Clinical Practice Evidence for Perampanel in Epilepsy Patients with Tumor Etiology
Abstract number :
3.211
Submission category :
4. Clinical Epilepsy / 4C. Clinical Treatments
Year :
2021
Submission ID :
1825926
Source :
www.aesnet.org
Presentation date :
12/6/2021 12:00:00 PM
Published date :
Nov 22, 2021, 06:51 AM
Authors :
Antonietta Coppola, MD - Epilepsy Centre, Department of Neuroscience, Odontostomatological and Reproductive sciences, Federico II University of Naples, Naples, Italy; Shuichi Izumoto - Department of Neurosurgery, Kindai University, Osaka-Sayama, Japan; Xiana Rodriguez-Osorio - Department of Neurology, Complexo Hospitalario Universitario de Santiago, Santiago, Spain; Tony Wu - Chang Gung Memorial Hospital Linkou Medical Center and Chang Gung University College of Medicine, Taoyuan, Taiwan; Wendyl D'Souza - Department of Medicine, St Vincent's Hospital Melbourne, The University of Melbourne, Victoria, Australia; Marta Maschio - Center for Brain Tumor-Related Epilepsy, UOSD Neuro-Oncology, I.R.C.C.S. Regina Elena National Cancer Institute, Rome, Italy; Samantha Goldman - Eisai Europe Ltd, Hatfield, Hertfordshire, UK; Mariana Valente Fernandes - Instituto Português de Oncologia de Lisboa, Lisbon, Portugal; Vicente Villanueva - Refractory Epilepsy Unit, Hospital Universitario y Politécnico La Fe, Valencia, Spain
Rationale: Patients with epilepsy with tumor 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 patients with epilepsy with tumor etiology.
Methods: Patients with epilepsy with tumor etiology were identified from a pooled analysis of 44 prospective, retrospective and cross-sectional clinical practice studies/work groups. Retention was assessed after 3, 6 and 12 months of PER treatment. 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: A total of 127 patients with focal-onset and/or generalized-onset seizures with tumor etiology were identified (mean age, 46.6 years; 54.8% male; mean duration of epilepsy, 9.7 years). Seizure types at baseline were focal-onset only (97.6%), generalized-onset only (1.6%), and focal-onset and generalized-onset (0.8%). Mean (standard deviation) PER doses at baseline and last visit were 2.6 (1.4) and 5.8 (2.5) mg/day, respectively. Retention was assessed for 125 patients; effectiveness for 120 patients; safety and tolerability for 116 patients. At 3, 6 and 12 months, retention rates were 88.0% (110/125), 79.5% (97/122) and 65.3% (62/95), respectively. Reasons for discontinuation included AEs (16.8%) and lack of efficacy (5.3%). Mean (95% confidence interval) time under PER treatment was 11.0 (10.2–12.0) months. At the last visit (last observation carried forward), responder and seizure freedom rates were 66.9% and 34.2%, respectively, and the percentages of patients with unchanged or worsening seizure frequency were 15.3% and 6.8%, respectively (Figure). AEs were reported for 36.2% (42/116) of patients; the most frequently reported AEs were dizziness/vertigo (13.8%) and somnolence (9.5%) (Table). AEs led to discontinuation of 16.8% (16/95) of patients over 12 months and 13.0% (15/115) of patients experienced psychiatric AEs.
Conclusions: PER was effective and generally well tolerated when used to treat patients with epilepsy with tumor etiology in clinical practice.
Funding: Please list any funding that was received in support of this abstract.: Supported by Eisai.
Clinical Epilepsy