Perampanel in Elderly Patients: An Overview of Data from Studies 307, 335, 412, 342, and 506
Abstract number :
2.218
Submission category :
7. Anti-seizure Medications / 7B. Clinical Trials
Year :
2021
Submission ID :
1825605
Source :
www.aesnet.org
Presentation date :
12/5/2021 12:00:00 PM
Published date :
Nov 22, 2021, 06:44 AM
Authors :
Ilo E. Leppik, MD - University of Minnesota; Robert T. Wechsler, MD - Idaho Comprehensive Epilepsy Center; Dae-Won Seo, MD, PhD, - Samsung Medical Center, Sungkyunkwan University School of Medicine; Takamichi Yamamoto, MD, MS, DMSc, FAES - Seirei Hamamatsu General Hospital; Anna Patten, PhD - Eisai Europe Ltd.; Ji Woong Lee, BPharma - Eisai Korea Inc.; Leock Y. Ngo, PhD - Eisai Inc.; Manoj Malhotra, MD - Eisai Inc.
Rationale: Epilepsy incidence is higher in the elderly than in the general population. Aging populations may therefore expect rising numbers of patients with epilepsy. Perampanel is a once-daily oral anti-seizure medication for focal-onset seizures (FOS) and generalized tonic-clonic seizures (GTCS). Here, we provide an overview of perampanel efficacy and safety data in elderly patients (aged ≥ 60 years) who participated in Phase III or IV Studies 307, 335 open-label extension (OLEx), 412, 342, and 506.
Methods: Studies 307, 335 OLEx, 412, and 342 included patients aged ≥ 12 years (Study 342, 12–74 years) with FOS, with/without focal to bilateral tonic-clonic seizures (FBTCS); patients were refractory in Studies 307, 335, and 412, and had newly diagnosed/recurrent FOS in Study 342. Perampanel was adjunctive (Studies 307/335 OLEx), first add-on (Study 412), or monotherapy (Study 342). In Study 506, patients with any type of epilepsy received perampanel during routine clinical care. Further details are given in Table 1. Endpoints varied across studies and included changes in seizure frequency, 50% responder and seizure-freedom rates, seizure-onset rate, and retention rates. Treatment-emergent adverse events (TEAEs) were monitored. In this report, patients aged ≥ 60 years were selected for analysis from these studies.
Results: Pooled data from Studies 307 and 335 OLEx (N=71; mean [SD] age, 64.0 [3.8] years) showed median reduction from baseline in FOS (with/without FBTCS) frequency per 28 days of 31.7%, 44.5%, 49.8%, and 69.3% during Years 1, 2, 3, and 4 of treatment, respectively; 50% responder rates were 24/71 (33.8%), 18/38 (47.4%), 9/19 (47.4%), and 9/14 (64.3%), respectively, and seizure-freedom rates were 0/71 (0.0%), 1/38 (2.6%), 1/19 (5.3%), and 0/14 (0.0%), respectively. In Study 412 (N=15; mean [SD] age, 65.2 [4.5] years); 50% responder and seizure-freedom rates were 12/15 (80%) and 9/15 (60%), respectively. In Study 342 (N=23; mean [SD] age, 64.6 [3.7] years), 12/19 (63.2%) patients with FOS were seizure free during 4-mg/day Maintenance; the cumulative probability of seizure-onset rate at Maintenance Week 26 was 32.0% (95% confidence interval, 15.8, 57.9). In Study 506 (N=75; mean [SD] age, 66.5 [5.9] years), median reduction from baseline in total seizure frequency per 28 days was 59.7% (Months 1–3; n=13), 68.6% (Months 10–12; n=8), and 100.0% (Months 22–24; n=5). 50% responder and seizure-freedom rates were, respectively, 7/13 (53.8%) and 4/13 (30.8%) for Months 1–3, 5/8 (62.5%) and 3/8 (37.5%) for Months 10–12, and 4/5 (80.0%) and 3/5 (60.0%) for Months 22–24. Retention rate in Study 506 was 52.9% (n=27/51) at Month 24. An overview of TEAEs from all studies is given in Table 2.
Conclusions: Perampanel was efficacious and generally well tolerated in this subpopulation of patients aged ≥ 60 years with epilepsy when administered as adjunctive, first add-on, or monotherapy, which is consistent with the overall study populations. These data suggest perampanel may be a suitable treatment option in refractory and newly diagnosed elderly patients.
Funding: Please list any funding that was received in support of this abstract.: Eisai Inc./Ltd./Korea Inc./Co., Ltd.
Anti-seizure Medications