was a retrospective, observational, multicenter study conducted across 17 neurology centers in Spain. We evaluated adult patients with focal onset epilepsy who had inadequate seizure control after at least 3 months of ASM monotherapy and were treated with dual therapy, combining BRV with their previous ASM, with the intention of maintaining this treatment for at least 6 months. Data were collected from medical records on seizure frequency, ASM doses, and adverse events (AEs), taking into account the end of this 6-month period of dual therapy. The primary efficacy outcomes were the proportion of patients achieving ≥50% reduction in seizure frequency and those achieving seizure freedom. Safety outcomes included the incidence of treatment-related AEs. Results: A total of 195 patients (mean age: 43.2 years; 52.3% male; mean disease duration: 11.5 years) were included in the study. The main location of epilepsy was identified (53.8%) as the frontal lobe (27.7%). The mean number of seizures during the last 3 months of ASM monotherapy was 12.1 (SD 39.5), which decreased to 6.4 (SD 21.2) after 6 months of BRV add-on therapy. A ≥ 50% reduction in seizure frequency was achieved by 90.8% of patients, while 49.7% reached seizure freedom. The most common AEs were related to the central nervous system, reported by 22.1% of patients, with a treatment discontinuation rate due to AEs of 12.8%. Significance: BRV as an add-on therapy is effective in reducing seizure frequency and is well-tolerated in patients with focal onset seizures. This study supports the use of BRV as an add-on option in patients who do not achieve adequate seizure control with ASM monotherapy. Plain Language Summary: This study evaluated how effective and safe brivaracetam (BRV) is when added to another medication for patients with focal onset seizures. The results showed that adding BRV helped many patients reduce the number of seizures, and some patients stopped having seizures completely. Side effects were generally mild.