Real-life evidence about the use of intravenous brivaracetam in urgent seizures: The BRIV-IV study.

Purpose: Urgent seizures are a medical emergency for which new therapies are still needed. This study evaluated the use of intravenous brivaracetam (IV-BRV) in an emergency setting in clinical practice.
Methods: BRIV-IV was a retrospective, multicenter, observational study. It included patients ≥18 years old who were diagnosed with urgent seizures (including status epilepticus (SE), acute repetitive seizures, and high-risk seizures) and who were treated with IV-BRV according to clinical practice in 14 hospital centers. Information was extracted from clinical charts and included in an electronic database. Primary effectiveness endpoints included the rate of IV-BRV responder patients, the rate of patients with a sustained response without seizure relapse in 12 h, and the time between IV-BRV administration and clinical response. Primary safety endpoints were comprised the percentage of patients with adverse events and those with adverse events leading to discontinuation.
Results: A total of 156 patients were included in this study. The mean age was 57.7 ± 21.5 years old with a prior diagnosis of epilepsy for 57.1% of patients. The most frequent etiologies were brain tumor-related (18.1%) and vascular (11.2%) epilepsy. SE was diagnosed in 55.3% of patients. The median time from urgent seizure onset to IV treatment administration was 60.0 min (range: 15.0-360.0), and the median time from IV treatment to IV-BRV was 90.0 min (range: 30.0-2400.0). Regarding dosage, the mean bolus infusion was 163.0 ± 73.0 mg and the mean daily dosage was 195.0 ± 87.0 mg. A total of 77.6% of patients responded to IV-BRV (66.3% with SE vs. 91% other urgent seizures) with a median response time of 30.0 min (range: 10.0-60.0). A sustained response was achieved in 62.8% of patients. However, adverse events were reported in 14.7%, which were predominantly somnolence and fatigue, with 4.5% leading to discontinuation. Eighty-six percent of patients were discharged with oral brivaracetam.
Conclusion: IV-BRV in emergency settings was effective, and tolerability was good for most patients. However, a larger series is needed to confirm the outcomes.
Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: V. Villanueva has received honoraria and/or research funds from Angelini Pharma, Bial, Eisai, Jazz Pharmaceuticals, Neuraxpharm, Novartis, Nutricia, Takeda, UCB Pharma, and Xenon. X. Rodríguez-Osorio has received honoraria and/or research funds from Angelini Pharma, Bial, Eisai, Jazz Pharmaceuticals, Neuraxpharm, UCB Pharma, and LivaNova. A Juiz-Fernández declares research funding and speaking fees from Bial Pharmaceutical, Jazz Pharmaceuticals, Eisai Inc., and UCB Pharma. M. Garcés has received consultant and/or speaker honoraria from Angelini-Pharma, Bial, Eisai, and UCB Pharma. E Rubio-Nazábal has received honoraria from BIAL, Eisai, and UCB Pharma for speaking. E Santamarina reports grants and personal fees from UCB Pharma, Eisai, and Bial; personal fees from Angelini Pharma, Esteve, and Ferrer outside the submitted work. M Falip has received speaker honoraria from UCB. I Garcia-Morales has received honoraria consultant and/or speaker honoraria from UCB, EISAI, Neuraxpharm, and Angelini. Ana Belén Martínez has received consultant and/or speaker honoraria from Angelini-Pharma, Eisai, and UCB Pharma. B Chavarria has received travel support from UCB. Rodrigo Rocamora has received travel support and honoraria as advisor from UCB, EISAI, Angelini, and Jazz Pharmaceutical. D Sayas, K Hampel, A Castillo, J Montoya, D Campos, A Fernández-Cabrera, A Gifreu, G Hernández Pérez, B Parejo-Carbonell, M Massot, M Asensio, J Giménez, V Guillen, J Ruiz-Giménez, R Rocamora, and I Escalza have no conflicts of interest
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