Effectiveness and Tolerability of Brivaracetam in Adults with Epilepsy Etiology of Cerebral Neoplasm, Cerebrovascular Accident or Cranial Trauma: Pooled Data Analyses from Two Real-world Studies
Abstract number :
1.303
Submission category :
7. Anti-seizure Medications / 7E. Other
Year :
2023
Submission ID :
382
Source :
www.aesnet.org
Presentation date :
12/2/2023 12:00:00 AM
Published date :
Authors :
Presenting Author: Hina Dave, MD – McGovern Medical School, The University of Texas Health Science Center at Houston, Houston, TX
Michael Sperling, MD – Thomas Jefferson University, Philadelphia; Brian Moseley, MD – UCB Pharma, Morrisville; Sami Elmoufti, MSc – UCB Pharma, Morrisville; Allison Little, PharmD – UCB Pharma, Smyrna; Dimitrios Bourikas, PhD – UCB Pharma, Alimos; Bernhard Steinhoff, MD, PhD – Kork Epilepsy Center, Kehl-Kork and Medical Facility, University of Frieburg, Freiburg
Rationale:
To assess the effectiveness and tolerability of adjunctive brivaracetam (BRV) in adults with acquired structural epilepsy etiology of cerebral neoplasm (CN), cerebrovascular accident (CVA) or cranial trauma (CT) in real-life settings.
Methods:
Post hoc analysis of pooled data from two, prospective, noninterventional studies in patients initiating BRV in Europe (EP0077/NCT02687711) or the United States (EP0088) was conducted. Adult patients (≥18 years) with focal onset seizures, and ≥1 lifetime antiseizure medication (ASM; stopped before BRV initiation and/or ongoing at BRV initiation) received BRV as prescribed by their physician and were followed for up to 12 months from BRV initiation. Patients with etiology of CN, CVA or CT were included in this analysis (patients with >1 etiology recorded were excluded). BRV retention and seizure freedom were assessed at 12 months. Other reported outcomes included Kaplan‑Meier estimated time to discontinuation of BRV/early study termination and incidence of treatment‑emergent adverse events (TEAEs) during the study.
Results:
Of 720 patients aged ≥18 years with focal onset seizures, and ≥1 lifetime ASM, 30 (4.2%) patients had etiology of CN, 22 (3.1%) patients had etiology of CVA, and 52 (7.2%) patients had etiology of CT. At baseline, a higher percentage of patients with CVA were ≥65 years of age and were older at time of diagnosis (Table 1). Patients with etiology of CT were predominantly male, had a longer median epilepsy duration, and a higher median number of lifetime ASMs. Before BRV initiation, 50.0–60.0% of patients in all subgroups had discontinued LEV. The most common reason for BRV initiation was lack of efficacy of current treatment in 24 (80.0%), 18 (81.8%), and 36 (69.2%) patients with etiology of CN, CVA, and CT, respectively, followed by behavioral adverse events in 6 (20.0%), 5 (22.7%), and 12 (23.1%) patients. BRV retention at 12 months was numerically similar in patients with etiology of CN (70.0%) and CVA (68.2%), and numerically lower in patients with etiology of CT (51.9%) (Figure 1A; Kaplan-Meier analysis, Figure 1B). At 12 months, 8.7%, 11.8%, and 8.9% of patients with etiology of CN (n=23), CVA (n=17), and CT (n=45), respectively were seizure free since baseline. TEAEs were reported in 40.0%, 13.6%, and 36.5% of patients with etiology of CN, CVA, and CT, respectively; 20.0%, 9.1%, and 21.2% had drug‑related TEAEs; 13.3%, 0%, and 13.5% reported behavioral adverse events; and 16.7%, 4.5%, and 23.1% discontinued due to TEAEs.
Conclusions:
In this descriptive analysis of pooled data from two real-world studies, BRV treatment was effective and generally well tolerated in patients with acquired structural epilepsy with etiology of cerebral neoplasm, cerebrovascular accident, and cranial trauma. However, further studies with greater patient numbers are needed to confirm these findings.
Funding: UCB Pharma-sponsored
Anti-seizure Medications