Authors :
Presenting Author: Magdalena Bosak, MD PhD – Department of Neurology Jagiellonian University Kraków Poland
Hanna Podraza, MD Phd – Epimed, Szczecin, Poland.
Dorota Włoch-Kopeć, MD PhD – Jagiellonian University
Kamil Wężyk, MD – Jagiellonian University
Andrzej Rysz, MD PhD – 1 Military Clinical Hospital in Lublin
Katarzyna Grabska-Radzikowska, MD PhD – Institute of Psychiatry and Neurology
Piotr Sobolewski, MD PhD – Jan Kochanowski University in Kielce
Tomasz Siwek, MD PhD – University of Warmia and Mazury in Olsztyn
Iwona Kurkowska-Jastrzębska, MD PhD – Institute of Psychiatry and Neurology
Monika Służewska-Niedźwiedź, MD PhD – Wrocław Medical University
Katarzyna Sulima, MD PhD – Wrocław Medical University
Lech Kipiński, MD PhD – Wrocław Medical University
Lidia Kiryła, MD PhD – Bielański Hospital
Katarzyna Stopińska, MD PhD – Medical University of Warsaw
Elżbieta Płonka-Półtorak, MD PhD – Saint Jadwiga the Queen Clinical Provincial Hospital No 2
Justyna Tabaka-Pardela, MD PhD – Prof. K. Gibiński University Medical Center
Magdalena Konopko, MD PhD – Institute of Psychiatry and Neurology
Agnieszka Meller, MD PhD – Pomeranian Medical University in Szczecin
Monika Chorąży, MD PhD – Medical University in Białystok
Maja Kopytek-Beuzen, MD PhD – Medical University of Warsaw
Dorota Dzianott-Pabijan, MD PhD – Kuyavian-Pomeranian Pulmonology Centre
Małgorzata Klimas, MD PhD – Zabobrze Medical Center
Krzysztof Nicpoń, MD PhD – Collegium Medicum in Bydgoszcz
Łukasz Jasek, MD PhD – Antiepileptic Outpatient Clinic Pro Salus
Karolina Makowska-Sempruch, MD PhD – Pomeranian Medical University in Szczecin
Katarzyna Fuksa, MD PhD – Saint Jadwiga the Queen Clinical Provincial Hospital No 2
Katarzyna Zawiślak-Fornagiel, MD PhD – Prof. K. Gibiński University Medical Center,
Rationale:
Epilepsy is a prevalent neurological condition, and around one-third of affected individuals suffer from drug-resistant epilepsy (DRE), which poses substantial clinical, social, and economic challenges. In March 2023, cenobamate — a new-generation antiseizure medication (ASM) — was introduced into the Polish treatment landscape.
Methods:
This retrospective, multicenter study was conducted at 20 centers. Medical records of adult patients with DRE treated with cenobamate for at least twelve months were reviewed. Collected data included demographic characteristics, seizure frequency, treatment regimens, and adverse events (AEs). Descriptive statistical methods were employed to assess outcomes, with the primary efficacy endpoint of ≥50 % reduction in seizure frequency. Protocol of the study followed the principles of Helsinki Declaration and received approval from the university bioethical committee.Results:
The study cohort consisted of 291 patients (138 ; 47.3% females), with a median age of 37 years (range 18-77) and median age at the epilepsy onset 11 years (range 0-70). Median duration of cenobamate treatment was 16 months (range 12-56). The majority of patients had a history of receiving multiple ASMs: 4-7 ASMs: 141 (48.5%); >7 ASMs: 125 (42.9%). Thirty seven (12.7%) patients were treated previously with VNS, 5 (1.7%) with DBS, and, 31 (10.6%) underwent epilepsy surgery. At baseline median number of concomitant ASMs was 3 ( range 1-5) and median number of seizures 8/ month (range 0.3-390)
Treatment with cenobamate (median maximal daily dose, 250 mg) resulted in a ≥ 50 % reduction in seizure frequency in 63.6 % of patients, with 16.3 % (41) achieving seizure freedom during the final three months of observation, with better responses when the treatment was initiated earlier. The burden of polytherapy decreased, as two third of patients reduced ( 159; 54.6%) or discontinued (122; 41.9%)at least one concomitant ASMs. Adverse events were reported in 142 (48.9 %) patients, most commonly somnolence (n = 82), dizzines (n = 27), with no cases of severe dermatological reactions. Discontinuation of cenobamate occurred in 12 % of patients.
Conclusions:
Cenobamate demonstrated notable efficacy in patients with treatment-resistant epilepsy, and its early initiation may improve outcomes. Treatment has a large potential for significant simplification of treatment regimens. Adverse events were manageable. Cenobamate is a highly effective and well-tolerated ASM for patients with DRE, offering significant clinical benefits, including improved seizure control and reduced polytherapy.
Funding: no