Effectiveness and tolerability of brivaracetam in patients with epilepsy stratified by comorbidities and etiology in the real world: 12-month subgroup data from the international EXPERIENCE pooled analysis

Szaflarski, Jerzy P.; Besson, Hervé; D’Souza, Wendyl; Faught, Edward; Klein, Pavel; Reuber, Markus; Rosenow, Felix; Salas-Puig, Javier; Soto Insuga, Victor; Steinhoff, Bernhard J.; Strzelczyk, Adam; Bourikas, Dimitrios; Daniels, Tony; Floricel, Florin; Friesen, David; Laloyaux, Cédric; Villanueva, Vicente

doi:10.1007/s00415-024-12253-z

Cited by 4 publications

(2 citation statements)

References 32 publications

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“…Subgroup analyses of epilepsy patients with psychiatric comorbidities (PC) and cognitive or learning disability (CLD) in the EXPERIENCE study demonstrated that BRV was effective and well tolerated in these patients [ 67 ]. These subgroup analyses included 403 patients with and 1232 patients without CLD at baseline.…”

Section: Introductionmentioning

confidence: 99%

“…Additional subgroup analyses from the EXPERIENCE study demonstrated that BRV was well tolerated and effective in patients with different etiologies: PSE, brain-tumor related epilepsy (BTRE), and traumatic brain injury-related epilepsy (TBIE) [ 67 ]. These subgroup analyses included 51 patients with PSE at baseline and 1397 patients without PSE at baseline.…”

Section: Introductionmentioning

confidence: 99%

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Narrative Review of Brivaracetam: Preclinical Profile and Clinical Benefits in the Treatment of Patients with Epilepsy

Klein,

Bourikas

2024

Adv Ther

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One third of patients with epilepsy will continue to have uncontrolled seizures despite treatment with antiseizure medications (ASMs). There is therefore a need to develop novel ASMs. Brivaracetam (BRV) is an ASM that was developed in a major drug discovery program aimed at identifying selective, high-affinity synaptic vesicle protein 2A (SV2A) ligands, the target molecule of levetiracetam. BRV binds to SV2A with 15to 30-fold higher affinity and greater selectivity than levetiracetam. BRV has broad-spectrum antiseizure activity in animal models of epilepsy, a favorable pharmacokinetic profile, few clinically relevant drug-drug interactions, and rapid brain penetration. BRV is available in oral and intravenous formulations and can be initiated at target dose without titration. Efficacy and safety of adjunctive BRV (50-200 mg/day) treatment of focal-onset seizures was demonstrated in three pivotal phase III trials (NCT00490035/

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Narrative Review of Brivaracetam: Preclinical Profile and Clinical Benefits in the Treatment of Patients with Epilepsy

Klein,

Bourikas

2024

Adv Ther

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BRIVA‐ONE study: 12‐month outcomes of brivaracetam monotherapy in clinical practice

Villanueva,

Villar,

Fernandez‐Cabrera

et al. 2024

Epilepsia Open

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ObjectiveThis study investigated the effectiveness and tolerability of brivaracetam (BRV) monotherapy in a large series of patients with epilepsy.MethodThis was a multicenter, retrospective, observational, non‐interventional study in 24 hospitals across Spain. Patients aged ≥18 years who started on BRV monotherapy, either as first‐line or following conversion, at least 1 year before database closure were included. Patients were evaluated at baseline and at 3, 6 and 12 months after initiation of BRV monotherapy, in accordance with usual clinical practice at these centers. Data were collected retrospectively from patients' individual charts by participating physicians. The primary effectiveness and safety endpoints were the percentage of seizure‐free patients 1 year after initiation of BRV monotherapy and the proportion of patients reporting adverse events (AEs) over the complete follow‐up period. Retention rates and subpopulation analysis (levetiracetam switchers, elderly and different etiologies) were also investigated.ResultsA total of 276 patients were included (48 with BRV as first‐line monotherapy and 228 who converted to BRV monotherapy). The overall retention rate in monotherapy at 12 months was 89.9% (87.5% for first‐line monotherapy group; 90.4% for conversion‐to‐monotherapy group). Seizure‐freedom rates at 12 months were 77.8% (75% for first‐line monotherapy group; 78.4% for conversion‐to‐monotherapy group). AEs occurred in 39.5% of patients at 12 months (35.4% for first‐line monotherapy group; 40.4% for conversion‐to‐monotherapy group). Most AEs were mild‐to‐moderate. The most frequent AEs were irritability (12.3%) and dizziness (10.1%). The most frequent AEs leading to BRV withdrawal were dizziness (1.8%) and memory problems (1.4%). Similar outcomes in terms of effectiveness and tolerability of BRV monotherapy were observed in patients switching from levetiracetam, those with different epilepsy etiologies, and elderly patients.SignificanceBRV was effective and well tolerated both as first‐line monotherapy and following conversion to monotherapy in a real‐world setting of patients with epilepsy.Plain Language SummaryThe goal of the medical treatment of epilepsy is to ensure best possible patient quality of life, by maximizing seizure control and minimizing medication toxicity. Brivaracetam (BRV) is a new‐generation epilepsy treatment that is well tolerated by patients. In our study, monotherapy with BRV reduced seizures in patients who had not received other treatments and in patients who switched from a previous treatment to BRV monotherapy. BRV was well tolerated and also effective in sensitive patients (i.e., the elderly and those who had epilepsy caused by a brain tumor or a brain injury).

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Brivaracetam use in clinical practice: a Delphi consensus on its role as first add-on therapy in focal epilepsy and beyond

Lattanzi,

Chiesa,

Di Gennaro

et al. 2024

Neurol Sci

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Background Antiseizure medications remain the cornerstone of treatment for epilepsy, although a proportion of individuals with the condition will continue to experience seizures despite appropriate therapy. Treatment choices for epilepsy are based on variables related to both the individual patient and the available medications. Brivaracetam is a third-generation agent antiseizure medication. Methods We carried out a Delphi consensus exercise to define the role of brivaracetam in clinical practice and to provide guidance about its use as first add-on ASM and in selected clinical scenarios. A total of 15 consensus statements were drafted by an expert panel following review of the literature and all were approved in the first round of voting by panelists. The consensus indicated different clinical scenarios for which brivaracetam can be a good candidate for treatment, including first add-on use. Results Overall, brivaracetam was considered to have many advantageous characteristics that render it a suitable option for patients with focal epilepsy, including a fast onset of action, favorable pharmacokinetic profile with few drug-drug interactions, broad-spectrum activity, and being well tolerated across a range of doses. Brivaracetam is also associated with sustained clinical response and good tolerability in the long term. Conclusions These characteristics also make it suitable as an early add-on for the elderly and for patients with post-stroke epilepsy or status epilepticus as highlighted by the present Delphi consensus.

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Effectiveness and tolerability of brivaracetam in patients with epilepsy stratified by comorbidities and etiology in the real world: 12-month subgroup data from the international EXPERIENCE pooled analysis

Cited by 4 publications

References 32 publications

Narrative Review of Brivaracetam: Preclinical Profile and Clinical Benefits in the Treatment of Patients with Epilepsy

Narrative Review of Brivaracetam: Preclinical Profile and Clinical Benefits in the Treatment of Patients with Epilepsy

BRIVA‐ONE study: 12‐month outcomes of brivaracetam monotherapy in clinical practice

Brivaracetam use in clinical practice: a Delphi consensus on its role as first add-on therapy in focal epilepsy and beyond

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