Brivaracetam in treating epileptic encephalopathy and refractory focal epilepsies in patients under 14 years of age.
Iranian Journal of Child Neurology,
Vol. 15 No. 4 (2021),
1 Mehr 2021
https://doi.org/10.22037/ijcn.v15i4.29819
Abstract
Objectives: To analyze the efficacy and safety of Brivaracetam in pediatric patients with epileptic encephalopathy or unresponsive focal epilepsy.
Materials & Methods: This retrospective study was performed on 8 pediatric patients with EE or unresponsive focal epilepsy. Inclusion criteria: (1) 14 years or younger, (2) history of refractory epilepsy, (3) at least 1 month of continuous therapy with BRV, and (4) at least 6 months of follow-up. Exclusion criteria: (1) variation of concomitant antiepileptic drugs during the previous and/or subsequent 4 weeks of the introduction of BRV, (2) levetiracetam in therapy, (3) an epilepsy secondary to a progressive cerebral disease, tumor, or any other progressive neurodegenerative diseases, and (4) a status epilepticus in the month before screening or during the baseline period. The efficacy of BRV was defined as ≥50% of seizure frequency reduction at the end of the follow-up compared to baseline.
Results: All patients showed ≥50% seizure frequency reduction, of which 37.5% were seizure-free, 25% had a frequency reduction of ≥75% and 37.5% ≥ 50%. All patients with an epilepsy onset >12 months and duration of the epilepsy ≤6 years were seizure-free. The maximum effect was achieved at 2 mg/kg/day. Focal seizures showed a better response than epileptic encephalopathy. A remarkably positive effect of the Brivaracetam in patients with encephalopathy related to status epilepticus during sleep was noted. No relevant adverse events were noted.
Conclusion: Brivaracetam was an effective and well-tolerated treatment in pediatric patients with epileptic encephalopathy or unresponsive focal epilepsy, especially when the epilepsy onset was >12 months and the epilepsy duration ≤6 years. The overall effect was not dose dependent. Brivaracetam could have an indication in encephalopathy related to status epilepticus during sleep.
- Brivaracetam
- childhood epilepsy
- drug-resistant epilepsy
- epileptic encephalopathy.
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References
Bajjalieh SM, Peterson K, Shinghal R, et al. SV2, a brain synaptic vesicle protein homologous to bacterial transporters. Science 1992; 257:1271-3.
Feany MB, Lee S, Edwards RH, Buckley KM. The synaptic vesicle protein SV2 is a novel type of transmembrane transporter. Cell 1992; 70:861-7
Lynch BA, Lambeng N, Nocka K, et al. The synaptic vesicle protein SV2A is the binding site for the antiepileptic drug levetiracetam. Proc Natl Acad Sci U S A 2004; 101:9861-6.
Gillard M, Fuks B, Leclercq K, et al. Binding characteristics of brivaracetam, a selective, high affinity SV2A ligand in rat, mouse and human brain: relationship to anti-convulsant properties. Eur J Pharmacol 2011; 664:36-44. 9.
UCB, Brussels, Belgium. Briviact US Prescribing information. 2018. https://www.ucb.com/_up/ucb_com_products/documents/ Briviact_20180510_US-PI.pdf. Accessed 5 June 2019.
UCB, Brussels, Belgium. Summary of product characteristics Briviact® (EU). https://www.ema.europa.eu/en/documents/product-information/briviact-epar-product-information_en.pdf. Accessed 5 June 2019
Kasteleijn-Nolst Trenité DG, Genton P, Parain D, et al. Evaluation of brivaracetam, a novel SV2A ligand, in the photosensitivity model. Neurology 2007; 69(10):1027-34.
French JA, Costantini C, Brodsky A, et al. Adjunctive brivaracetam for refractory partial-onset seizures: a randomized, controlled trial. Neurology 2010; 75(6):519-25.
Van Paesschen W, Hirsch E, Johnson M, et al. Efficacy and tolerability of adjunctive brivaracetam in adults with uncontrolled partial-onset seizures: a phase IIB, randomized, controlled trial. Epilepsia 2013; 54(1):89–97.
Biton V, Berkovic SF, Abou-Khalil B, et al. Brivaracetam as adjunctive treatment for uncontrolled partial epilepsy in adults: a phase III randomized, double-blind, placebo-controlled trial. Epilepsia 2014; 55(1):57−66.
Ryvlin P, Werhahn KJ, Blaszczyk B, et al. Adjunctive brivaracetam in adults with uncontrolled focal epilepsy: results from a double-blind, randomized, placebo-controlled trial. Epilepsia 2014; 55(1):47−56.
Klein P, Schiemann J, Sperling MR, et al. A randomized, double-blind, placebo-controlled, multicenter, parallel-group study to evaluate the efficacy and safety of adjunctive brivaracetam in adult patients with uncontrolled partial-onset seizures. Epilepsia 2015; 56(12):1890-8.
Kwan P, Trinka E, van Paesschen W, et al. Adjunctive brivaracetam for uncontrolled focal and generalized epilepsies: results of a phase III, double-blind, randomized, placebocontrolled, flexible-dose trial. Epilepsia 2014; 55(1):38-46.
Strzelczyk A, Steinig I, Willems LM, et al. Treatment of refractory and super-refractory status epilepticus with brivaracetam: a cohort study from two German university hospitals. Epilepsy Behav 2017; 70(Pt A):177-81.
Steinhoff BJ, Bacher M, Bucurenciu I, et al. Real-life experience with brivaracetam in 101 patients with difficult-to-treat epilepsy - A monocenter survey. Seizure 2017; 48:11-4
Steinig I, von Podewils F, Moddel G, et al. Postmarketing experience with brivaracetam in the treatment of epilepsies: a multicenter cohort study from Germany. Epilepsia 2017; 58(7):1208-16.
Zahnert F, Krause K, Immisch I, et al. Brivaracetam in the Treatment of Patients with Epilepsy‐First Clinical Experiences. Front Neurol 2018; 6:9-38.
Hirsch M, Hintz M, Specht A, et al. Tolerability, efficacy and retention rate of Brivaracetam in patients previously treated with Levetiracetam: A monocenter retrospective outcome analysis. Seizure 2018; 61:98‐103.
Santamarina E, Parejo Carbonell B, Sala J, et al. Use of intravenous brivaracetam in status epilepticus: A multicenter registry. Epilepsia 2019; 60(8):1593-601.
Toledo M, Abraira L, Mazuela G, et al. Effect of brivaracetam on the anger levels of epilepsy patients. A prospective open-labelled controlled study. Seizure 2019; 69:198-203.
Villanueva V, López-González FJ, Mauri JA, et al. BRIVA-LIFE-A multicenter retrospective study of the long-term use of brivaracetam in clinical practice. Acta Neurol Scand 2019; 139(4):360-8.
Strzelczyk A, Kay L, Bauer S, et al. Use of brivaracetam in genetic generalized epilepsies and for acute, intravenous treatment of absence status epilepticus. Epilepsia 2018; 59:1549‐56.
Willems LM, Bertsche A, Bösebeck F, et al. Efficacy, retention, and tolerability of brivaracetam in patients with epileptic encephalopathies: A Multicenter Cohort Study From Germany. Front Neurol 2018; 9:569.
Liu E, Dilley D, McDonough B, et al. Safety and Tolerability of Adjuntive Brivaracetam in Pediatric Patients < 16 years Wih Epilepsy: an open-Label Trial. Paediatr Drugs 2019; 21(4):291-301.
Schubert-Bast S, Willems LM, Kurlemann G, et al. Postmarketing experience with brivaracetam in the treatment of focal epilepsy in children and adolescents. Epilepsy Behav 2018; 89:89-93.
Scheffer IE, Berkovic S, Capovilla G, et al. ILAE classification of the epilepsies: Position paper of the ILAE Commission for Classification and Terminology. Epilepsia 2017; 58(4):512-21.
Fisher RS, Cross JH, French JA, et al. Operational classification of seizure types by the International League Against Epilepsy: Position Paper of the ILAE Commission for Classification and Terminology. Epilepsia 2017; 58(4):512-21.
FDA, 2014. U.S. Food and Drug Administration. CFR—Code of Federal Regulations Title 21, vol. 5, 21CFR312.32.
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