Real-world use of cenobamate in pediatric focal epilepsies and developmental epileptic encephalopathies: A multicenter retrospective series.
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Soto-Insuga Víctor, Valls Carbó Adrián, Pinzón-Acevedo Anna Gretel, González-Alguacil Elena, Peñas Juan José García, Jamardo Andrea Sariego, Aznar-Laín Gemma, Ibáñez-Micó Salvador, Martínez Helena Alarcón, Buenache Raquel, Rekarte Saray, Olivera Andrea Parejo, Tuero-Montiel Ezequiel, DomínguezCarral Jana, López María, Ribes Ainhoa García, González María Jesús Martínez, Arias Eva, Ron Adrián García, Boronat Susana, Viñas Eulalia Turón, Casellas Dolors, Navarro Virginia, Conejo David, Miravet Elena, Román Irene Sánchez-Miranda, Nagel-Rein Antonio Gil, Cabeza María Muñoz, Smeyers Patricia, Aledo-Serrano Ángel
Аннотация
METHODS: We conducted a retrospective, multicenter study of 169 pediatric patients (0-18 years) with DRE treated with CNB across centers in Spain. Seizure response (≥50% reduction) and seizure freedom (no seizures in the previous month) were assessed at 3, 6, and 12 months.
RESULTS: At 12 months, CNB showed a retention rate of 89.2%, with 83.9% of patients achieving seizure response and 19.6% reaching seizure freedom. Response rates were 73.4% at 3 months and 77.1% at 6 months, with seizure freedom increasing from 11.8% at 3 months to 21.1% at 6 months. Outcomes were comparable between DEEs and focal epilepsies, indicating broad-spectrum efficacy. Seizure worsening occurred in 4.7% of patients, all with DEEs. After adjusting for seizure type, those patients with focal seizures had higher odds of achieving seizure response (odds ratio [OR] 95% confidence interval [95% CI] 5.46, 1.27-23.52; p = 0.02) and seizure freedom (OR 95% CI 5.32, 1.57-17.97; p < 0.01). Median CNB doses (mg/kg/day) were 1.78 (range 0.37-12.5), 2.5 (range 0.67-12.5), and 3.19 (range 0.96-9.09) at 3, 6, and 12 months, respectively. Adverse events occurred in 44.9% of patients, most commonly somnolence (42.3%) and dizziness (22.4%), which improved with slower titration.
SIGNIFICANCE: CNB appears effective and well-tolerated in pediatric DRE, including DEE, with high retention and sustained efficacy over time. Adverse events were generally manageable with dose adjustments, and slow, weight-based titration improved tolerability. Prospective studies are warranted to confirm these findings.