Sustained seizure freedom with adjunctive brivaracetam in patients with focal onset seizures

Lattanzi, Simona; Ascoli, Michele; Canafoglia, Laura; Canevini, Maria Paola; Casciato, Sara; Irelli, Emanuele Cerulli; Chiesa, Valentina; Dainese, Filippo; Maria, G. De; Didato, Giuseppe; Gennaro, Giancarlo Di; Falcicchio, Giovanni; Fanella, Martina; Gangitano, Massimo; Neve, Angela La; Mecarelli, Oriano; Montalenti, Elisa; Morano, Alessandra; Piazza, Federico; Pizzanelli, Chiara; Pulitano, Patrizia; Ranzato, Federica; Rosati, Eleonora; Tassi, Laura; Bonaventura, Carlo Di; Alicino, Angela; Assenza, Giovanni; Avorio, Federica; Badioni, Valeria; Banfi, Paola; Bartolini, Emanuele; Basili, Luca Manfredi; Belcastro, Vincenzo; Beretta, Simone; Berto, Irene; Biggi, Martina; Billo, Giuseppe; Boero, Giovanni; Bonanni, Paolo; Bongiorno, Jole; Brigo, Francesco; Caggia, Emanuele; Cagnetti, Claudia; Calvello, Carmen; Cesnik, Carlos E. S.; Chianale, Gigliola; Ciampanelli, Domenico; Ciuffini, Roberta; Cocito, Dario; Colella, Donato; Contento, Margerita; Costa, Cinzia; Cumbo, Eduardo; D’Aniello, Alfredo; Deleo, Francesco; DiFrancesco, Jacopo C.; Giacomo, Roberta Di; Liberto, Alessandra Di; Domina, Elisabetta; Donato, Francesco; Dono, Fedele; Durante, Vania; Elia, Maurizio; Estraneo, Anna; Evangelista, Giacomo; Faedda, M. T.; Failli, Ylenia; Fallica, Elisa; Fattouch, Jinane; Ferrari, Alessandra; Ferreri, Florinda; Fisco, Giacomo; Fonti, Davide; Fortunato, Francesco; Foschi, Nicoletta; Francavilla, T.; Galli, Rosita; Gasparini, Sara; Gazzina, Stefano; Giallonardo, Anna Teresa; Giorgi, Filippo Sean; Giuliano, Loretta; Habetswallner, Francesco; Izzi, Francesca; Kassabian, Benedetta; Kiferle, Lorenzo; Labate, Angelo; Luisi, Concetta; Magliani, Matteo; Maira, Giulia; Mari, Luisa; Marino, Daniela; Mascia, Addolorata; Mazzeo, Alessandra; Meletti, Stefano; Milano, Chiara; Nilo, Annacarmen; Orlando, Biagio; Paladin, Francesco; Pascarella, Maria Grazia; Pastori, Chiara; Pauletto, Giada; Peretti, Alessia; Perri, Gabriella; Pezzella, Marianna; Piccioli, Marta; Pignatta, Pietro; Pilolli, Nicola; Pisani, Francesco; Pisani, Laura Rosa; Placidi, Fabio; Pollicino, Patrizia; Porcella, Vittoria; Puligheddu, Monica; Quadri, Stefano; Quarato, Pier Paolo; Quintas, Rui; Renna, Rosaria; Rum, A.; Salamone, Enrico Michele; Savastano, Ersilia; Sessa, Maria; Stokelj, David; Tartara, Elena; Tombini, Mario; Tumminelli, Gemma; Vaudano, Anna Elisabetta; Ventura, Maria; Viganò, Ilaria; Viglietta, Emanuela; Vignoli, Aglaia; Villani, Flavio; Zambrelli, Elena; Zummo, Leila

doi:10.1111/epi.17223

Cited by 14 publications

(8 citation statements)

References 23 publications

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“…Effectiveness outcomes included sustained seizure response (SSR) and sustained freedom (SSF); seizure worsening (greater than 25% increase in monthly seizure frequency relative to baseline) and treatment discontinuation at 12 months were also considered. Sustained seizure response (freedom) was defined as a reduction of at least 50 (100%) in baseline seizure frequency that continued without interruption from the first time it was achieved through the 12-month follow-up without BRV withdrawal in patients with at least one seizure during the 3 months before introducing BRV; the time of achievement of SSR and SSF was established using data at visits at 3, 6, and 12 months [ 11 ].…”

Section: Methodsmentioning

confidence: 99%

“…Simple and multivariable logistic regression models were performed to identify baseline characteristics of patients associated with SSR and SSF. Selected independent variables were age, number of concomitant ASMs, concomitant use of sodium channel blockers (SCBs), baseline monthly seizure frequency, and early add-on treatment with BRV [ 11 , 12 ]. Carbamazepine, phenytoin, lamotrigine, oxcarbazepine, eslicarbazepine acetate, lacosamide, and rufinamide were classified as SCBs; patients in the SCB group were those receiving at least one SCB, whereas those in the no-SCB group did not take any SCB.…”

Section: Methodsmentioning

confidence: 99%

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Brivaracetam as Early Add-On Treatment in Patients with Focal Seizures: A Retrospective, Multicenter, Real-World Study

et al. 2022

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Introduction:In randomized controlled trials, add-on brivaracetam (BRV) reduced seizure frequency in patients with drug-resistant focal epilepsy. Most real-world research on BRV has focused on refractory epilepsy. The aim of this analysis was to assess the 12-month effectiveness and tolerability of adjunctive BRV when used as early or late adjunctive treatment in patients included in the BRIVAracetam add-on First Italian netwoRk Study (BRIVAFIRST). Methods: BRIVAFIRST was a 12-month retrospective, multicenter study including adult patients prescribed adjunctive BRV. Effective-The members of the BRIVAracetam add-on First Italian netwoRk Study (BRIVAFIRST) Group are listed in the Acknowledgements section.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Brivaracetam as Early Add-On Treatment in Patients with Focal Seizures: A Retrospective, Multicenter, Real-World Study

et al. 2022

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“…Age, duration of epilepsy, and number of concomitant ASMs were selected as independent variables of the multivariate models for their well-known association with seizure outcomes. [9][10][11] Data analysis was performed using Stata/IC 13.1 (StataCorp). The study is reported according to STROBE guidelines.…”

Section: Discussionmentioning

confidence: 99%

“…Simple and multivariate logistic regression models were performed to evaluate whether baseline seizure frequency (<5, 5–20, and >20 seizures per month) and number of prior ASMs (<5 and ≥6) were associated with SSF and SSR. Age, duration of epilepsy, and number of concomitant ASMs were selected as independent variables of the multivariate models for their well‐known association with seizure outcomes 9–11 . Data analysis was performed using Stata/IC 13.1 (StataCorp).…”

Section: Methodsmentioning

confidence: 99%

“…Study outcomes were sustained seizure response (SSR) and sustained seizure freedom (SSF), defined as ≥50% (SSR) and 100% (SSF) reduction in baseline seizure frequency that continued without interruption from the first time it was achieved through 12 months without BRV discontinuation. 9 The time of achievement of SSF and SSR was established using data at visits at 3, 6, and 12 months. The rate and reasons for treatment discontinuation and the rate of AEs considered BRV-related by physicians were also considered.…”

Section: Participantsmentioning

confidence: 99%

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Adjunctive brivaracetam and sustained seizure frequency reduction in very active focal epilepsy

Lattanzi,

Canafoglia,

Canevini

et al. 2023

Epilepsia

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ObjectiveThe study aimed to explore the effectiveness of brivaracetam (BRV) according to baseline seizure frequency and past treatment history in subjects with focal epilepsy who were included in the BRIVAracetam add‐on First Italian netwoRk Study (BRIVAFIRST).MethodsBRIVAFIRST was a 12‐month retrospective, multicenter study including adults prescribed adjunctive BRV. Study outcomes included sustained seizure response (SSR), sustained seizure freedom (SSF), and the rates of treatment discontinuation and adverse (AEs). Baseline seizure frequency was stratified as <5, 5 to 20, and >20 seizures per month, and the number of prior antiseizure medications (ASMs) as <5 and ≥6.ResultsParticipants included were 994. During the 1‐year study period, SSR was reached by 45.8%, 39.3%, and 22.6% of subjects with a baseline frequency of <5, 5‐20, and > 20 seizures per month (p<0.001); the corresponding figures for the SSF were 23.4%, 9.8%, and 2.8% (p<0.001). Sustained seizure response was reached by 51.2% and 26.5% participants with a history of 1‐5 and ≥6 ASMs (p<0.001); the corresponding rates of SSF were 24.7% and 4.5% (p<0.001). Treatment discontinuation due to lack of efficacy was more common in participants with >20 seizures compared to those with <5 seizures per month (25.8% versus 9.3%; p<0.001), and in participants with history of ≥6 prior ASMs compared to those with history of 1‐5 ASMs (19.6% versus 12.2%; p=0.002). There were no differences in the rates of BRV withdrawal due to AEs and the rates of AEs across the groups of participants defined according to the number of seizures at baseline and the number of prior ASMs.SignificanceThe baseline seizure frequency and the number of previous ASMs were predictors of sustained seizure frequency reduction with adjunctive BRV in subjects with focal epilepsy.

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Efficacy, safety, and tolerability of adjunctive brivaracetam in adult Asian patients with uncontrolled focal‐onset seizures: A phase III randomized, double‐blind, placebo‐controlled trial

Inoue,

Tiamkao,

Zhou

et al. 2024

Epilepsia Open

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ObjectiveEvaluate efficacy, safety, and tolerability of adjunctive brivaracetam (BRV) in adult Asian patients with focal‐onset seizures (FOS).MethodsPhase III, randomized, double‐blind, placebo‐controlled study (EP0083; NCT03083665) evaluating BRV 50 mg/day and 200 mg/day in patients (≥16–80 years) with FOS with/without secondary generalization (focal to bilateral tonic–clonic seizures) despite current treatment with 1 or 2 concomitant antiseizure medications. Following an 8‐week baseline, patients were randomized 1:1:1 to placebo, BRV 50 mg/day, or BRV 200 mg/day, and entered a 12‐week treatment period. Efficacy outcomes: percent reduction over placebo in 28‐day FOS frequency (primary); 50% responder rate in FOS frequency; median percent reduction in FOS frequency from baseline; seizure freedom during treatment period (secondary). Primary safety endpoints: incidences of treatment‐emergent adverse events (TEAEs); TEAEs leading to discontinuation; serious TEAEs.ResultsIn this study, 448/449 randomized patients (mean age, 34.5 years; 53.8% female) received ≥1 dose of study medication (placebo/BRV 50 mg/BRV 200 mg/day: n = 149/151/148). Percent reduction over placebo in 28‐day adjusted FOS frequency was 24.5% (p = 0.0005) and 33.4% (p < 0.0001) with BRV 50 mg/day and 200 mg/day, respectively, 50% responder rate was 19.0%, 41.1%, and 49.3% with placebo, BRV 50 mg/day, and BRV 200 mg/day, respectively (p < 0.0001 for both BRV groups vs. placebo). Median percent reduction in FOS frequency from baseline was 21.3%/38.9%/46.7% in patients on placebo/BRV 50 mg/BRV 200 mg/day, respectively. Overall, 0, 7 (4.6%), and 10 (6.8%) patients were classified as seizure‐free during the treatment period on placebo, BRV 50 mg/day, and BRV 200 mg/day, respectively (p = 0.0146/p = 0.0017 for BRV 50 mg/200 mg/day vs. placebo, respectively). TEAE incidences were similar between patients on placebo (58.4%) and all patients receiving BRV (58.5%); TEAE incidences for BRV 50 mg/day and BRV 200 mg/day were 57.0% and 60.1%, respectively. Overall, 0.7% of patients on placebo and 2.0% of all patients on BRV reported serious TEAEs (incidences for BRV 50 mg/day and BRV 200 mg/day were 1.3% and 2.7%, respectively), 20.1% of patients on placebo and 33.1% of all patients on BRV reported drug‐related TEAEs (incidences for BRV 50 mg/day and BRV 200 mg/day were 26.5% and 39.9%, respectively), and 4.7% of patients on placebo and 3.0% of all patients on BRV discontinued due to TEAEs (discontinuation incidences for BRV 50 mg/day and BRV 200 mg/day were 2.6% and 3.4%, respectively).SignificanceAdjunctive BRV was efficacious and well tolerated in adult Asian patients with FOS. Efficacy and safety profiles were consistent with BRV studies in predominantly non‐Asian populations.Plain Language SummaryBrivaracetam is used to treat partial or focal seizures in people with epilepsy. Most studies with brivaracetam tablets have involved people from non‐Asian racial backgrounds. In this study, 449 Asian adults with epilepsy took part. One third took 50 mg of brivaracetam, one third took 200 mg of brivaracetam, and one third took a placebo each day for 12 weeks. On average, those who took brivaracetam had fewer seizures than those given the placebo. Most of the side effects were mild and the number and type of side effects seen were as expected for this medication.

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Sustained seizure freedom with adjunctive brivaracetam in patients with focal onset seizures

Cited by 14 publications

References 23 publications

Brivaracetam as Early Add-On Treatment in Patients with Focal Seizures: A Retrospective, Multicenter, Real-World Study

Brivaracetam as Early Add-On Treatment in Patients with Focal Seizures: A Retrospective, Multicenter, Real-World Study

Adjunctive brivaracetam and sustained seizure frequency reduction in very active focal epilepsy

Efficacy, safety, and tolerability of adjunctive brivaracetam in adult Asian patients with uncontrolled focal‐onset seizures: A phase III randomized, double‐blind, placebo‐controlled trial

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