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Adjunctive cenobamate in highly active and ultra‐refractory focal epilepsy: A “real‐world” retrospective study

Objective Recent clinical trials have shown that cenobamate substantially improves seizure control in focal‐onset drug‐resistant epilepsy (DRE). However, little is known about cenobamate's performance in highly active (≥20 seizures/month) and ultra‐refractory focal epilepsy (≥6 failed epilepsy...

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Published in:Epilepsia (Copenhagen) 2023-05, Vol.64 (5), p.1225-1235
Main Authors: Peña‐Ceballos, Javier, Moloney, Patrick B., Munteanu, Tudor, Doyle, Michael, Colleran, Niamh, Liggan, Brenda, Breen, Annette, Murphy, Sinead, El‐Naggar, Hany, Widdess‐Walsh, Peter, Delanty, Norman
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creator Peña‐Ceballos, Javier
Moloney, Patrick B.
Munteanu, Tudor
Doyle, Michael
Colleran, Niamh
Liggan, Brenda
Breen, Annette
Murphy, Sinead
El‐Naggar, Hany
Widdess‐Walsh, Peter
Delanty, Norman
description Objective Recent clinical trials have shown that cenobamate substantially improves seizure control in focal‐onset drug‐resistant epilepsy (DRE). However, little is known about cenobamate's performance in highly active (≥20 seizures/month) and ultra‐refractory focal epilepsy (≥6 failed epilepsy treatments, including antiseizure medications [ASMs], epilepsy surgery, and vagus nerve stimulation). Here, we studied cenobamate's efficacy and tolerability in a “real‐world” severe DRE cohort. Methods We conducted a single‐center retrospective analysis of consecutive adults treated with cenobamate between October 2020 and September 2022. All patients received cenobamate through an Early Access Program. Cenobamate retention, seizure outcomes, treatment‐emergent adverse events, and adjustments to concomitant ASMs were analyzed. Results Fifty‐seven patients received cenobamate for at least 3 months (median duration, 11 months). The median cenobamate dose was 250 mg/day (range 75–350 mg). Baseline demographics were consistent with highly active (median seizure frequency, 60/month) and ultra‐refractory epilepsy (median previously failed ASMs, nine). Most (87.8%) had prior epilepsy surgery and/or vagus nerve stimulation. Six patients stopped cenobamate due to lack of efficacy and/or adverse events. One patient died from factors unrelated to cenobamate. Among patients who continued cenobamate, three achieved seizure freedom (5.3% of cohort), 24 had a 75%–99% reduction in seizures (42.1% of cohort), and 16 had a 50%–74% reduction (28.1% of cohort). Cenobamate led to abolition of focal to bilateral tonic–clonic seizures in 55.6% (20/36) of patients. Among treatment responders, 67.4% (29/43) were treated with cenobamate doses of ≥250 mg/day. Three‐fourths of patients reported at least one side‐effect, most commonly fatigue and somnolence. Adverse events most commonly emerged at cenobamate doses of ≥250 mg/day. Side‐effects were partially manageable by reducing the overall ASM burden, most often clobazam, eslicarbazepine, and perampanel. Significance Patients with highly active and ultra‐refractory focal epilepsy experienced meaningful seizure outcomes on cenobamate. Emergence of adverse events at doses above 250 mg/day may limit the potential for further improvements in seizure control at higher cenobamate doses.
doi_str_mv 10.1111/epi.17549
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However, little is known about cenobamate's performance in highly active (≥20 seizures/month) and ultra‐refractory focal epilepsy (≥6 failed epilepsy treatments, including antiseizure medications [ASMs], epilepsy surgery, and vagus nerve stimulation). Here, we studied cenobamate's efficacy and tolerability in a “real‐world” severe DRE cohort. Methods We conducted a single‐center retrospective analysis of consecutive adults treated with cenobamate between October 2020 and September 2022. All patients received cenobamate through an Early Access Program. Cenobamate retention, seizure outcomes, treatment‐emergent adverse events, and adjustments to concomitant ASMs were analyzed. Results Fifty‐seven patients received cenobamate for at least 3 months (median duration, 11 months). The median cenobamate dose was 250 mg/day (range 75–350 mg). Baseline demographics were consistent with highly active (median seizure frequency, 60/month) and ultra‐refractory epilepsy (median previously failed ASMs, nine). Most (87.8%) had prior epilepsy surgery and/or vagus nerve stimulation. Six patients stopped cenobamate due to lack of efficacy and/or adverse events. One patient died from factors unrelated to cenobamate. Among patients who continued cenobamate, three achieved seizure freedom (5.3% of cohort), 24 had a 75%–99% reduction in seizures (42.1% of cohort), and 16 had a 50%–74% reduction (28.1% of cohort). Cenobamate led to abolition of focal to bilateral tonic–clonic seizures in 55.6% (20/36) of patients. Among treatment responders, 67.4% (29/43) were treated with cenobamate doses of ≥250 mg/day. Three‐fourths of patients reported at least one side‐effect, most commonly fatigue and somnolence. Adverse events most commonly emerged at cenobamate doses of ≥250 mg/day. Side‐effects were partially manageable by reducing the overall ASM burden, most often clobazam, eslicarbazepine, and perampanel. Significance Patients with highly active and ultra‐refractory focal epilepsy experienced meaningful seizure outcomes on cenobamate. Emergence of adverse events at doses above 250 mg/day may limit the potential for further improvements in seizure control at higher cenobamate doses.</description><identifier>ISSN: 0013-9580</identifier><identifier>EISSN: 1528-1167</identifier><identifier>DOI: 10.1111/epi.17549</identifier><identifier>PMID: 36790345</identifier><language>eng</language><publisher>United States: Wiley Subscription Services, Inc</publisher><subject>Adult ; Adverse events ; cenobamate ; Clinical trials ; Convulsions &amp; seizures ; Drug Resistant Epilepsy - drug therapy ; Drug-Related Side Effects and Adverse Reactions ; drug‐resistant epilepsy ; Epilepsies, Partial - drug therapy ; Epilepsy ; focal epilepsy ; highly active epilepsy ; Humans ; Patients ; Retrospective Studies ; Seizures ; Surgery ; Vagus nerve</subject><ispartof>Epilepsia (Copenhagen), 2023-05, Vol.64 (5), p.1225-1235</ispartof><rights>2023 The Authors. published by Wiley Periodicals LLC on behalf of International League Against Epilepsy.</rights><rights>2023 The Authors. 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Baseline demographics were consistent with highly active (median seizure frequency, 60/month) and ultra‐refractory epilepsy (median previously failed ASMs, nine). Most (87.8%) had prior epilepsy surgery and/or vagus nerve stimulation. Six patients stopped cenobamate due to lack of efficacy and/or adverse events. One patient died from factors unrelated to cenobamate. Among patients who continued cenobamate, three achieved seizure freedom (5.3% of cohort), 24 had a 75%–99% reduction in seizures (42.1% of cohort), and 16 had a 50%–74% reduction (28.1% of cohort). Cenobamate led to abolition of focal to bilateral tonic–clonic seizures in 55.6% (20/36) of patients. Among treatment responders, 67.4% (29/43) were treated with cenobamate doses of ≥250 mg/day. Three‐fourths of patients reported at least one side‐effect, most commonly fatigue and somnolence. Adverse events most commonly emerged at cenobamate doses of ≥250 mg/day. 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However, little is known about cenobamate's performance in highly active (≥20 seizures/month) and ultra‐refractory focal epilepsy (≥6 failed epilepsy treatments, including antiseizure medications [ASMs], epilepsy surgery, and vagus nerve stimulation). Here, we studied cenobamate's efficacy and tolerability in a “real‐world” severe DRE cohort. Methods We conducted a single‐center retrospective analysis of consecutive adults treated with cenobamate between October 2020 and September 2022. All patients received cenobamate through an Early Access Program. Cenobamate retention, seizure outcomes, treatment‐emergent adverse events, and adjustments to concomitant ASMs were analyzed. Results Fifty‐seven patients received cenobamate for at least 3 months (median duration, 11 months). The median cenobamate dose was 250 mg/day (range 75–350 mg). Baseline demographics were consistent with highly active (median seizure frequency, 60/month) and ultra‐refractory epilepsy (median previously failed ASMs, nine). Most (87.8%) had prior epilepsy surgery and/or vagus nerve stimulation. Six patients stopped cenobamate due to lack of efficacy and/or adverse events. One patient died from factors unrelated to cenobamate. Among patients who continued cenobamate, three achieved seizure freedom (5.3% of cohort), 24 had a 75%–99% reduction in seizures (42.1% of cohort), and 16 had a 50%–74% reduction (28.1% of cohort). Cenobamate led to abolition of focal to bilateral tonic–clonic seizures in 55.6% (20/36) of patients. Among treatment responders, 67.4% (29/43) were treated with cenobamate doses of ≥250 mg/day. Three‐fourths of patients reported at least one side‐effect, most commonly fatigue and somnolence. Adverse events most commonly emerged at cenobamate doses of ≥250 mg/day. Side‐effects were partially manageable by reducing the overall ASM burden, most often clobazam, eslicarbazepine, and perampanel. Significance Patients with highly active and ultra‐refractory focal epilepsy experienced meaningful seizure outcomes on cenobamate. Emergence of adverse events at doses above 250 mg/day may limit the potential for further improvements in seizure control at higher cenobamate doses.</abstract><cop>United States</cop><pub>Wiley Subscription Services, Inc</pub><pmid>36790345</pmid><doi>10.1111/epi.17549</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0002-3953-9842</orcidid><orcidid>https://orcid.org/0000-0001-6500-5273</orcidid><orcidid>https://orcid.org/0000-0003-4217-2575</orcidid><orcidid>https://orcid.org/0000-0003-0997-2087</orcidid><oa>free_for_read</oa></addata></record>
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subjects Adult
Adverse events
cenobamate
Clinical trials
Convulsions & seizures
Drug Resistant Epilepsy - drug therapy
Drug-Related Side Effects and Adverse Reactions
drug‐resistant epilepsy
Epilepsies, Partial - drug therapy
Epilepsy
focal epilepsy
highly active epilepsy
Humans
Patients
Retrospective Studies
Seizures
Surgery
Vagus nerve
title Adjunctive cenobamate in highly active and ultra‐refractory focal epilepsy: A “real‐world” retrospective study
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