Introduction: Subjects with intellectual disability are usually excluded from clinical trials and there is limited evidence-based guidance for the choice of antiseizure medications in this vulnerable population. The study explored the effectiveness of brivaracetam (BRV) in people with epilepsy and intellectual disability. Methods: BRIVAracetam add-on First Italian netwoRk Study (BRIVAFIRST) was a 12-month retrospective, multicenter study including adults prescribed adjunctive BRV. Main outcomes included the rates of seizure‐freedom, seizure response (≥ 50% reduction in baseline seizure frequency), and treatment discontinuation. The occurrence of adverse events (AEs) was also considered. Analyses by the presence and severity of intellectual disability were performed. Results: Subjects with intellectual disability were 253 (24.6%) out of 1029 participants. The 12-month rates of seizure freedom were 18.4% and 10.3% in participants without and with intellectual disability, respectively; the corresponding values for seizure response were 40.0% and 28.9%. Intellectual disability was not an independent predictor of seizure outcomes. The rates of treatment discontinuation were 25.8% and 26.4% in participants without and with intellectual disability. respectively. There were no statistically significant differences in the rates of any AEs, somnolence, nervousness/agitation, and aggressiveness by the presence and degree of intellectual disability. Conclusion: Brivaracetam can be a suitable treatment option and offer opportunities for clinical improvement in subjects with intellectual disability and uncontrolled seizures.
Adjunctive Brivaracetam in People with Epilepsy and Intellectual Disability: Evidence from the BRIVAracetam Add-On First Italian netwoRk Study / Lattanzi, S.; Canafoglia, L.; Canevini, M. P.; Casciato, S.; Irelli, E. C.; 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.; Zumm, L.; Zambrelli, E.; Villani, F.; Vignoli, A.; Viglietta, E.; Vigano, I.; Ventura, M.; Vaudano, A. E.; Tumminelli, G.; Tombini, M.; Tartara, E.; Stokelj, D.; Sessa, M.; Savastano, E.; Salamone, E. M.; Rum, A.; Rizzo, G. R.; Renna, R.; Quintas, R.; Quarato, P. P.; Quadri, S.; Puligheddu, M.; Pradella, S.; Porcella, V.; Pollicino, P.; Placidi, F.; Pisani, L. R.; Pisani, F.; Pilolli, N.; Pignatta, P.; Piccioli, M.; Pezzella, M.; Perri, G.; Peretti, A.; Pauletto, G.; Pastori, C.; Pascarella, M. G.; Paladin, F.; Orlando, B.; Nilo, A.; Milano, C.; Meletti, S.; Mazzeo, A.; Mascia, A.; Marino, D.; Mari, L.; Maira, G.; Magliani, M.; Luisi, C.; Labate, A.; Kassabian, B.; Izzi, F.; Habetswallner, F.; Giuliano, L.; Giorgi, F. S.; Giallonardo, A. T.; Gazzina, S.; Galli, R.; Francavilla, T.; Foschi, N.; Fortunato, F.; Fonti, D.; Fisco, G.; Ferreri, F.; Ferrari, A.; Fattouch, J.; Fallica, E.; Failli, Y.; Faedda, M. T.; Evangelista, G.; Estraneo, A.; Elia, M.; Durante, V.; Dono, F.; Domina, E.; Liberto, A. R. D.; Giacomo, R. D.; Difrancesco, J. C.; Deleo, F.; D'Aniello, A.; Cumbo, E.; Costa, C.; Contento, M.; Colella, D.; Cocito, D.; Ciuffini, R.; Ciampanelli, D.; Chianale, G.; Cesnik, E.; Calvello, C.; Cagnetti, C.; Caggia, E.; Brigo, F.; Bongiorno, J.; Bonanni, P.; Boero, G.; Billo, G.; Biggi, M.; Berto, I.; Beretta, S.; Belcastro, V.; Basili, L. M.; Bartolini, E.; Banfi, P.; Badioni, V.; Avorio, F.; Assenza, G.; Ascoli, M.; Alicino, A.. - In: NEUROLOGY AND THERAPY. - ISSN 2193-8253. - 14:3(2025), pp. 775-786. [10.1007/s40120-025-00717-x]
Adjunctive Brivaracetam in People with Epilepsy and Intellectual Disability: Evidence from the BRIVAracetam Add-On First Italian netwoRk Study
Vaudano A. E.;Meletti S.;
2025
Abstract
Introduction: Subjects with intellectual disability are usually excluded from clinical trials and there is limited evidence-based guidance for the choice of antiseizure medications in this vulnerable population. The study explored the effectiveness of brivaracetam (BRV) in people with epilepsy and intellectual disability. Methods: BRIVAracetam add-on First Italian netwoRk Study (BRIVAFIRST) was a 12-month retrospective, multicenter study including adults prescribed adjunctive BRV. Main outcomes included the rates of seizure‐freedom, seizure response (≥ 50% reduction in baseline seizure frequency), and treatment discontinuation. The occurrence of adverse events (AEs) was also considered. Analyses by the presence and severity of intellectual disability were performed. Results: Subjects with intellectual disability were 253 (24.6%) out of 1029 participants. The 12-month rates of seizure freedom were 18.4% and 10.3% in participants without and with intellectual disability, respectively; the corresponding values for seizure response were 40.0% and 28.9%. Intellectual disability was not an independent predictor of seizure outcomes. The rates of treatment discontinuation were 25.8% and 26.4% in participants without and with intellectual disability. respectively. There were no statistically significant differences in the rates of any AEs, somnolence, nervousness/agitation, and aggressiveness by the presence and degree of intellectual disability. Conclusion: Brivaracetam can be a suitable treatment option and offer opportunities for clinical improvement in subjects with intellectual disability and uncontrolled seizures.
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