Brivaracetam Retention Rate and Seizure Outcomes in Patients with Drug-Resistant Focal Epilepsy Included in the Medical Need Program in Belgium: A Real-World, Multicenter, Chart Review

Abstract

Background New treatments are needed for patients with drug-resistant epilepsy to improve seizure control without decreasing quality of life. Objective In Belgium, a Medical Need Program (MNP) was initiated to make a new antiepileptic drug (brivaracetam; highaffinity synaptic vesicle protein 2A ligand) available as adjunctive therapy to treat focal seizures in patients failing treatment with three or more different antiepileptic drugs. This is a real-world chart review of the majority of patients (71%) enrolled in the MNP. Patients and Methods Retention and seizure outcomes of brivaracetam adjunctive treatment were evaluated in 175 patients aged ≥ 16 years enrolled in the MNP between June 2016 and May 2017 at six centers; 95.4% were previously/concomitantly treated with levetiracetam. Safety events data were also collected. Results In this highly drug-resistant population, 85.8%, 73.9%, and 64.9% of patients remained on brivaracetam, while seizure frequency decreased from baseline in 32.0%, 37.1%, and 37.3% of patients after 3, 6, and 9 months' treatment, respectively. Patients achieving 3-month seizure freedom increased from 3.2% after 3 months' treatment to 10.2% and 10.7% after 6 and 9 months' treatment, respectively. Six-month seizure freedom was achieved by 5.7% of patients at any time. Qualitative evaluation of seizures by physicians demonstrated 44.2%, 38.8%, and 43.2% of patients improved and 42.8%, 50.9%, and 50.6% remained unchanged during 3, 6, and 9 months' follow-up, respectively. No safety signals were identified. Conclusions Retention was high during 9 months of brivaracetam treatment in drug-resistant patients, including those previously/concomitantly treated with levetiracetam; 3-month seizure freedom increased from 3.2% after 3 months to 10.7% after 9 months of treatment.

Real-Life Effectiveness and Tolerability of Brivaracetam in Focal to Bilateral and Primary Generalized Tonic-Clonic Seizures

“…However, half the patients with drugresistant epilepsy were free of tonic-clonic seizures during follow-up, and up to 24% were free of all seizures. These results uphold the potential benefit of this treatment even in patients with refractory epilepsy and failure to several ASMs [33,34].…”

“…Similar to the findings in postcommercialization studies, adverse events occurred in almost 30% of our patients, and in most cases, they were mild and did not lead to treatment discontinuation. Nonetheless, TEAEs were the main reason for discontinuation, as has been reported [23,[34][35][36]. Some clinical trials have described higher TEAE [16,19], but they were mainly considered mild and did not require treatment discontinuation.…”

Efficacy and Tolerability of Brivaracetam in Chinese Population: Focus on Switch From Levetiracetam

“…[10][11][12][13]15,16,18 The seizure-freedom rate in our cohort is moderately higher than those of previous studies. [10][11][12][13][14][15][16]18,19 Although most of our cohort suffered from DRE (76%), the considerable high seizure-free proportion before using BRV may contribute to the favorable seizurefreedom rate in our study. Higher number of concomitant ASM significantly predicted poorer respond to BRV.…”

“…11,12 Only a few postmarketing studies focused on Asian countries. [13][14][15][16][17] In this multicenter retrospective cohort study, we detail our experiences of using BRV in a Chinese population.…”