Perampanel for Treatment of Focal and Generalized Epilepsy in Everyday Clinical Practice: Evidence from PERMIT and PROVE
Abstract number :
1.316
Submission category :
7. Anti-seizure Medications / 7E. Other
Year :
2022
Submission ID :
2204077
Source :
www.aesnet.org
Presentation date :
12/3/2022 12:00:00 PM
Published date :
Nov 22, 2022, 05:23 AM
Authors :
Eugen Trinka, MD – Christian-Doppler University Hospital, Paracelsus Medical University, Salzburg, Austria; Robert Wechsler, M.D. – Idaho Comprehensive Epilepsy Center, Boise, ID, USA; Wendyl D´Souza, M.D. – Department of Medicine – St Vincent’s Hospital Melbourne, The University of Melbourne, Victoria, Australia; Tony Wu, M.D. – Chang Gung Memorial Hospital Linkou Medical Center and Chang Gung University College of Medicine, Taoyuan, Taiwan; Imad Najim, M.D. – Cleveland Clinic Epilepsy Center, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA; Leock Y Ngo, M.D. – Eisai Inc, Nutley, NJ, USA; Rob McMurray, M.D. – Eisai Europe Ltd, Hatfield, Hertfordshire, UK; Vicente Villanueva, M.D. – Hospital Universitario y Politécnico La Fe, Valencia, Spain
Rationale: Perampanel (PER) is a once-daily oral antiseizure medication indicated in the U.S. 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 are needed to complement evidence from clinical trials by providing data on a drug when used in everyday clinical practice, outside the relative restrictions of clinical trials._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. Safety and tolerability were assessed by evaluating adverse events (AEs). A pooled analysis of data from PERMIT and PROVE is currently ongoing and will be presented._x000D_
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. _x000D_
Funding: Eisai
Anti-seizure Medications