Abstract Details

Title Perampanel in Real-World Clinical Care of Patients with Epilepsy: Results from the Retrospective, Phase IV PROVE Study 506

Topic Epilepsy/Clinical Neurophysiology (EEG)

Presentation(s) P8 - Poster Session 8 (8:00 AM-9:00 AM)

Poster/Presentation
Number 12-008

Objective

To report retention rates, safety, and efficacy of perampanel administered to patients with epilepsy during routine clinical care from PROVE (Study 506; NCT03208660), a retrospective, multicenter, non-interventional Phase IV study.

Background Perampanel is a once-daily oral anti-seizure medication (ASM) for partial-onset seizures and primary generalized tonic-clonic seizures. There are limited data on real-world use of perampanel as an ASM in the US.

Design/Methods

Data were obtained from medical records of patients who initiated perampanel treatment after January 1, 2014. Follow-up was completed on March 15, 2019. Based on the Safety Analysis Set (SAS), the primary endpoint was retention rate (proportion of patients remaining on perampanel at 3, 6, 12, 18, and 24 months following treatment initiation). Safety, efficacy, and dosing experience were secondary objectives.

Results The SAS included 1703 patients (mean [standard deviation (SD)] age, 28.5 [16.5] years; 52.7% female). Median (minimum, maximum) time since epilepsy diagnosis was 12.0 (0.0, 65.0) years. At data collection, 868 (51.0%) patients were ongoing on perampanel; 816 (47.9%) had discontinued. Most common primary reasons for discontinuation were adverse event (AE; n=388 [22.8%]) and inadequate therapeutic effect (n=225 [13.2%]). Mean (SD, range) cumulative duration of exposure was 17.4 (15.7, 0.0–77.1) months. Mean (SD, range) maximum perampanel dose was 6.6 (3.2, 0–22) mg/day. Retention rate on perampanel at 24 months was 48.1% (n=501/1042). At Months 22–24, median reduction in seizure frequency/28 days was 89.4%; 50% responder rate was 76.5%; and 39.2% of patients achieved seizure freedom. Treatment-emergent AEs (TEAEs) occurred in 704 (41.3%) patients; the most common were dizziness (n=125 [7.3%]) and aggression (n=90 [5.3%]). Serious TEAEs occurred in 79 (4.6%) patients, including 15 (0.9%) deaths.

Conclusions

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

Funding: Eisai Inc.

Authors/Disclosures
James W. Wheless, MD, FAAP, FACP, FAES, FCNS, F�鶹��ýӳ�� PRESENTER	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.
	No disclosure on file
Manoj Malhotra, MD	Dr. Malhotra has received personal compensation for serving as an employee of Eisai.

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