Pooled Analysis of Adult Epilepsy Patients Treated with Perampanel in Everyday Clinical Practice
Abstract number :
V.052
Submission category :
4. Clinical Epilepsy / 4C. Clinical Treatments
Year :
2021
Submission ID :
1825919
Source :
www.aesnet.org
Presentation date :
12/9/2021 12:00:00 PM
Published date :
Nov 22, 2021, 06:51 AM
Authors :
Adam Strzelczyk, MD - Epilepsy Center Frankfurt Rhine‐Main, Department of Neurology, Goethe University, Frankfurt am Main, Germany; Tim Wehner – NIHR University College London Hospitals Biomedical Research Centre, UCL Institute of Neurology, Queen Square, London, UK; Francesco Deleo – Epilepsy Unit, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy; Mar Carreño – Hospital Clinic Barcelona, Barcelona, Spain; Eugen Trinka – Christian Doppler Medical Centre, Paracelsus Medical University, Salzburg, Austria; Tony Wu – Chang Gung Memorial Hospital Linkou Medical Center and Chang Gung University College of Medicine, Taoyuan, Taiwan; Amitabh Dash – Eisai Singapore Pte Ltd, Singapore; Bernhard Steinhoff – Kork Epilepsy Center, Kehl-Kork, Germany, and Albert-Ludwigs University of Freiburg, Freiburg, Germany; Vicente Villanueva – Epilepsy Unit, Hospital Universitario y Politécnico La Fe, Valencia, Spain
Rationale: Perampanel (PER) is a once-daily oral anti-seizure medication (ASM) for focal-onset seizures, with or without focal to bilateral tonic-clonic seizures, and generalized tonic-clonic seizures. Real-world studies complement the evidence collected in clinical trials by providing data on a drug when used in everyday clinical practice, outside the relative restrictions of clinical trials. In this pooled analysis of real-world studies, we evaluated the effectiveness and safety profile of PER in adult epilepsy patients treated in clinical practice.
Methods: A pooled analysis was conducted of real-world studies that have collected data on patients treated with PER for focal-onset and/or generalized-onset seizures. Retention rate was evaluated at 3, 6 and 12 months. Effectiveness was assessed by seizure type (focal-onset, generalized-onset) at the last visit. Effectiveness was assessed by evaluating 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), psychiatric AEs, and AEs leading to discontinuation. Here we report the results for the subgroup of adult patients aged ≥ 18 to < 65 years.
Results: Data from 44 studies/work groups were pooled: of the 5193 patients included in the analysis, 4247 were aged ≥ 18 to < 65 years (50.6% female; mean age 38.7 years). Seizures were classified as focal-onset seizures (83.1%), generalized-onset seizures (12.4%) and both focal and generalized-onset seizures (4.5%). At treatment initiation, the majority of patients were on 2 or 3 concomitant ASMs (only 3.5% initiated PER as monotherapy). The mean (standard deviation) PER dosage was 2.3 (1.0) mg/day at baseline and 6.4 (2.6) mg/day at last visit (last observation carried forward). Effectiveness was assessed for 3644 patients; safety/tolerability was assessed for 3817 patients. Retention rates at 3, 6, and 12 months were 90.9% (3593/3954), 80.1% (3023/3775) and 64.8% (2302/3554), respectively. Mean retention time on PER treatment was 10.8 months. Overall, 35.2% (1252/3554) of patients discontinued PER: 8.8% due to lack of efficacy, 14.0% due to AEs and 2.8% due to both lack of efficacy and AEs. Among patients with focal-onset seizures only, seizure freedom and responder rates at the last visit were 14.5% and 44.6%, respectively (Figure). Among patients with generalized-onset seizures only, seizure freedom and responder rates at the last visit were 52.0% and 73.3%, respectively. Overall, 50.7% (1935/3817) of patients experienced AEs (Table). The most common AEs were dizziness/vertigo (16.0%), somnolence (10.7%) and irritability (8.3%). Psychiatric AEs were reported for 21.0% of patients and led to discontinuation in 9.4% of patients.
Conclusions: In this analysis of real-world studies, PER was effective and generally well tolerated in controlling focal-onset and generalized-onset seizures in adult patients.
Funding: Please list any funding that was received in support of this abstract.: Supported by Eisai.
Clinical Epilepsy