Effectiveness and safety of adjunctive cenobamate in people with focal‐onset epilepsy: Interim results after 24‐week observational period from the BLESS study
Year: 2025
Type: article
Study design: Observational Study
Abstract: OBJECTIVE: Cenobamate is an antiseizure medication (ASM) with a dual mechanism of action that was recently approved for the treatment of focal seizures in adults. This analysis aimed to describe the outcomes at 12 and 24 weeks after starting cenobamate therapy in a real-world setting. 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.
Source: Epilepsia
DOI: 10.1111/epi.18357
Authors: Simona Lattanzi, Fedele Dono, Giuseppe d'Orsi, Alfredo D'Aniello, Mariangela Panebianco, Paolo Bonanni, Carlo Di Bonaventura, Elisa Montalenti, Antonio Gambardella, Federica Ranzato, Giada Pauletto, Elena Tartara, Angela La Neve, Francesca Bisulli, Giampaolo Vatti, Patrizia Pulitano, Claudio Liguori, Giovanni Assenza, Alfonso Giordano, Pietro Pignatta, Vincenzo Belcastro, Michela Cecconi, Simone Beretta, Chiara Pizzanelli, Marianna Pezzella, Massimo Gangitano, Maurizio Elia, Rosaria Renna, Catello Vollono, Angelo Pascarella, Luciana Tramacere, Giovanni De Maria, Daniela Audenino, Maria Pia Pasolini, Loretta Giuliano, Rosita Galli, Gionata Strigaro, Monica Puligheddu, Angelo Labate, Pietro Penza, Stefano Quadri, David Stokelj, Giovanni Boero, Elisa Fallica, Monica Santo Sabato, Giovanni Falcicchio, Nicoletta Foschi, Michela Procaccini, Valentina Villano, Gabriele Camattari, Fabiano Mele, Barbara Roncari, Giancarlo Di Gennaro, BLESS Study Group
Institutions: Marche Polytechnic University, University of Chieti-Pescara, Casa Sollievo della Sofferenza, Istituto Neurologico Mediterraneo, Ospedale Garibaldi, IRCCS Eugenio Medea, Policlinico Umberto I, Azienda Ospedaliera Citta' della Salute e della Scienza di Torino, Azienda Ospedaliero-Universitaria "Renato Dulbecco", Ospedale San Bortolo, Azienda sanitaria universitaria Friuli Centrale, Azienda Universitaria Ospedaliera Consorziale - Policlinico Bari, Istituto delle Scienze Neurologiche di Bologna, University of Bologna, Azienda Ospedaliera Universitaria Senese, University of Rome Tor Vergata, Policlinico Tor Vergata, Campus Bio Medico University Hospital, Azienda Ospedaliera Universitaria Università degli Studi della Campania Luigi Vanvitelli, Ospedale Humanitas Gradenigo, Ospedale Maggiore di Lodi, Azienda Ospedaliera di Perugia, University of Milano-Bicocca, University of Pisa, Ospedale Antonio Cardarelli, Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone" di Palermo, Oasi Maria SS, I.R.C.C.S. Oasi Maria SS, Agostino Gemelli University Polyclinic, Istituti di Ricovero e Cura a Carattere Scientifico, Magna Graecia University, Nuovo Ospedale San Giovanni di Dio, Fondazione Poliambulanza Istituto Ospedaliero, Ente Ospedaliero Ospedali Galliera, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, Azienda Ospedaliero Universitaria Policlinico "G.Rodolico - San Marco", Ospedale San Donato, Azienda Ospedaliero Universitaria Maggiore della Carita, University of Cagliari, Azienda Ospedaliero-Universitaria Cagliari, University of Messina, AOU San Giovanni di Dio e Ruggi d'Aragona, Ospedale Papa Giovanni XXIII, Azienda sanitaria universitaria Giuliano Isontina, Ospedale SS. Annunziata, Arcispedale Sant'Anna, Ospedale Vito Fazzi, Azienda Ospedaliero-Universitaria delle Marche, Angelini Pharma (Italy)
Language: English
Subfield: Psychiatry and Mental health
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,360
Funder: Angelini Pharma
OpenAlex ID: W4408469590