The first combined russian experience of using perampanel in children and adolescents with epilepsy in everyday clinical practice

Background. Real world data help to provide more information on the effects and tolerability of therapy. However, data on the use of perampanel in Russian population of children remain limited. aim. To conduct a retrospective analysis of perampanel efficacy and tolerability in children and adolescents with epilepsy in real clinical practice. Materials and methods. A total of 106 children aged 4–18 years receiving perampanel as part of combination therapy for epilepsy were observed at 18 centers. Seizure frequency at 1–3, after 6 and 12 months of treatment, presence and type of adverse events (AEs) were analyzed. The main assessed efficacy parameters were seizure control, significant (≥50 %) decrease in seizure frequency. All other outcomes (<50 % decrease, no change or increased seizure frequency) were considered to be no effect. The assessed safety parameters were the percentage of patients with or without AEs and the percentage of perampanel withdrawals due to AEs. results. We defined 3 age groups for comparison: children 4–6, 7–11 and 12–17 years old. Perampanel efficacy was 69 % (seizure control – 23.6 %, ≥50 % decrease in seizure frequency – 45.3 %). The mean duration of the effect was 7.3 ± 4.1 months. No significant difference in efficacy between age groups was found. However, some greater efficacy of perampanel was noted in adolescents: absence of effect in the form of remission or significant decrease in seizures frequency was noted only in 25.5 %, with 40 % in children 4–11 years old. Among those with inefficacy, 3.8 % reported seizure aggravation. AEs occurred in only 23 % of patients, with the least frequent occurrence in adolescents (11.8 %) and the most frequent in children aged 7–11 years (40 %). The most frequent AEs was sluggishness and/or drowsiness. Discontinuation of perampanel due to AEs was required in 7.6 %. Conclusion. Perampanel has demonstrated high efficacy and good tolerability in real clinical practice among children from 4 years of age and adolescents with partial (focal) and secondary generalized seizures. The AEs that developed were not serious and very rarely led to withdrawal of the therapy. The results are comparable to those of phase III studies and previous real-world data. The usage of perampanel in children with primary generalized seizures should be further investigated. © 2022 ABV-Press Publishing House. All rights reserved.EisaiО.А. Рахманина / O.A. Rakhmanina: https://orcid.org/0000-0001-9218-2531 И.В. Волков / I.V. Volkov: https://orcid.org/0000-0002-7816-7535 О.К. Волкова / O.K. Volkova: https://orcid.org/0000-0003-3314-3895 Ю.А. Александров / Yu.A. Aleksandrov: https://orcid.org/0000-0003-3887-5219 М.В. Бархатов / M.V. Barkhatov: https://orcid.org/0000-0002-6372-4677 И.С. Бахтин / I.S. Bakhtin: https://orcid.org/0000-0003-3600-687X Г.М. Бережная / G.M. Berezhnaya: https://orcid.org/0000-0003-3917-422X А.Ю. Карась / A.Yu. Karas: https://orcid.org/0000-0001-9089-9627 Д.В. Морозов / D.V. Morozov: https://orcid.org/0000-0003-4389-9143 И.С. Бахтин / I.S. Bakhtin: https://orcid.org/0000-0003-3600-687X Т.Р. Томенко / T.R. Tomenko: https://orcid.org/0000-0002-0652-1996 Ж.М. Цоцонава / Zh.M. Tsotsonava: https://orcid.org/0000-0003-3275-5099 Конфликт интересов и финансирование. Публикация подготовлена при финансовой поддержке компании «Эйсай». Авторы несут полную ответственность за содержание статьи и редакционные решения. Conflict of interest and funding. This publication was funded by Eisai. The authors are fully responsible for the content of the article and editorial decisions