Abstracts

Rationale:
This was a planned interim analysis of an ongoing, prospective, non-interventional study (BRITOBA; EP0103) to evaluate quality of life (QoL) outcomes with adjunctive brivaracetam (BRV) in earlier treatment lines in adults with focal-onset seizures (FOS) for up to 12 months (mos).

Methods:
BRITOBA is a postmarketing study at 81 clinical/office-based sites in Europe and Canada prescribing BRV per standard practice. Selection criteria include age ≥18 years, history of FOS (with/without focal to bilateral tonic-clonic seizures [FBTCS]), no BRV treatment prior to study entry, ≥1 antiseizure medication (ASM) at BRV initiation, ≤3 lifetime (prior and at BRV initiation) ASMs. Patients are observed for up to ~12 mos. QoL was assessed using patient-reported questionnaires (Patient-Weighted Quality of Life in Epilepsy Inventory-10-P [QOLIE-10-P], Treatment Satisfaction Questionnaire for Medication-9 [TSQM-9], Work Productivity and Activity Impairment Questionnaire: General Health [WPAI:GH], Seizure Severity Questionnaire [SSQ], and Neurological Disorders Depression Inventory for Epilepsy [NDDI-E]).

Results:
At time of data snapshot (June 3, 2022), 252 patients had received ≥1 dose of BRV in BRITOBA (Safety Set; SS); of these, 176 met selection criteria and were included in the Per Protocol Set (PPS). 97 (38.5%) patients in the SS (PPS: 65 [36.9%]) completed the 6-mo visit. In the SS, mean time since diagnosis was 13.24 years (n=249) (PPS: 13.59 years [n=176]); mean baseline (BL) 28-day FOS frequency was 4.07 (n=245) (PPS: 4.74 [n=175]); 35% of patients (n=251) had FBTCS at BL (PPS: 41% [n=176]); mean number of lifetime ASMs was 1.9 (n=247) (PPS: 2.0 [n=176]). At 6 mos, patients reported higher median QOLIE-10-P total score vs BL (SS: 52.4 to 65.3 points; PPS: 51.2 to 65.1 points) and epilepsy distress score (SS and PPS: 50.0 to 75.0 points) vs BL, indicating numerically improved QoL and less distress (Table 1). Median TSQM-9 global satisfaction and effectiveness scores were numerically higher at 6 mos versus BL (SS and PPS), suggesting better satisfaction and effectiveness of newly introduced adjunctive BRV (Table 1). WPAI:GH showed numerical reductions in median percent overall work impairment due to health problems from BL to 6 mos (SS and PPS) (Table 1). SSQ showed the percentage of patients reporting cognitive effects after seizures (Q5) was numerically lower at 6 mos versus BL (SS: 61.7% to 37.3%; PPS: 64.1% to 38.6%) and median seizure severity score (Q8) decreased (SS: 4.0 to 1.5; PPS: 4.0 to 2.0), suggesting fewer cognitive effects after seizures and improved seizure severity (Fig 1). Median NDDI-E scores decreased numerically from BL to 6 mos for SS and PPS, showing fewer depressive thoughts.

Conclusions:
6-mo interim results of BRITOBA indicate the positive impact of introducing adjunctive BRV in earlier treatment lines on overall QoL, distress in epilepsy, depressive thoughts, and activity impairment. Patients reported satisfaction with treatment and improved cognitive effects after seizures and seizure severity.

Funding:
UCB Pharma-sponsored