Authors :
First Author: Marta Maschio, MD – Center for Tumor-Related Epilepsy, UOSD Neuroncology, IRCCS IFO Regina Elena National Cancer Institute, Rome, Italy
Presenting Author: Vicente Villanueva, MD, PhD – Hospital Universitario y Politecnico La Fe, Valencia, Spain
Antonietta Coppola, MD – Department of Neuroscience, Odontostomatological and Reproductive Sciences, Federico II University of Naples, Naples, Italy; Marina Valente-Fernandes, MD – Instituto Português de Oncologia de Lisboa, Lisbon, Portugal; Satoru Takahasi, MD – Department of Neurosurgery, Tokyo Medical and Dental University, Tokyo, Japan; Shuichi Izumoto, MD – Department of Neurosurgery, Kindai University Faculty of Medicine, Osaka-Sayama, Japan; Eugen Trinka, MD – Department of Neurology, Christian-Doppler University Hospital, Paracelsus Medical University, Centre for Cognitive Neuroscience, Member of EpiCARE, Salzburg, Austria; Sheri Cappucci, MD – Eisai Inc, Nutley, NJ, USA; Ricardo Sainz-Fuertes, MD – Eisai Europe Ltd; Vicente Villanueva, MD – Refractory Epilepsy Unit, Hospital Universitario y Politécnico La Fe, Valencia, Spain
Rationale:
Identification of an underlying etiology is essential for the diagnosis and management of epilepsy. The International League Against Epilepsy classification includes six etiological categories: structural, genetic, infectious, metabolic, immune and unknown. Perampanel (PER) is a once-daily antiseizure medication indicated for focal seizures and for generalized tonic-clonic seizures in people with idiopathic generalized epilepsy. The PERMIT Extension study represents the largest pooled analysis of PER clinical practice data conducted to date and showed that PER is effective and generally well tolerated when used to treat people with focal or generalized epilepsy in everyday clinical practice. This study assessed PER when used to treat people with epilepsy (PWE) with different etiologies using data from PERMIT Extension.
Methods:
The PERMIT Extension study pooled patient data from PERMIT (a pooled analysis of 44 real-world studies of people with focal and generalized epilepsy treated with PER) and PROVE (a Phase IV, retrospective, noninterventional study of PER when used during routine clinical care in the US). Retention was assessed after 3, 6 and 12 months of PER treatment. Effectiveness was assessed after 12 months and at the last visit (last observation carried forward). Effectiveness assessments included responder rate (≥50% seizure frequency reduction) and seizure freedom rate (no seizures since at least the prior visit). Safety and tolerability were assessed by evaluating adverse events (AEs).
Results:
Of the 6822 PWE included in PERMIT Extension (51.1% female; mean age, 36.9 years), etiology was known for 5582: structural (n=1945; 34.8%), genetic (n=1012; 18.1%), infectious (n=93; 1.7%), immune (n=26; 0.5%) and unknown (n=2506; 44.9%). Retention rates at 12 months were 61.1%, 65.9%, 56.8%, 56.5% and 59.5% for PWE with structural, genetic, infectious, immune and unknown etiology, respectively. Responder and seizure freedom rates after 12 months are shown in Figure 1. At the last visit, responder and seizure freedom rates by etiology group were, respectively, 43.3% and 15.8% for structural etiology, 68.3% and 46.5% for genetic etiology, 37% and 11.1% for infectious etiology, 20% and 5% for immune etiology, and 46.8% and 14.7% for unknown etiology. AEs were reported by 58.0%, 46.5%, 51.1%, 65.0% and 49.6% of PWE with structural, genetic, infectious, immune and unknown etiology, respectively, and led to discontinuation in 18.9%, 16.4%, 18.5%, 21.7% and 19.0% of PWE, respectively (Table 1).
Conclusions:
PER was effective and generally well tolerated when used to treat PWE in clinical practice, regardless of etiology. PER’s effectiveness and safety/tolerability were most favorable in PWE with genetic etiology.
Funding: Supported by Eisai