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Open Access 12-03-2025 | Intellectual Disability | ORIGINAL RESEARCH

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

Authors: 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, on behalf of BRIVAracetam add‑on First Italian netwoRk Study (BRIVAFIRST) Group Membership

Published in: Neurology and Therapy

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.

Asadi-Pooya AA, Brigo F, Lattanzi S, Blumcke I. Adult epilepsy. Lancet. 2023;402:412–24.CrossRefPubMed

McGrother CW, Bhaumik S, Thorp CF, Hauck A, Branford D, Watson JM. Epilepsy in adults with intellectual disabilities: prevalence, associations and service implications. Seizure. 2006;15:376–86.CrossRefPubMed

Fiest KM, Sauro KM, Wiebe S, et al. Prevalence and incidence of epilepsy: a systematic review and meta-analysis of international studies. Neurolog. 2017;88:296–303.CrossRef

Robertson J, Hatton C, Emerson E, Baines S. Prevalence of epilepsy among people with intellectual disabilities: a systematic review. Seizure. 2015;29:46–62.CrossRefPubMed

Lattanzi S, Cagnetti C, Foschi N, Provinciali L, Silvestrini M. Brivaracetam add-on for refractory focal epilepsy: a systematic review and meta-analysis. Neurology. 2016;86:1344–52.CrossRefPubMed

US Food and Drug Administration. Brivaracetam. Highlights of prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205836s009,205837s007,205838s006lbl.pdf. Accessed Dec 2024.

European Medicines Agency. Brivaracetam. https://www.ema.europa.eu/en/documents/overview/briviact-epar-medicineoverview_en.pdf. Accessed Oct 2024.

Lattanzi S, Canafoglia L, Canevini MP, BRIVAFIRST Group Membership, et al. Adjunctive brivaracetam in focal epilepsy: real-world evidence from the BRIVAracetam add-on First Italian netwoRk STudy (BRIVAFIRST). CNS Drugs. 2021;35:1289–301.CrossRefPubMedPubMedCentral

Lattanzi S, Canafoglia L, Canevini MP, BRIVAFIRST Group Membership, et al. Correction to: Adjunctive brivaracetam in focal epilepsy: real-world evidence from the BRIVAracetam add-on First Italian netwoRk Study (BRIVAFIRST). CNS Drugs. 2021;35:1329–31.CrossRefPubMedPubMedCentral

10.

Fisher RS, Cross JH, French JA, Higurashi N, Hirsch E, Jansen FE, et al. Operational classification of seizure types by the International League Against Epilepsy: position paper of the ILAE Commission for Classification and Terminology. Epilepsia. 2017;58:522–30.CrossRefPubMed

11.

World Health Organization. The ICD-10 classification of mental and behavioural disorders: clinical descriptions and diagnostic guidelines. Geneva: World Health Organization. https://www.who.int/iris/handle/10665/37958. Accessed Oct 2024.

12.

Lattanzi S, Ascoli M, Canafoglia L, et al. Sustained seizure freedom with adjunctive brivaracetam in patients with focal onset seizures. Epilepsia. 2022;63:e42-50.CrossRefPubMedPubMedCentral

13.

Lattanzi S, De Maria G, Rosati E, Didato G, Chiesa V, Ranzato F, et al. Brivaracetam as add-on treatment in focal epilepsy: a real-world time-based analysis. Epilepsia. 2021;62:e1-6.CrossRefPubMed

14.

Lattanzi S, Cagnetti C, Foschi N, Provinciali L, Silvestrini M. Lacosamide monotherapy for partial onset seizures. Seizure. 2015;27:71–4.CrossRefPubMed

15.

von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP, STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Ann Intern Med. 2007;147:573–7.CrossRef

16.

Allard J, Henley W, Sellers A, et al. Efficacy and tolerability of Brivaracetam in people with intellectual disability compared to those without intellectual disability. Epilepsy Behav. 2024;158: 109906.CrossRefPubMed

17.

Gillis RME, Wammes-van der Heijden EA, Schelhaas HJ, et al. Efficacy and tolerability of brivaracetam in patients with intellectual disability and epilepsy. Acta Neurol Belg. 2021;121:677–84.CrossRefPubMed

18.

Andres E, Kerling F, Hamer H, Winterholler M. Behavioural changes in patients with intellectual disability treated with brivaracetam. Acta Neurol Scand. 2018;138:195–202.CrossRefPubMed

Title: Adjunctive Brivaracetam in People with Epilepsy and Intellectual Disability: Evidence from the BRIVAracetam Add-On First Italian netwoRk Study
Authors: 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
on behalf of BRIVAracetam add‑on First Italian netwoRk Study (BRIVAFIRST) Group Membership
Publication date: 12-03-2025
Publisher: Springer Healthcare
Keywords: Intellectual Disability
Brivaracetam
Epilepsy
Published in: Neurology and Therapy
Print ISSN: 2193-8253
Electronic ISSN: 2193-6536
DOI: https://doi.org/10.1007/s40120-025-00717-x

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