Authors :
Presenting Author: Sergey Burd, MD – Pirogov Russian National Research Medical University and Federal Center of Brain Research and Neurotechnologies, Moscow, Russia
Giovanni Assenza, MD, PhD – UOC Neurologia, Fondazione Policlinico Universitario Campus Bio-Medico, Rome, Italy; Research Unit of Neurology, Department of Medicine and Surgery, Università Campus Bio-Medico di Roma, Rome, Italy; Sofia Quintas, MD – Centro Hospitalar Universitário Lisboa Norte, Lisbon, Portugal; Francisco José Gil López, MD – Hospital Universitari del Sagrat Cor, Barcelona, Spain; Jan Wagner, MD – University of Ulm and Universitäts- und Rehabilitationskliniken Ulm, Ulm, Germany; Anna Patten, PhD – Eisai Europe Ltd., Hatfield, Hertfordshire, UK; Ricardo Sáinz-Fuertes, PhD – Eisai Europe Ltd., Hatfield, Hertfordshire, UK; Stanislas Lagarde, MD, PhD – University Hospitals of Marseille, Aix-Marseille University, Epileptology and Cerebral Rythmology Department, Timone Hospital, Institute of Systems Neuroscience, Marseille, France; Tobias Sejbaek, MD, PhD – Hospital Southwest Jutland, University Hospital of Southern Denmark, Esbjerg, Denmark; University of Southern Denmark, Odense, Denmark; Pavel Vlasov, MD, PhD – Moscow State University of General Medicine and Dentistry named after A.I. Evdokimov, Moscow, Russia; Vadim Kharkovskiy, MD – Moscow State University of General Medicine and Dentistry named after A.I. Evdokimov, Moscow, Russia; Anna Lebedeva, MD, PhD – Pirogov Russian National Research Medical University and Federal Center of Brain Research and Neurotechnologies, Moscow, Russia
Rationale: Patients with epilepsy who do not achieve seizure control while on
anti-seizure medication (ASM) monotherapy are often prescribed adjunctive therapy. Perampanel is an approved ASM in > 70 countries and territories including Japan, the United States, China, and other countries in Europe and Asia. It is approved for focal-onset seizures (FOS), with/without focal to bilateral tonic-clonic seizures (FBTCS), in patients aged ≥ 4 years (US, monotherapy/adjunctive; EU, adjunctive), and for generalized tonic-clonic seizures (GTCS) associated with idiopathic generalized epilepsy (IGE) as an adjunctive ASM in patients aged ≥ 12 (≥ 7, EU) years. Study 512 (NCT04252846) was a 12-month prospective, observational, multicenter study evaluating the effectiveness and safety of perampanel as first adjunctive therapy in patients aged ≥ 12 years with FOS, with/without FBTCS, or with GTCS associated with IGE in clinical care in Europe. Here, we present results from the final effectiveness and safety analysis of Study 512.Methods: Patients who were previously treated with ≤ 2 ASM monotherapies received perampanel as first adjunctive therapy in line with the approved indication. The decision to prescribe perampanel was based on the clinical judgment of the treating physician. The primary endpoint was retention rate at Month 12. Secondary endpoints included seizure-freedom, 50% responder, and seizure worsening rates at Months 6 and 12, and safety outcomes. Descriptive statistics were used for endpoint analyses. The Safety Analysis Set included patients who received
≥ 1 dose of perampanel and had ≥ 1 post-dose safety measurement.
Results: The Safety Analysis Set included
182 patients who received adjunctive perampanel in 38 study sites across seven countries in Europe. The median (minimum, maximum) age of patients was 36.0 (12.0, 84.0) years; the most common seizure type was FOS (n=144/182; 79.1%). Most patients were receiving one ASM at baseline; most commonly levetiracetam (n=78/182; 42.9%) and lamotrigine (n=24/182; 13.2%). The retention rate of perampanel at Month 12 was 74.2% (n=135/182). Seizure-freedom, 50% responder, and seizure-worsening rates were comparable between Months 6 and 12 of the study (Table 1). The safety outcomes throughout Study 512 are presented in Table 2; 22 withdrawals due to treatment-emergent adverse events (TEAEs) occurred during the 12-month study period. The most frequently occurring TEAEs were dizziness, irritability, and somnolence.Conclusions:
Adjunctive perampanel was effective, had a high retention rate at Month 12, and was generally well tolerated with no new safety signals emerging during Study 512. These results support the use of perampanel as first adjunctive therapy in patients aged ≥ 12 years with FOS, with/without FBTCS, or with GTCS associated with IGE.
Funding:
Eisai Inc.; Eisai Ltd.; Eisai Co., Ltd.