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. 2025 Apr;14(2):627-642.
doi: 10.1007/s40120-024-00697-4. Epub 2025 Feb 20.

Effectiveness During 12-Month Adjunctive Brivaracetam Treatment in Patients with Focal-Onset Seizures in a Real-Life Setting: A Prospective, Observational Study in Europe

Bernhard J Steinhoff  1   2 , Jakob Christensen  3 , Colin P Doherty  4   5 , Marian Majoie  6 , Anne-Liv Schulz  7 , Fiona Brock  8 , Dimitrios Bourikas  9 , Iryna Leunikava  7 , Anna Kelemen  10 , Eduardo Rubio-Nazabal  11
Affiliations

Effectiveness During 12-Month Adjunctive Brivaracetam Treatment in Patients with Focal-Onset Seizures in a Real-Life Setting: A Prospective, Observational Study in Europe

Bernhard J Steinhoff et al. Neurol Ther. 2025 Apr.

Abstract

Introduction: Efficacy/tolerability of adjunctive brivaracetam (BRV) for focal-onset seizures (FOS) in patients aged ≥ 16 years was established in randomized controlled trials. This study aimed to evaluate the effectiveness of adjunctive BRV in patients (≥ 16 years) with FOS with/without focal to bilateral tonic-clonic seizures in daily clinical practice.

Methods: A 12-month, prospective, real-world, noninterventional study in nine European countries (EP0077/NCT02687711). BRV was prescribed per clinical practice and European Summary of Product Characteristics. Eligible patients had never received BRV before inclusion. Treating physicians made the decision to prescribe BRV, independently of study participation. Primary effectiveness outcome: BRV retention rate at 12 months; secondary effectiveness outcomes: 50% responder rate, seizure freedom.

Results: A total of 544 patients received ≥ 1 BRV dose (mean age: 43.6 years; 52.8% female; mean time since diagnosis: 22.7 years). Patients had a mean of 7.3 lifetime antiseizure medications (ASMs) and median of 3.7 FOS/28 days during 3-month retrospective baseline. Median total ASM drug load (including BRV) was 3.0 at BRV initiation (n = 539) and 3.3 at study end (n = 314). At 12 months, 57.7% of 541 patients remained on BRV, 60.4% of 230 were responders (≥ 50% seizure reduction since baseline), and 13.8% of 269 were seizure-free since BRV initiation. Historical levetiracetam use appeared not to impact retention rate (56.6% of 320 and 59.3% of 221 patients with and without historical levetiracetam use, respectively). 36.0% of 544 patients had drug-related treatment-emergent adverse events (TEAEs), mostly (≥ 5% of patients) drug ineffective (11.4%) and seizure (6.3%). The three most common drug-related TEAEs leading to permanent BRV discontinuation (of 544 patients) were drug ineffective (10.1%), seizure (5.1%), and behavior disorder (3.3%).

Conclusions: Adjunctive BRV was effective in clinical practice in patients with predominantly difficult-to-treat FOS, as shown by BRV retention rate of 57.7% at 12 months, which is in line with real-world retention rates for other new-generation ASMs.

Keywords: Adjunctive; Adolescent; Brivaracetam; Effectiveness; Epilepsy; Focal-onset seizure; Noninterventional; Observational; Real-world; Tolerability.

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Conflict of interest statement

Declarations. Conflict of Interest: Bernhard J. Steinhoff has received honoraria for consulting from Angelini Pharma, B. Braun Melsungen, Desitin, Eisai, and UCB, for serving on a scientific advisory board from GW Pharmaceuticals, Precisis, UCB, and Zogenix, and for speaking from Arvelle, Desitin, Eisai, Hikma Pharmaceuticals, UCB, and Zogenix, and has received research support from Eisai, SK Life Science, and UCB. Jakob Christensen has received honoraria from serving on the scientific advisory board of Eisai AB and UCB, received honoraria for giving lectures from Eisai AB and UCB, and received funding for a trip from UCB. Colin P. Doherty has received honoraria from Eisai and UCB. Marian Majoie has received financial compensation through her institution for participating in contract research from Eisai, GW Pharmaceuticals, UCB, and Zogenix. Anne-Liv Schulz, Fiona Brock, Dimitrios Bourikas, and Iryna Leunikava are employees of UCB. Anne-Liv Schulz and Dimitrios Bourikas have received UCB stocks from their employment. Anna Kelemen has received honoraria for serving on advisory boards from Eisai and Zogenix, and has received honoraria for lectures and publications from GW Pharmaceuticals, Richter Gedeon, and UCB. Eduardo Rubio-Nazabal has received honoraria from BIAL, Eisai, and UCB for speaking. Ethical Approval: The study protocol was reviewed and approved by an Institutional Review Board/Independent Ethics Committee (see Institutional Review Board/Independent Ethics Committee appendix in the Supplementary Material), according to country-specific regulations. Written data consent was obtained from the patient, parent(s), or legal representative before study participation, in accordance with local regulations and the Declaration of Helsinki.

Figures

Fig. 1
Fig. 1
Patient disposition. BRV brivaracetam, FAS Full Analysis Set, mFAS Modified Full Analysis Set, SS Safety Set
Fig. 2
Fig. 2
Effectiveness outcomes at 12 months for the overall study population (FAS). For BRV retention, percentages were based on the number of patients with data in the FAS, while for 50% responder rate and seizure freedom, percentages were based on the number of patients with data at the 12-month visit in the FAS. BRV brivaracetam, FAS Full Analysis Set. aPatients who remained in the study and were on BRV treatment ≥ 12 months (≥ 330 days) after first BRV administration were classified as having 12 months of treatment retention. The 95% confidence interval was 53.4, 61.9. bThe proportion of patients with a ≥ 50% reduction from baseline in 28-day adjusted focal-onset seizure frequency. Patients with a baseline seizure frequency of zero were excluded. cSeizure freedom was defined as having no date of first seizure recorded in the study on or before the target visit date (day 330), having not discontinued before the visit, and having available seizure data at the visit. Patients with a date of first seizure before the target visit date or patients who discontinued BRV or terminated the study before the target visit date were counted as not seizure-free. Patients with missing seizure data but who were still on the study were excluded from the analysis
Fig. 3
Fig. 3
Seizure freedom since BRV initiation at 12 months, by reason for BRV initiation (FAS). Seizure freedom was defined as having no date of first seizure recorded in the study on or before the target visit date (day 330), having not discontinued before the visit, and having available seizure data at the visit. Patients with a date of first seizure before the target visit date or patients who discontinued BRV or terminated the study before the target visit date were counted as not seizure-free. Patients with missing seizure data but who were still on the study were excluded from the analysis. The categorization of a side effect as a behavioral side effect was done by the treating physician without guidance from UCB. BRV brivaracetam, FAS Full Analysis Set
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