Authors :
Presenting Author: Vicente Villanueva, MD, PhD – Hospital Universitario y Politecnico La Fe, Valencia, Spain
Wendyl D'Souza, MBChB – The University of Melbourne, Melbourne, Austrailia; Edward Faught, MD – Emory Epilepsy Center, Atlanta, GA, USA; Pavel Klein, MD – Mid-Atlantic Epilepsy and Sleep Center, Bethesda, MD, USA; Markus Reuber, MD, PhD – The University of Sheffield, Sheffield, UK; Felix Rosenow, MD – Epilepsy Center Frankfurt Rhine-Main, Frankfurt, Germany; Javier Salas-Puig, MD – Universitari Vall d'Hebron, Barcelona, Spain; Victor Soto Insuga, MD, PhD – Hospital Universitario Infantil Nino Jesus, Madrid, Spain; Adam Strzelczyk, MD, MHBA – Epilepsy Center Frankfurt Rhine-Main, Frankfort, Germany; Jerzy Szaflarski, MD, PhD – UAB Epilepsy Center, Birmingham, AL, USA; Herve Besson, PhD – UCB Pharma, Breda, Netherlands; Dimitrios Bourikas, PhD – UCB Pharma, Alimos, Greece; Tony Daniels, BS – UCB Pharma, Morrisville, NC, USA; Florin Floricel, MD, PhD – UCB Pharma, Monheim am Rhein, Germany; David Friesen, BS – UCB Pharma, Slough, England, UK; Cedric Laloyaux, PhD – UCB Pharma, Brussels, Belgium; Veronica Sendersky, PharmD – UCB Pharma, Brussels, Belgium; Bernhard Steinhoff, MD, PhD – University of Freiburg, Freiburg, Germany
Rationale:
This pooled analysis of real-world data from a large international population (North America/Europe/Australia) assessed effectiveness and tolerability of brivaracetam in patients with epilepsy and specific comorbidities: cognitive or learning disability (CLD) and psychiatric comorbidities (PC).
Methods:
Subgroup analysis from EXPERIENCE/EPD332, a pooled analysis of retrospective cohorts that included patients with epilepsy initiating BRV in clinical practice. Outcomes included ≥50% seizure reduction from baseline and continuous seizure freedom (CSF; no seizures after baseline) at 3, 6, and 12 months, and treatment-emergent adverse events (TEAEs) since prior visit at 6 and 12 months. Patients with missing data after BRV discontinuation were considered non-responders and not seizure free.Results:
Analyses by CLD status included 1635 patients: 403 with and 1232 without CLD. Patients with vs without CLD were younger (96.3/89.3% aged <65 years), had a higher median seizure frequency (7.7/4.0 seizures/28 days) and median number of prior ASMs (7.0/4.0) at index, and a higher incidence of neurological (43.5/22.9%) and PC (43.5/35.5%) (Table). In both subgroups, median BRV dose at index was 100.0 (50.0, 100.0) mg/day (with/without CLD: n=395/1211). In patients with vs without CLD, ≥50% seizure reduction was numerically lower at 3 (20.4/36.1%) and 6 months (29.5/40.1%) and similar at 12 months (35.6/37.4%). CSF was numerically lower in patients with CLD at all timepoints (Figure). At 6 and 12 months, patients with vs without CLD had similar incidences of TEAEs (6 months: 15.5/13.8%; 12 months: 11.3/8.7%), and of psychiatric (3.4/2.3%; 3.5/2.2%), cognitive (1.9/1.0%; 1.1/0.8%) and behavioral TEAEs (1.9/0.5%; 1.8/0.3%) (Figure). BRV discontinuations during whole study follow-up were 37.1/32.6% (n=402/1228).
Analyses by PC status included 1616 patients: 605 with and 1011 without PC. Baseline characteristics were generally similar in both subgroups (Table). Neurological comorbidities (30.7/25.9%) and CLD (28.2/22.0%) were more common in patients with vs without PC. In both subgroups, median BRV dose at index was 100.0 (50.0, 100.0) mg/day (with/without PC: n=597/996). Patients with vs without PC had similar ≥50% seizure reduction and CSF at all timepoints (Figure). At 6 and 12 months, patients with vs without PC had similar incidences of TEAEs (6 months: 14.0/13.9%; 12 months: 10.0/8.8%), and of psychiatric (2.1/2.6%; 2.7/2.5%), cognitive (1.0/1.4%; 1.2/0.9%) and behavioral TEAEs (0.6/0.7%; 0.7/0.5%) (Figure). BRV discontinuations during whole study follow-up were 30.7/35.4% (n=603/1008).
Conclusions:
In this large descriptive real-world analysis, BRV was effective and well tolerated in adults with epilepsy and CLD or PC. BRV treatment did not appear to exacerbate CLD or PC, as shown by the low incidences of psychiatric, cognitive, and behavioral TEAEs.
Funding: UCB Pharma-sponsored