Abstracts

Rationale: Current focus of managing focal seizures (FS) is controlling seizures primarily using antiseizure medication (ASMs) therapies while maintaining or improving patients’ HRQoL. Knowledge about the relationship between response to third generation ASMs like ESL and HRQoL provides important information for physicians and patients. Hence, the objective of this study is to identify the effect of response to ESL treatment as first adjunctive therapy on HRQoL among patients with FS from a Phase IV, open-label study.

Methods: We conducted a post hoc analysis of a multicenter, open-label, non-randomized phase IV clinical trial study of adjunctive ESL in patients aged ≥ 18 years with FS in the U.S. and Canada (NCT03116828). ESL was either used as first adjunctive therapy with levetiracetam (LEV) or lamotrigine (LTG) with no history of other ASM therapy (Arm 1) or as later adjunctive therapy, following current or prior use of adjunctive therapy (Arm 2). The study was not powered to detect a statistical difference between arms. For the purposes of this post hoc analysis, we focused on patients in Arm 1. We excluded patients who dropped out prior to the completion of the maintenance period. HRQoL, was measured by Quality of Life in Epilepsy Inventory-31 (QOLIE-31) that included 31 questions on a scale 0-100, with higher score indicating better wellbeing. We utilized seizure freedom (SF) and >= 50% reduction in seizures per 28 days (SR) as measures of treatment response to ESL. We examined the effect of response on changes in QOLIE-31 scores overall and for each question from baseline to week 27.

Results: The median age was 46.3 years (N=32 patients), 46.9% of the population were female. SF and SR were 25.0% and 62.5%. Among patients who did not experience SF, the overall QOLIE-31 score decreased by 0.7 (baseline, 70.8; week 27, 70.2; p-value=0.65) from baseline to week 27 with a decline in the question related to feeling full of pep (-14.2, p=0.095). The overall QOLIE-31 score increased by 3.5 (baseline, 66.8; week 27, 70.3; p= 0.22) among patients experiencing SF with the largest increases in questions related to seizure worry (SW) like being bothered by seizure (21.9, p=0.31), fear of seizure (20.8, p=0.27), and worry about embarrassment from a seizure (25.0, p=0.22), indicating less worry about the seizures Among patients who did not experience SR, the overall QOLIE-31 score significantly decreased by 7.3 (baseline, 72.0; week 27, 64.7; p= 0.001) by week 27 with reductions in feeling worn-out (-21.7, p=0.08) and tired (-21.7, p=0.06). The overall QOLIE-31 score increased significantly by 4.9 (baseline, 68.6; week 27, 73.5, p= 0.004) among patients experiencing SR with significant improvements observed in questions related to SW and social functioning like worry about seizure (22.0, p=0.05) and embarrassment from a seizure (21.7, p=0.05), and being bothered by social limitations (18.8, p=0.04) and health limiting social activities (17.0, p=0.03).

Conclusions: Our post hoc analysis of the Phase IV trial suggests that response to ESL treatment as first adjunctive regimen to LEV or LTG resulted in improvement in patient’s HRQoL as measured by QOLIE-31.

Funding: Sunovion Pharmaceuticals Inc.