Abstract Details

Title Perampanel in Real-World Clinical Care of Patients with Epilepsy: Retrospective Phase IV Study 506 – Second Interim Analysis

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) P5 - Poster Session 5 (5:30 PM-6:30 PM)

Poster/Presentation
Number 6-008

Objective Assess retention rate, safety, and dosing experience of perampanel administered to patients with epilepsy during routine clinical care.

Background Perampanel is a once-daily oral antiepileptic drug for partial-onset seizures and primary generalized tonic-clonic seizures. We report the second interim analysis of the multicenter, non-interventional, Phase IV retrospective Study 506 (NCT03208660).

Design/Methods Exposure, safety, and efficacy data were obtained from medical records of patients initiating perampanel after January 1, 2014. Primary endpoint is retention rate (proportion of patients in Safety Analysis Set [SAS] remaining on perampanel). Safety, efficacy, and dosing experience are secondary objectives.

Results The interim SAS (n=605; 55.9% female) included 430 (71.8%) patients aged ≥18 years, 68 (11.4%) <12 years, and 101 (16.9%) 12-<18 years (data unavailable: 6 patients); mean (standard deviation [SD]) age was 29.6 (16.4) years. At data cut-off (March 5, 2018), 317 (52.4%) patients remained on perampanel; 285 (47.1%) had discontinued. Most common reasons for discontinuation were adverse event (n=157 [26.0%]) and inadequate therapeutic effect (n=86 [14.2%]). Mean (SD) cumulative duration of exposure to perampanel was 15.4 (13.9) months. Mean (SD) maximum perampanel dose was 6.5 (3.2) mg. Retention rates at 3, 6, 12, 18, and 24 months were 80.2% (n=479/597), 69.0% (n=392/568), 58.1% (n=288/496), 52.7% (n=216/410), and 49.8% (n=154/309), respectively. At Months 22-24, median reduction in seizure frequency per 28 days was 93.3% (n=27), 50% responder rate was 77.8% (n=21/27), and 40.7% (n=11/27) patients achieved seizure-freedom. Treatment-emergent adverse events (TEAEs) occurred in 304 (50.2%) patients; most common were dizziness (n=62 [10.2%]), aggression (n=37 [6.1%]), and irritability (n=30 [5.0%]). TEAEs leading to perampanel dose adjustments occurred in 239 (39.5%) patients. Serious TEAEs occurred in 14 (2.3%) patients, including 3 (0.5%) deaths.

Conclusions

This interim analysis demonstrates favorable retention rates and sustained efficacy of perampanel for ≤2 years in patients with epilepsy treated during routine clinical care.

Funding: Eisai Inc.

Authors/Disclosures
Robert T. Wechsler, MD, PhD, FAAN (Consultants in Epilepsy & Neurology) PRESENTER	The institution of Dr. Wechsler has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Otsuka. The institution of Dr. Wechsler has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for UCB. The institution of Dr. Wechsler has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for SK Life Science. The institution of Dr. Wechsler has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Aquestive. The institution of Dr. Wechsler has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Engage. The institution of Dr. Wechsler has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Jazz. The institution of Dr. Wechsler has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cerevel. The institution of Dr. Wechsler has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Eisai. The institution of Dr. Wechsler has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Sunovion. The institution of Dr. Wechsler has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Eliem. The institution of Dr. Wechsler has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. The institution of Dr. Wechsler has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Epalex. The institution of Dr. Wechsler has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Engrail. The institution of Dr. Wechsler has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Equilibre. The institution of Dr. Wechsler has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Rapport. The institution of Dr. Wechsler has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Neurona. Dr. Wechsler has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Neurelis. Dr. Wechsler has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Sunovion. Dr. Wechsler has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for UCB. Dr. Wechsler has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Greenwich/Jazz. Dr. Wechsler has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Eisai. Dr. Wechsler has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Aquestive. Dr. Wechsler has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for SK Life Science. Dr. Wechsler has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for Epilepsy Studies Consortium. Dr. Wechsler has a non-compensated relationship as a Board President with Epilepsy Foundation of Idaho that is relevant to AAN interests or activities.
James W. Wheless, MD, FAAP, FACP, FAAN, FAES, FCNS, FAAN (UTHSC-Pediatric Neurology)	Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Jazz. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurelis. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Azurity. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for UCB. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Biocodex. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for LivaNova. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Stoke. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for LivaNova. Dr. Wheless has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Jazz. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for UCB. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for UCB. Dr. Wheless has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Neurelius.
Marcelo E. Lancman, MD (Northeast Regional Epilepsy Group)	No disclosure on file
Sami M. Aboumatar, MD (Austin Epilepsy Care Center)	Dr. Aboumatar has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eisai. Dr. Aboumatar has received personal compensation in the range of $500-$4,999 for serving as a Consultant for SK Life Science, Inc.. Dr. Aboumatar has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Eisai. Dr. Aboumatar has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sunovion.
	No disclosure on file
Betsy N. Williams, PhD	Dr. Williams has received personal compensation for serving as an employee of IQVIA.
Manoj Malhotra, MD	Dr. Malhotra has received personal compensation for serving as an employee of Eisai.

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