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Introduction <p>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.</p> Methods <p>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 (≥&#xa0;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.</p> Results <p>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.</p> Conclusion <p>Brivaracetam can be a suitable treatment option and offer opportunities for clinical improvement in subjects with intellectual disability and uncontrolled seizures.</p>

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

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  • 发表日期：

    2025年3月12日

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  • Simona Lattanzi,
  • Laura Canafoglia,
  • Maria Paola Canevini,
  • Sara Casciato,
  • Emanuele Cerulli Irelli,
  • Valentina Chiesa,
  • Filippo Dainese,
  • Giovanni De Maria,
  • Giuseppe Didato,
  • Giancarlo Di Gennaro,
  • Giovanni Falcicchio,
  • Martina Fanella,
  • Edoardo Ferlazzo,
  • Massimo Gangitano,
  • Angela La Neve,
  • Oriano Mecarelli,
  • Elisa Montalenti,
  • Alessandra Morano,
  • Federico Piazza,
  • Chiara Pizzanelli,
  • Patrizia Pulitano,
  • Federica Ranzato,
  • Eleonora Rosati,
  • Laura Tassi,
  • Carlo Di Bonaventura,
  • Angela Alicino,
  • Michele Ascoli,
  • Giovanni Assenza,
  • Federica Avorio,
  • Valeria Badioni,
  • Paola Banfi,
  • Emanuele Bartolini,
  • Luca Manfredi Basili,
  • Vincenzo Belcastro,
  • Simone Beretta,
  • Irene Berto,
  • Martina Biggi,
  • Giuseppe Billo,
  • Giovanni Boero,
  • Paolo Bonanni,
  • Jole Bongiorno,
  • Francesco Brigo,
  • Emanuele Caggia,
  • Claudia Cagnetti,
  • Carmen Calvello,
  • Edward Cesnik,
  • Gigliola Chianale,
  • Domenico Ciampanelli,
  • Roberta Ciuffini,
  • Dario Cocito,
  • Donato Colella,
  • Margherita Contento,
  • Cinzia Costa,
  • Eduardo Cumbo,
  • Alfredo D’Aniello,
  • Francesco Deleo,
  • Jacopo C DiFrancesco,
  • Roberta Di Giacomo,
  • Alessand ra Di Liberto,
  • Elisabetta Domina,
  • Fedele Dono,
  • Vania Durante,
  • Maurizio Elia,
  • Anna Estraneo,
  • Giacomo Evangelista,
  • Maria Teresa Faedda,
  • Ylenia Failli,
  • Elisa Fallica,
  • Jinane Fattouch,
  • Alessandra Ferrari,
  • Florinda Ferreri,
  • Giacomo Fisco,
  • Davide Fonti,
  • Francesco Fortunato,
  • Nicoletta Foschi,
  • Teresa Francavilla,
  • Rosita Galli,
  • Stefano Gazzina,
  • Anna Teresa Giallonardo,
  • Filippo Sean Giorgi,
  • Loretta Giuliano,
  • Francesco Habetswallner,
  • Francesca Izzi,
  • Benedetta Kassabian,
  • Angelo Labate,
  • Concetta Luisi,
  • Matteo Magliani,
  • Giulia Maira,
  • Luisa Mari,
  • Daniela Marino,
  • Addolorata Mascia,
  • Alessandra Mazzeo,
  • Stefano Meletti,
  • Chiara Milano,
  • Annacarmen Nilo,
  • Biagio Orlando,
  • Francesco Paladin,
  • Maria Grazia Pascarella,
  • Chiara Pastori,
  • Giada Pauletto,
  • Alessia Peretti,
  • Gabriella Perri,
  • Marianna Pezzella,
  • Marta Piccioli,
  • Pietro Pignatta,
  • Nicola Pilolli,
  • Francesco Pisani,
  • Laura Rosa Pisani,
  • Fabio Placidi,
  • Patrizia Pollicino,
  • Vittoria Porcella,
  • Silvia Pradella,
  • Monica Puligheddu,
  • Stefano Quadri,
  • Pier Paolo Quarato,
  • Rui Quintas,
  • Rosaria Renna,
  • Giada Ricciardo Rizzo,
  • Adriana Rum,
  • Enrico Michele Salamone,
  • Ersilia Savastano,
  • Maria Sessa,
  • David Stokelj,
  • Elena Tartara,
  • Mario Tombini,
  • Gemma Tumminelli,
  • Anna Elisabetta Vaudano,
  • Maria Ventura,
  • Ilaria Viganò,
  • Emanuela Viglietta,
  • Aglaia Vignoli,
  • Flavio Villani,
  • Elena Zambrelli,
  • Lelia Zumm

摘要

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.