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Abstract Details

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
Epilepsy/Clinical Neurophysiology (EEG)
P8 - Poster Session 8 (5:30 PM-6:30 PM)
1-008
Planned interim analysis of BRITOBA/EP0103, an ongoing, prospective, postmarketing, noninterventional study at 81 sites in Europe/Canada prescribing BRV per standard practice.
Evaluate effectiveness of adjunctive brivaracetam (BRV) in earlier treatment lines in adults with focal-onset seizures (FOS) for ≤12months(m).

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).

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.

Adjunctive BRV was effective and well tolerated in adults with FOS in earlier treatment lines.

Authors/Disclosures
Alyssa Jameson, PA (UCB)
PRESENTER
Ms. Jameson has nothing to disclose.
No disclosure on file
No disclosure on file
Eliane Kobayashi, MD, PhD (Montreal Neurological Institute, McGill University) Dr. Kobayashi has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Paladin Laboratories. The institution of Dr. Kobayashi has received research support from UCB Canada.
No disclosure on file
No disclosure on file
No disclosure on file
No disclosure on file
No disclosure on file
No disclosure on file