Adjunctive Brivaracetam in Early Treatment Line Combinations: 12-Month Real-World Experience and Impact on Health Outcomes in Adult Patients with Focal Seizures

BACKGROUND: Postmarketing data for adjunctive brivaracetam (BRV) suggest potential benefit in earlier antiseizure medication (ASM) regimens. OBJECTIVE: We aimed to evaluate real-world effectiveness of BRV in earlier ASM therapy lines (over ~12 months) in patients with focal seizures with/without focal to bilateral tonic-clonic seizures (primary objective) and assess patient characteristics, health outcomes, and tolerability. METHODS: Prospective, postmarketing, noninterventional study of adjunctive BRV in Europe/Canada (December 2020-January 2024; BRITOBA/EP0103). Selection criteria are adults (≥ 18 years) with history of focal seizures, no prior BRV treatment, and ≤ 3 lifetime (prior/at BRV initiation) ASMs when initiating adjunctive BRV. RESULTS: A total of 392 patients received ≥ 1 BRV dose (mean age 44.9 years; mean lifetime ASMs 2.0). Of 298 patients, 41.9% were seizure-free for ≥ 6 consecutive months during up to ~12 months' observation. At 12 months, 20.5% of 254 patients were seizure-free from baseline, 75.7% of 292 achieved ≥ 50% focal seizure reduction from baseline, 75.5% of 392 remained on BRV, and 72.0% of 289 and 66.8% of 211 had improved (minimally/much/very much) on Clinical Global Impression of Change and Patient's Global Impression of Change. From baseline to 12 months, Ten-Item Patient-Weighted Quality of Life in Epilepsy Inventory (QOLIE-10-P) total score improved by a mean of 9.9 points (n = 152); Nine-Item Treatment Satisfaction Questionnaire for Medication effectiveness, convenience, and global satisfaction scores improved by a mean of 21.6 (n = 144), 6.1 (n = 146), and 19.1 (n = 145) points; Work Productivity and Activity Impairment Questionnaire: General Health scores showed numerical mean improvements in percentages of activity impairment due to health problem (-14.0 [n = 157]), work time missed due to health problem (-12.3 [n = 50]), impairment while working due to health problem (-7.8 [n = 63]), and overall work impairment due to health problem (-9.0 [n = 48]); and the Neurological Disorders Depression Inventory in Epilepsy score improved by a mean of -1.1 points (n = 158). Seizure Severity Questionnaire (questions 5 and 8 only) showed numerically fewer reports of postictal cognitive effects (37.0% of 135 patients versus 63.6% of 308) and improved median seizure severity score (2.0 [n = 124] versus 4.0 points [n = 301]) at 12 months versus baseline. Of 392 patients, 13.8% experienced ≥ 1 drug-related treatment-emergent adverse event (TEAE), 9.4% discontinued BRV due to TEAEs. CONCLUSIONS: In adults with focal seizures, BRV in earlier ASM regimens was effective and well tolerated. At 12 months, there were improvements in quality of life, clinical condition, work productivity, and treatment satisfaction.