Conversion to Brivaracetam Monotherapy in Clinical Practice: A Retrospective Study.

Antiseizure medication Brivaracetam Epilepsy Focal seizures

Journal

Neurology and therapy
ISSN: 2193-8253
Titre abrégé: Neurol Ther
Pays: New Zealand
ID NLM: 101637818

Informations de publication

Date de publication:
Apr 2024
Historique:
received: 27 11 2023
accepted: 09 01 2024
pubmed: 1 2 2024
medline: 1 2 2024
entrez: 1 2 2024
Statut: ppublish

Résumé

The study aimed to evaluate the effectiveness and safety of brivaracetam (BRV) as conversion monotherapy in adults with focal epilepsy treated in the context of real-world clinical practice. This was a retrospective, observational, non-interventional study in adults with focal epilepsy who converted to BRV monotherapy following the withdrawal of background antiseizure medications (ASMs). Primary effectiveness outcome was the retention rate of BRV as single ASM at 6 and 12 months. Secondary outcomes included the 6- and 12-month rates of seizure freedom. Safety and tolerability outcomes included the frequency and type of adverse events (AEs) and the occurrence of treatment discontinuation due to AEs. A total of 44 participants with a median age of 63.5 (interquartile range 44-73.5) years were included; 17 subjects were seizure free at baseline, and 9 of them switched from levetiracetam because of lack of tolerability. The retention rate of BRV monotherapy was 88.6% (39/44) at 6 months and 83.9% (26/31) at 12 months. The rates of seizure freedom were 72.7% (32/44) in subjects with 6-month follow-up and 58.1% (18/31) in subjects with 12-month follow-up. The median maintenance dosage of BRV monotherapy was 150 (100-200) mg/day at 6 months and 125 (100-200) mg/day in subjects with 12-month follow-up. Adverse events were recorded in 6/44 (13.6%) participants and led to BRV discontinuation in 2/44 (4.5%) cases. The reported AEs were somnolence (n = 3), fatigue (n = 2), and irritability (n = 1); no serious AEs were experienced. In 21/44 (47.7%) participants, BRV monotherapy resulted from the direct switch from levetiracetam. The rates of treatment retention and seizure freedom at 6 and 12 months were higher among people who switched from levetiracetam to BRV monotherapy. Brivaracetam may be a valuable treatment of focal seizures in people who converted to monotherapy in a real-life setting.

Identifiants

pubmed: 38300459
doi: 10.1007/s40120-024-00580-2
pii: 10.1007/s40120-024-00580-2
doi:

Types de publication

Journal Article

Langues

eng

Pagination

389-398

Informations de copyright

© 2024. The Author(s).

Références

Klein P, Diaz A, Gasalla T, Whitesides J. A review of the pharmacology and clinical efficacy of brivaracetam. Clin Pharmacol. 2018;10:1–22.
pubmed: 29403319 pmcid: 5783144
Brivaracetam. Highlight of prescribing information. https://www.briviact.com/briviact-PI.pdf . Accessed Oct 2023.
Moseley BD, Chanteux H, Nicolas JM, Laloyaux C, Gidal B, Stockis A. A review of the drug-drug interactions of the antiepileptic drug brivaracetam. Epilepsy Res. 2020;163: 106327.
doi: 10.1016/j.eplepsyres.2020.106327 pubmed: 32361205
EMA. Guideline on clinical investigation of medicinal products in the treatment of epileptic disorders. https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-clinical-investigation-medicinal-products-treatment-epileptic-disorders-revision-3_en.pdf . Accessed Oct 2023.
Lattanzi S, Cagnetti C, Foschi N, Provinciali L, Silvestrini M. Lacosamide monotherapy for partial onset seizures. Seizure. 2015;27:71–4.
doi: 10.1016/j.seizure.2015.03.003 pubmed: 25891931
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;58:522–30.
doi: 10.1111/epi.13670 pubmed: 28276060
Lattanzi S, Ascoli M, Canafoglia L, et al. Sustained seizure freedom with adjunctive brivaracetam in patients with focal onset seizures. Epilepsia. 2022;63:e42–50.
doi: 10.1111/epi.17223 pubmed: 35278335 pmcid: 9311068
Lattanzi S, Canafoglia L, Canevini MP, et al. Adjunctive brivaracetam and sustained seizure frequency reduction in very active focal epilepsy. Epilepsia. 2023;64:2922–33.
doi: 10.1111/epi.17740 pubmed: 38079181
von Elm E, Altman DG, Egger M, et al. STROBE Initiative. The strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies. Ann Intern Med. 2007;147:573–7.
doi: 10.7326/0003-4819-147-8-200710160-00010
Hirsch M, Hintz M, Specht A, Schulze-Bonhage A. Tolerability, efficacy and retention rate of brivaracetam in patients previously treated with levetiracetam: a monocenter retrospective outcome analysis. Seizure. 2018;61:98–103.
doi: 10.1016/j.seizure.2018.07.017 pubmed: 30118932
Yates SL, Fakhoury T, Liang W, Eckhardt K, Borghs S, D’Souza J. An open-label, prospective, exploratory study of patients with epilepsy switching from levetiracetam to brivaracetam. Epilepsy Behav. 2015;52:165–8.
doi: 10.1016/j.yebeh.2015.09.005 pubmed: 26432008
Steinhoff BJ, Klein P, Klitgaard H, et al. Behavioral adverse events with brivaracetam, levetiracetam, perampanel, and topiramate: a systematic review. Epilepsy Behav. 2021;118: 107939.
doi: 10.1016/j.yebeh.2021.107939 pubmed: 33839453
Lattanzi S, Cagnetti C, Foschi N, Provinciali L, Silvestrini M. Brivaracetam add-on for refractory focal epilepsy: a systematic review and meta-analysis. Neurology. 2016;86:1344–52.
doi: 10.1212/WNL.0000000000002545 pubmed: 26944275
Lattanzi S, Trinka E, Zaccara G, et al. Third-generation antiseizure medications for adjunctive treatment of focal-onset seizures in adults: a systematic review and network meta-analysis. Drugs. 2022;82:199–218.
doi: 10.1007/s40265-021-01661-4 pubmed: 35061214 pmcid: 8843918
Lattanzi S, Canafoglia L, Canevini MP, et al. Adjunctive brivaracetam in focal epilepsy: real-world evidence from the BRIVAracetam add-on First Italian netwoRk STudy (BRIVAFIRST). CNS Drugs. 2021;35:1289–301.
doi: 10.1007/s40263-021-00856-3 pubmed: 34476770 pmcid: 8642333
Lattanzi S, Canafoglia L, Canevini MP, et al. Brivaracetam as early add-on treatment in patients with focal seizures: a retrospective, multicenter. Real-World Study Neurol Ther. 2022;11:1789–804.
doi: 10.1007/s40120-022-00402-3 pubmed: 36109431 pmcid: 9588144
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;139:360–8.
doi: 10.1111/ane.13059 pubmed: 30506559
Arnold S, Badalamenti V, Diaz A, et al. Conversion to brivaracetam monotherapy for the treatment of patients with focal seizures: two double-blind, randomized, multicenter, historical control, phase III studies. Epilepsy Res. 2018;141:73–82.
doi: 10.1016/j.eplepsyres.2018.02.005 pubmed: 29486396
Villanueva V, Laloyaux C, D’Souza W, et al. Effectiveness and tolerability of 12-month brivaracetam in the real world: EXPERIENCE, an international pooled analysis of individual patient records. CNS Drugs. 2023;37:819–35.
doi: 10.1007/s40263-023-01033-4 pubmed: 37684497 pmcid: 10501958
Zahnert F, Krause K, Immisch I, et al. Brivaracetam in the treatment of patients with epilepsy-first clinical experiences. Front Neurol. 2018;9:38.
doi: 10.3389/fneur.2018.00038 pubmed: 29467714 pmcid: 5808159

Auteurs

Simona Lattanzi (S)

Neurological Clinic, Department of Experimental and Clinical Medicine, Marche Polytechnic University, Via Conca 71, 60020, Ancona, Italy. alfierelattanzisimona@gmail.com.

Nicoletta Foschi (N)

Neurological Clinic, Department of Experimental and Clinical Medicine, Marche Polytechnic University, Via Conca 71, 60020, Ancona, Italy.

Chiara Martellino (C)

Neurophysiopathology and Movement Disorders Clinic, University of Messina, Messina, Italy.

Daniela Audenino (D)

S.C. Neurologia, S.S.C. Neurofisiopatologia, E.O. Ospedali Galliera, Genoa, Italy.

Giovanni Boero (G)

Division of Neurology, SS Annunziata Hospital, Taranto, Italy.

Paolo Bonanni (P)

Epilepsy and Clinical Neurophysiology Unit, Scientific Institute IRCCS Eugenio Medea, Conegliano, Treviso, Italy.

Edoardo Ferlazzo (E)

Department of Medical and Surgical Sciences, Magna Græcia University of Catanzaro, Catanzaro, Italy.

Valentina Chiesa (V)

Epilepsy Center, Child Neuropsychiatry Unit, AAST Santi Paolo Carlo, Milan, Italy.

Filippo Dainese (F)

Unit of Neurology and Unit of Clinical Neurophysiology, Department of Neuroscience, University of Padua, Padua, Italy.

Marta Piccioli (M)

Neurology Unit, PO San Filippo Neri, ASL Roma 1, Rome, Italy.

Alessandra Ferrari (A)

Division of Clinical Neurophysiology and Epilepsy Centre, Department of Neuroscience, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.

Angelo Labate (A)

Neurophysiopathology and Movement Disorders Clinic, University of Messina, Messina, Italy.

Classifications MeSH