Abstracts

Rationale: Perampanel (PER) is a once-daily oral antiseizure medication indicated in the US for the treatment of focal-onset seizures, with or without focal to bilateral tonic-clonic seizures, in patients with epilepsy aged ≥ 4 years, and as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients with epilepsy aged ≥ 12 years. Real-world studies complement evidence from clinical trials by providing information on the treatment of patients who are more diverse in terms of age and clinical characteristics than those recruited for clinical trials. The purpose of this study was to assess the real-world effectiveness, safety and tolerability of PER when used to treat adults (age ≥ 18 years) in everyday clinical practice.

Methods: The PERaMpanel pooled analysIs in effecTiveness and tolerability (PERMIT) study was a pooled analysis of real-world data from 44 prospective, retrospective and cross-sectional studies and work groups worldwide in which patients with focal and generalized epilepsy were treated with PER. The Perampanel Real-world Evidence (PROVE) study was a Phase IV, retrospective, noninterventional study that assessed the retention, dosing, efficacy and safety of PER when administered to patients with epilepsy during routine clinical care at centers across the U.S. Retention timepoints included 3, 6 and 12 months. Effectiveness assessments included responder rate (≥ 50% seizure frequency reduction) and seizure freedom rate (no seizures since at least the prior visit [PERMIT] or within the last 28 days [PROVE]). Safety and tolerability were assessed by evaluating adverse events (AEs). A pooled analysis of data from adult patients included in PERMIT and PROVE is currently ongoing and will be presented.

Results: PERMIT included 4247 patients aged ≥ 18 to < 65 years (50.6% female; mean age 38.7 years; mean duration of epilepsy, 24.3 years; Full Analysis Set). PROVE included 1157 patients aged ≥ 18 to ≤ 84 years (53.8% female; mean age, 36.4 years; mean duration of epilepsy, 19.6 years; Safety Analysis Set). Mean time under PER treatment was 10.8 months in PERMIT and 17.8 months in PROVE. Retention rates at 12 months were 64.8% (PERMIT) and 58.0% (PROVE). At the last visit in PERMIT, responder rates in patients with focal-onset and generalized-onset seizures were 44.6% and 73.3%, respectively, and corresponding seizure freedom rates were 14.5% and 52.0%, respectively. At 10‒12 months in PROVE, responder and seizure freedom rates (for total seizures) were 60.9% and 33.7%, respectively. AEs were reported by 50.7% of patients in PERMIT and 44.3% of patients in PROVE. The most frequently reported AEs (≥ 5% of patients) were dizziness/vertigo (16.0%), somnolence (10.7%), irritability (8.3%) and behavioral disorders (5.1%) in PERMIT, and dizziness (9.2%) in PROVE. AEs led to discontinuation of 16.8% of patients in PERMIT and 25.8% of patients in PROVE._x000D_
Conclusions: This study will provide insights into the use of PER to treat a large number of adult patients with focal and generalized epilepsy in clinical practice and add to the current evidence.

Funding: Supported by Eisai