Real-Life Effectiveness and Tolerability of Brivaracetam in Focal to Bilateral and Primary Generalized Tonic-Clonic Seizures

Effectiveness; Brivaracetam; Tonic-clonic seizuresEfectividad; Brivaracetam; Convulsiones tónico-clónicasEfectivitat; Brivaracetam; Convulsions tònic-clòniquesPurpose. Brivaracetam (BRV), an antiseizure medication indicated for focal-onset seizures, has shown efficacy in the treatment of focal to bilateral tonic-clonic seizures (FBTCS). We aimed to determine the effectiveness and safety of BRV in patients with FBTCS and generalized tonic-clonic seizures (GTCS). Methods. We performed a multicenter, retrospective, longitudinal study in adult patients with epilepsy who experienced at least one FBTCS or GTCS before starting BRV (baseline visit). Data were collected from consecutive outpatient visits over a 4-year period. All patients had been followed for at least 3 months before the baseline visit and completed a minimum follow-up of 3 months after starting BRV. Response (≥50% reduction in FBTCS/GTCS frequency) and retention rates, as well as seizure freedom and presence of adverse events at 3, 6, and 12 months, were recorded as outcome measures. Results. 114 patients were included (mean age years, 52% male, 36.6% genetic generalized epilepsy); 94 had a 12-month follow-up period. At 12 months’ follow-up, the response rate was 83%, and 73.4% of patients were FBTCS/GTCS-free. Retention was 79% at 12 months. Adverse events occurred in 29.8% of patients, the most common being drowsiness (14.9%). No significant differences were found in response rates between FBTCS and GTCS. Drug resistance was independently associated with lower response and seizure freedom rates at follow-up. The absence of a titration period predicted seizure freedom and response at 3 months. Conclusions. BRV is an effective and well-tolerated treatment in patients with focal to bilateral tonic-clonic seizures and generalized tonic-clonic seizures.E. Fonseca declares research funding and honoraria from UCB Pharma, Esteve Laboratorios, Eisai Inc., Bial Pharmaceutical, GW Pharmaceuticals, Angelini Pharma, and Sanofi Genzyme. A. Gifreu declares research funding from UCB Pharma and Bial Pharmaceutical. Manuel Quintana has received honoraria from UCB Pharma, Eisai Inc., Sanofi, GW Pharmaceuticals, Neuraxpharm Spain, and Pierre Fabre Ibérica. S. Lallana has received travel support and research funding from UCB Pharma and Bial Pharmaceutical. S. López-Maza declares travel support and research funding from Eisai Inc., UCB Pharma, and Neuraxpharm Spain. L. Abraira has received research funding and speaker fees from UCB Pharma, Bial Pharmaceutical, Eisai Inc., Sanofi Genzyme, and Esteve Laboratorios. D. Campos-Fernández has received research funding from UCB Pharma. E. Santamarina has received research funding and speaker fees from UCB Pharma, Bial Pharmaceutical, Eisai Inc., Arvelle, and Esteve Laboratorios. J. Rodríguez Uranga declares honoraria from Arvelle, Angelini Pharma, Bial Pharmaceutical, Eisai Inc., Esteve Laboratorios, UCB Pharma, and Pfizer Inc. M. Toledo declares research funding and speaker fees from UCB Pharma, GW Pharmaceuticals, Bial Pharmaceutical, Eisai Inc., Sanofi, Arvelle, and Esteve Laboratorios. J Abril Jaramillo and L. Redondo Vergé have no conflict of interest to declare