12-month Effectiveness and Tolerability of Brivaracetam in Patients with Epilepsy Aged ≥65 Years vs ≥16– < 65 Years in the Real-world: Subgroup Data from the International EXPERIENCE Pooled Analysis
Abstract number :
1.299
Submission category :
7. Anti-seizure Medications / 7C. Cohort Studies
Year :
2022
Submission ID :
2203963
Source :
www.aesnet.org
Presentation date :
12/3/2022 12:00:00 PM
Published date :
Nov 22, 2022, 05:22 AM
Authors :
Edward Faught, MD – Emory Epilepsy Center, Emory University, Atlanta, Georgia, US; Wendyl D'Souza, MBChB – Department of Medicine – St Vincent’s Hospital Melbourne, The University of Melbourne, Melbourne, Australia; Pavel Klein, MD – Mid-Atlantic Epilepsy and Sleep Center, Atlanta, Georgia, US; Markus Reuber, MD, PhD – The University of Sheffield, Sheffield, UK; Felix Rosenow, MD – Epilepsy Center Frankfurt Rhine-Main, Center of Neurology and Neurosurgery, Frankfurt, Germany; Javier Salas-Puig, MD – Universitari Vall d’Hebron, Barcelona, Spain; Victor Soto Insuga, MD, PhD – Pediatric Neurology, Hospital Universitario Infantil Niño Jesús, Madrid, Spain; Bernhard Steinhoff, MD, PhD – Kork Epilepsy Center, Kehl-Kork, Germany; Adam Strzelczyk, MD, MHBA – Epilepsy Center Frankfurt Rhine-Main, Center of Neurology and Neurosurgery, Frankfurt, Germany; Jerzy Szaflarski, MD, PhD – UAB Epilepsy Center, Birmingham, Alabama, US; Herve Besson, PhD – UCB Pharma, Breda, Netherlands; Tony Daniels, BS – UCB Pharma, Morrisville, North Carolina, US; Florin Floricel, MD, PhD – UCB Pharma, Monheim am Rhein, Germany; Cedric Laloyaux, PhD – UCB Pharma, Brussels, Belgium; Veronica Sendersky, PharmD – UCB Pharma, Brussels, Belgium; Sophia Zhou, MS – UCB Pharma, Morrisville, North Carolina, US; Vicente Villanueva, MD, PhD – Hospital Universitario y Politécnico La Fe, Valencia, Spain
Rationale: This pooled analysis of real-world data from a large international population (North America, Europe, Australia) was performed to assess the effectiveness and tolerability of brivaracetam (BRV) in older (≥65 years) and younger (≥16 – < 65 years) adults with epilepsy.
Methods: Subgroup analysis from EXPERIENCE/EPD332, a pooled analysis of retrospective cohorts that included patients with epilepsy initiating BRV in clinical practice. 50% responder rate (≥50% seizure reduction from baseline), seizure freedom (SF; no seizures within 3 months prior to timepoint), continuous SF after baseline (CSF; no seizures within 3 months prior to the timepoint and previous follow-up timepoints), and treatment-emergent adverse events (TEAEs) since prior visit were assessed at 3, 6, and 12 months. Patients with missing data after BRV discontinuation were assigned nonresponse for 50% responder rate, and no SF for SF and CSF.
Results: This analysis included 147 patients aged ≥65 years (97.3% with focal-onset seizures at baseline) and 1497 aged ≥16 – < 65 years (91.6% with focal-onset seizures at baseline; Table). In comparison to patients aged ≥16 – < 65 years, those aged ≥65 years had a longer median time since epilepsy diagnosis (33.0 vs 17.0 years), less commonly had 2 or more prior antiseizure medications (ASMs; any ASM used and stopped before BRV initiation) (75.2% vs. 85.5%), and had a lower median seizure frequency at index (2.0 seizures/28 days [Q1–Q3, 1.0–5.3; n=129] vs. 4.0 seizures/28 days [1.3–13.4; n=1256]). The most common epilepsy etiologies were vascular in patients aged ≥65 years, and malformation of cortical development in patients aged ≥16 – < 65 years. At index, the median BRV dose was 100.0 mg/day (Q1–Q3, 50.0–100.0) in both age groups (≥65 years, n=144; ≥16 – < 65 years, n=1471). The median duration of BRV treatment was 352.6 days in patients aged ≥65 years and 344.0 days in patients aged ≥16 – < 65 years. 50% responder rates, and SF and CSF rates were numerically higher in patients aged ≥65 years vs. patients aged ≥16– < 65 years at 3, 6, and 12 months (Figure). The incidence of TEAEs was similar in each age group at 3 months (≥65 years vs. ≥16 – < 65 years: 38/138 [27.5%] vs. 356/1404 [25.4%]), 6 months (19/119 [16.0%] vs. 176/1257 [14.0%]), and 12 months (8/104 [7.7%] vs. 107/1128 [9.5%]). A similar proportion of patients in each age group discontinued BRV before 12 months, and also at 12 months (≥65 years vs. ≥16 – < 65 years: 11/146 [7.5%] vs. 130/1483 [8.8%]). In both age groups, discontinuation of BRV during the whole study follow-up was mostly due to insufficient effectiveness and/or tolerability.
Conclusions: In this subgroup analysis of patients in a variety of real-world settings, BRV was effective in patients aged ≥65 years and in patients aged ≥16 – < 65 years, with numerically higher effectiveness observed in the older age group. Incidence of TEAEs was similar in the two age groups.
Funding: Sponsored by UCB Pharma
Anti-seizure Medications