Brivaracetam effectiveness and patient-reported outcomes in clinical practice: Data from a 12-month prospective, observational study in the United States
- PMID: 40614390
- DOI: 10.1016/j.yebeh.2025.110565
Brivaracetam effectiveness and patient-reported outcomes in clinical practice: Data from a 12-month prospective, observational study in the United States
Abstract
Objective: Evaluate real-world effectiveness, patient-reported outcomes (PROs), and safety/tolerability of brivaracetam in patients (≥16 years) with focal-onset seizures currently receiving ≥ 1 antiseizure medication (ASM), and with historical or current use of levetiracetam, lamotrigine, oxcarbazepine, and/or carbamazepine.
Methods: EP0088 was a 12-month, prospective, observational study of brivaracetam in a clinical practice setting in the US. Primary study outcome was brivaracetam retention at 12 months after brivaracetam initiation. Effect of brivaracetam on patients' perceptions of their health was assessed using Patient-Reported Outcomes Measurement Information System (PROMIS) short forms and Seizure-Related Disability Assessment Scale (SERDAS). Safety outcomes included incidence of treatment-emergent adverse events (TEAEs).
Results: 254 patients (mean age: 44.3 years; median duration of epilepsy: 17.3 years) received ≥ 1 brivaracetam dose (Safety Set; SS). Patients had a median of 3.0 historical and 2.0 concomitant ASMs (SS). For all patients (SS), including those who dropped out with unknown brivaracetam treatment status, 12-month brivaracetam retention was 57.1 % (n = 145/254); in patients with known brivaracetam treatment status (post hoc analysis), 12-month brivaracetam retention was 72.1 % (n = 145/201). Slight improvements in mean PROMIS T-scores, and improvements in mean SERDAS scores, were seen by month 1.5, and generally maintained up to 12 months (Full Analysis Set). 49.6 % of patients reported ≥ 1 TEAE, 38.2 % had drug-related TEAEs, and 16.1 % discontinued due to TEAEs (SS).
Conclusions: Brivaracetam was effective in patients with difficult-to-control focal-onset seizures; as shown by brivaracetam retention at 12 months. Improvements in PROs were seen early. Brivaracetam was well-tolerated and no new safety signals were observed.
Keywords: Antiseizure medication; Focal-onset; PROMIS; Real–world evidence; SERDAS.
Copyright © 2025 The Authors. Published by Elsevier Inc. All rights reserved.
Conflict of interest statement
Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: H Dave has served as a consultant/advisory board member for Medtronic, Neurelis, and UCB; and has received research support from Engage Therapeutics, UCB, and Xenon Pharmaceuticals. MRSperling has served as a consultant for Medtronic and Neurelis; has received research grants from Biohaven, Bytflies, Cavion, Cerevel Therapeutics, EpiwatchMedtronic, Neurelis, SK Life Science, Takeda, UCB, and Xenon Pharmaceuticals; has served as a speaker for/received honoraria from Medscape; and has received book royalties from Cambridge University Press and Oxford University Press. HH Altalib has received research grants from Eisai, Engage Therapeutics, Epilepsy Study Consortium, Sunovion, and UCB. RJ Porter has received research funding from AXONIS Therapeutics, Engrail, Longboard Pharmaceuticals, Neurocrine, and Xenon Pharmaceuticals. HHenninger serves as a speaker and participates in advisory boards for UCB, and is currently employed as a consultant for UCB. M Gelfand has received research funding from Aquestive Therapeutics, Cerevel Therapeutics, LivaNova, Otsuka, SK-Pharma, UCB, and Xenon Pharmaceuticals. P Dongre, S Elmoufti, MS Martin, and A-LSchulz are employees of UCB. PDongre and A-L Schulz have stocks or stock options in UCB. JA French receives salary support from the Epilepsy Foundation and for consulting work and/or attending scientific advisory boards on behalf of the Epilepsy Study Consortium for Adamas, Aeonian/Aeovian, Alterity Therapeutics, Anavex Life Sciences, Arkin Holdings, Arvelle Therapeutics, Athenen Therapeutics/Carnot Pharma, Baergic Bio, Biogen, BioMarin Pharmaceutical, BioXcel Therapeutics, BridgeBio Pharma, Cavion, Cerebral Therapeutics, Cerevel Therapeutics, Clinical Education Alliance, Corlieve Therapeutics, Crossject, CuroNZ, Eisai, Eliem Therapeutics, Encoded Therapeutics, Engage Therapeutics, Engrail, Epalex, Epihunter, Epiminder, Equilibre BioPharmaceuticals, Fortress Biotech, Greenwich Biosciences, GW Pharma, Janssen Pharmaceuticals, Knopp Biosciences, LivaNova, Longboard Pharmaceuticals, Lundbeck, Marinus Pharmaceuticals, Mend Neuroscience, Merck, NeuCyte, Neumirna Therapeutics, Neurocrine, NeuroPace, NxGen MDx, Otsuka Pharmaceutical Development, Ovid Therapeutics, Passage Bio, Pfizer, Praxis, PureTech Health, Redpin, Sage Therapeutics, SK Life Science, Sofinnova, Stoke Therapeutics, Supernus, Synergia Medical, Takeda, UCB, West Therapeutic Development, Xenon Pharmaceuticals, Xeris Pharmaceuticals, Zogenix, and Zynerba; has received research support from the Epilepsy Study Consortium (funded by Andrews Foundation, Eisai, Engage Therapeutics, Lundbeck, Pfizer, SK Life Science, Sunovion, UCB, and Vogelstein Foundation), Epilepsy Study Consortium/Epilepsy Foundation (funded by UCB), GW/FACES, and NINDS; is on the editorial board of Lancet Neurology and Neurology Today; is chief medical/innovation officer for the Epilepsy Foundation; and has received travel reimbursement related to research, advisory meetings, or presentation of results at scientific meetings from Arvelle Therapeutics, Biogen, Cerevel Therapeutics, Clinical Education Alliance, Engage Therapeutics, Epilepsy Foundation, Epilepsy Study Consortium, Lundbeck, NeuCyte, Otsuka, Sage Therapeutics, UCB, Xenon Pharmaceuticals, and Zogenix.
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