Neurologist Epilepsy Unit, Department of Neurology, Hospital Universitari Sagrat Cor, Barcelona, Spain
Rationale: Perampanel (PER) is indicated in the U.S. for the treatment of focal-onset seizures in patients aged ≥ 4 years, and as adjunctive therapy for generalized-onset tonic-clonic seizures in patients aged ≥ 12 years. Clinical practice studies complement evidence from clinical trials by providing information on patients who are more diverse in terms of age and clinical characteristics than those recruited for clinical trials. The purpose of this study was to assess the effectiveness, safety and tolerability of PER when used to treat adolescent patients in everyday clinical practice. Methods: Adolescent patients (aged ≥ 12 – < 18 years) who were treated with PER for focal or generalized seizures were identified from an interim pooled analysis of clinical practice data. Retention was assessed after three, six, and 12 months of PER treatment. Effectiveness was assessed by seizure type (focal or generalized) at the last visit. Effectiveness assessments comprised seizure freedom rate (no seizures since at least the prior visit), responder rate (≥ 50% seizure frequency reduction), and the proportions of patients with unchanged or worsening seizure frequency. Safety and tolerability were assessed by evaluating adverse events (AEs), AEs leading to discontinuation, psychiatric AEs, and psychiatric AEs leading to discontinuation. Results: A total of 102 adolescent patients (54.1% male; mean age, 15.2 years; mean duration of epilepsy, 8.5 years; mean number of previous antiepileptic drugs, 4.7) were included from 18 studies/work groups from a range of countries. Effectiveness was assessed for 101 patients; safety and tolerability were assessed for 91 patients. Seizure types at baseline were focal only (68.0%), generalized only (28.2%), and focal and generalized (3.9%). PER was used as adjunctive therapy in 94.5% of patients and as monotherapy in 5.5% of patients. Mean (standard deviation) PER dosage was 2.5 (1.2) mg/day at baseline and 6.9 (2.3) mg/day at the last visit. Retention rates at 3, 6 and 12 months were 92.2% (94/102), 77.5% (79/102) and 60.2% (59/98), respectively. The most common reasons for discontinuation were AEs (13.7%), lack of efficacy (11.8%) and both (3.9%). Mean (95% confidence interval) time under PER treatment was 10.0 (9.1–11.0) months. At the last visit, seizure freedom rates in patients with focal and generalized seizures were 12.7% and 57.7%, respectively, and corresponding values for responder rates were 48.1% and 80.8%, respectively (Figure 1). AEs were reported for 53.8% of patients; the most frequently reported AEs were behavioral (aggression/anger/irritability; 25.3%), dizziness/vertigo (17.6%) and somnolence (12.1%) (Table 1). Psychiatric AEs were reported for 27.5% of patients and led to discontinuation of 9.9% of patients (Table 1). Conclusions: PER was effective and generally well tolerated when used to treat adolescent patients with focal and generalized seizures under everyday clinical practice conditions. Funding: Please list any funding that was received in support of this abstract.: Study supported by Eisai. Click here to view image/table
