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. 2022 Dec;7(4):687-696.
doi: 10.1002/epi4.12649. Epub 2022 Sep 22.

Effectiveness of perampanel as the only add-on: Retrospective, multicenter, observational real-life study on epilepsy patients

Sara Gasparini  1   2 , Edoardo Ferlazzo  1   2   3 , Sabrina Neri  1   2 , Vittoria Cianci  2 , Alfonso Iudice  4 , Francesca Bisulli  5 , Paolo Bonanni  6 , Emanuele Caggia  7 , Alfredo D'Aniello  8 , Carlo Di Bonaventura  9 , Jacopo C DiFrancesco  10 , Elisabetta Domina  11 , Fedele Dono  12 , Antonio Gambardella  1   3   13 , Carla Marini  14 , Alfonso Marrelli  15 , Sara Matricardi  14 , Alessandra Morano  8 , Francesco Paladin  16 , Rosaria Renna  17 , Pasquale Striano  18   19 , Angelo Pascarella  1 , Michele Ascoli  20 , Umberto Aguglia  1   2   3 ; PEROC Study Group
Collaborators, Affiliations

Effectiveness of perampanel as the only add-on: Retrospective, multicenter, observational real-life study on epilepsy patients

Sara Gasparini et al. Epilepsia Open. 2022 Dec.

Abstract

Objective: Perampanel (PER) is indicated as adjunctive antiseizure medication (ASM) in adolescents and adults with epilepsy. Data from clinical trials show good efficacy and tolerability, while limited information is available on the routine clinical use of PER, especially when used as only add-on treatment.

Methods: We performed an observational, retrospective, multicenter study on people with focal or generalized epilepsy aged >12 years, consecutively recruited from 52 Italian epilepsy centers. All patients received PER as the only add-on treatment to a background ASM according to standard clinical practice. Retention rate, seizure frequency, and adverse events were recorded at 3, 6, and 12 months after PER introduction. Subanalyses by early or late use of PER and by concomitant ASM were also conducted.

Results: Five hundred and three patients were included (age 36.5 ± 19.9 years). Eighty-one percent had focal epilepsy. Overall, the retention rate was very high in the whole group (89% at 12 months) according with efficacy measures. No major differences were observed in the subanalyses, although patients who used PER as early add-on, as compared with late add-on, more often reached early seizure freedom at 3-month follow-up (66% vs 53%, P = .05). Treatment-emergent adverse events occurred in 25%, far less commonly than in PER randomized trials.

Significance: This study confirms the good efficacy and safety of PER for focal or generalized epilepsy in real-life conditions. We provide robust data about its effectiveness as only add-on treatment even in patients with a long-standing history of epilepsy and previously treated with many ASMs.

Keywords: early add‐on; perampanel; real‐world; seizure freedom.

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Conflict of interest statement

Prof. Umberto Aguglia (speaker honoraria from Eisai); Dr Fedele Dono (travel support and speaker honoraria from EISAI); Dr. Alfredo D'Aniello (Research grant for UCB Pharma and Speaker/Honoraria for Eisai, UCB Pharma, Angelini Pharma and Lusofarmaco); Dr. Giancarlo Di Gennaro (speaker honoraria from EISAI, UCB‐Pharma, Livanova, Lusofarmaco, GW Pharmaceuticals. Served on advisory boards for Bial, Arielle therapeutics, Angelini Pharma); Prof. Edoardo Ferlazzo (speaker honoraria from UCB, Eisai, Angelini); Dr. Pasquale Striano (P.S. speaker honoraria and participated on advisory boards for Biomarin, Zogenyx, GW Pharmaceuticals, research funding by ENECTA BV, GW Pharmaceuticals, Kolfarma Srl). All other authors have no conflicts of interest to declare. We confirm that we have read the Journal's position on issues involved in ethical publication and affirm that this report is consistent with those guidelines.

Figures

FIGURE 1
FIGURE 1
Kaplan–Meier curve depicting cumulative survival of the whole sample
FIGURE 2
FIGURE 2
Kaplan–Meier curve depicting cumulative survival of the early add‐on group
See this image and copyright information in PMC

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