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Objectives <p>At The Danish Epilepsy Centre, Dianalund, Denmark, we aimed to assess the long-term efficacy, tolerability profile, and influence on concomitant antiseizure medications (ASMs) of cenobamate as an&#xa0;add-on treatment in patients with ultra-refractory focal epilepsies.</p> Methods <p>Adult patients with ultra-refractory epilepsy (defined as focal epilepsies in which ≥ 6 treatments, including ASM trials, epilepsy surgery, and vagus nerve stimulator, failed to achieve seizure control) treated with add-on cenobamate between October 2021 and June 2024 were included in our retrospective, observational study. Data were collected through electronic patient records and seizure-diaries.</p> Results <p>32 patients were included. The mean length of treatment was 21&#xa0;months (range 2–32&#xa0;months) and the median dose of cenobamate was 250&#xa0;mg (range 50-400&#xa0;mg). Fourteen/32 (44%) patients were responders (≥ 50% reduction in seizure frequency) to cenobamate, including five patients who became seizure-free (15.6% of the total cohort). Eleven/32 (34%) discontinued due to adverse effects (AEs) or lack of efficacy. Patients with active focal-to-bilateral-tonic–clonic seizures remaining on treatment decreased by 50%. The ASM most frequently reduced was lacosamide, while the one most often discontinued was lamotrigine. Fifteen/32 (47%) patients reported at least one AE during the treatment period of 32&#xa0;months. Two-thirds were&#xa0;resolved by dose-reduction of ASMs or cenobamate. AEs most frequently reported were tiredness and dizziness; the lowest incidence of these AE was found when cenobamate was added as the third drug.</p> Significance <p>Our study underlines the usefulness of cenobamate in treating patients with ultra-refractory epilepsy and indicates its long-term effectiveness in real-world clinical practice.</p>

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Cenobamate as add-on treatment in ultra-refractory focal epilepsy: Real-world results from The Danish Epilepsy Centre, Dianalund, Denmark

  • 期刊论文

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  • 发表日期：

    2025年4月15日

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  • Cathrine E. Gjerulfsen,
  • Stefan Juhl,
  • Katarzyna M. Mieszczanek,
  • Lucie Spanilá,
  • Kristin S. Thygesen,
  • Agnieszka Pavbro,
  • Rikke S. Møller,
  • Guido Rubboli

摘要

Objectives

At The Danish Epilepsy Centre, Dianalund, Denmark, we aimed to assess the long-term efficacy, tolerability profile, and influence on concomitant antiseizure medications (ASMs) of cenobamate as an add-on treatment in patients with ultra-refractory focal epilepsies.

Methods

Adult patients with ultra-refractory epilepsy (defined as focal epilepsies in which ≥ 6 treatments, including ASM trials, epilepsy surgery, and vagus nerve stimulator, failed to achieve seizure control) treated with add-on cenobamate between October 2021 and June 2024 were included in our retrospective, observational study. Data were collected through electronic patient records and seizure-diaries.

Results

32 patients were included. The mean length of treatment was 21 months (range 2–32 months) and the median dose of cenobamate was 250 mg (range 50-400 mg). Fourteen/32 (44%) patients were responders (≥ 50% reduction in seizure frequency) to cenobamate, including five patients who became seizure-free (15.6% of the total cohort). Eleven/32 (34%) discontinued due to adverse effects (AEs) or lack of efficacy. Patients with active focal-to-bilateral-tonic–clonic seizures remaining on treatment decreased by 50%. The ASM most frequently reduced was lacosamide, while the one most often discontinued was lamotrigine. Fifteen/32 (47%) patients reported at least one AE during the treatment period of 32 months. Two-thirds were resolved by dose-reduction of ASMs or cenobamate. AEs most frequently reported were tiredness and dizziness; the lowest incidence of these AE was found when cenobamate was added as the third drug.

Significance

Our study underlines the usefulness of cenobamate in treating patients with ultra-refractory epilepsy and indicates its long-term effectiveness in real-world clinical practice.