12-month Effectiveness and Tolerability of Brivaracetam in Patients with Epilepsy and Cognitive or Psychiatric Comorbidities: Subgroup Data from the International EXPERIENCE Pooled Analysis
Vicente Villanueva1, Wendyl D'Souza2, Edward Faught3, Pavel Klein4, Markus Reuber5, Felix Rosenow6, Javier Salas-Puig7, Victor Soto Insuga8, Adam Strzelczyk6, Jerzy P. Szaflarski9, Herve Besson10, Dimitrios Bourikas10, Tony Daniels10, Florin Floricel10, David Friesen10, Cedric Laloyaux11, Veronica Sendersky10, Bernhard J. Steinhoff12
1Hospital Universitario y Politecnico La Fe, 2The University of Melbourne, 3Emory Epilepsy Center, Emory University School of Medicine, 4Mid-atlantic Epilepsy and Sleep Center, 5Sheffield Teaching Hospitals NHS Trust, The University of Sheffield, 6Epilepsy Center Frankfurt Rhine-Main, 7Universitari Vall d'Hebron, 8Hospital Universitario Infantil Nino Jesus, 9UAB Epilepsy Center, 10UCB Pharma, 11UCBMedical Affairs Center of Expertise, UCB Pharma, 12University of Freiburg
Objective:

Assess effectiveness and tolerability of brivaracetam in epilepsy patients with cognitive or learning disability (CLD) or psychiatric comorbidities (PC) at baseline.

Background:

EXPERIENCE/EPD332 was a pooled analysis of retrospective cohorts of patients with epilepsy initiating brivaracetam in clinical practice.

Design/Methods:
Subgroup analysis of patients with CLD or PC. Outcomes: ≥50% seizure reduction from baseline and continuous seizure freedom (CSF; no seizures after baseline) and treatment-emergent adverse events (TEAEs) since prior visit at 12 months. Patients with missing data after brivaracetam discontinuation were considered not seizure free.
Results:

Analyses by CLD status included 1635 patients (403/1232 with/without CLD). Patients with vs without CLD were younger (96.3/89.3% <65 years), had higher median seizure frequency (7.7/4.0 seizures/28 days [n=342/1035]) and higher median number of prior antiseizure medications (7.0/4.0 [n=396/1215]) at index (date of brivaracetam initiation). In both subgroups, median brivaracetam dose at index was 100 mg/day (with/without CLD: n=395/1211). At 12 months, ≥50% seizure reduction was 35.6/37.4% (n=264/553) and CSF was 5.7/14.2% (n=318/788). Patients with/without CLD (n=283/942) had similar incidences of TEAEs (11.3/8.7%), psychiatric (3.5/2.2%), cognitive (1.1/0.8%) and behavioral TEAEs (1.8/0.3%). Brivaracetam discontinuations during study follow-up were 37.1/32.6% (n=402/1228).

Analyses by PC status included 1616 patients (605/1011 with/without PC). Baseline characteristics were generally similar between subgroups. In both subgroups, median brivaracetam dose at index was 100 mg/day (with/without PC: n=597/996). At 12 months, patients with/without PC had similar 50% seizure reduction (38.7/36.1% [n=310/493]) and CSF (13.7/10.4% [n=424/661]). Patients with/without PC (n=410/803) had similar incidences of TEAEs (10.0/8.8%), psychiatric (2.7/2.5%), cognitive (1.2/0.9%) and behavioral TEAEs (0.7/0.5%). Brivaracetam discontinuations during study follow-up were 30.7/35.4% (n=603/1008).

Conclusions:

In this large descriptive real-world analysis, brivaracetam was effective and well tolerated in adults with epilepsy and CLD or PC at baseline. Brivaracetam treatment did not appear to exacerbate CLD or PC, as shown by low incidences of psychiatric, cognitive, and behavioral TEAEs.

10.1212/WNL.0000000000204898