Cenobamate Shows Effectiveness in Real-World Patients With Drug-Resistant Epilepsy
Nearly half of real-world patients with drug-resistant epilepsy who received adjunctive cenobamate through an early access program experienced a 50% reduction in seizure frequency, and 13.6% were completely seizure-free, after 3 months of maintenance therapy. Researchers reported the findings in Epilepsia Open.
“This responder rate steadily increased over time, till the last observation period: at 6 and 12 months of maintenance, the responder rates in terms of 100% and 50% seizure reduction were 24.2%, 53.2%, 45%, and 60%, respectively,” reported corresponding author Alessandro Lovera, of Angelini Pharma, Rome, Italy, and study coauthors.
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The study included data for 298 patients with drug-resistant epilepsy who received cenobamate as adjunctive treatment to other antiseizure medication (ASM) through early access programs in Germany, France, and the United Kingdom. Among patients, the median history of epilepsy was 22.2 years, the median number of failed ASMs was 9, and the median number of seizures per month was 8.8 at baseline. Some 41.9% had previous epilepsy surgery, including vagus nerve stimulation.
“A key strength of this study is that it mirrors the real-world practice in a highly refractory population for whom compassionate use was required,” researchers wrote. “Many of the patients in this study would not have been eligible for clinical trials due to their high number of concomitant ASMs and associated psychiatric disorders.”
The primary effectiveness endpoint, evaluated for 216 patients with seizure data available, was the 50% responder rate, defined as a 50% or greater drop in seizure frequency.
After 3 months on maintenance therapy, 49.3% of patients achieved the 50% responder endpoint, according to the study, and the median seizure reduction was 49.1%. Seizures stopped completely for 13.6% of patients, and decreased by 90% or more for 20.0% of patients and by 75% or more for 33.6% of patients.
Both responder rates and median percentage seizure reduction increased over the course of observation.
At 12 months of maintenance therapy, the retention rate was 69.7%. Adverse drug reactions linked to cenobamate occurred in 30.9% of patients. Asthenia, dizziness, and somnolence were most frequent, were mild-to-moderate for most patients, and resolved over the observation period. Three patients experienced a total 7 serious adverse drug reactions, which occurred during titration.
“In this study, cenobamate demonstrated to be an effective option for people with uncontrolled epilepsy,” researchers wrote, “even after multiple failed ASMs or failure of epilepsy surgery.”
Angelini Pharma, which licenses cenobamate in Europe, sponsored the study. Study authors reported various affiliations with Angelini Pharma in a conflict of interest statement accompanying the report.
