Long-term cenobamate retention, efficacy, and safety: outcomes from Expanded Access Programme
Anetta Lasek-Bal1, Barbara Kściuk2, Tomasz Zieliński2
1Medical University of Silesia, Katowice, Poland.
Neurologia I Neurochirurgia Polska
|December 19, 2023
Summary
Adjunctive cenobamate (CNB) demonstrated sustained long-term effectiveness in drug-resistant epilepsy patients within Poland's Expanded Access Programme (EAP). The study showed a 100% retention rate and significant seizure reduction over 41 months, with no new safety concerns.
Area of Science:
- Neurology
- Epileptology
- Pharmacology
Background:
- Drug-resistant epilepsy poses a significant challenge in patient management.
- Long-term retention rates of antiseizure medications are crucial indicators of treatment effectiveness, encompassing efficacy, safety, and tolerability.
- The Polish Expanded Access Programme (EAP) provided an avenue for continued access to cenobamate (CNB) for eligible patients.
Purpose of the Study:
- To evaluate the long-term retention rate, efficacy, and tolerability of adjunctive cenobamate (CNB) in patients with drug-resistant epilepsy.
- To assess the sustained benefits of CNB treatment within the framework of the Polish Expanded Access Programme (EAP).
Main Methods:
- A multicentre retrospective analysis was conducted on patients with focal epilepsy receiving CNB within the EAP from January 2020 to May 2023.
- Data collected included cenobamate retention rates, seizure outcomes (frequency reduction, seizure freedom), and adverse events.
- Patients included those who completed open-label extension phases of relevant clinical trials and continued CNB in the EAP.
Main Results:
- 38 patients received CNB for a median of 41 months, with a 100% retention rate observed.
- Adjunctive CNB treatment reduced mean monthly seizure frequency from 8.1 to 3.0.
- Over 63% of patients achieved ≥ 50% seizure reduction, and 21% achieved seizure freedom for at least 12 months. Common adverse events included dizziness, somnolence, and headache, which were generally manageable.
Conclusions:
- Long-term treatment with adjunctive cenobamate in drug-resistant epilepsy patients within the EAP sustained significant efficacy, evidenced by a ≥ 50% seizure reduction and a 100% retention rate over 41 months.
- No new safety concerns were identified during the long-term follow-up period.
- These findings support the potential for cenobamate to offer substantial long-term clinical benefits for patients with refractory epilepsy.
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