Journal Article

Adjunctive Brivaracetam in Focal Epilepsy: Real-World Evidence from the BRIVAracetam add-on First Italian netwoRk STudy (BRIVAFIRST)

Pulitano, Patrizia, Tassi, Laura, Mecarelli, Oriano, Giorgi, Filippo Sean, Canafoglia, Laura, De Maria, Giovanni, Dainese, Filippo, Falcicchio, Giovanni, La Neve, Angela, Chiesa, Valentina, Montalenti, Elisa, Di Bonaventura, Carlo, Canevini, Maria Paola, Quarato, Pier Paolo, Casciato, Sara, Piazza, Federico, Rosati, Eleonora, Fanella, Martina, Fisco, Giacomo, Didato, Giuseppe, Gangitano, Massimo, Giallonardo, Anna Teresa, Lattanzi, Simona, Ranzato, Federica, Ferlazzo, Edoardo

2021

Overview

Background In randomized controlled trials, add-on brivaracetam (BRV) reduced seizure frequency in patients with drug-resistant focal epilepsy. Studies performed in a naturalistic setting are a useful complement to characterize the drug profile. Objective This multicentre study assessed the effectiveness and tolerability of adjunctive BRV in a large population of patients with focal epilepsy in the context of real-world clinical practice. Methods The BRIVAFIRST (BRIVAracetam add-on First Italian netwoRk STudy) was a retrospective, multicentre study including adult patients prescribed adjunctive BRV. Patients with focal epilepsy and 12-month follow-up were considered. Main outcomes included the rates of seizure‐freedom, seizure response (≥ 50% reduction in baseline seizure frequency), and treatment discontinuation. The incidence of adverse events (AEs) was also considered. Analyses by levetiracetam (LEV) status and concomitant use of strong enzyme-inducing antiseizure medications (EiASMs) and sodium channel blockers (SCBs) were performed. Results A total of 1029 patients with a median age of 45 years (33–56) was included. At 12 months, 169 (16.4%) patients were seizure-free and 383 (37.2%) were seizure responders. The rate of seizure freedom was 22.3% in LEV-naive patients, 7.1% in patients with prior LEV use and discontinuation due to insufficient efficacy, and 31.2% in patients with prior LEV use and discontinuation due to AEs ( p  < 0.001); the corresponding values for ≥ 50% seizure frequency reduction were 47.9%, 29.7%, and 42.8% ( p  < 0.001). There were no statistically significant differences in seizure freedom and seizure response rates by use of strong EiASMs. The rates of seizure freedom (20.0% vs. 16.6%;   p  = 0.341) and seizure response (39.7% vs. 26.9%; p  = 0.006) were higher in patients receiving SCBs than those not receiving SCBs; 265 (25.8%) patients discontinued BRV. AEs were reported by 30.1% of patients, and were less common in patients treated with BRV and concomitant SCBs than those not treated with SCBs (28.9% vs. 39.8%; p  = 0.017). Conclusion The BRIVAFIRST provided real-world evidence on the effectiveness of BRV in patients with focal epilepsy irrespective of LEV history and concomitant ASMs, and suggested favourable therapeutic combinations.

• Publisher: Springer International Publishing,Springer Nature B.V
• Subject: Acids / Adult / Adverse events / Anticonvulsants - administration & dosage / Anticonvulsants - therapeutic use / Chemotherapy, Adjuvant / Clinical medicine / Clinical trials / Convulsions & seizures / Drug dosages / Drug Resistant Epilepsy - drug therapy / Enzymes / Epilepsies, Partial - drug therapy / Epilepsy / Etiracetam / Female / Humans / Italy / Levetiracetam - administration & dosage / Levetiracetam - therapeutic use / Male / Medicine / Medicine & Public Health / Metabolism / Metabolites / Middle Aged / Neurology / Neurosciences / Original / Original Research Article / Patients / Performance evaluation / Pharmacokinetics / Pharmacotherapy / Plasma / Psychiatry / Psychopharmacology / Pyrrolidinones - administration & dosage / Pyrrolidinones - therapeutic use / Retrospective Studies / Seizures / Statistical analysis / Substance abuse treatment / Treatment Outcome