Long-Term Perampanel Monotherapy and Health-Related Quality of Life in Patients with Newly Diagnosed/Currently Untreated Recurrent Focal-Onset Seizures (FOS): FREEDOM Study 342 Extension Phase
Abstract number :
2.201
Submission category :
7. Anti-seizure Medications / 7B. Clinical Trials
Year :
2021
Submission ID :
1825621
Source :
www.aesnet.org
Presentation date :
12/5/2021 12:00:00 PM
Published date :
Nov 22, 2021, 06:44 AM
Authors :
Leock Y Ngo, PhD - Eisai Inc., Woodcliff Lake, New Jersey, USA; Ji Hyun Kim, MD, PhD – Korea University, Guro Hospital; Takamichi Yamamoto, MD, PhD – Seirei Hamamatsu General Hospital; Sung Chul Lim, MD, PhD – The Catholic University of Korea, St. Vincent’s Hospital; Hirotomo Ninomiya, MD – Itami City Hospital; Yuichi Kubota, MD – Tokyo Women’s Medical University Medical Center East; Anna Patten, PhD – Eisai Europe Ltd.; Manoj Malhotra, MD – Eisai Inc.
Rationale: In the US/Japan/Korea, perampanel is approved for FOS, with/without focal to bilateral tonic-clonic seizures (FBTCS) in patients aged ≥ 4 years (monotherapy/adjunctive), and generalized tonic-clonic seizures in patients aged ≥ 12 (≥ 7, Korea) years (adjunctive). Study 342 (FREEDOM; NCT03201900) was a multicenter, Phase III, open-label study of perampanel monotherapy in patients aged ≥ 12 years with newly diagnosed/currently untreated recurrent FOS, with/without FBTCS. We report Health-Related Quality of Life (HRQoL) data from FREEDOM as measured by the EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) questionnaire.
Methods: During the Core Study, patients received perampanel 4 mg/day (4-week Pretreatment [baseline]; 32-week Treatment [6-week Titration; 26-week Maintenance]). If a patient had a seizure, they could be up-titrated to 8 mg/day (4-week Titration; 26-week Maintenance). Patients could enter an Extension Phase for an additional 26 weeks (total: 52 weeks of treatment). Seizure freedom was the primary endpoint (modified Intent-to-Treat [mITT] Analysis Set). EQ-5D-5L (exploratory endpoint) was assessed (mITT) and included 5 domains (mobility, self-care, doing usual activities, pain/discomfort, and anxiety/depression); EQ visual analog scale (VAS) was also assessed. Changes from baseline to End of Treatment (EoT) during the study (Core [26 weeks]/Extension [52 weeks]) are presented for 4–8 mg/day.
Results: Overall, 89 patients received ≥ 1 perampanel dose; 73 patients entered the 4-mg/day Maintenance Period (mITT Analysis Set); 21 patients entered the 8-mg/day Treatment Phase. Forty-six patients entered the Extension Phase. Of 39 patients who entered the Extension from the 4- and/or 8-mg/day Treatment Phase while seizure free, 31 (79.5%) patients had sustained seizure freedom for 52 weeks. Based on 71 patients with non-missing data (mITT Analysis Set), the mean (standard deviation) change in EQ VAS from baseline to EoT (up to 52 weeks) was 0.9 (15.4), suggesting that overall there was no change in the self-perceived health of patients following perampanel treatment. Results of the EQ-5D-5L at baseline and EoT are shown in Figure 1. In each domain, ≥ 77.5% of patients reported no problems at baseline and ≥ 77.5% of patients reported no problems at EoT; no patients reported an inability to carry out the activity/extreme problems at baseline/EoT. Based on shift from baseline analyses, most (≥ 60.6%) patients remained at the same level at EoT as at baseline, 2.8–21.1% showed an improvement of problems across domains, and 7.0–18.3% patients had a worsening of problems (Table 1).
Conclusions: These data indicate that, in general, long-term (up to 52 weeks) perampanel monotherapy 4 or 8 mg/day is effective at sustaining seizure freedom and does not negatively affect HRQoL (based on all EQ-5D-5L domains) in patients with newly diagnosed/currently untreated recurrent FOS with/without FBTCS, with some patients showing an improvement in HRQoL across the 5 domains (2.8–21.1%).
Funding: Please list any funding that was received in support of this abstract.: Eisai Co., Ltd.
Anti-seizure Medications