Effectiveness and safety of adjunctive cenobamate in people with focal-onset epilepsy: Interim results after 24-week observational period from the BLESS study.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Lattanzi Simona, Dono Fedele, d'Orsi Giuseppe, D'Aniello Alfredo, Panebianco Mariangela, Bonanni Paolo, Di Bonaventura Carlo, Montalenti Elisa, Gambardella Antonio, Ranzato Federica, Pauletto Giada, Tartara Elena, La Neve Angela, Bisulli Francesca, Vatti Giampaolo, Pulitano Patrizia, Liguori Claudio, Assenza Giovanni, Giordano Alfonso, Pignatta Pietro, Belcastro Vincenzo, Cecconi Michela, Beretta Simone, Pizzanelli Chiara, Pezzella Marianna, Gangitano Massimo, Elia Maurizio, Renna Rosaria, Vollono Catello, Pascarella Angelo, Tramacere Luciana, De Maria Giovanni, Audenino Daniela, Pasolini Maria Pia, Giuliano Loretta, Galli Rosita, Strigaro Gionata, Puligheddu Monica, Labate Angelo, Penza Pietro, Quadri Stefano, Stokelj David, Boero Giovanni, Fallica Elisa, Santo Sabato Monica, Falcicchio Giovanni, Foschi Nicoletta, Procaccini Michela, Villano Valentina, Camattari Gabriele, Mele Fabiano, Roncari Barbara, Di Gennaro Giancarlo, BLESS Study Group
Аннотация
METHODS: BLESS [NCT05859854] is an ongoing, observational, retrospective and prospective cohort study to evaluate the real-world effectiveness and safety of adjunctive cenobamate in adults with uncontrolled focal epilepsy. Subgroup analysis was performed in subjects with 2 to 3 previous ASMs (early users) and those with >3 previous ASMs (late users).
RESULTS: The second interim analysis of the BLESS study included 388 participants with a median (interquartile range) age of 43.0 (31.0-54.0) years. They had a median of 6.0 (4.0-9.0) prior ASMs and a median of 7.2 (3.0-20.6) monthly seizures at baseline. The median monthly seizure frequency was reduced by 59.9% (19.2%-87.3%) from baseline to 24 weeks; 229 (59.0%) subjects had a ≥50% seizure frequency reduction, and 44 (11.3%) showed sustained seizure freedom. The proportion of participants taking ≤2 concomitant ASMs increased from 217 (56.5%) at baseline to 239 (65.7%) at 24 weeks. Among the early users (n = 76, 19.6%), the median reduction in monthly seizure frequency at 24 weeks was 78.0% (50.0-97.1%), and 76.3% of subjects had a ≥50% response rate. The frequency of adverse drug reactions (ADRs) was 5.3% and 23.4% in early and late users. The most frequent ADRs were somnolence, dizziness, and balance disorder; after the occurrence of ADRs, 63.5% of participants maintained the prescribed dose, and 5.2% permanently discontinued treatment.
SIGNIFICANCE: Cenobamate was effective in reducing seizure frequency in a real-world setting and showed a manageable safety profile. The treatment with cenobamate also reduced the burden of concomitant ASMs in both early and late users.