Perampanel for the Treatment of Patients with Lennox-Gastaut Syndrome in Clinical Practice
Abstract number :
2.107
Submission category :
4. Clinical Epilepsy / 4C. Clinical Treatments
Year :
2021
Submission ID :
1825952
Source :
www.aesnet.org
Presentation date :
12/9/2021 12:00:00 PM
Published date :
Nov 22, 2021, 06:51 AM
Authors :
Paolo Bonanni, MD - Scientific Institute, IRCCS Eugenio Medea, Conegliano, Treviso, Italy; Carlo Di Bonaventura – Sapienza University of Rome, Rome, Italy; Wendyl D'Souza – Department of Medicine, St Vincent's Hospital Melbourne, The University of Melbourne, Victoria, Australia; Tony Wu – Chang Gung Memorial Hospital Linkou Medical Center and Chang Gung University College of Medicine Taoyuan, Taiwan; Rob McMurray – Eisai Europe Ltd, Hatfield, Hertfordshire, UK; Vicente Villanueva – Refractory Epilepsy Unit, Hospital Universitario y Politécnico La Fe, Valencia, Spain
Rationale: Lennox-Gastaut syndrome (LGS) is a severe epileptic encephalopathy characterized by multiple seizure types, abnormal electroencephalographic features, and intellectual disability. Treatment of LGS is challenging due to the presence of multiple seizure types and comorbidities. Perampanel (PER) is a once-daily oral anti-seizure medication for focal-onset seizures, with or without focal to bilateral tonic-clonic seizures, and generalized tonic-clonic seizures. This study assessed the effectiveness, safety and tolerability of PER when used to treat patients with LGS in clinical practice.
Methods: Patients with LGS who were treated with PER for focal-onset and/or generalized-onset seizures were identified from a pooled analysis of 44 clinical practice studies/work groups. Retention was assessed after 3, 6 and 12 months. Effectiveness assessments comprised responder rate (≥ 50% seizure frequency reduction), seizure freedom rate (no seizures since at least the prior visit), and the proportions of patients with unchanged or worsening seizure frequency. Safety and tolerability were assessed by evaluating adverse events (AEs), psychiatric AEs, and AEs leading to discontinuation.
Results: Thirty-five patients with LGS were identified. Retention was assessed for 33 patients; effectiveness for 30 patients; and safety/tolerability for 22 patients. Mean (standard deviation) PER dose was 2.0 (0.0) mg/day at baseline and 6.1 (2.8) mg/day at the last visit (last observation carried forward). Retention rates at 3, 6 and 12 months were 90.9% (30/33), 75.8% (25/33) and 63.3% (19/30), respectively. Reasons for discontinuation were AEs (16.7%), lack of efficacy (13.3%), and both AEs and lack of efficacy (6.7%). Mean (95% confidence interval) time under PER treatment was 10.3 (8.2–12.0) months. At the last visit, responder and seizure freedom rates were 56.7% and 3.3%, respectively; and the proportions of patients with unchanged and worsening seizure frequency were 23.3% and 6.7%, respectively (Figure). AEs were reported for 68.2% (15/22) of patients and psychiatric AEs were reported for 33.3% (7/21) of patients (Table). The most frequently reported AEs were irritability (22.7%), instability/ataxia (9.1%) and somnolence (9.1%).
Conclusions: In this difficult-to-treat, small population of LGS patients, PER demonstrated effectiveness and was generally well tolerated when used in everyday clinical practice.
Funding: Please list any funding that was received in support of this abstract.: Supported by Eisai.
Clinical Epilepsy