Effectiveness and safety of adjunctive cenobamate for focal seizures in adults with developmental disability treated in clinical practice

Connor, Gregory S.; Williamson, A.C.

doi:10.1016/j.ebr.2022.100533

Cited by 8 publications

(7 citation statements)

References 28 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In our study, which used the titration schedule outlined in the label for CNB, there were no new safety concerns, including no hypersensitivity reactions and no serious cutaneous reactions. These data are consistent with data published from other clinical practice series 20–24 …”

Section: Discussionsupporting

confidence: 92%

“…These data are consistent with data published from other clinical practice series. [20][21][22][23][24] The mean CNB dosage in the current research was consistent with previous studies. [11][12][13][14][15] A subset of patients reported a benefit with a low dose of CNB (<200 mg per day), as has been reported in a recent opinion article by an Italian expert group.…”

Section: Discussionsupporting

confidence: 91%

“…[16][17][18] However, the number of publications with CNB in this setting are limited and include low numbers of patients. [19][20][21][22][23][24] Expanded Access Programs (EAPs) provide an opportunity to expand the real-world dataset for CNB in a larger series of patients in order to gain knowledge on its clinical use. 25 The aims of this study were to describe the demographics of patients participating in a Spanish EAP, to report the effectiveness and tolerability of CNB in a large population, and to collate information on the use of CNB in clinical practice.…”

Section: Key Pointsmentioning

confidence: 99%

“…To further characterize the safety and efficacy profile of CNB and to evaluate the dosage, combinations, concomitant ASM adjustment, and use in populations excluded from clinical trials, it is necessary to go beyond clinical trial designs and to collect data from real‐world clinical practice 16–18 . However, the number of publications with CNB in this setting are limited and include low numbers of patients 19–24 . Expanded Access Programs (EAPs) provide an opportunity to expand the real‐world dataset for CNB in a larger series of patients in order to gain knowledge on its clinical use 25 …”

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Real‐world safety and effectiveness of cenobamate in patients with focal onset seizures: Outcomes from an Expanded Access Program

Villanueva,

Santos‐Carrasco,

Cabezudo‐García

et al. 2023

Epilepsia Open

View full text Add to dashboard Cite

ObjectiveThis study investigated early, real‐world outcomes with cenobamate (CNB) in a large series of patients with highly drug‐resistant epilepsy within a Spanish Expanded Access Program (EAP).MethodThis was a multicenter, retrospective, observational study in 14 hospitals. Inclusion criteria were age ≥18 years, focal seizures, and EAP authorization. Data were sourced from patient clinical records. Primary effectiveness endpoints included reductions (100%, ≥90%, ≥75%, and ≥50%) or worsening in seizure frequency at 3‐, 6‐, and 12‐month visits and at the last visit. Safety endpoints included rates of adverse events (AEs) and AEs leading to discontinuation.ResultsThe study included 170 patients. At baseline, median epilepsy duration was 26 years and median number of seizures/month was 11.3. The median number of prior antiseizure medications (ASMs) and concomitant ASMs were 12 and 3, respectively. Mean CNB dosages/day were 176 mg, 200 mg, and 250 mg at 3, 6, and 12 months. Retention rates were 98.2%, 94.5%, and 87% at 3, 6, and 12 months. At last available visit, the rate of seizure freedom was 13.3%; ≥90%, ≥75%, and ≥50% responder rates were 27.9%, 45.5%, and 63%, respectively. There was a significant reduction in the number of seizures per month (mean: 44.6%; median: 66.7%) between baseline and the last visit (P < 0.001). Responses were maintained regardless of the number of prior or concomitant ASMs. The number of concomitant ASMs was reduced in 44.7% of patients. The cumulative percentage of patients with AEs and AEs leading to discontinuation were 68.2% and 3.5% at 3 months, 74.1% and 4.1% at 6 months, and 74.1% and 4.1% at 12 months. The most frequent AEs were somnolence and dizziness.SignificanceIn this highly refractory population, CNB showed a high response regardless of prior and concomitant ASMs. AEs were frequent but mostly mild‐to‐moderate, and few led to discontinuation.

show abstract

Section: Discussionsupporting

confidence: 92%

Section: Discussionsupporting

confidence: 91%

Section: Key Pointsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Real‐world safety and effectiveness of cenobamate in patients with focal onset seizures: Outcomes from an Expanded Access Program

Villanueva,

Santos‐Carrasco,

Cabezudo‐García

et al. 2023

Epilepsia Open

View full text Add to dashboard Cite

show abstract

“…Most patients with these severe epilepsy syndromes benefited from cenobamate, although patients with combined generalized and focal epilepsy had less impressive seizure outcomes (Table 2). Our findings complement retrospective studies reporting significant seizure‐frequency reductions with cenobamate treatment in adults with focal epilepsy and developmental delay 27 and Dravet syndrome caused by loss‐of‐function mutations in SCN1A 28 …”

Section: Discussionsupporting

confidence: 84%

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

et al. 2023

View full text Add to dashboard Cite

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 stimula-How to cite this article:

show abstract

Effectiveness and Safety of Adjunctive Cenobamate in People with Focal-Onset Epilepsy: Evidence from the First Interim Analysis of the BLESS Study

Lattanzi,

Ranzato,

Di Bonaventura

et al. 2024

Neurol Ther

View full text Add to dashboard Cite

Introduction Despite new anti-seizure medications (ASMs) being introduced into clinical practice, about one-third of people with epilepsy do not reach seizure control. Cenobamate is a novel tetrazole-derived carbamate compound with a dual mechanism of action. In randomized controlled trials, adjunctive cenobamate reduced the frequency of focal seizures in people with uncontrolled epilepsy. Studies performed in real-world settings are useful to complement this evidence and better characterize the drug profile. Methods The Italian BLESS (“Cenobamate in Adults With Focal-Onset Seizures”) study is an observational cohort study aimed to evaluate the effectiveness, tolerability, and safety of adjunctive cenobamate in adults with uncontrolled focal epilepsy in the context of real-world clinical practice. The study is ongoing and conducted at 50 centers in Italy. This first interim analysis includes participants enrolled until June 2023 and with 12-week outcome data available. Results Forty participants with a median age of 36.5 (interquartile range [IQR] 26.0–47.5) years were included. The median monthly seizure frequency at baseline was 6.0 (IQR 2.5–17.3) seizures and 31 (77.5%) participants had failed four or more ASMs before cenobamate. At 12 weeks from starting cenobamate, the median reduction in monthly seizure frequency was 52.8% (IQR 27.1–80.3%); 22 (55.0%) participants had a ≥ 50% reduction in baseline seizure frequency and six (15.0%) reached seizure freedom. The median number of concomitant ASMs decreased from 3 (IQR 2–3) at baseline to 2 (IQR 2–3) at 12 weeks and the proportion of patients treated with > 2 concomitant ASMs decreased from 52.5% to 40.0%. Seven (17.5%) patients reported a total of 12 adverse events, 11 of which were considered adverse drug reactions to cenobamate. Conclusion In adults with uncontrolled focal seizures, the treatment with adjunctive cenobamate was well tolerated and was associated with improved seizure control and a reduction of the burden of concomitant ASMs. Trial Registration Number NCT05859854 (ClinicalTrials.gov Identifier). Supplementary Information The online version contains supplementary material available at 10.1007/s40120-024-00634-5.

show abstract

Effectiveness and safety of adjunctive cenobamate for focal seizures in adults with developmental disability treated in clinical practice

Cited by 8 publications

References 28 publications

Real‐world safety and effectiveness of cenobamate in patients with focal onset seizures: Outcomes from an Expanded Access Program

Real‐world safety and effectiveness of cenobamate in patients with focal onset seizures: Outcomes from an Expanded Access Program

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

Effectiveness and Safety of Adjunctive Cenobamate in People with Focal-Onset Epilepsy: Evidence from the First Interim Analysis of the BLESS Study

Contact Info

Product

Resources

About