Efficacy and safety of adjunctive perampanel in children with refractory epilepsy_Journal of Epilepsy

Authors：

CHU Sijia ,  TANG Jihong , LI Yan , ZHANG Bingbing , XIAO Xiao , WANG Manli

Department of Neurology, Children’s Hospital of Soochow University(Jiangsu Suzhou 215025, China;

Corresponding author：

TANG Jihong, Email: tjhzsh@126.com

Keywords：

Perampanel; Refractory epilepsy; Children; Effectiveness; Adverse reactions

DOI：

10.7507/2096-0247.20210062

Video：

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Objective In order to evaluate the efficacy, safety and tolerability of adjunctive perampanel in children with refractory epilepsy. Methods This study collected medical records of 34 children with refractory epilepsy, who were admitted to Children’s Hospital of Soochow University from January 2020 to January 2021. By comparing the baseline status with the status at 4, 8, 12, 24, 36, and 48 weeks of follow-up, the efficacy and adverse reactions of perampanel were evaluated. Results The mean age of the patients treated with perampanel was 8.1±4.1 years. The male-to-female ratio was 1: 1. After the addition of perampanel, the average responder rate at the 4th, 8th, 12th, 24th, 36th, 48th weeks were 37.5%, 46.7%, 50.0%, 47.4%, 53.8%, 42.9%. The adverse events were reported by 32.4%, and the retention rate was 88.2%. Conclusions Perampanel has good efficacy, safety and tolerability in the treatment of refractory epilepsy. Moreover, personalized treatment and better baseline seizure control may increase the effectiveness and retention rate of perampanel.

Citation： CHU Sijia, TANG Jihong, LI Yan, ZHANG Bingbing, XIAO Xiao, WANG Manli. Efficacy and safety of adjunctive perampanel in children with refractory epilepsy. Journal of Epilepsy, 2021, 7(5): 385-391. doi: 10.7507/2096-0247.20210062 Copy

1.	Leo A, Giovannini G, Russo E, et al. The role of ampa receptors and their antagonists in status epilepticus. Epilepsia, 2018, 59(6): 1098-1108.
2.	Nishida T, Lee SK, Inoue Y, et al. Adjunctive perampanel in partial-onset seizures: Asia-pacific, randomized phase iii study. Acta Neurol Scand, 2018, 137(4): 392-399.
3.	Kanemura H, Sano F, Aihara M. Usefulness of perampanel with concomitant levetiracetam for patients with drug-resistant epilepsy. Eur J Paediatr Neuro, 2019, 23(1): 197-203.
4.	Ishikawa N, Tateishi Y, Tani H, et al. Clinical profiles associated with serum perampanel concentrations in children with refractory epilepsy. Epilepsy Behav, 2019, 94: 82-86.
5.	Renfroe JB, Mintz M, Davis R, et al. Adjunctive perampanel oral suspension in pediatric patients from > = 2 to < 12 years of age with epilepsy: Pharmacokinetics, safety, tolerability, and efficacy. J Child Neurol, 2019, 34(5): 284-294.
6.	Yoshitomi S, Takahashi Y, Yamaguchi T, et al. Efficacy and tolerability of perampanel in pediatric patients with dravet syndrome. Epilepsy Res, 2019, 154: 34-38.
7.	Kwan P, Arzimanoglou A, Berg AT, et al. Definition of drug resistant epilepsy: Consensus proposal by the ad hoc task force of the ilae commission on therapeutic strategies. Epilepsia, 2010, 51(6): 1069-1077.
8.	Vaughn BV, Ali I. Sleep and epilepsy opportunities for diagnosis and treatment. Neurol Clin, 2012, 30(4): 1249-1274.
9.	Krauss GL, Perucca E, Kwan P, et al. Final safety, tolerability, and seizure outcomes in patients with focal epilepsy treated with adjunctive perampanel for up to 4 years in an open-label extension of phase iii randomized trials: Study 307. Epilepsia, 2018, 59(4): 866-876.
10.	褚思嘉, 汤继宏. 第三代新型抗癫痫药吡仑帕奈在癫痫治疗中的研究进展. 癫痫杂志, 2021, 7(1): 58-61.
11.	Pina-Garza JE, Rosenfeld W, Saeki K, et al. Efficacy and safety of adjunctive perampanel in adolescent patients with epilepsy: Post hoc analysis of six randomized studies. Epilepsy Behav, 2020: 104.
12.	Rektor I, Krauss GL, Inoue Y, et al. Assessment of the long-term efficacy and safety of adjunctive perampanel in tonic-clonic seizures: Analysis of four open-label extension studies. Epilepsia, 2020, 61(7): 1491-1502.
13.	Fogarasi A, Flamini R, Milh M, et al. Open-label study to investigate the safety and efficacy of adjunctive perampanel in pediatric patients (4 to < 12 years) with inadequately controlled focal seizures or generalized tonic-clonic seizures. Epilepsia, 2020, 61(1): 125-137.
14.	De Liso P, Vigevano F, Specchio N, et al. Effectiveness and tolerability of perampanel in children and adolescents with refractory epilepsies-an italian observational multicenter study. Epilepsy Res, 2016, 127: 93-100.
15.	Rosenfeld W, Conry J, Lagae L, et al. Efficacy and safety of perampanel in adolescent patients with drug-resistant partial seizures in three double-blind, placebo-controlled, phase iii randomized clinical studies and a combined extension study. Eur J Paediatr Neurol, 2015, 19(4): 435-445.
16.	Ikemoto S, Hamano S, Hirata Y, et al. Efficacy and serum concentrations of perampanel for treatment of drug-resistant epilepsy in children, adolescents, and young adults: Comparison of patients younger and older than 12 years. Seizure-Eur J Epilep, 2019, 73: 75-78.
17.	Hwang SK, Lee YJ, Nam SO, et al. Real-life effectiveness and tolerability of perampanel in pediatric patients aged 4 years or older with epilepsy: A korean national multicenter study. J Clin Neurol, 2020, 16(1): 53-59.
18.	Chang FM, Fan PC, Weng WC, et al. The efficacy of perampanel in young children with drug-resistant epilepsy. Seizure-Eur J Epilep, 2020, 75: 82-86.
19.	Yeon KS, Joong KW, Hyuna K, et al. Clinical experience with perampanel in intractable focal epilepsy over 12 months of follow-up. Journal of epilepsy research, 2018, 8(2): 61-65.
20.	De Liso P, Moavero R, Coppola G, et al. Current role of perampanel in pediatric epilepsy. Ital J Pediatr, 2017, 43(1): 51-56.
21.	Lagae L, Villanueva V, Meador KJ, et al. Adjunctive perampanel in adolescents with inadequately controlled partial-onset seizures: A randomized study evaluating behavior, efficacy, and safety. Epilepsia, 2016, 57(7): 1120-1129.
22.	Yun Y, Kim D, Lee YJ, et al. Efficacy and tolerability of adjunctive perampanel treatment in children under 12 years of age with refractory epilepsy. Korean J Pediatr, 2019, 62(7): 269-273.
23.	Trinka E, Steinhoff BJ, Nikanorova M, et al. Perampanel for focal epilepsy: Insights from early clinical experience. Acta Neurol Scand, 2016, 133(3): 160-172.
24.	Rohracher A, Kalss G, Leitinger M, et al. Two-year real-world experience with perampanel in patients with refractory focal epilepsy: Austrian data. Ther Adv Neurol Diso, 2016, 9(6): 445-453.
25.	Iwaki H, Jin K, Sugawara N, et al. Perampanel-induced weight gain depends on level of intellectual disability and its serum concentration. Epilepsy Res, 2019, 152: 1-6.
26.	Pina-Garza JE, Lagae L, Villanueva V, et al. Long-term effects of adjunctive perampanel on cognition in adolescents with partial seizures. Epilepsy Behav, 2018, 83: 50-58.

1. Leo A, Giovannini G, Russo E, et al. The role of ampa receptors and their antagonists in status epilepticus. Epilepsia, 2018, 59(6): 1098-1108.
2. Nishida T, Lee SK, Inoue Y, et al. Adjunctive perampanel in partial-onset seizures: Asia-pacific, randomized phase iii study. Acta Neurol Scand, 2018, 137(4): 392-399.
3. Kanemura H, Sano F, Aihara M. Usefulness of perampanel with concomitant levetiracetam for patients with drug-resistant epilepsy. Eur J Paediatr Neuro, 2019, 23(1): 197-203.
4. Ishikawa N, Tateishi Y, Tani H, et al. Clinical profiles associated with serum perampanel concentrations in children with refractory epilepsy. Epilepsy Behav, 2019, 94: 82-86.
5. Renfroe JB, Mintz M, Davis R, et al. Adjunctive perampanel oral suspension in pediatric patients from > = 2 to < 12 years of age with epilepsy: Pharmacokinetics, safety, tolerability, and efficacy. J Child Neurol, 2019, 34(5): 284-294.
6. Yoshitomi S, Takahashi Y, Yamaguchi T, et al. Efficacy and tolerability of perampanel in pediatric patients with dravet syndrome. Epilepsy Res, 2019, 154: 34-38.
7. Kwan P, Arzimanoglou A, Berg AT, et al. Definition of drug resistant epilepsy: Consensus proposal by the ad hoc task force of the ilae commission on therapeutic strategies. Epilepsia, 2010, 51(6): 1069-1077.
8. Vaughn BV, Ali I. Sleep and epilepsy opportunities for diagnosis and treatment. Neurol Clin, 2012, 30(4): 1249-1274.
9. Krauss GL, Perucca E, Kwan P, et al. Final safety, tolerability, and seizure outcomes in patients with focal epilepsy treated with adjunctive perampanel for up to 4 years in an open-label extension of phase iii randomized trials: Study 307. Epilepsia, 2018, 59(4): 866-876.
10. 褚思嘉, 汤继宏. 第三代新型抗癫痫药吡仑帕奈在癫痫治疗中的研究进展. 癫痫杂志, 2021, 7(1): 58-61.
11. Pina-Garza JE, Rosenfeld W, Saeki K, et al. Efficacy and safety of adjunctive perampanel in adolescent patients with epilepsy: Post hoc analysis of six randomized studies. Epilepsy Behav, 2020: 104.
12. Rektor I, Krauss GL, Inoue Y, et al. Assessment of the long-term efficacy and safety of adjunctive perampanel in tonic-clonic seizures: Analysis of four open-label extension studies. Epilepsia, 2020, 61(7): 1491-1502.
13. Fogarasi A, Flamini R, Milh M, et al. Open-label study to investigate the safety and efficacy of adjunctive perampanel in pediatric patients (4 to < 12 years) with inadequately controlled focal seizures or generalized tonic-clonic seizures. Epilepsia, 2020, 61(1): 125-137.
14. De Liso P, Vigevano F, Specchio N, et al. Effectiveness and tolerability of perampanel in children and adolescents with refractory epilepsies-an italian observational multicenter study. Epilepsy Res, 2016, 127: 93-100.
15. Rosenfeld W, Conry J, Lagae L, et al. Efficacy and safety of perampanel in adolescent patients with drug-resistant partial seizures in three double-blind, placebo-controlled, phase iii randomized clinical studies and a combined extension study. Eur J Paediatr Neurol, 2015, 19(4): 435-445.
16. Ikemoto S, Hamano S, Hirata Y, et al. Efficacy and serum concentrations of perampanel for treatment of drug-resistant epilepsy in children, adolescents, and young adults: Comparison of patients younger and older than 12 years. Seizure-Eur J Epilep, 2019, 73: 75-78.
17. Hwang SK, Lee YJ, Nam SO, et al. Real-life effectiveness and tolerability of perampanel in pediatric patients aged 4 years or older with epilepsy: A korean national multicenter study. J Clin Neurol, 2020, 16(1): 53-59.
18. Chang FM, Fan PC, Weng WC, et al. The efficacy of perampanel in young children with drug-resistant epilepsy. Seizure-Eur J Epilep, 2020, 75: 82-86.
19. Yeon KS, Joong KW, Hyuna K, et al. Clinical experience with perampanel in intractable focal epilepsy over 12 months of follow-up. Journal of epilepsy research, 2018, 8(2): 61-65.
20. De Liso P, Moavero R, Coppola G, et al. Current role of perampanel in pediatric epilepsy. Ital J Pediatr, 2017, 43(1): 51-56.
21. Lagae L, Villanueva V, Meador KJ, et al. Adjunctive perampanel in adolescents with inadequately controlled partial-onset seizures: A randomized study evaluating behavior, efficacy, and safety. Epilepsia, 2016, 57(7): 1120-1129.
22. Yun Y, Kim D, Lee YJ, et al. Efficacy and tolerability of adjunctive perampanel treatment in children under 12 years of age with refractory epilepsy. Korean J Pediatr, 2019, 62(7): 269-273.
23. Trinka E, Steinhoff BJ, Nikanorova M, et al. Perampanel for focal epilepsy: Insights from early clinical experience. Acta Neurol Scand, 2016, 133(3): 160-172.
24. Rohracher A, Kalss G, Leitinger M, et al. Two-year real-world experience with perampanel in patients with refractory focal epilepsy: Austrian data. Ther Adv Neurol Diso, 2016, 9(6): 445-453.
25. Iwaki H, Jin K, Sugawara N, et al. Perampanel-induced weight gain depends on level of intellectual disability and its serum concentration. Epilepsy Res, 2019, 152: 1-6.
26. Pina-Garza JE, Lagae L, Villanueva V, et al. Long-term effects of adjunctive perampanel on cognition in adolescents with partial seizures. Epilepsy Behav, 2018, 83: 50-58.

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