|The following article is part of conference coverage from the American Epilepsy Society’s Annual Meeting in New Orleans, LA. The Neurology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from AES 2018.|
Perampanel at a median maximum dose of 6 mg (1 to 20 mg) is associated with good long-term treatment retention and sustained efficacy when administered to patients with epilepsy during routine clinical care, according to research findings presented at the 2018 American Epilepsy Society meeting held November 30-December 4, 2018 in New Orleans, Louisiana.
The findings reported at the meeting were from a second interim analysis of an ongoing retrospective multicenter center phase 4 study assessing the retention rate, dosing experience, and safety of perampanel treatment in patients with epilepsy.
“Perampanel is a once-daily oral antiepileptic drug for partial-onset seizures and primary generalized tonic-clonic seizures,” the researchers wrote. “There are limited data on real-world use of perampanel in the United States as an [antiepileptic drug].”
Patients with epilepsy who started treatment on perampanel after January 1, 2014 (n=605) were enrolled in the study. A medical record review was used to evaluate perampanel exposure, efficacy, and safety. The primary study end point was the retention rate, or the percentage of patients who remained on the treatment drug at 3, 6, 12, 18, and 24 months. Secondary end points included safety, efficacy, and dosing experience. At baseline, approximately 81% of patients (n=490) were treated with 1 to 3 concomitant antiepileptic drugs.
By March 5, 2018, up to 52.4% of participants were still receiving perampanel. Treatment discontinuation was primarily due to either adverse events (26%) or inadequate therapeutic effect (14.2%). Daily treatment doses of perampanel were 4 mg (n=116 [19.2%]), 6 mg (n=108 [17.9%]), and 8 mg (n=79 [13.1%]), and the median cumulative exposure duration to perampanel was 10.8 (0.0 to 66.9) months. In addition, the median maximum dose of perampanel in the cohort was 6 mg (overall minimum 1 mg, overall maximum 20mg).
Over a 2-year period, the retention rate on perampanel was 49.8%. During months 22 to 24, the 50% responder rate was high (77.8%) and the median seizure frequency per 28 days was reduced in 93.3% of participants.
In addition, 40.7% of patients achieved seizure freedom during this time. Improvement in seizure frequency was noted in 57.3% of patients compared with 29.5% and 13.2% of patients who experienced either no change or worsening of seizures, respectively.
Approximately half (50.2%) of patients experienced treatment-emergent adverse events during the study period, including dizziness (10.2%), aggression (6.1%), and irritability (5.0%).
Disclosures: This study was funded by Eisai Inc.
For more coverage of AES 2018, click here.
Wechsler RT, Wheless JW, Lancman M, et al. Perampanel in real-world clinical care of patients with epilepsy: retrospective phase IV study 506 – second interim analysis. Presented at: AES 2018; November 29-December 4, 2018; New Orleans, Louisiana. Abstract #3.284.