Correction to: Adjunctive Brivaracetam in Focal Epilepsy: Real‑World Evidence from the BRIVAracetam add‑on First Italian netwoRk Study (BRIVAFIRST)

Lattanzi, Simona; Canafoglia, Laura; Canevini, Maria Paola; Casciato, Sara; Chiesa, Valentina; Dainese, Filippo; Maria, G. De; Didato, Giuseppe; Falcicchio, Giovanni; Fanella, Martina; Ferlazzo, Edoardo; Fisco, Giacomo; Gangitano, Massimo; Giallonardo, Anna Teresa; Giorgi, Filippo Sean; Neve, Angela La; Mecarelli, Oriano; Montalenti, Elisa; Piazza, Federico; Pulitano, Patrizia; Quarato, Pier Paolo; Ranzato, Federica; Rosati, Eleonora; Tassi, Laura; Bonaventura, Carlo Di; Alicino, Angela; Ascoli, Michele; 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; Bongorno, Jole; Brigo, Francesco; Caggia, Emanuele; Cagnetti, Claudia; Calvello, Carmen; Irelli, Emanuele Cerulli; 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.; Gennaro, Giancarlo Di; Giacomo, Roberta Di; Liberto, Alessandra Di; Domina, Elisabetta; Donato, Francesco Di; Durante, Vania; Elia, Maurizio; Estraneo, Anna; Evangelista, Giacomo; Faedda, M. T.; Failli, Ylenia; Fallica, Elisa; Fattouch, Jinane; Ferrari, Alessandra; Ferreri, Florinda; Fonti, Davide; Fortunato, Francesco; Foschi, Nicoletta; Francavilla, T.; Galli, Rosita; Gazzina, Stefano; Giuliano, Loretta; Habetswallner, Francesco; Izzi, Francesca; Kassabian, Benedetta; Labate, Angelo; Luisi, Concetta; Magliani, Matteo; Maira, Giulia; Mari, Luisa; Marino, Daniela; Mascia, Addolorata; Mazzeo, Alessandra; Meletti, Stefano; Morano, Alessandra; Nilo, Annacarmen; Orlando, Biagio; Paladin, Francesco; Pascarella, Maria Grazia; Pastori, Chiara; Pauletto, Giada

doi:10.1007/s40263-021-00868-z

Cited by 3 publications

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“…BRIVAFIRST was a retrospective study conducted across 62 Italian centers [ 8 , 9 ]. Adult patients attending participating centers who were prescribed to BRV (March 2018–March 2020) and were on stable treatment with at least one ASM during the prior 90 days were retrospectively identified.…”

Section: Methodsmentioning

confidence: 99%

“…The BRIVAracetam add-on First Italian netwoRk Study (BRIVAFIRST) investigated the use of adjunctive BRV in a large population of patients with focal epilepsy treated according to daily clinical practice over a 1-year period [ 8 , 9 ]. BRIVAFIRST represents the largest real-world study of BRV, and the size of the cohort allows for sub-analyses to be performed.…”

Section: Introductionmentioning

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: Introductionmentioning

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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“…Discontinuation and real‐world AE rates for individuals living with DRE were harder to locate because most AE data on ASMs are reported from clinical trials with very constricted study population and a relatively short follow‐up, and real‐world studies either focused on one or two ASMs or used data from a single practice, often with unclear number of prior lines of ASM therapy. For example, a real‐world study on Italians taking brivaracetam as an add‐on therapy for focal epilepsy found that 26% individuals discontinued their ASM treatment during the 1‐year follow‐up, and 30% individuals reported at least 1 AE 19 . An European study on real‐world use of eslicarbazepine as adjunctive treatment found that discontinuation rate was 14%, and 34% reported AEs 20 .…”

Section: Discussionmentioning

confidence: 99%

Real‐world anti‐seizure treatment and adverse events among individuals living with drug‐resistant focal epilepsy in the United States

Mao,

Takahashi,

Cheng

et al. 2024

Epilepsia Open

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ObjectiveThis study aimed to understand how people living with drug‐resistant focal epilepsy (DRE) navigate through lines of antiseizure medications (ASM) and experience adverse events (AEs) in the real‐world setting in the United States.MethodsA retrospective study was conducted with medical chart data from clinical practices in the United States. Eligible adults had a confirmed diagnosis of DRE and initiated a third‐line ASM therapy between January 2013 and January 2020 (i.e., the index date). Subjects must have medical history data available for ≥1 year prior to (the baseline) and ≥2 years after the index date (the follow‐up). Treatment patterns were captured from first to fourth lines. After the emergence of drug resistance, time to ASM discontinuation, reasons for discontinuation, AE experience and AE management were reported separately during third and fourth lines of treatment and beyond.ResultsThe study included a total of 345 individuals, with an average (standard deviation) age of 23.9 (11.9) years at first diagnosis. All individuals had at least three lines of ASMs with first and second lines during baseline, and third line during follow‐up. The first line for most individuals was monotherapy. As individuals progressed through additional lines of ASM therapy, they were more likely to receive polytherapy. The regimens were more individualized after meeting drug resistance criteria. The top reasons for discontinuing were uncontrolled seizure and/or intolerance/AEs for both third and subsequent lines. More than a third of individuals experienced at least one AE. Among those with at least one AE, many individuals had to manage these AEs with dose adjustment (39.4%), discontinuation of offending ASM (37.9%), de novo pharmacotherapy (25.8%), emergency room visit (13.6%), and hospitalization (12.1%).SignificanceThis study demonstrated that individuals living with DRE experience significant AEs, and many of these AEs lead to treatment disruption and significant healthcare resource utilization.Plain Language SummaryThis study examined how individuals with focal epilepsy are treated across various clinics in United States and reported the adverse events these individuals experienced during treatment, along with the consequence associated with these adverse events. We found that as individuals progressed through additional treatments, they were more and more likely to receive more than one antiseizure medication, and a significant portion of individuals experienced at least one adverse event, often manifested as headache, somnolence, dizziness, and fatigue.

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“…Studies based on data generated in a real‐life context can complement the evidence coming from the randomized, controlled trials and provide original insights on issues not captured in regulatory trials. The Brivaracetam Add‐On First Italian Network Study (BRIVAFIRST) is the largest study to have assessed the 1‐year effectiveness and tolerability of BRV as adjunctive treatment of focal seizures in people with epilepsy treated according to daily clinical practice 3,4 . This analysis of the BRIVAFIRST data aimed to explore the response to adjunctive BRV according to the baseline seizure frequency and as a function of the number of previous ASMs.…”

Section: Introductionmentioning

confidence: 99%

“…• Baseline seizure frequency and number of previous treatments predicted sustained seizure frequency reduction with brivaracetam • Sustained seizure frequency reduction was observed in brivaracetam-treated subjects with very active focal epilepsy • No differences in tolerability of brivaracetam emerged according to baseline seizure frequency and number of prior treatments and tolerability of BRV as adjunctive treatment of focal seizures in people with epilepsy treated according to daily clinical practice. 3,4 This analysis of the BRIVAFIRST data aimed to explore the response to adjunctive BRV according to the baseline seizure frequency and as a function of the number of previous ASMs.…”

mentioning

confidence: 99%

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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Correction to: Adjunctive Brivaracetam in Focal Epilepsy: Real‑World Evidence from the BRIVAracetam add‑on First Italian netwoRk Study (BRIVAFIRST)

Cited by 3 publications

References 0 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

Real‐world anti‐seizure treatment and adverse events among individuals living with drug‐resistant focal epilepsy in the United States

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

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