Freedon study: Real-life outcomes of cenobamate in different lines of treatment.
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Villanueva Vicente, Serratosa José María, Fernández-Cabrera Alejandro, Toledo Manuel, González-Giráldez Beatriz, Estevez José C, Rodríguez Uranga Juan Jesús, Machio Castelló Maria, Castro-Vilanova Maria Dolores, Poza Juan José, Rodríguez-Osorio Xiana, Hampel Kevin G, Fonseca Elena, López-González Francisco Javier, Garcés Mercedes, Abraira Laura, Ciurans Jordi, Campos-Fernández Daniel, Santamarina Estevo, Sanchez-Caro Juan María, Iacampo Lucas, Renau Julia, García-Quesada Miguel Ángel, Anciones Carla, Chamorro María Isabel, Maestro Iratxe, Cabezudo Pablo, Calle Raquel, Macarron Jesús, Cabezas Beatriz, Carrasco María, López María, Marín Marta, Querol Rosa, Baena Belén, García-Morales Vanessa, López-Maza Samuel, Juiz Álvaro, Mercedes-Alvarez Blanca, Amarante Carla, Del Villar Ana, Castillo Ascensión, Rubio-Roy Marta, Martinez-Poles Javier, Gómez-Ibáñez Asier, Parejo-Carbonell Beatriz, Martínez Garcia Anabelén, Carrera Ignacio, Iriarte Pablo, Romero-Aguilera Fátima, Pharmacological Therapy Working group of the Spanish Epilepsy Society and Freedon Group
Аннотация
METHODS: This was a multicenter, retrospective, observational study. Adults with focal epilepsy, 2-6 prior ASMs, and ≥12 months between cenobamate initiation and database closure were included. Data from patients' charts were collected and included in the Drug-Resistant Epilepsy Registry of the Spanish Epilepsy Society using Research Electronic Data Capture. Primary effectiveness endpoints included changes in seizure frequency at 3, 6, and 12 months after cenobamate initiation according to different treatment lines. Primary safety endpoints included the percentage of patients with adverse events (AEs).
RESULTS: In total, 486 patients were included (mean age 42.8 years). The mean number of prior ASMs was 4.4 (2-6); the mean number of concomitant ASMs at cenobamate initiation was 2.5 (1-5). At 12 months, treatment retention was 92% and median dose was 200 mg. One-year seizure-freedom rates were 32.5%, 33.3%, 21.4%, 24.2%, and 11.4% in those treated with 2-6 prior ASMs, respectively. The proportions of patients achieving ≥50%, ≥75%, ≥90%, and 100% reductions in seizure frequency at 12 months were significantly higher in patients with 2-3 (earlier treatment lines) vs 4-6 prior ASMs (later treatment lines; p ≤ .004). Improvements in seizure severity were reported in 71.9% of patients during follow-up (82.5% and 62.1% in those with 2 and 6 prior ASMs, respectively). At 12 months, 56.4% of patients had reported AEs, with somnolence the most frequent, and 4.9% had AEs requiring cenobamate discontinuation.
SIGNIFICANCE: Cenobamate was effective and well tolerated in patients who had tried 2-6 prior ASMs in a real-world setting. High effectiveness was confirmed at 1 year, with better outcomes in earlier users.