Long-term Efficacy/Tolerability of brivaracetam in pediatric patients with focal-onset seizures and Cognitive/Learning comorbidities

<h3>Objective</h3> Long-term tolerability and efficacy of adjunctive brivaracetam (BRV) in pediatric patients with focal-onset seizures (FOS) with/without cognitive or learning comorbidities (CLC) were assessed. <h3>Methods</h3> Post-hoc analysis of Phase-3, open-label, follow-up trial (N01266/NCT01364597). Patients with FOS (≥1month–&lt;17years at core-trial entry) received ≤5mg/kg/day BRV (max ≤200mg/day). Patients with and without ongoing CLC were evaluated. <h3>Results</h3> The CLC subgroup (84/185 [45.4%]) had longer epilepsy duration, higher proportion of patients with ≥5 prior antiseizure medications, and higher incidence of comorbid conditions. Estimated BRV-retention at 1, 3, 5 years was 75.0/78.2%, 61.9/61.9%, 52.2/53.3% in patients with/without CLC. No differences in the proportion of BRV discontinuations due to lack of efficacy or treatment-emergent adverse events (TEAEs) were observed. Efficacy assessments (&gt;2-year-old patients) showed numerically-lower median percent reduction from baseline in FOS/28 days (43.8/74.1% [n=63/60]), 50% FOS responder rates (46.0/61.7% [n=63/60]), and ≥12-month seizure freedom (31.7/55.9% [n=60/68]) in patients with/without CLC. Incidences of TEAEs, drug-related TEAEs, serious TEAEs, and discontinuations due to TEAEs during long-term BRV treatment were similar in both subgroups. <h3>Conclusions</h3> BRV retention and tolerability were similar in pediatric patients with and without CLC. Although efficacy was numerically-lower in CLC subgroup (generally more difficult-to-treat), it still indicated a clinically-relevant seizure-frequency reduction. UCB Pharma-sponsored