Perampanel for the Treatment of Asian Patients with Focal and Generalized Epilepsy in Clinical Practice: Evidence from the PERMIT Study
Abstract number :
1.311
Submission category :
7. Anti-seizure Medications / 7E. Other
Year :
2022
Submission ID :
2204048
Source :
www.aesnet.org
Presentation date :
12/3/2022 12:00:00 PM
Published date :
Nov 22, 2022, 05:23 AM
Authors :
Amitabh Dash, Dr – Eisai Singapore Pte. Ltd., Singapore; Tony Wu, MD - Chang Gung Memorial Hospital Linkou Medical Center and Chang Gung University College of Medicine; Dong Wook Kim, MD – Konkuk University School of Medicine, Seoul, Korea; Taoufik Alsaadi, MD – American Center for Psychiatry & Neurology, United Arab Emirates; Hiroko Goji, MD – Aichi Medical University, Aichi, Japan; Yotin Chinvarun, MD – Phramongkutklao Hospital, Bangkok, Thailand; Hugh JiWoong Lee, M.D. – Eisai Korea Inc., Seoul, Korea; Yahui Cheng, MD – Eisai Taiwan Inc., Taipei, Taiwan; Vicente Villanueva, MD – Hospital Universitario y Politécnico La Fe, Valencia, Spain
Rationale: Patients with different ethnic backgrounds may experience variations in response and tolerability to an antiseizure medication (ASM). Perampanel (PER) is a once-daily oral ASM for focal-onset seizures, with or without focal to bilateral tonic-clonic seizures, and generalized tonic-clonic seizures. Real-world studies complement evidence from clinical trials by providing data on a drug when used outside the relative restrictions of clinical trials. The purpose of this pooled analysis was to evaluate the effectiveness, safety and tolerability of PER in Asian patients treated in clinical practice._x000D_
Methods: The PERMIT study was an international pooled analysis of real-world data from 44 prospective, retrospective and cross-sectional studies and work groups in which patients with focal and generalized epilepsy were treated with PER. Here we report results for a subgroup of Asian patients in PERMIT. Retention rate was evaluated at 3, 6 and 12 months. Effectiveness was assessed by seizure type (focal-onset, generalized-onset) at the last visit (last observation carried forward). Effectiveness assessments included seizure freedom rate (no reported seizures since at least the prior visit) and responder rate (≥ 50% reduction in seizure frequency). Tolerability was assessed by evaluating adverse events (AEs). _x000D_
Results: A total of 689 Asian patients were included in PERMIT (47.0% female; mean age 40.9 years). Seizure types at baseline were focal-onset seizures (80.9%), generalized-onset seizures (18.8%) and both focal and generalized-onset seizures (0.3%). At treatment initiation, most patients received PER as adjunctive therapy (30.4% initiated PER as monotherapy). The mean (standard deviation) PER dosage was 2.3 (0.9) mg/day at baseline and 4.5 (2.5) mg/day at the last visit. Retention was assessed for 657 patients; effectiveness for 508 patients; safety/tolerability for 677 patients. Retention rates at 3, 6, and 12 months were 80.8% (531/657), 65.7% (360/548) and 53.7% (271/505), respectively. Mean retention time on PER treatment was 6.9 months. Overall, 46.3% (234/505) of patients discontinued PER over 12 months (AEs, 21.6%; lack of efficacy, 14.1%; both AEs and lack of efficacy, 1.2%; unknown/other reasons, 9.5%). Among patients with focal-onset seizures only, seizure freedom and responder rates at the last visit were 32.6% and 62.2%, respectively (Figure). Among patients with generalized-onset seizures only, seizure freedom and responder rates at the last visit were 48.0% and 68.6%, respectively. Overall, 47.7% (323/677) of patients experienced AEs (Table). The most common AE was dizziness/vertigo (10.5%). Over 12 months, 22.8% of patients discontinued due to AEs. Psychiatric AEs were reported for 17.8% of patients and 7.6% of patients with psychiatric AEs discontinued due to AEs._x000D_
Conclusions: This large pooled analysis demonstrated that PER was effective and generally well tolerated when used to treat Asian patients with focal and generalized epilepsy in everyday clinical practice. _x000D_
Funding: Supported by Eisai
Anti-seizure Medications