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. 2024 Jun;271(6):3169-3185.
doi: 10.1007/s00415-024-12253-z. Epub 2024 Mar 4.

Effectiveness and tolerability of brivaracetam in patients with epilepsy stratified by comorbidities and etiology in the real world: 12-month subgroup data from the international EXPERIENCE pooled analysis

Jerzy P Szaflarski  1 , Hervé Besson  2 , Wendyl D'Souza  3 , Edward Faught  4 , Pavel Klein  5 , Markus Reuber  6 , Felix Rosenow  7   8 , Javier Salas-Puig  9 , Victor Soto Insuga  10 , Bernhard J Steinhoff  11 , Adam Strzelczyk  7   8 , Dimitrios Bourikas  12 , Tony Daniels  13 , Florin Floricel  14 , David Friesen  15 , Cédric Laloyaux  16 , Vicente Villanueva  17
Affiliations

Effectiveness and tolerability of brivaracetam in patients with epilepsy stratified by comorbidities and etiology in the real world: 12-month subgroup data from the international EXPERIENCE pooled analysis

Jerzy P Szaflarski et al. J Neurol. 2024 Jun.

Abstract

Objective: To assess the effectiveness and tolerability of brivaracetam (BRV) in adults with epilepsy by specific comorbidities and epilepsy etiologies.

Methods: EXPERIENCE/EPD332 was a pooled analysis of individual patient records from several non-interventional studies of patients with epilepsy initiating BRV in clinical practice. Outcomes included ≥ 50% reduction from baseline in seizure frequency, seizure freedom (no seizures within prior 3 months), continuous seizure freedom (no seizures since baseline), BRV discontinuation, and treatment-emergent adverse events (TEAEs) at 3, 6, and 12 months. Analyses were performed for all adult patients (≥ 16 years of age) and stratified by comorbidity and by etiology at baseline (patients with cognitive/learning disability [CLD], psychiatric comorbidity, post-stroke epilepsy, brain tumor-related epilepsy [BTRE], and traumatic brain injury-related epilepsy [TBIE]).

Results: At 12 months, ≥ 50% seizure reduction was achieved in 35.6% (n = 264), 38.7% (n = 310), 41.7% (n = 24), 34.1% (n = 41), and 50.0% (n = 28) of patients with CLD, psychiatric comorbidity, post-stroke epilepsy, BTRE, and TBIE, respectively; and continuous seizure freedom was achieved in 5.7% (n = 318), 13.7% (n = 424), 29.4% (n = 34), 11.4% (n = 44), and 13.8% (n = 29), respectively. During the study follow-up, in patients with CLD, psychiatric comorbidity, post-stroke epilepsy, BTRE, and TBIE, 37.1% (n = 403), 30.7% (n = 605), 33.3% (n = 51), 39.7% (n = 68), and 27.1% (n = 49) of patients discontinued BRV, respectively; and TEAEs since prior visit at 12 months were reported in 11.3% (n = 283), 10.0% (n = 410), 16.7% (n = 36), 12.5% (n = 48), and 3.0% (n = 33), respectively.

Conclusions: BRV as prescribed in the real world is effective and well tolerated among patients with CLD, psychiatric comorbidity, post-stroke epilepsy, BTRE, and TBIE.

Keywords: Brivaracetam; Comorbidity; Effectiveness; Etiology; Real world; Tolerability.

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Conflict of interest statement

JPS has received research funding from Biogen, Department of Defense, Eisai, GW Pharmaceuticals companies, National Institutes of Health, National Science Foundation, NeuroPace, Serina Therapeutics, Shor Foundation for Epilepsy Research, State of Alabama General Funds, and UCB Pharma; has served as a consultant or advisory board member for Elite Medical Experts, GW Pharmaceuticals, LivaNova, Lundbeck, Medical Association of the State of Alabama, NeuroPace, Serina Therapeutics, SK Life Science, and UCB Pharma; has served as an investigator on GW Research Ltd trials; and is an editorial board member for Epilepsy & Behavior, Epilepsy & Behavior Reports (editor-in-chief), Folia Medica Copernicana, Journal of Epileptology (associate editor), and Journal of Medical Science. HB, DB, TD, FF, VS, and CL are employees of UCB Pharma. WDS has a salary that is part-funded by The University of Melbourne; he has received travel, investigator-initiated, scientific advisory board, and speaker honoraria from UCB Pharma Australia & Global; investigator-initiated, scientific advisory board, travel, and speaker honoraria from Eisai Australia & Global; advisory board honoraria from LivaNova and Tilray; educational grants from Novartis, Pfizer, and Sanofi-Synthélabo; educational, travel, and fellowship grants from GSK Neurology Australia; and honoraria from ScieGen Pharmaceuticals; he has an equity interest in the device company Epiminder. EF has received research grants from UCB Pharma. PK has served as a consultant for Abbott, Arvelle Therapeutics, Neurelis, and SK Life Science; has been a consultant, advisory board member, and speaker for Aquestive, Eisai, Sunovion, and UCB Pharma; is a member of the medical advisory board of Stratus and the scientific advisory board of OB Pharma; is the CEO of PrevEp; and has received research support from Department of Defense/Lundbeck and CURE. MR receives payment from Elsevier as editor-in-chief of Seizure; and has received research grants and speaker’s fees from Eisai, LivaNova, and UCB Pharma. FR reports personal fees from Angelini Pharma, Arvelle Therapeutics, Eisai, and GW Pharmaceuticals; personal fees and other from Novartis; personal fees and grants from UCB Pharma; and grants from the Detlev-Wrobel-Fonds for Epilepsy Research Frankfurt, Deutsche Forschungsgemeinschaft, the European Union, and the State of Hessen, outside of the submitted work. JS-P has received grants from Bial and UCB Pharma; and reports personal fees from Bial, Eisai, Esteve, Sanofi, and UCB Pharma, outside of the submitted work; VSI has received speaker honoraria from Bial, Eisai, and UCB Pharma. BJS has received speaker honoraria from Al-Jazeera, Desitin, Eisai, GW Pharmaceuticals, Hikma, Novartis, Sandoz, and UCB Pharma; and has served as a consultant for Arvelle Therapeutics, B. Braun, Bial, Desitin, Eisai, GW Pharmaceuticals, and UCB Pharma. AS reports personal fees and grants from Angelini Pharma, Biocodex, Desitin Arzneimittel, Eisai, GW/Jazz Pharmaceuticals, Marinus Pharma, Precisis, Takeda, UCB Pharma/Zogenix, and UNEEG Medical; and is editor-in-chief of Clinical Epileptology and section editor of Neurological Research and Practice. DF is an independent contractor working for UCB Pharma. VV has served as a consultant or on an advisory board for Angelini Pharma, Bial, Biocodex, Eisai, Jazz Pharmaceuticals, Novartis, SK Life Science, Takeda, UCB Pharma, and Xenon; has received research grants from Bial, Eisai, and UCB Pharma; and has received speaker’s honoraria from Angelini Pharma, Bial, Eisai, Jazz Pharmaceuticals, Novartis, and UCB Pharma. DB, TD, FF and CL have stocks or stock options in UCB Pharma. We confirm that we have read the Journal’s position on issues involved in ethical publication and affirm that this report is consistent with those guidelines.

Figures

Fig. 1
Fig. 1
Analyses of effectiveness by comorbidity (patients with/without CLD and patients with/without psychiatric comorbidity) at baseline: a  ≥ 50% seizure reduction (mFAS), b seizure freedom (FAS), c continuous seizure freedom (FAS), and d BRV retention (FAS). n represents the number of patients with data for the reported variable at each visit. Patients with missing data were excluded from all seizure analyses. Patients with missing data after BRV discontinuation were considered non-responders and not seizure free. BRV brivaracetam, CLD cognitive/learning disability, FAS full analysis set, mFAS modified full analysis set
Fig. 2
Fig. 2
Analyses of effectiveness by etiology (patients with/without post-stroke epilepsy, patients with/without BTRE, and patients with/without TBIE) at baseline: a  ≥ 50% seizure reduction (mFAS), b seizure freedom (FAS), c continuous seizure freedom (FAS), and d BRV retention (FAS). n represents the number of patients with data for the reported variable at each visit. Patients with missing data were excluded from all seizure analyses. Patients with missing data after BRV discontinuation were considered non-responders and not seizure free. BRV brivaracetam, BTRE brain tumor–related epilepsy, FAS full analysis set, mFAS modified full analysis set, TBIE traumatic brain injury–related epilepsy
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References

    1. Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000;342:314–319. doi: 10.1056/NEJM200002033420503. - DOI - PubMed
    1. Asadi-Pooya AA, Beniczky S, Rubboli G, Sperling MR, Rampp S, Perucca E. A pragmatic algorithm to select appropriate antiseizure medications in patients with epilepsy. Epilepsia. 2020;61:1668–1677. doi: 10.1111/epi.16610. - DOI - PubMed
    1. Doerrfuss JI, Kowski AB, Holtkamp M. Etiology-specific response to antiseizure medication in focal epilepsy. Epilepsia. 2021;62:2133–2141. doi: 10.1111/epi.17017. - DOI - PubMed
    1. Domínguez-Aguilera MC, Muñiz-Landeros CE. Prevalence of psychiatric disorders in patients with epilepsy in a tertiary level care hospital: Detection through the MINI PLUS International Structured Interview. Medicina Universitaria. 2017;19:3–6. doi: 10.1016/j.rmu.2016.11.003. - DOI
    1. Novak A, Vizjak K, Rakusa M. Cognitive Impairment in People with Epilepsy. J Clin Med. 2022;11:267. doi: 10.3390/jcm11010267. - DOI - PMC - PubMed