Abstracts

Rationale: To evaluate the long-term efficacy of adjunctive brivaracetam (BRV) for treatment of partial-onset (focal) seizures (POS).Methods: Data from patients recruited to the core Phase 2/3 studies (NCT00175929, NCT00175825, NCT00490035, NCT00464269, NCT00504881, and NCT01261325) who received BRV in follow-up studies NCT00175916, NCT00150800, and NCT01339559 were pooled. Adults with uncontrolled POS received BRV 5–200 mg/day. Efficacy assessments were performed at protocol-specified time points until 17 January 2014.Results: Among 1904 patients who received BRV, a total of 1500, 1188, 847, and 553 patients were exposed to BRV for 6, 12, 24, and 60 months, respectively; 22 patients received BRV for ≥8.0 years. At baseline, mean (SD) age was 36.8 (12.6) years and 51.0% were male. Median (IQR) partial seizure frequency at baseline was 8.9 (5.5–20.0) and the most common concomitant antiepileptic drugs (AEDs), used by ≥20% of patients, were carbamazepine (42.5%), lamotrigine (24.6%), and valproate (22.5%). Overall, there was a median reduction in POS frequency of 48.8% from baseline (49.4%, 56.5%, 61.1%, and 65.2% in the 6-, 12-, 24-, and 60-month cohorts, respectively; Table). The overall ≥50% responder rate was 48.9% and 49.3%, 56.4%, 63.2%, and 66.4% in the 6-, 12-, 24-, and 60-month cohorts, respectively. Additionally, in the 6-, 12-, 24-, and 60-month cohorts, the percentage of patients who were continuously seizure-free for their treatment duration was 5.3%, 4.6%, 3.7%, and 3.6%, respectively. Patients receiving BRV showed an overall improvement in health-related quality of life (HRQoL), as measured by QOLIE-31P total score over time (Figure). Treatment is ongoing in 870 patients (45.7%); 1034 (54.3%) discontinued treatment. The most common reasons for discontinuation (≥10% of patients) were lack of efficacy (26.2%) and adverse events (11.1%).Conclusions: This pooled analysis indicates that BRV is an effective add-on AED when administered long term (up to 8.0 years). Improvements were also seen in overall HRQoL, as assessed by QOLIE-31P total score. UCB supported.