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. 2025 Jun;14(3):775-786.
doi: 10.1007/s40120-025-00717-x. Epub 2025 Mar 12.

Adjunctive Brivaracetam in People with Epilepsy and Intellectual Disability: Evidence from the BRIVAracetam Add-On First Italian netwoRk Study

Simona Lattanzi  1 , Laura Canafoglia  2 , Maria Paola Canevini  3   4 , Sara Casciato  5 , Emanuele Cerulli Irelli  6 , Valentina Chiesa  3 , Filippo Dainese  7 , Giovanni De Maria  8 , Giuseppe Didato  9 , Giancarlo Di Gennaro  5 , Giovanni Falcicchio  10 , Martina Fanella  6 , Edoardo Ferlazzo  11 , Massimo Gangitano  12 , Angela La Neve  10 , Oriano Mecarelli  6 , Elisa Montalenti  13 , Alessandra Morano  6 , Federico Piazza  14 , Chiara Pizzanelli  15   16 , Patrizia Pulitano  6 , Federica Ranzato  17 , Eleonora Rosati  18 , Laura Tassi  19 , Carlo Di Bonaventura  6 ; BRIVAracetam add‑on First Italian netwoRk Study (BRIVAFIRST) Group Membership
Collaborators, Affiliations

Adjunctive Brivaracetam in People with Epilepsy and Intellectual Disability: Evidence from the BRIVAracetam Add-On First Italian netwoRk Study

Simona Lattanzi et al. Neurol Ther. 2025 Jun.

Abstract

Introduction: Subjects with intellectual disability are usually excluded from clinical trials and there is limited evidence-based guidance for the choice of antiseizure medications in this vulnerable population. The study explored the effectiveness of brivaracetam (BRV) in people with epilepsy and intellectual disability.

Methods: BRIVAracetam add-on First Italian netwoRk Study (BRIVAFIRST) was a 12-month retrospective, multicenter study including adults prescribed adjunctive BRV. Main outcomes included the rates of seizure-freedom, seizure response (≥ 50% reduction in baseline seizure frequency), and treatment discontinuation. The occurrence of adverse events (AEs) was also considered. Analyses by the presence and severity of intellectual disability were performed.

Results: Subjects with intellectual disability were 253 (24.6%) out of 1029 participants. The 12-month rates of seizure freedom were 18.4% and 10.3% in participants without and with intellectual disability, respectively; the corresponding values for seizure response were 40.0% and 28.9%. Intellectual disability was not an independent predictor of seizure outcomes. The rates of treatment discontinuation were 25.8% and 26.4% in participants without and with intellectual disability. respectively. There were no statistically significant differences in the rates of any AEs, somnolence, nervousness/agitation, and aggressiveness by the presence and degree of intellectual disability.

Conclusion: Brivaracetam can be a suitable treatment option and offer opportunities for clinical improvement in subjects with intellectual disability and uncontrolled seizures.

Keywords: Antiseizure medication; Brivaracetam; Epilepsy; Focal seizures; Intellectual disability.

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Conflict of interest statement

Declarations. Conflict of Interest: Simona Lattanzi has received speaker’s or consultancy fees from Angelini, Eisai, GW Pharmaceuticals, NewBridge Pharmaceuticals, and UCB Pharma, and has served on advisory boards for Angelini, Arvelle Therapeutics, Bial, EISAI, GW Pharmaceuticals, Rapport Therapeutics, and UCB Pharma. Laura Canafoglia has received consultancy fee from Eisai. Maria Paola Canevini has received speaker’s or consultancy fees from Bial, Eisai, Italfarmaco, Sanofi, and UCB Pharma. Sara Casciato has participated in pharmaceutical industry-sponsored symposia for Eisai, UCB Pharma and Lusofarmaco. Valentina Chiesa has received speaker’s or consultancy fees from Eisai and UCB Pharma. Edoardo Ferlazzo has received speaker’s or consultancy fees from Angelini, Arvelle Therapeutics, Eisai, GW Pharmaceuticals, and UCB Pharma. Angela La Neve has received speaker’s or consultancy fees from Angelini, Arvelle Therapeutics, Bial, Eisai, GW Pharmaceuticals, Mylan, Sanofi, and UCB Pharma. Patrizia Pulitano has received consulting fees or speaker honoraria from UCB Pharma and Eisai. Federica Ranzato has received speaker’s fees from Eisai, UCB, and Livanova. Eleonora Rosati has received fees for participation in advisory board or scientific consultation from Eisai, GW Pharmaceuticals, Bial, and UCB Pharma. Laura Tassi has received speaker’s or consultancy fees from Arvelle Therapeutics, Eisai and UCB Pharma. Carlo Di Bonaventura has received consulting fees or speaker honoraria from UCB Pharma, Eisai, GW Pharmaceuticals, Bial, and Lusopharma. Emanuele Cerulli Irelli, Filippo Dainese, Giovanni De Maria, Giuseppe Didato, Giancarlo Di Gennaro, Giovanni Falcicchio, Martina Fanella, Massimo Gangitano, Oriano Mecarelli, Elisa Montalenti, Alessandra Morano, Federico Piazza and Chiara Pizzanelli have no conflicts of interest to declare. Simona Lattanzi is an Editorial Board member of Neurology and Therapy. Simona Lattanzi was not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. Ethical Approval: The BRIVAFIRST was approved by the ethical committee at any participating site and conducted in accordance with the Declaration of Helsinki. Prior to participation in the study, informed consent (e.g., explanation of the purposes of the research, information about handling of personal data and results of the research, description of the procedures adopted for ensuring data protection) was obtained from any patient or from one of the parents or from the legal representative.

Figures

Fig. 1
Fig. 1
Seizure outcomes according to the presence and degree of intellectual disability. Rates of seizure response, seizure freedom, and seizure worsening at 3, 6, and 12 months are reported. Seizure response was defined as a ≥ 50% reduction in seizure frequency in comparison to baseline seizure frequency. Seizure worsening was defined as an increase in seizure frequency of > 25% in comparison to baseline seizure frequency. ID intellectual disability
See this image and copyright information in PMC

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