P11.08.A Clinical practice evidence for perampanel in epilepsy patients with tumour aetiology

Abstract

Abstract Background Real-world studies can provide information on those patients routinely excluded from clinical trials such as epilepsy patients with tumour aetiology. Perampanel (PER) is a once-daily oral anti-seizure medication for focal-onset seizures, with or without focal to bilateral tonic-clonic seizures, and generalised tonic-clonic seizures. This study evaluated PER’s effectiveness and safety when used in everyday clinical practice to treat epilepsy patients with tumour aetiology. Material and Methods Patients with epilepsy with tumour aetiology were identified from a pooled analysis of 44 prospective/retrospective/cross-sectional clinical practice studies. Retention was assessed after 3, 6 and 12 months of PER treatment. Effectiveness assessments comprised responder rate (≥50% seizure frequency reduction), seizure freedom rate (no seizures since at least the prior visit), and the proportions of patients with unchanged or worsening seizure frequency. Adverse events (AEs), psychiatric AEs, and AEs leading to discontinuation were also evaluated. Results Overall, 127 patients with focal-onset and/or generalised-onset seizures with tumour aetiology were identified (mean age, 46.6 years; 54.8% male; mean duration of epilepsy, 9.7 years). Seizure types at baseline were focal-onset only (97.6%), generalised-onset only (1.6%), and focal-onset and generalized-onset (0.8%). Mean (standard deviation) PER doses at baseline and last visit were 2.6 (1.4) and 5.8 (2.5) mg/day, respectively. At 3, 6 and 12 months, retention rates were 88.0%, 79.5% and 65.3%, respectively. Reasons for discontinuation included AEs (16.8%) and lack of efficacy (5.3%). Mean time under PER treatment was 11.0 months. At 12 months, 71.2% of patients were responders and 38.3% were seizure free; 11.9% and 3.4% of patients had unchanged and worsening seizure frequency, respectively. At the last visit (last observation carried forward), responder and seizure freedom rates were 66.9% and 34.2%, respectively, and the percentages of patients with unchanged or worsening seizure frequency were 15.3% and 6.8%, respectively. AEs were reported for 36.2% of patients, most frequently dizziness/vertigo (13.8%) and somnolence (9.5%). AEs led to discontinuation of 16.8% of patients over 12 months and 13.0% of patients experienced psychiatric AEs. Conclusion PER was effective and generally well tolerated when used to treat patients with epilepsy with tumour aetiology in clinical practice. Supported by Eisai