Background: In randomized controlled trials, add-on brivaracetam (BRV) reduced seizure frequency in patients with drug-resistant focal epilepsy. Studies performed in a naturalistic setting are a useful complement to characterize the drug profile. Objective: This multicentre study assessed the effectiveness and tolerability of adjunctive BRV in a large population of patients with focal epilepsy in the context of real-world clinical practice. Methods: The BRIVAFIRST (BRIVAracetam add-on First Italian netwoRk STudy) was a retrospective, multicentre study including adult patients prescribed adjunctive BRV. Patients with focal epilepsy and 12-month follow-up were considered. Main outcomes included the rates of seizure‐freedom, seizure response (≥ 50% reduction in baseline seizure frequency), and treatment discontinuation. The incidence of adverse events (AEs) was also considered. Analyses by levetiracetam (LEV) status and concomitant use of strong enzyme-inducing antiseizure medications (EiASMs) and sodium channel blockers (SCBs) were performed. Results: A total of 1029 patients with a median age of 45 years (33–56) was included. At 12 months, 169 (16.4%) patients were seizure-free and 383 (37.2%) were seizure responders. The rate of seizure freedom was 22.3% in LEV-naive patients, 7.1% in patients with prior LEV use and discontinuation due to insufficient efficacy, and 31.2% in patients with prior LEV use and discontinuation due to AEs (p < 0.001); the corresponding values for ≥ 50% seizure frequency reduction were 47.9%, 29.7%, and 42.8% (p < 0.001). There were no statistically significant differences in seizure freedom and seizure response rates by use of strong EiASMs. The rates of seizure freedom (20.0% vs. 16.6%; p = 0.341) and seizure response (39.7% vs. 26.9%; p = 0.006) were higher in patients receiving SCBs than those not receiving SCBs; 265 (25.8%) patients discontinued BRV. AEs were reported by 30.1% of patients, and were less common in patients treated with BRV and concomitant SCBs than those not treated with SCBs (28.9% vs. 39.8%; p = 0.017). Conclusion: The BRIVAFIRST provided real-world evidence on the effectiveness of BRV in patients with focal epilepsy irrespective of LEV history and concomitant ASMs, and suggested favourable therapeutic combinations.
Adjunctive Brivaracetam in Focal Epilepsy: Real-World Evidence from the BRIVAracetam add-on First Italian netwoRk STudy (BRIVAFIRST) / Lattanzi, S.; Canafoglia, L.; Canevini, M. P.; Casciato, S.; Chiesa, V.; Dainese, F.; De Maria, G.; Didato, G.; Falcicchio, G.; Fanella, M.; Ferlazzo, E.; Fisco, G.; Gangitano, M.; Giallonardo, A. T.; Giorgi, F. S.; La Neve, A.; Mecarelli, O.; Montalenti, E.; Piazza, F.; Pulitano, P.; Quarato, P. 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.; Bongorno, J.; Brigo, F.; Caggia, E.; Cagnetti, C.; Calvello, C.; Irelli, E. 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 Gennaro, G.; Di Giacomo, R.; Di Liberto, A.; Domina, E.; Donato, F.; Dono, F.; Durante, V.; Elia, M.; Estraneo, A.; Evangelista, G.; Faedda, M. T.; Failli, Y.; Fallica, E.; Fattouch, J.; Ferrari, A.; Ferreri, F.; Fonti, D.; Fortunato, F.; Foschi, N.; Francavilla, T.; Galli, R.; Gazzina, 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.; Meletti, S.; Morano, A.; 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.; Quintas, R.; Renna, R.; Rossi, J.; Rum, A.; Salamone, E. M.; Savastano, E.; Sessa, M.; Stokelj, D.; Tartara, E.; Tombini, M.; Tumminelli, G.; Ventura, M.; Vigano, I.; Viglietta, E.; Vignoli, A.; Villani, F.; Zambrelli, E.; Zummo, L.. - In: CNS DRUGS. - ISSN 1172-7047. - 35:12(2021), pp. 1289-1301. [10.1007/s40263-021-00856-3]
Adjunctive Brivaracetam in Focal Epilepsy: Real-World Evidence from the BRIVAracetam add-on First Italian netwoRk STudy (BRIVAFIRST)
Meletti S.;Rossi J.;
2021
Abstract
Background: In randomized controlled trials, add-on brivaracetam (BRV) reduced seizure frequency in patients with drug-resistant focal epilepsy. Studies performed in a naturalistic setting are a useful complement to characterize the drug profile. Objective: This multicentre study assessed the effectiveness and tolerability of adjunctive BRV in a large population of patients with focal epilepsy in the context of real-world clinical practice. Methods: The BRIVAFIRST (BRIVAracetam add-on First Italian netwoRk STudy) was a retrospective, multicentre study including adult patients prescribed adjunctive BRV. Patients with focal epilepsy and 12-month follow-up were considered. Main outcomes included the rates of seizure‐freedom, seizure response (≥ 50% reduction in baseline seizure frequency), and treatment discontinuation. The incidence of adverse events (AEs) was also considered. Analyses by levetiracetam (LEV) status and concomitant use of strong enzyme-inducing antiseizure medications (EiASMs) and sodium channel blockers (SCBs) were performed. Results: A total of 1029 patients with a median age of 45 years (33–56) was included. At 12 months, 169 (16.4%) patients were seizure-free and 383 (37.2%) were seizure responders. The rate of seizure freedom was 22.3% in LEV-naive patients, 7.1% in patients with prior LEV use and discontinuation due to insufficient efficacy, and 31.2% in patients with prior LEV use and discontinuation due to AEs (p < 0.001); the corresponding values for ≥ 50% seizure frequency reduction were 47.9%, 29.7%, and 42.8% (p < 0.001). There were no statistically significant differences in seizure freedom and seizure response rates by use of strong EiASMs. The rates of seizure freedom (20.0% vs. 16.6%; p = 0.341) and seizure response (39.7% vs. 26.9%; p = 0.006) were higher in patients receiving SCBs than those not receiving SCBs; 265 (25.8%) patients discontinued BRV. AEs were reported by 30.1% of patients, and were less common in patients treated with BRV and concomitant SCBs than those not treated with SCBs (28.9% vs. 39.8%; p = 0.017). Conclusion: The BRIVAFIRST provided real-world evidence on the effectiveness of BRV in patients with focal epilepsy irrespective of LEV history and concomitant ASMs, and suggested favourable therapeutic combinations.
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