Abstracts

Rationale:
Perampanel (PER) is indicated in the US for the treatment of focal-onset seizures in patients aged ≥ 4 years, and as adjunctive therapy in the treatment of generalized-onset tonic-clonic seizures in patients aged ≥ 12 years. 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.
Method:
Patients treated with PER as early add-on therapy for focal and/or generalized seizures were identified from an interim pooled analysis of data from 18 clinical practice studies/work groups. Retention was assessed after 3, 6 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 430 patients treated with PER as early add-on therapy for focal and/or generalized seizures were identified (52.1% male; mean age, 41.9 years; mean epilepsy duration, 12.2 years). Seizure types at baseline were focal only (85.0%), generalized only (14.3%), and focal and generalized (0.7%). Patients had been treated with a median of 1 previous antiepileptic drug (AED) and were receiving a median of 1 concomitant AED at baseline and at the last visit. Mean (standard deviation) PER dosage was 3.3 (1.7) mg/day at baseline and 5.7 (2.2) mg/day at the last visit. Effectiveness was assessed for 423 patients; safety and tolerability were assessed for 425 patients. At 3, 6 and 12 months, retention rates were 94.4% (401/425), 86.1% (366/425) and 79.3% (333/420), respectively. Mean (95% confidence interval) time under PER treatment was 12.0 (11.6–12.4) months. At the last visit, seizure freedom rates in patients with focal and generalized seizures were 34.8% and 56.1%, respectively, and the corresponding responder rates were 80.2% and 80.7%, respectively (Figure 1). AEs were reported for 40.9% of patients; the most frequently reported AEs were behavioral AEs (aggression/anger/irritability; 15.1%), somnolence (12.9%) and dizziness/vertigo (10.6%) (Table 1). Overall, 13.4% of patients discontinued due to AEs. Psychiatric AEs were reported for 19.3% of patients and led to discontinuation of 7.8% of patients (Table 1). 
Conclusion:
PER was effective and generally well tolerated when used as early add-on therapy to treat patients with focal and/or generalized seizures in everyday clinical practice.
Funding:
:Study supported by Eisai