MSL Experienced, Medical Eisai Korea Inc., Seoul, Republic of Korea
Rationale: In the U.S. and Korea, perampanel is approved for partial-onset seizures (POS; adjunctive and monotherapy) in patients aged ≥ 4 years, and adjunctive treatment of primary generalized tonic-clonic seizures in patients aged ≥ 12 (≥ 7, Korea) years. We report results from univariate and multivariate analyses from the FAME study (Fycompa as first Add-on to Monotherapy in patients with Epilepsy; Study 412, NCT02726074) to identify potential predictors for patients with POS with/without secondarily generalized seizures (SGS) achieving a ≥ 50%, ≥ 75%, or 100% reduction in seizure frequency per 28 days from baseline with perampanel. Methods: Patients in FAME were aged ≥ 12 years with POS with/without SGS and had failed antiepileptic drug monotherapy. Perampanel was up-titrated to ≤ 12 mg/day (12 weeks), followed by a 24-week maintenance period. Post hoc univariate analysis followed by multivariate analysis, both using logistic regression, were performed to determine odds ratios and 95% confidence intervals for several clinical variables to explore if they are predictors of response to perampanel treatment. Results: The Full Analysis Set consisted of 85 patients with POS with/without SGS. Overall, 68 (80.0%) and 61 (71.8%) patients achieved a ≥ 50% or ≥ 75% reduction in seizure frequency per 28 days from baseline, respectively, and seizure freedom was attained by 40 (47.1%) patients. In univariate analyses, lower frequency of POS (with/without SGS) (P=0.0443) or complex POS (P=0.0490) at baseline, presence of a concomitant non-antiepileptic medication (P=0.0091), and higher perampanel dose (P=0.0067) were significant predictors of a 50% response; presence of a concomitant non-antiepileptic medication (P=0.0094) was a significant predictor of a 75% response; and older age (P=0.026), lower frequency of POS (with/without SGS) (P=0.0058) or complex POS (P=0.0204) at baseline, and presence of a concomitant non-antiepileptic medication (P=0.0143) were significant predictors of seizure freedom (Table 1). In multivariate analyses, longer total administration period (P=0.0121) and higher perampanel dose (P=0.0084) were significant predictors of a 50% response; higher perampanel dose (P=0.0373) was a significant predictor of a 75% response; and presence of a concomitant non-antiepileptic medication (P=0.0421) was a significant predictor of seizure freedom (Table 2). Conclusions: Based on multivariate analyses, longer total administration period, higher perampanel dose, and presence of a concomitant non-antiepileptic medication were identified as potential predictors of response to perampanel. None of the epilepsy-specific or demographic variables were associated with a greater seizure response, suggesting that a broad range of patients may achieve seizure control with perampanel received as first adjunctive treatment. Funding: Please list any funding that was received in support of this abstract.:
