Perampanel for Treatment of Focal and Generalized Epilepsy in Elderly Patients (Aged ≥ 65 Years) in Clinical Practice: Evidence from PERMIT and PROVE
Abstract number :
1.312
Submission category :
7. Anti-seizure Medications / 7E. Other
Year :
2022
Submission ID :
2204052
Source :
www.aesnet.org
Presentation date :
12/3/2022 12:00:00 PM
Published date :
Nov 22, 2022, 05:23 AM
Authors :
Ricardo Sainz Fuertes, LMS, MSc, MRCPsych, PhD – Eisai Inc.; Motoki Inaji, MD - Tokyo Medical and Dental University; James Wheless, MD – University of Tennessee Health Science Center, Le Bonheur Children's Hospital, Memphis, Tennessee, USA; Rob McMurray, MD – Eisai Europe Ltd, Hatfield, Hertfordshire, UK; Alexandra Astner-Rohracher, MD – Department of Neurology, Christian-Doppler University Hospital, Paracelsus Medical University, Salzburg, Austria; Dong Wook Kim, MD – Department of Neurology, Konkuk University School of Medicine, Seoul, Korea; Eugen Trinka, MD – Department of Neurology, Christian-Doppler University Hospital, Paracelsus Medical University, Salzburg, Austria; Claudio Liguori, MD – University of Rome “Tor Vergata”, Rome, Italy; Vicente Villanueva, MD – Hospital Universitario y Politécnico La Fe, Valencia, Spain
Rationale: Perampanel (PER) is a once-daily oral antiseizure medication indicated in the U.S. for focal-onset seizures, with or without focal to bilateral tonic-clonic seizures, in patients with epilepsy aged ≥ 4 years, and as adjunctive therapy for primary generalized tonic-clonic seizures in patients with epilepsy aged ≥ 12 years. Elderly patients are often excluded from clinical trials, due to high levels of comorbidity and associated comedications, and consequently there is limited information about the effects of PER in this population. The purpose of this analysis was to assess the effectiveness, safety and tolerability of PER in epilepsy patients aged ≥ 65 years treated in everyday clinical practice. _x000D_
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 US. 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 elderly patients (age ≥ 65 years) who were included in PERMIT and PROVE is currently ongoing and will be presented._x000D_
Results: A total of 342 elderly patients were identified from PERMIT (52.3% female; mean age, 72.4 years; mean duration of epilepsy, 28.6 years; Full Analysis Set) and 40 were identified from PROVE (52.5% female; mean age, 70.6 years; mean duration of epilepsy, 20.2 years; Safety Analysis Set). Mean time under PER treatment was 10.4 months in PERMIT and 20.6 months in PROVE. Retention rates at 12 months were 61.5% (PERMIT) and 55.9% (PROVE). In PERMIT, responder and seizure freedom rates at 12 months were 75.0% and 39.8 %, respectively. In PROVE, responder and seizure freedom rates at 10‒12 months were 75.0% and 50.0%, respectively. AEs were reported by 54.8% of elderly patients in PERMIT and 52.5% of in PROVE. The most frequently reported AEs (≥ 5% of patients) were dizziness/vertigo (16.4%), somnolence (12.0%) irritability (8.4%) and instability/ataxia (7.4%) in PERMIT, and dizziness (15.0%), agitation (7.5%), balance disorder (5.0%), death (5.0%), dysarthria (5.0%) and fatigue (5.0%) in PROVE. AEs led to discontinuation of 26.5% of patients in PERMIT and 30.0% of patients in PROVE._x000D_
Conclusions: This large pooled analysis of PER clinical practice data will provide valuable insights into the use of PER to treat elderly patients, a population that is often excluded from clinical trials. _x000D_
Funding: Supported by Eisai
Anti-seizure Medications