Long-Term, Real-World Study Results Show Xcopri Is Highly Effective as a Treatment for Reducing Seizures
A study presented at the 2023 American Epilepsy Society (AES) Annual Meeting revealed that long-term treatment with Xcopri (cenobamate tablet; SK Life Sciences, Paramus, NJ) was safe and highly effective in reducing seizure frequency. In 2019, Xcopri was approval by the Food and Drug Administration (FDA) as a treatment for partial-onset seizures in adult patients.
The prospective, open label study included 222 adult patients aged 17 to 75 years treated at a single center (Mid-Atlantic Epilepsy and Sleep Center, North Bethesda, MD) since 2011, including those who participated in earlier clinical trials investigating the use Xcopri as a treatment for drug-resistant focal epilepsy (NCT01397968; NCT01866111; NCT02535091) as well as patients treated since the medication became available in 2020. Researchers assessed ≥50%, ≥75%, ≥90%, and 100% responder rates for seizure reduction from baseline in continuous treatment and maintenance treatment periods. Maintenance treatment was defined in this study as ≥1 month after the last maximum Xcopri dose adjustment at ≥50 mg/d until analysis date or treatment discontinuation.. The final analysis included data from 177 individuals: those who had received treatment for ≥6 months and patients who stopped at 6 months due to treatment-emergent adverse events (TEAEs).
In terms of results, response rates for those in the whole treatment group were as follows:
- 17.0% were 100% responders
- 36.2% were ≥90% responders
- 47.5% were ≥75% responders
- 62.7% were ≥50% responders
For those in the maintenance treatment group, response rates were as follows:
- 37.3% were 100% responders
- 49.2% were ≥90% responders
- 59.3% were ≥75% responders
- 71.8% were ≥50% responders
Patients had a mean 5.7 prior antiseizure medications (ASMs) and 2.3 concomitant ASMs at index. Of patients with 100%, 90% and 75% seizure frequency reduction (n = 105), 28 discontinued 1, 6 discontinued 2, and 1 discontinued 3 concomitant ASMs without a loss in seizure response. The median treatment duration with Xcopri was 16.5 months; 14.7% of patients were treated for ≥5 years, 18.6% for ≥3 years, and 37.3% for ≥2 years.
The most common TEAEs were somnolence, fatigue, dizziness, ataxia, headache, diplopia, dysarthria, loss of appetite, nausea, and falls. The main TEAES that led to treatment discontinuation were somnolence, ataxia, rash, dizziness, and nausea. No instances of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) occurred in this study.
The authors of this study are affiliated with the Mid-Atlantic Epilepsy and Sleep Center, North Bethesda, MD.