Perampanel for the Treatment of Focal-Onset and Generalized-Onset Seizures in Patients with Post-Traumatic Brain Injury Etiology: Evidence from Clinical Practice
Abstract number :
2.109
Submission category :
4. Clinical Epilepsy / 4C. Clinical Treatments
Year :
2021
Submission ID :
1825940
Source :
www.aesnet.org
Presentation date :
12/9/2021 12:00:00 PM
Published date :
Nov 22, 2021, 06:51 AM
Authors :
Yotin Chinvarun, MD, PhD FAES - Phramongkutklao Hospital, Bangkok, Thailand; Chen-Jui Ho – Department of Neurology, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, Taiwan; Galina Odintsova – Almazov National Medical Research Center, St Petersburg, Russia; Wendyl D'Souza – Department of Medicine, St Vincent's Hospital Melbourne, The University of Melbourne, Victoria, Australia; Eugen Trinka – Department of Neurology, and Medical Director of the Christian Doppler Medical Centre, Paracelsus Medical University, Salzburg, Austria; Manoj Malhotra – Eisai Inc, Woodcliff Lake, New Jersey, USA; Vicente Villanueva – Epilepsy Unit, Hospital Universitario y Politécnico La Fe, Valencia, Spain
Rationale: Epilepsy patients with post-traumatic brain injury (TBI) etiology are typically excluded from epilepsy clinical trials. Real-world evidence from clinical practice studies is therefore required in order to inform treatment decisions in this patient group. 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. The purpose of this study was to assess the real-world effectiveness, safety and tolerability of PER when used in everyday clinical practice to treat epilepsy patients with post-TBI etiology.
Methods: Patients with epilepsy with post-TBI etiology were identified from a pooled analysis of 44 clinical practice studies/work groups in which patients with focal-onset and generalized-onset seizures were treated with PER. Retention was assessed after 3, 6 and 12 months of PER treatment. 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 seizures since at least the prior visit), responder rate (≥50% seizure frequency reduction), and the proportions of patients with unchanged or worsening seizure frequency. Safety and tolerability were assessed by evaluating adverse events (AEs), AEs leading to discontinuation, psychiatric AEs, and psychiatric AEs leading to discontinuation.
Results: A total of 76 patients with focal-onset and/or generalized-onset seizures with post-TBI etiology were identified (mean age, 44.3 years; 76.3% male; mean duration of epilepsy, 16.4 years). Seizure types at baseline were focal-onset only (92.0%) and generalized-onset only (8.0%). Patients received PER as adjunctive therapy (92.1%) and monotherapy (7.9%). Mean (standard deviation) PER dosage was 2.6 (1.3) mg/day at baseline and 5.1 (2.3) mg/day at the last visit. Effectiveness was assessed for 60 patients; safety/tolerability was assessed for 74 patients. At 3, 6 and 12 months, retention rates were 94.7% (71/75), 87.3% (62/71) and 68.3% (43/63), respectively. Mean (95% confidence interval) time under PER treatment was 10.1 (9.4–10.9) months. At the last visit, seizure freedom rates in patients with focal-onset and generalized-onset seizures were 44.4% and 40.0%, respectively, and corresponding values for responder rates were 81.1% and 40.0%, respectively (Figure). AEs were reported for 45.9% of patients; the most frequently reported AEs were somnolence (14.9%), dizziness/vertigo (12.2%), and irritability (12.2%) (Table). After 12 months, 20.6% of patients had discontinued due to AEs. Psychiatric AEs were reported for 20.3% of patients.
Conclusions: PER was effective and generally well tolerated when used to treat patients with epilepsy with post-TBI etiology in clinical practice.
Funding: Please list any funding that was received in support of this abstract.: Supported by Eisai.
Clinical Epilepsy