Effectiveness and Tolerability of Brivaracetam by Number of Lifetime Antiseizure Medications in Adults with Focal Onset Seizures: Pooled Data From Two Real-world Studies
Melinda S. Martin1, Dimitrios Bourikas1, Fiona Brock1, Prashant Dongre1, Sami Elmoufti1, Iryna Leunikava1, Allison Little1, Anne-Liv Schulz1
1UCB Pharma
Objective:
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.
Background:
Increasing number of lifetime ASMs is associated with poorer response to newly administered ASM.
Design/Methods:
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).
Results:
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.
Conclusions:
Patients with fewer lifetime ASMs upon BRV initiation had numerically higher retention, and numerically lower incidences of TEAEs/discontinuations due to TEAEs.