Brivaracetam Adjunctive Therapy in Earlier Treatment Lines in Adults with Focal-onset Seizures in Europe and Canada: Interim Results of 12-month Real-world Data From BRITOBA
Susanne Knake1, Marco De Curtis2, Elaine Kobayashi3, Teresa Lema-Facal4, Louis-Georges Maillard5, Bonita Rehel6, Sylvain Rheims7, Anne-Liv Schulz6, Iryna Leunikava6
1Department of Neurology, Epilepsy Center, University Hospital Marburg, 2Epilepsy Units, Fondazione IRCCS Istituto Neurologico Carlo Besta, 3Montreal Neurological Institute and Hosptial, 4Coruna University Hospital, 5Centre Hospitalier Universitaire Nancy, 6UCB Pharma, 7Department of Functional Neurology and Epileptology, Hospices Civils de Lyon and Lyon 1 University
Objective:
Evaluate effectiveness of adjunctive brivaracetam (BRV) in earlier treatment lines in adults with focal-onset seizures (FOS) for ≤12months(m).
Background:
Planned interim analysis of BRITOBA/EP0103, an ongoing, prospective, postmarketing, noninterventional study at 81 sites in Europe/Canada prescribing BRV per standard practice.
Design/Methods:
Selection criteria: age ≥18years(y), history of FOS (with/without focal to bilateral tonic-clonic seizures [FBTCS]), no BRV treatment before study entry, ≥1 antiseizure medication (ASM) at BRV initiation, ≤3 lifetime (prior/at BRV initiation) ASMs. Observation: ≤~12m. Endpoints: seizure freedom for ≥6m consecutively, ≥50% reduction in FOS (all types), Clinical and Patient’s Global Impression of Change (CGIC; PGIC), treatment-emergent adverse events (TEAEs).
Results:
At data snapshot (06/03/2022), 252 patients received ≥1 BRV dose (Safety Set; SS), 176 followed SmPC and were included in Per Protocol Set (PPS). At baseline, mean age in SS/PPS was 45.4/46.4y (n=252/176), mean time since epilepsy diagnosis was 13.24/13.59y (n=249/176), mean 28-day FOS frequency was 4.07/4.74 (n=245/175), 35.1%/40.9% had FBTCS (n=251/176), mean number of lifetime ASMs was 1.9/2.0 (n=247/176). Mean/median BRV dose (SS) was 81.8/100.0 mg/day (n=249) at visit 1 (PPS: 88.6/100.0 mg/day [n=175]), 128.7/100.0 mg/day (n=41) at 12m (PPS: 137.1/125.0 mg/day [n=31]). In SS/PPS, 174/126 (69.0%/71.6%) patients completed the 3m visit, 97/65 (38.5%/36.9%) the 6m visit, 42/31 (16.7%/17.6%) the 12m visit. For SS/PPS patients who completed the 12m period and had data, 51.4%/51.9% (n=35/27) were seizure-free for ≥6m consecutively; ≥50% reduction in FOS frequency at 6/9/12m was 74.7%/70.9%/73.2% in SS (n=91/55/41), 71.4%/65.8%/67.7% in PPS (n=63/38/31). In SS/PPS, median percent reduction in FOS frequency was ≥89.9%/≥83.3% at 6/9/12m. In SS, patients with improvement (very much/much improved) at 3/6/12m was 42.0%/48.4%/51.2% (n=169/91/41) for CGIC, 36.4%/37.3%/55.0% (n=129/59/20) for PGIC. In SS/PPS, 35/19 (13.9%/10.8%) patients reported TEAEs, 24/12 (9.5%/6.8%) reported drug-related TEAEs, 12/6 (4.8%/3.4%) discontinued due to TEAEs.
Conclusions:
Adjunctive BRV was effective and well tolerated in adults with FOS in earlier treatment lines.