Perampanel as Early Add-On Therapy for Epilepsy Patients with Focal-Onset and Generalized-Onset Seizures Treated in Clinical Practice
Abstract number :
3.213
Submission category :
4. Clinical Epilepsy / 4C. Clinical Treatments
Year :
2021
Submission ID :
1825950
Source :
www.aesnet.org
Presentation date :
12/6/2021 12:00:00 PM
Published date :
Nov 22, 2021, 06:51 AM
Authors :
Estevo Santamarina, MD - Epilepsy Unit, Neurology Department, Vall d’Hebron University Hospital, Barcelona, Spain; Javier Abril-Jaramillo - Centro de Neurología Avanzada, Sevilla, Spain; Xiana Rodriguez-Osorio - Department of Neurology, Complexo Hospitalario Universitario de Santiago, Santiago, Spain; Takamichi Yamamoto - Comprehensive Epilepsy Center, Seirei Hamamatsu General Hospital, Shizuoka, Japan; Rob McMurray - European Knowledge Centre, Eisai Europe Ltd, Hatfield, Hertfordshire, UK; Eugen Trinka - Department of Neurology, Christian-Doppler University Hospital, Paracelsus Medical University, Centre for Cognitive Neuroscience, Salzburg, Austria; Wendyl D'Souza - Department of Medicine, St Vincent's Hospital Melbourne, The University of Melbourne, Victoria, Australia; Rosaria Renna - Neurological Clinic and Stroke Unit, "A. Cardarelli" Hospital, Napoli, Italy; Vicente Villanueva - Refractory Epilepsy Unit, Hospital Universitario y Politécnico La Fe, Valencia, Spain
Rationale: Perampanel (PER) is a once-daily oral anti-seizure medication for focal-onset seizures, with or without focal to bilateral tonic-clonic seizures, and generalized tonic-clonic seizures. Real-world clinical practice data complement evidence from clinical trials by providing information on patients who are more diverse in terms of clinical characteristics than those recruited for clinical trials. The purpose of this study was to assess the real-world effectiveness, safety and tolerability of PER when used as early add-on therapy in everyday clinical practice.
Methods: Patients treated with PER for focal-onset and/or generalized-onset seizures were identified from a pooled analysis of 44 prospective, retrospective and cross-sectional clinical practice studies/work groups. Data were compared for patients treated with PER as early add-on therapy versus late add-on therapy (as defined by each individual study). Retention was assessed after 3, 6 and 12 months of PER treatment. Effectiveness assessments comprised responder rate (≥50% seizure frequency reduction), seizure freedom rate (no seizures since at least the prior visit), and the proportions of patients with unchanged or worsening seizure frequency. Safety and tolerability were assessed by evaluating adverse events (AEs), psychiatric AEs, and AEs leading to discontinuation.
Results: A total of 2532 patients were treated with PER as early (n=632) or late (n=1900) add-on therapy; median number (range) of concomitant antiepileptic drugs were 1 (1-2) and 3 (1-7) at baseline, respectively. Retention was assessed for 2437 patients (early add-on, n=622; late add-on, n=1815); effectiveness for 2190 patients (early add-on, n=592; late add-on, n=1598); and safety/tolerability for 2319 patients (early add-on, n=608; late add-on, n=1711). Retention rates were significantly higher for patients treated with early versus late add-on therapy at all timepoints (Month 12: 77.1% vs. 61.8%; p< 0.001) (Figure 1). At the last visit (last observation carried forward), seizure freedom rate was significantly higher in patients treated with early versus late add-on therapy (40.1% vs. 8.7%; p< 0.001), as was responder rate (73.0% vs. 36.4%; p< 0.001) (Figure 2). At the last visit, the proportion of patients with unchanged seizure frequency was significantly lower in patients treated with early versus late add-on therapy (10.2% vs. 31.8%; p< 0.001), as was the proportion of patients with worsening seizure frequency (6.1% vs. 13.6%; p< 0.001) (Figure 2). Incidence of AEs was significantly lower for patients treated with early versus late add-on therapy (41.8% vs. 54.5%; p< 0.001), as was the proportion of patients with psychiatric AEs (18.3% vs. 22.2%; p=0.046), and the rate of discontinuation due to AEs at 12 months (15.0% vs. 18.7%; p=0.045).
Conclusions: PER was significantly more effective and better tolerated when used as early versus late add-on therapy to treat patients with focal-onset and/or generalized-onset seizures in everyday clinical practice.
Funding: Please list any funding that was received in support of this abstract.: Supported by Eisai.
Clinical Epilepsy