Effectiveness and Tolerability of Brivaracetam by Number of Lifetime Antiseizure Medications in Adults with Focal Onset Seizures: Pooled Data From Two Real-world Studies (P11-1.010)

Abstract

<h3>Objective:</h3> Analyze impact of number of lifetime antiseizure medications (ASMs) on effectiveness and tolerability of brivaracetam (BRV) in adults with focal-onset seizures in a real-world clinical setting. <h3>Background:</h3> Increasing number of lifetime ASMs is associated with poorer response to newly administered ASM. <h3>Design/Methods:</h3> Pooled analysis of data from two 12-month, prospective, noninterventional studies (Europe: EP0077/NCT02687711; United States: EP0088) in patients initiating BRV as prescribed by their physician and followed for ≤12 months. Post hoc analysis included patients (≥18 years) with focal-onset seizures and ≥1 lifetime ASM at BRV initiation. Outcomes were assessed by number of lifetime ASMs (ASMs stopped before BRV initiation/ongoing at BRV initiation). <h3>Results:</h3> Of 720 included patients, 14.0%, 22.9%, 16.5%, and 46.5% had 1–2, 3–4, 5–6, and ≥7 lifetime ASMs, respectively. Across ASM subgroups, main reason for BRV initiation was lack of efficacy of current treatment (range: 73.3% [1–2 ASMs] to 89.0% [≥7 ASMs]). In patients with 1–2, 3–4, 5–6, and ≥7 lifetime ASMs, respectively, 12-month BRV retention was 68.3%, 66.1%, 55.5%, and 51.3%; 20.0%, 14.8%, 6.8%, and 2.7% had 12-month seizure freedom since baseline. Patients with 1–2 and 3–4 lifetime ASMs were less likely to discontinue BRV/terminate the study vs those with ≥5 lifetime ASMs. A lower proportion of patients with fewer lifetime ASMs discontinued BRV due to lack of efficacy (range: 1.0% [1–2 ASMs] to 14.9% [≥7 ASMs]) or treatment-emergent adverse events (TEAEs, 5.0% [1–2 ASMs] to 15.2% [≥7 ASMs]). In patients with 1–2, 3–4, 5–6, and ≥7 lifetime ASMs, respectively, TEAEs were reported in 26.7%, 37.0%, 46.2%, and 50.4%; 13.9%, 17.0%, 21.8%, and 30.1% discontinued due to TEAEs. <h3>Conclusions:</h3> Patients with fewer lifetime ASMs upon BRV initiation had numerically higher retention, and numerically lower incidences of TEAEs/discontinuations due to TEAEs. <b>Disclosure:</b> Dr. Martin has received personal compensation for serving as an employee of UCB. Dr. Martin has received stock or an ownership interest from UCB. Dr. Bourikas has nothing to disclose. Mrs. Brock has received personal compensation for serving as an employee of UCB. Dr. Dongre has received personal compensation for serving as an employee of UCB Inc. Dr. Dongre has stock in UCB Inc. Sami Elmoufti has nothing to disclose. Iryna Leunikava has nothing to disclose. Dr. Little has received personal compensation for serving as an employee of UCB. Anne-Liv Schulz has received personal compensation for serving as an employee of UCB. Anne-Liv Schulz has received stock or an ownership interest from UCB.