Brivaracetam as add-on treatment in patients with post-stroke epilepsy: real-world data from the BRIVAracetam add-on First Italian netwoRk Study (BRIVAFIRST)

Lattanzi, S.; Canafoglia, L.; Canevini, M. P.; Casciato, S.; Cerulli Irelli, E.; Chiesa, V.; Dainese, F.; De Maria, G.; Didato, G.; Di Gennaro, G.; Falcicchio, G.; Fanella, M.; Ferlazzo, E.; Gangitano, M.; La Neve, A.; Mecarelli, O.; Montalenti, E.; Morano, A.; Piazza, F.; Pizzanelli, C.; Pulitano, P.; Ranzato, F.; Rosati, E.; Tassi, L.; Di Bonaventura, C.; Alicino, A.; Ascoli, M.; Assenza, G.; Avorio, F.; Badioni, V.; Banfi, P.; Bartolini, E.; Basili, L. M.; Belcastro, V.; Beretta, S.; Berto, I.; Biggi, M.; Billo, G.; Boero, G.; Bonanni, P.; Bongiorno, J.; Brigo, F.; Caggia, E.; Cagnetti, C.; Calvello, C.; Cesnik, E.; Chianale, G.; Ciampanelli, D.; Ciuffini, R.; Cocito, D.; Colella, D.; Contento, M.; Costa, C.; Cumbo, E.; D'Aniello, A.; Deleo, F.; Difrancesco, J. C.; Di Giacomo, R.; Di Liberto, A.; Domina, E.; Dono, F.; Durante, V.; Elia, M.; Estraneo, A.; Evangelista, G.; Faedda, M. T.; Failli, Y.; Fallica, E.; Fattouch, J.; Ferrari, A.; Ferreri, F.; Fisco, G.; Fonti, D.; Fortunato, F.; Foschi, N.; Francavilla, T.; Galli, R.; Gazzina, S.; Giallonardo, A. T.; Giorgi, F. S.; Giuliano, L.; Habetswallner, F.; Izzi, F.; Kassabian, B.; Labate, A.; Luisi, C.; Magliani, M.; Maira, G.; Mari, L.; Marino, D.; Mascia, A.; Mazzeo, A.; Milano, C.; Meletti, S.; Nilo, A.; Orlando, B.; Paladin, F.; Pascarella, M. G.; Pastori, C.; Pauletto, G.; Peretti, A.; Perri, G.; Pezzella, M.; Piccioli, M.; Pignatta, P.; Pilolli, N.; Pisani, F.; Pisani, L. R.; Placidi, F.; Pollicino, P.; Porcella, V.; Pradella, S.; Puligheddu, M.; Quadri, S.; Quarato, P. P.; Quintas, R.; Renna, R.; Rizzo, G. R.; Rum, A.; Salamone, E. M.; Savastano, E.; Sessa, M.; Stokelj, D.; Tartara, E.; Tombini, M.; Tumminelli, G.; Vaudano, A. E.; Ventura, M.; Viganò, I.; Viglietta, E.; Vignoli, A.; Villani, F.; Zambrelli, E.; Zummo, L.

doi:10.1016/j.seizure.2022.03.007

Objective: Post-stroke epilepsy (PSE) is one of the most common causes of acquired epilepsy and accounts for about 10-15% of all newly diagnosed epilepsy cases. However, evidence about the clinical profile of antiseizure medications in the PSE setting is currently limited. Brivaracetam (BRV) is a rationally developed compound characterized by high-affinity binding to synaptic vesicle protein 2A. The aim of this study was to assess the 12-month effectiveness and tolerability of adjunctive BRV in patients with PSE treated in a real-world setting. Methods: This was a subgroup analysis of patients with PSE included in the BRIVAracetam add-on First Italian netwoRk Study (BRIVAFIRST). The BRIVAFIRST was a 12-month retrospective, multicentre study including adult patients prescribed adjunctive BRV. Effectiveness outcomes included the rates of seizure response (≥50% reduction in baseline seizure frequency), seizure‐freedom, and treatment discontinuation. Safety and tolerability outcomes included the rate of treatment discontinuation due to adverse events (AEs) and the incidence of AEs. Results: Patients with PSE included in the BRIVAFIRST were 75 and had a median age of 57 (interquartile range, 42-66) years. The median daily doses of BRV at 3, 6, and 12 months from starting treatment were 100 (100-150) mg, 125 (100-200) mg and 100 (100-200) mg, respectively. At 12 months, 32 (42.7%) patients had a reduction in their baseline seizure frequency by at least 50%, and the seizure freedom rates was 26/75 (34.7%). During the 1-year study period, 10 (13.3%) patients discontinued BRV. The reasons of treatment withdrawal were insufficient efficacy in 6 (8.0%) patients and poor tolerability in 4 (5.3%) patients. Adverse events were reported by 13 (20.3%) patients and were rated as mild in 84.6% and moderate in 15.4% of cases. Significance: Adjunctive BRV was efficacious and generally well-tolerated when used in patients with PSE in clinical practice. Adjunctive BRV can be a suitable therapeutic option for patients with PSE.