2628 12-Month effectiveness and tolerability of brivaracetam in the real-world in the international EXPERIENCE pooled analysis: final results and Australian subgroup

ObjectivesAssess effectiveness/tolerability of brivaracetam (BRV) in routine practice in a large international population (Spain/Germany/Australia/United States) and Australian patients only.MethodEXPERIENCE/EPD332 was a pooled analysis of patient-level data from patients with epilepsy initiating BRV in clinical practice. Effectiveness/tolerability outcomes were assessed at 3/6/12 months. Patients with missing data after BRV discontinuation were considered non-responders/not seizure free. Subgroup analyses were performed in Australian patients.ResultsAnalyses included 1644 adults; 92.2%/7.7% had focal-onset/generalized-onset seizures at baseline (mean: 5.5 prior ASMs at baseline [n=1620], 2.1 concomitant ASMs at index [n=1644]; 605/1616 (37.4%) reported psychiatric comorbidities at index). Median BRV duration: 345.5 days (n=1629); median dose at index: 100 mg/day (n=1615). ≥50% seizure reduction from baseline at 3/6/12 months: 32.1%/36.7%/36.9% (n=619/867/822); seizure-freedom (no seizures within 3 months before timepoint): 22.4%/17.9%/14.9% (n=923/1165/1111); continuous seizure-freedom after baseline (CSF: no seizures from baseline): 22.4%/15.7%/11.7% (n=923/1165/1111). Treatment-emergent adverse events (TEAEs) since prior visit at 3/6/12 months: 25.6%/14.2%/9.3% (n=1542/1376/1232). Of patients with TEAEs at 3/6/12 months, 6.4%/2.6%/2.6% had psychiatric TEAEs and 1.6%/0.8%/0.6% had behavioural TEAEs. During follow-up, 551/1639 (33.6%) patients discontinued BRV.In Australian patients (n=291), 82.5%/16.2% had focal-onset/generalized-onset seizures at baseline (mean: 4.9 prior ASMs at baseline, 2.3 concomitant ASMs at index). ≥50% seizure reduction from baseline at 3/6/12 months: 41.4%/30.8%/20.5% (n=87/107/88); seizure-freedom: 39.0%/29.1%/24.0% (n=159/158/121); CSF: 39.0%/24.7%/19.8% (n=159/158/121); TEAEs since prior visit at 3/6/12 months: 15.1%/5.8%/2.7% (n=291/291/291). During follow-up, 66/291 (22.7%) patients discontinued BRV.ConclusionBRV was effective and well tolerated in highly drug-resistant cohorts in a variety of real-world settings, including Australian patients.FundingUCB Pharma-sponsored.