A long-term follow-up (LTFU) study published in Epilepsy & Behavior analyzed the long-term safety and tolerability of brivaracetam (BRV) in patients with uncontrolled epilepsy and assessed BRV’s efficacy over time.
This open-label, multicenter, flexible-dose trial included patients aged ≥16 years with focal or generalized-onset seizures who had taken part in a placebo-controlled trial of adjunctive BRV.
Final analysis included 766 patients in the LTFU trial, of whom 753 had focal seizures and 13 had generalized-onset seizures. At 12 months, the Kaplan–Meier-estimated retention was 71.9%, and at 36 months, 53.7%. Most patients (n=643) reported treatment-emergent adverse events (TEAEs), the most common of which were headache (n=104) and dizziness (n=100). About a third of patients experienced drug-related TEAEs (n=257), the most common of which were somnolence (n=49) and dizziness (n=41). Ninety-one patients discontinued BRV permanently due to TEAEs.
Among patients with focal seizures, the median percentage reduction in focal seizure frequency was 52%; 51.7% of patients were 50% responders (sustained over time), while 26% remained seizure-free for six months, and 17.9% for 12 months. At 12 months, 42.4% of patients exhibited clinically meaningful improvements in Patient Weighted Quality of Life in Epilepsy Questionnaire 31 total score, and at 24 months, this increased to 46.8%.
“In this select group of patients who entered the LTFU trial, BRV was generally safe and well tolerated. Results indicate the long-term efficacy of BRV in patients with focal seizures,” the study authors concluded.