Patient-reported Outcomes in Adults with Focal-onset Seizures Who Completed 12 Months of Adjunctive Brivaracetam in Earlier Treatment Lines: Post Hoc Analysis of Interim Real-world Data from BRITOBA
Abstract number :
2.386
Submission category :
7. Anti-seizure Medications / 7C. Cohort Studies
Year :
2024
Submission ID :
739
Source :
www.aesnet.org
Presentation date :
12/8/2024 12:00:00 AM
Published date :
Authors :
Presenting Author: Dimitrios Bourikas, PhD – UCB Pharma, Alimos, Greece
Edouard Hirsch, MD – University of Strasbourg
Christine de la Loge, MSc – UCB Pharma, Brussels, Belgium
Sami Elmoufti, MSc – UCB Pharma, Morrisville, NC, USA
Iryna Leunikava, MSc – UCB Pharma
Bonita Rehel, MSc – UCB Pharma, Oakville, Ontario, Canada
Adrien Didelot, MD, PhD – Hopital Saint Joseph-Saint Luc, Lyon, France
Rationale: To assess change in clinical condition, health-related quality of life (HRQoL), seizure severity, depressive symptoms, productivity, and treatment satisfaction in adults with focal-onset seizures (FOS) as assessed by patients after 12 months of adjunctive brivaracetam (BRV) therapy in earlier treatment lines.
Methods: Post hoc of second interim analysis from BRITOBA/EP0103, a prospective, postmarketing, noninterventional study of adjunctive BRV in Europe/Canada. Study selection criteria: age ≥ 18 years, history of FOS, no prior BRV, ≥ 1 antiseizure medication (ASM) at BRV initiation, failure of ≤ 3 lifetime ASMs (prior and at BRV initiation). This analysis included patients in the Safety Set (SS; patients who took ≥ 1 BRV dose) who completed ≥ 1 patient-reported outcome assessment both at baseline (BL) and at 12 mos.
Results: At data cutoff, 139 of the 392 patients in the SS completed ≥ 1 patient-reported outcome assessment at both BL and 12 mos. In these patients, the mean age was 49.2 years, the mean time since epilepsy diagnosis was 12.6 years (n=138), 138 (99.3%) had FOS at BL (median 28-day frequency 2.0), the mean number of lifetime ASMs was 2.0, and the mean number of concomitant ASMs was 1.5. The most common concomitant ASMs (≥ 20% of patients) were lacosamide (44 [31.7%] patients), levetiracetam (37 [26.6%]), and lamotrigine (33 [23.7%]). The most common reason for starting BRV was lack of efficacy of the current therapy (131 [94.2%]). Median BRV total daily dose was 100.0 mg/day at both BRV initiation and 12 mos. At 12 mos (vs BL), most patients reported improved clinical condition (Patient Global Impression of Change) (Table). Observed results of Patient-Weighted Quality of Life in Epilepsy Inventory-10-P total and epilepsy distress scores showed improved HRQoL and reduced distress at 12 mos vs BL, respectively (Fig A). Overall, patients showed improved satisfaction with the therapy regime at 12 mos vs BL (Treatment Satisfaction Questionnaire for Medication-9) (Table). Work Productivity and Activity Impairment Questionnaire: General Health showed lower activity impairment due to health problems at 12 mos vs BL (Table). Seizure Severity Questionnaire showed that the percentage of patients with cognitive effects after seizures and seizure severity were numerically reduced at 12 mos vs BL (observed results and shift from BL) (Table and Fig B). Observed results and shift from BL in Neurological Disorders Depression Inventory in Epilepsy showed a trend toward lower severity in depressive symptoms and a smaller percentage of patients with possible major depressive disorder at 12 mos vs BL (Table and Fig C). 23 (16.5%) of patients reported treatment-emergent adverse events.
Conclusions: The results indicated that in patients who completed 12 mos of adjunctive BRV treatment, improvements in clinical condition, HRQoL, treatment satisfaction, cognitive effects after seizures, and depressive symptoms were observed, as assessed by patient-reported outcomes.
Funding: UCB Pharma-sponsored
Anti-seizure Medications