Abstracts

Rationale: Clinical practice studies provide valuable information on the treatment of patients who are more diverse in terms of age and clinical characteristics than those recruited in clinical trials. 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. 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 to < 18 years) who were treated with PER for focal-onset or generalized-onset seizures were identified from a pooled analysis of 44 prospective, retrospective and cross-sectional clinical practice studies/work groups. Retention was assessed after 3, 6 and 12 months of PER treatment. Effectiveness was assessed by seizure type (focal-onset, generalized-onset) at the last visit (last observation carried forward). 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 279 adolescent patients were identified (52% male; mean age, 15 years; mean duration of epilepsy, 9 years; mean number of previous ASMs, 4.2). Effectiveness and safety/tolerability were assessed for 258 patients. Seizure types at baseline were focal-onset only (67.5%) generalized-onset only (26.7%), and focal-onset and generalized-onset (5.8%). PER was used as adjunctive therapy in 93% of patients and as monotherapy in 7% of patients. Mean (standard deviation) PER dosage was 2.5 (1.2) mg/day at baseline and 6.5 (2.4) mg/day at the last visit. Retention rates at 3, 6 and 12 months were 91.7% (244/266), 82.9% (208/251) and 63.5% (129/203), respectively. The most common reasons for discontinuation were AEs (9.9%), lack of efficacy (13.8%) and both AEs and lack of efficacy (3.9%). Mean (95% confidence interval) time under PER treatment was 11.1 (10.6–11.7) months. At last visit, seizure freedom rates in patients with focal-onset and generalized-onset seizures were 18.1% and 45.9%, respectively, and corresponding values for responder rates were 48.7% and 65.6%, respectively (Figure). AEs were reported for 42.6% of patients; the most frequently reported AEs (≥5% of patients) were irritability (12.8%), dizziness/vertigo (10.9%) and somnolence (9.7%) (Table). Overall, 13.8% of patients discontinued due to AEs over 12 months. Psychiatric AEs were reported for 22.3% of patients and led to discontinuation of 7.3% of patients.

Conclusions: PER was effective and generally well tolerated when used to treat adolescent patients (aged ≥12 to < 18 years) with focal-onset and generalized-onset seizures under everyday clinical practice conditions.

Funding: Please list any funding that was received in support of this abstract.: Supported by Eisai.