Long-term Quality of Life in Patients with Focal Seizures Treated with Eslicarbazepine Acetate: Pooled Analysis from 3 Phase III Open-label Extension Studies
Abstract number :
2.242
Submission category :
7. Anti-seizure Medications / 7B. Clinical Trials
Year :
2022
Submission ID :
2204882
Source :
www.aesnet.org
Presentation date :
12/4/2022 12:00:00 PM
Published date :
Nov 22, 2022, 05:27 AM
Authors :
David Cantu, PhD – Sunovion Pharmaceuticals Inc.; Suparna Krishnaiengar, MD – University of Florida College of Medicine – Jacksonville; Darshan Mehta, PhD – Sunovion Pharmaceuticals Inc.; Diane Hall, BS, Statistics – Sunovion Pharmaceuticals Inc.; Yi Zhang, DrPH, Biostatistics – Sunovion Pharmaceuticals Inc.; Helena Gama, MD – Bial Portela e C. SA; Ana Pereira, BS, Microbiology – Bial Portela e C. SA; Todd Grinnell, AB, Biochemistry – Sunovion Pharmaceuticals Inc.
Rationale: Eslicarbazepine acetate (ESL) is approved for the treatment of partial-onset (focal) seizures in the US and EU. By controlling seizures, anti-seizure medications can improve health-related quality of life (HRQOL). Data from a post-hoc pooled analysis was used to describe HRQOL measures, including overall quality of life, seizure worry, emotional well-being, energy/fatigue, cognitive functioning, medication effects, social function, and overall score over a period of up to one year.
Methods: Data from 3 multinational, randomized, placebo-controlled trials were used for this post-hoc analysis. Patients who completed Part 1 (double-blind treatment phase) of these trials were eligible to enter Part 2, the open label extension (OLE) period. The OLEs in each of the 3 studies were similar in design. The OLE began immediately after the maintenance period in 2 studies, and after a 4-week taper period in the third study. Patients initiated ESL at 400 mg or 800 mg once daily, which was titrated in 400 mg increments (up to a maximum of 1600 mg daily) based on efficacy and tolerability. HRQOL was measured at baseline and at the last assessment using the Quality of Life in Epilepsy Inventory (QOLIE-31) in all adult patients who entered the 1-year open label extension (OLE) and in patients that completed the 1-year OLE. The mean QOLIE-31 scores and mean change in scores were analyzed using the t-test. The percentage of patients with improvements in QOLIE-31 scores beyond the minimal important change (MIC) threshold from baseline to end of 1-year OLE is described.
Results: A total of 959 patients in the intent-to-treat population continued to part 2, and 677 patients completed the OLE. Of the patients who entered the OLE and had a final assessment, seizure worry, overall quality of life, emotional well-being, medication side effects, social functioning, and total score showed statistically significant mean improvements in scores, with seizure worry showing the greatest mean change to last assessment (4.93), and energy/fatigue showing the least mean change to last assessment (0.76) score. In patients who completed the OLE, the mean change to final assessment was statistically significantly improved for all QOLIE categories, with seizure worry showing the greatest mean improvement in score (6.58) and cognitive functioning showing the least mean improvement in score (2.16) (Table 1). Of the patients who entered the OLE with a final assessment, the percentage of patients meeting the MIC for social functioning was the highest (46.8%), followed by medication effects (43.8%), and seizure worry (42.1%). Patients who completed the OLE with a final assessment showed a similar rank ordering in QOLIE scale improvements compared to those who entered the OLE with a final assessment (Table 2). For both sets of patient groups, the least number of subjects met MIC criteria for the energy/fatigue QOLIE category.
Conclusions: Treatment with therapeutic doses of adjunctive ESL in patients with focal seizures was associated with improvements HRQOL for a period of up to one year.
Funding: Funded by Sunovion Pharmaceuticals, Inc. and Bial - Portela e Ca, SA
Anti-seizure Medications