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Randomized Controlled Trial
. 2021 Dec;35(12):1289-1301.
doi: 10.1007/s40263-021-00856-3. Epub 2021 Sep 2.

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

Simona Lattanzi  1 , Laura Canafoglia  2 , Maria Paola Canevini  3   4 , Sara Casciato  5 , Valentina Chiesa  3 , Filippo Dainese  6 , Giovanni De Maria  7 , Giuseppe Didato  8 , Giovanni Falcicchio  9 , Martina Fanella  10 , Edoardo Ferlazzo  11 , Giacomo Fisco  10 , Massimo Gangitano  12 , Anna Teresa Giallonardo  10 , Filippo Sean Giorgi  13   14 , Angela La Neve  9 , Oriano Mecarelli  10 , Elisa Montalenti  15 , Federico Piazza  16 , Patrizia Pulitano  10 , Pier Paolo Quarato  5 , Federica Ranzato  17 , Eleonora Rosati  18 , Laura Tassi  19 , Carlo Di Bonaventura  10 ; BRIVAFIRST Group Membership
Collaborators, Affiliations
Randomized Controlled Trial

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

Simona Lattanzi et al. CNS Drugs. 2021 Dec.

Erratum in

Abstract

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.

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Conflict of interest statement

Simona Lattanzi has received speaker’s or consultancy fees from Angelini, Eisai, GW Pharmaceuticals, and UCB Pharma, and has served on advisory boards for Angelini, Arvelle Therapeutics, Bial, and GW Pharmaceuticals. 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. Anna Teresa Giallonardo has received consulting fees or speaker honoraria from Eisai. Angela La Neve has received speaker’s or consultancy fees from Eisai, Mylan, Bial, Sanofi, and UCB Pharma. Patrizia Pulitano has received consulting fees or speaker honoraria from UCB Pharma and Eisai. Pier Paolo Quarato has participated in pharmaceutical industry-sponsored clinical trials and symposia for UCB Pharma. 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., Filippo Dainese, Giovanni De Maria, Giuseppe Didato, Giovanni Falcicchio, Martina Fanella, Edoardo Ferlazzo, Giacomo Fisco, Massimo Gangitano, Filippo Sean Giorgi, Oriano Mecarelli, Elisa Montalenti and Federico Piazza have no conflicts of interest to declare.

Figures

Fig. 1
Fig. 1
Clinical response to adjunctive brivaracetam. 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 with baseline seizure frequency, while seizure worsening was defined as an increase in seizure frequency of > 25% in comparison with baseline seizure frequency
Fig. 2
Fig. 2
Add-on brivaracetam efficacy according to concomitant use of sodium channel blockers. Rates of seizure response and seizure freedom at 12 months are reported according to concomitant use of sodium channel blockers (sodium channel blockers, n = 771; no sodium channel blockers, n = 130). Seizure response was defined as a ≥ 50% reduction in seizure frequency in comparison with baseline seizure frequency
Fig. 3
Fig. 3
Patient disposition according to brivaracetam discontinuation
See this image and copyright information in PMC

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