Brivaracetam effectiveness and tolerability in older and younger adults with epilepsy: EXPERIENCE, a pooled analysis of international data from retrospective studies.

Fecha de publicación: 01/09/2024 Fecha Ahead of Print: 05/07/2024

Autores de IIS La Fe

Vicente Enrique Villanueva Haba

Autor

Participantes ajenos a IIS La Fe

Faught, Edward
Besson, Herve
D'Souza, Wendyl
Rosenow, Felix
Klein, Pavel
Reuber, Markus
Insuga, Victor Soto
Salas-Puig, Javier
Steinhoff, Bernhard J
Strzelczyk, Adam
Szaflarski, Jerzy P
Bourikas, Dimitrios
Daniels, Tony
Laloyaux, Cedric
Floricel, Florin
Friesen, David

Abstract

This analysis assessed the effectiveness and tolerability of brivaracetam (BRV) in older (=65 years of age) and younger (=16 to <65 years of age) adults with epilepsy. This was a subgroup analysis from EXPERIENCE/EPD332, a pooled analysis of individual patient records from multiple independent, non-interventional studies of patients with epilepsy starting BRV in Australia, Europe, and the United States. Included patients had =6 months of follow-up data. Outcomes included responders (=50 % reduction from baseline in seizure frequency), seizure freedom (no seizures within 3 months before the time point), and continuous seizure freedom (no seizures from baseline) at 12 months; BRV discontinuation during the whole study follow-up; and treatment-emergent adverse events (TEAEs) at 3, 6, and 12 months. Patients with missing data after BRV discontinuation were deemed non-responders/not seizure-free. Analysis populations included the Full Analysis Set (FAS; patients who received =1 BRV dose and had seizure type and age documented at baseline) and the modified FAS (FAS patients who had =1 seizure recorded during baseline). The FAS was used for all outcomes except seizure reduction. The FAS included 147 (8.9 %) patients aged =65 years and 1497 (91.1 %) aged =16 to <65 years. Compared with the younger subgroup, patients aged =65 years had a longer median epilepsy duration (33.0 years [n = 144] vs 17.0 years [n = 1460]) and lower median seizure frequency at index (2.0 seizures/28 days [n = 129] vs 4.0 seizures/28 days [n = 1256]), and less commonly had >1 prior antiseizure medication (106/141 [75.2 %] vs 1265/1479 [85.5 %]). At 12 months, a numerically higher percentage of patients aged =65 years versus the younger subgroup achieved =50 % seizure reduction (46.5 % [n = 71] vs 36.0 % [n = 751]), seizure freedom (26.0 % [n = 100] vs 13.9 % [n = 1011]), and continuous seizure freedom (22.0 % [n = 100] vs 10.7 % [n = 1011]). During the whole study follow-up, 43/147 (29.3 %) patients aged =65 years and 508/1492 (34.0 %) aged =16 to <65 years discontinued BRV. The incidence of TEAEs since the prior visit was similar in both subgroups at 3 months (=65 years vs =16 to <65 years: 38/138 [27.5 %] vs 356/1404 [25.4 %]), 6 months (19/119 [16.0 %] vs 176/1257 [14.0 %]), and 12 months (8/104 [7.7 %] vs 107/1128 [9.5 %]). This real-world analysis suggests BRV was effective in patients aged =65 years and =16 to <65 years, with numerically higher effectiveness in the older subgroup. BRV was well tolerated in both subgroups.