PERMIT study: a global pooled analysis study of the effectiveness and tolerability of perampanel in routine clinical practice.
Vicente Villanueva, Wendyl D'Souza, Hiroko Goji, Dong Wook Kim, Claudio Liguori, Rob McMurray, Imad Najm, Estevo Santamarina, Bernhard J Steinhoff, Pavel Vlasov, Tony Wu, Eugen Trinka, PERMIT pooled analysis participants
Author Information
Vicente Villanueva: Refractory Epilepsy Unit, Hospital Universitario y Politécnico La Fe, Valencia, Spain. villanueva_vichab@gva.es.
Wendyl D'Souza: Department of Medicine, St Vincent's Hospital Melbourne, The University of Melbourne, Victoria, Australia. ORCID
Hiroko Goji: Neuropsychiatric Department, Aichi Medical University, Aichi, Japan.
Dong Wook Kim: Department of Neurology, Konkuk University School of Medicine, Seoul, Korea.
Claudio Liguori: Epilepsy Centre, Neurology Unit, University Hospital "Tor Vergata", Rome, Italy. ORCID
Rob McMurray: European Knowledge Centre, Eisai Europe Ltd, Hatfield, Hertfordshire, UK.
Imad Najm: Cleveland Clinic Epilepsy Center, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA.
Bernhard J Steinhoff: Kork Epilepsy Center, Kehl-Kork, Germany.
Pavel Vlasov: Department of Neurology, General Medical Faculty of Moscow State University of Dentistry named after A.I. Evdokimov, Moscow, Russian Federation. ORCID
Tony Wu: Chang Gung Memorial Hospital Linkou Medical Center and Chang Gung University College of Medicine, Taoyuan, Taiwan.
Eugen Trinka: Department of Neurology, Christian-Doppler University Hospital, Paracelsus Medical University, Affiliated EpiCARE Partner, Centre for Cognitive Neuroscience, Salzburg, Austria. ORCID
The PERaMpanel pooled analysIs of effecTiveness and tolerability (PERMIT) study was a pooled analysis of data from 44 real-world studies from 17 countries, in which people with epilepsy (PWE; focal and generalized) were treated with perampanel (PER). Retention and effectiveness were assessed after 3, 6, and 12 months, and at the last visit (last observation carried forward). Effectiveness assessments included 50% responder rate (≥ 50% reduction in seizure frequency from baseline) and seizure freedom rate (no seizures since at least the prior visit); in PWE with status epilepticus, response was defined as seizures under control. Safety and tolerability were assessed by evaluating adverse events (AEs) and discontinuation due to AEs. The Full Analysis Set included 5193 PWE. Retention, effectiveness and safety/tolerability were assessed in 4721, 4392 and 4617, respectively. Retention on PER treatment at 3, 6, and 12 months was 90.5%, 79.8%, and 64.2%, respectively. Mean retention time on PER treatment was 10.8 months. The 50% responder rate was 58.3% at 12 months and 50.0% at the last visit, and the corresponding seizure freedom rates were 23.2% and 20.5%, respectively; 52.7% of PWE with status epilepticus responded to PER treatment. Overall, 49.9% of PWE reported AEs and the most frequently reported AEs (≥ 5% of PWE) were dizziness/vertigo (15.2%), somnolence (10.6%), irritability (8.4%), and behavioral disorders (5.4%). At 12 months, 17.6% of PWEs had discontinued due to AEs. PERMIT demonstrated that PER is effective and generally well tolerated when used to treat people with focal and/or generalized epilepsy in everyday clinical practice.
