Adjunctive Brivaracetam in Older Patients with Focal Seizures: Evidence from the BRIVAracetam add‑on First Italian netwoRk Study (BRIVAFIRST)
- PMID: 35344198
- PMCID: PMC8995268
- DOI: 10.1007/s40266-022-00931-4
Adjunctive Brivaracetam in Older Patients with Focal Seizures: Evidence from the BRIVAracetam add‑on First Italian netwoRk Study (BRIVAFIRST)
Abstract
Background: The management of epilepsy in older adults has become part of daily practice because of an aging population. Older patients with epilepsy represent a distinct and more vulnerable clinical group as compared with younger patients, and they are generally under-represented in randomized placebo-controlled trials. Real-world studies can therefore be a useful complement to characterize the drug's profile. Brivaracetam is a rationally developed compound characterized by high-affinity binding to synaptic vesicle protein 2A and approved as adjunctive therapy for focal seizures in adults with epilepsy.
Objective: The aim of this study was to assess the 12-month effectiveness and tolerability of adjunctive brivaracetam in older patients (≥65 years of age) with epilepsy treated in a real-world setting.
Methods: The BRIVAFIRST (BRIVAracetam add-on First Italian netwoRk STudy) was a 12-month retrospective multicenter study including adult patients prescribed adjunctive brivaracetam. Effectiveness outcomes included the rates of seizure response (≥50% reduction in baseline seizure frequency), seizure freedom, and treatment discontinuation. Safety and tolerability outcomes included the rate of treatment discontinuation due to adverse events and the incidence of adverse events. Data were compared for patients aged ≥65 years of age ('older') vs those aged <65 years ('younger').
Results: There were 1029 patients with focal epilepsy included in the study, of whom 111 (10.8%) were aged ≥65 years. The median daily dose of brivaracetam at 3 months was 100 [interquartile range, 100-175] mg in the older group and 100 [100-200] mg in the younger group (p = 0.036); it was 150 [100-200] mg in both groups either at 6 months (p = 0.095) or 12 months (p = 0.140). At 12 months, 49 (44.1%) older and 334 (36.4%) younger patients had a reduction in their baseline seizure frequency by at least 50% (p = 0.110), and the seizure freedom rates were 35/111 (31.5%) and 134/918 (14.6%) in older and younger groups, respectively (p < 0.001). During the 1-year study period, 20 (18.0%) patients in the older group and 245 (26.7%) patients in the younger group discontinued brivaracetam (p = 0.048). Treatment withdrawal because of insufficient efficacy was less common in older than younger patients [older: n = 7 (6.3%), younger: n = 152 (16.6%); p = 0.005]. Adverse events were reported by 24.2% of older patients and 30.8% of younger patients (p = 0.185); the most common adverse events were somnolence, nervousness and/or agitation, vertigo, and fatigue in both study groups.
Conclusions: Adjunctive brivaracetam was efficacious, had good tolerability, and no new or unexpected safety signals emerged when used to treat older patients with uncontrolled focal seizures in clinical practice. Adjunctive brivaracetam can be a suitable therapeutic option in this special population.
© 2022. The Author(s).
Conflict of interest statement
SL has received speaker’s or consultancy fees from Angelini, Eisai, GW Pharmaceuticals, and UCB Pharma, and has served on advisory boards for Angelini, Arvelle Therapeutics, Bial, and GW Pharmaceuticals. LC has received consultancy fees from Eisai. MPC has received speaker’s or consultancy fees from Bial, Eisai, Italfarmaco, Sanofi, and UCB Pharma. SC has participated in pharmaceutical industry-sponsored symposia for Eisai, UCB Pharma, and Lusofarmaco. VC has received speaker’s or consultancy fees from Eisai and UCB Pharma. ALN has received speaker’s or consultancy fees from Eisai, Mylan, Bial, Sanofi, and UCB Pharma. PP has received consulting fees or speaker honoraria from UCB Pharma and Eisai. PPQ has participated in pharmaceutical industry-sponsored clinical trials and symposia for UCB Pharma. FR has received speaker’s fees from Eisai, UCB, and Livanova. ER has received fees for participation in advisory board or scientific consultation from Eisai, GW Pharmaceuticals, Bial, and UCB Pharma. LT has received speaker’s or consultancy fees from Arvelle Therapeutics, Eisai, and UCB Pharma. CDB has received consulting fees or speaker honoraria from UCB Pharma, Eisai, GW Pharmaceuticals, Bial, and Lusopharma. ECI, FD, GDM, GD, GF, MF, EF, MG, FSG, OM, EM, AM, and FP have no conflicts of interest to declare.
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