Comparative Effectiveness of Brivaracetam, Cenobamate, Lacosamide, and Perampanel in Focal Epilepsy.
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Cerulli Irelli Emanuele, Roberti Roberta, Borioni Maria Sole, Anzellotti Francesca, Belcastro Vincenzo, Beretta Simone, Boero Giovanni, Bonanni Paolo, Chiesa Valentina, D'Aniello Alfredo, Dainese Filippo, Deleo Francesco, De Maria Giovanni, Di Gennaro Giancarlo, Di Gennaro Gianfranco, Didato Giuseppe, Dono Fedele, Falcicchio Giovanni, Ferlazzo Edoardo, Fortunato Francesco, La Neve Angela, Mecarelli Oriano, Montalenti Elisa, Morano Alessandra, Nilo Annacarmen, Operto Francesca Felicia, Paladin Francesco, Pascarella Angelo, Pauletto Giada, Pietrafusa Nicola, Pignatta Pietro, Pulitano Patrizia, Renna Rosaria, Rosati Eleonora, Sammarra Ilaria, Di Bonaventura Carlo, Russo Emilio, Lattanzi Simona, Comparative REal-World Evidence (CREW) Study Group
Аннотация
OBJECTIVE: To compare effectiveness and safety of brivaracetam, cenobamate, lacosamide, and perampanel as adjunctive therapies in adults with drug-resistant focal epilepsy.
DESIGN, SETTING, AND PARTICIPANTS: This was a multicenter pooled analysis of 4 previously conducted retrospective real-world medical record-review studies (January 2017-January 2024). Included were adult patients (aged ≥16 years) with drug-resistant focal epilepsy, as defined by the International League Against Epilepsy. Participants were recruited from 71 epilepsy centers.
EXPOSURES: Add-on treatment with brivaracetam, cenobamate, lacosamide, or perampanel.
MAIN OUTCOMES AND MEASURES: The primary outcome was the responder rate at 6 months, defined as greater than or equal to 50% seizure frequency reduction from baseline. Secondary outcomes included 12-month responder rate, seizure freedom (≥3 months at 6 months and ≥6 months at 12 months), and 12-month ASM retention. Safety was assessed by incidence of adverse effects. Generalized linear mixed models adjusted for demographic and clinical covariates were used to compare treatment outcomes, with cenobamate as reference ASM.
RESULTS: Of 2386 ASM prescriptions screened, 1993 prescriptions from 1949 patients (1036 of 1947 female [53.2%]; sex information was missing in 0.1% of prescriptions) with a median (IQR) age of 42 (29-55) years at ASM prescription, met inclusion criteria and were included in the pooled analysis. Brivaracetam accounted for 953 prescriptions (47.8%), followed by perampanel (607 [30.5%]), lacosamide (241 [12.1%]), and cenobamate (192 [9.6%]). After adjustment, cenobamate demonstrated significantly higher odds of 50% or greater response at 6 months compared with brivaracetam (odds ratio [OR], 0.18; 95% CI, 0.12-0.28; P < .001), perampanel (OR, 0.26; 95% CI, 0.16-0.42; P < .001), and lacosamide (OR, 0.29; 95% CI, 0.17-0.49; P < .001). Results were consistent for secondary effectiveness outcomes at 12 months, with cenobamate outperforming other ASMs in terms of 50% or greater response and seizure freedom. Cenobamate was associated with the highest rate of adverse effects during follow-up (111 [57.8%]), and lacosamide was associated with the lowest (35 [14.8%]). Cenobamate was associated with a higher likelihood of treatment retention at 12 months compared with brivaracetam (OR, 0.43; 95% CI, 0.26-0.69; P < .001) and perampanel (OR, 0.56; 95% CI, 0.32-0.99; P = .047), with no significant difference vs lacosamide (OR, 0.81; 95% CI, 0.41-1.59; P = .53).
CONCLUSIONS AND RELEVANCE: These study findings suggest superior effectiveness of cenobamate over brivaracetam, lacosamide, and perampanel in adults with drug-resistant focal epilepsy in a large real-world setting.