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