2023 American Academy of Neurology Abstract Website

Eugen Trinka¹, Robert Wechsler², Wendyl D’Souza³, Tony Wu⁴, Imad Najm⁵, Leock Ngo⁶, Rob McMurray⁷, Vicente Villanueva⁸
¹Department of Neurology, Christian-Doppler University Hospital, Paracelsus Medical University, ²Idaho Comprehensive Epilepsy Center, ³Department of Medicine, St Vincent’s Hospital Melbourne, The University of Melbourne, ⁴Chang Gung Memorial Hospital Linkou Medical Center and Chang Gung University College of Medicine, ⁵Cleveland Clinic Epilepsy Center, Neurological Institute, Cleveland Clinic, ⁶Eisai Inc, ⁷Eisai Europe Ltd, ⁸Hospital Universitario y Politécnico La Fe

Objective:

To evaluate perampanel (PER) when used in everyday clinical practice.

Background:

PER is indicated in the US for the treatment of focal-onset seizures with or without focal to bilateral tonic-clonic seizures, and the adjunctive treatment of generalized tonic-clonic seizures.

Design/Methods:

A pooled analysis of real-world data from patients treated with PER in the PERaMpanel pooled analysIs of effecTiveness and tolerability (PERMIT) and the Perampanel Real-world Evidence (PROVE) studies is currently undergoing and will be presented. Retention timepoints included 3, 6 and 12 months. Effectiveness assessments included responder rate (≥50% seizure frequency reduction) and seizure freedom rate. Safety and tolerability were assessed by evaluating adverse events (AEs).

Results:

PERMIT included 5200 patients and the Full Analysis Set included 5193 patients (50.5% female; mean age, 39.7 years). PROVE included 1703 patients and all were included in the Safety Analysis Set (52.7% female; mean age, 28.5 years). Mean time under PER treatment was 18.7 months in PERMIT and 17.4 months in PROVE. Retention rates at 12 months were 64.2% (PERMIT) and 58.5% (PROVE). In PERMIT, responder and seizure freedom rates at 12 months were 58.3% and 23.2%, respectively. In PROVE, responder and seizure freedom rates at 10‒12 months were 62.6% and 30.9%, respectively. AEs were reported by 49.9% of patients in PERMIT and 41.3% of patients in PROVE. The most frequently reported AEs (≥5% of patients) were dizziness/vertigo (15.2%), somnolence (10.6%), irritability (8.4%) and behavioral disorders (5.4%) in PERMIT, and dizziness (7.3%) and aggression (5.3%) in PROVE. AEs led to discontinuation of 20.6% of patients in PERMIT and 24.3% of patients in PROVE.

Conclusions:

These data will comprise the largest pooled analysis of PER clinical practice data conducted to date, providing insights into the use of PER to treat patients with focal and generalized epilepsy in clinical practice.

Supported by Eisai