The study assessed the clinical response to add-on brivaracetam (BRV) in real-world practice by means of time-to-baseline seizure count methodology. Patients with focal epilepsy who were prescribed add-on BRV were identified. Primary endpoint was the time-to-baseline seizure count defined as the number of days until each patient experienced the number of focal seizures that occurred in the 90 days before BRV initiation. Subgroup analysis was performed according to levetiracetam (LEV) status (naive vs prior use). Three-hundred eighty-seven patients were included. The overall median time-to-baseline seizure count was 150 (95% confidence interval [CI] = 130-175) days. The median time-to-baseline seizure count was 198 (lower limit of 95% CI = 168) days for LEV-naive patients, 126 (95% CI = 105-150) days for patients with prior LEV use and withdrawal due to insufficient efficacy, and 170 (95% CI = 128-291) days for patients who discontinued LEV due to adverse events (P =.002). The number of prior antiseizure medications (adjusted hazard ratio [adjHR] = 1.07, 95% CI = 1.02-1.13, P =.009) and baseline monthly seizure frequency (adjHR = 1.004, 95% CI = 1.001-1.008, P =.028) were independently associated with the primary endpoint. Add-on BRV improved seizure control in LEV-naive and LEV-prior patients. The time-to-baseline seizure count represents an informative endpoint alongside traditional study outcomes and designs.
Brivaracetam as add-on treatment in focal epilepsy: A real-world time-based analysis / Lattanzi, S.; De Maria, G.; Rosati, E.; Didato, G.; Chiesa, V.; Ranzato, F.; Canafoglia, L.; Cesnik, E.; Anzellotti, F.; Meletti, S.; Pauletto, G.; Nilo, A.; Bartolini, E.; Marino, D.; Tartara, E.; Luisi, C.; Bonanni, P.; Marrelli, A.; Stokelj, D.; Dainese, F.; Foschi, N.; Cagnetti, C.; Gazzina, S.; Contento, M.; Biggi, M.; Magliani, M.; Di Giacomo, R.; Pastori, C.; Canevini, M. P.; Zambrelli, E.; Billo, G.; Casazza, M.; Fallica, E.; Rosa, G.; Dono, F.; Speranza, R.; Cioclu, C.; Vaudano, A. E.; Kiferle, L.; Galli, R.; Guadagni, M.; Galimberti, C. A.; Kassabian, B.; Ferreri, F.; Osanni, E.; Ciuffini, R.; Badioni, V.; Beretta, S.. - In: EPILEPSIA. - ISSN 0013-9580. - (2020). [10.1111/epi.16769]