150 PROVE study 506: Perampanel as adjunctive therapy or monotherapy in real- world care of epilepsy patients

Abstract

BackgroundWe report an analysis of PROVE Study 506 (NCT03208660) in epilepsy patients who received perampanel (adjunctive or monotherapy) during routine care.MethodsData were from patients initiating perampanel after 01-Jan-2014 (cut-off: 15-Mar-2019). Retention rate (primary endpoint; patients remaining on perampanel at 3/6/12/18/24 months following initiation [Safety Analysis Set (SAS)]), dosing and safety were assessed. Patients received adjunctive perampanel (with concomitant anti-seizure medications [ASMs]) or perampanel monotherapy (primary=without con- comitant ASMs; secondary=conversion to monotherapy).ResultsSAS included 1676 (98.4%) patients receiving adjunctive perampanel and 47 (2.8%) receiving monotherapy. Patients receiving adjunctive perampanel and perampanel monotherapy (primary, n=33/secondary, n=14) are in each relevant group. Most patients on adjunctive perampanel received 1–3 baseline ASMs (77.6%).Overall, 816 (47.9%) patients discontinued (monotherapy, n=23 [48.9%]); most commonly due to adverse event (overall, 22.8%; monotherapy, 14.9%) and inadequate therapeutic effect (overall, 13.2%; mono- therapy, 25.5%).Retention rates (24 months) were: 47.6% (adjunctive); 31.3% (primary monotherapy); 83.3% (secondary monotherapy). Mean (standard deviation) maximum perampanel doses (mg) were: adjunctive, 6.6 (3.2); monotherapy, 7.2 (2.7). Treatment-emergent adverse events occurred in 696 (adjunctive; 41.5%) and 17 (monotherapy; 36.2%) patients; dizziness was most common.ConclusionRetention on perampanel (adjunctive/monotherapy) was favourable for ≤2 years, with similar safety between groups.FundingEisai Inc.manoj_malhotra@eisai.com